REVIEW ARTICLE
Sexual Function After Transvaginal Cholecystectomy: A Systematic Review Anders M. Donatsky, MD,* Lars N. Jørgensen, MD, DMSc,w Søren Meisner, MD,w Peter Vilmann, MD, DMSc,* and Jacob Rosenberg, MD, DMSc*
Introduction: Despite several benefits, patients are concerned that transvaginal cholecystectomy has a negative impact on sexual health. The objective of this systematic review was to assess the impact of transvaginal cholecystectomy on postoperative dyspareunia and sexual function. Method: A literature search was performed in the PubMed and EMBASE databases. Papers reporting on postoperative dyspareunia, vaginal pain or discomfort, and sexual function were included. Results: Seventeen papers reported on dyspareunia and vaginal pain or discomfort. Two papers reported a rate of de novo dyspareunia of 3.8% and 12.5%, respectively. One study reported a nonsignificant reduction in painful sexual intercourse and the remaining 14 reported no incidents of dyspareunia. Eight papers reported on sexual function. One paper using a nonvalidated questionnaire found impaired sexual function. The papers that used validated questionnaires found no impairment of sexual function. Conclusions: The risk of sexual dysfunction and dyspareunia after transvaginal cholecystectomy seems minimal. Well-designed studies using validated questionnaires are necessary to fully assess these types of complications. Key Words: transvaginal, cholecystectomy, NOTES, sexual function, dyspareunia
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everal barriers for the implementation of Natural Orifice Translumenal Endoscopic Surgery (NOTES) in clinical practice have been identified.1 Specifically, worries about safe access, reliable closure, and prevention of infectious complications have prolonged clinical implementation, with the exception of the transvaginal route. Transvaginal access to the abdomen has been used in gynecological surgery for years, thus making clinical implementation easier.2–6
Received for publication May 27, 2013; accepted June 8, 2013. From the *Department of Surgery, Herlev Hospital; and wDepartment of Surgery, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark. L.N.J. has received a travel grant from Olympus and lecture fees from Covidien. S.M. is a consultant with Boston Scientific, Olympus Europa, and Coloplast Denmark. P.V. has received consultantship honorarium from MediGlobe GmbH, Grassau, Germany and reimbursed travel from Olympus, Denmark. J.R. has received payment for expert testimony from Baxter Healthcare, research support from Covidien and Baxter Healthcare, and has had travel/ accommodation expenses for international meetings covered by Johnson & Johnson. A.M.D. declares no conflicts of interest. Reprints: Anders M. Donatsky, MD, Department of Surgery, Herlev Hospital, Herlev Ringvej 75, Herlev 2730, Denmark (e-mail: [email protected]). Copyright r 2014 by Lippincott Williams & Wilkins
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Complication rates for transvaginal cholecystectomy have been found comparable to traditional laparoscopy.7–9 Furthermore, transvaginal cholecystectomy seems preferable to laparoscopy with respect to reduced postoperative pain.10–13 However, patients may be skeptical of this new technique, primarily because of concerns of a potential negative impact on sexual function.14–16 The objective of this systematic review was to assess the reported risk of postoperative sexual dysfunction and dyspareunia after transvaginal cholecystectomy.
METHODS This systematic review was conducted in accordance with the PRISMA guidelines.17 The literature search was completed in February 2013. The PubMed and Excerpta Medica (EMBASE) databases were used for the search. The exact search terms used are shown in Figure 1. The terms were used as free text and MeSH terms in PubMed. In EMBASE, the search was restricted to publication type “Journal: Article” to exclude conference abstracts. There were no restrictions on the year of publication. Titles and abstracts were screened to identify potential relevant papers for inclusion. Final inclusion was decided based on full text review. The potentially relevant papers were screened for inclusion based on the following eligibility criteria: Study Design: All study designs were eligible except case reports based on a single patient. Surgical Procedure: Both pure and hybrid transvaginal cholecystectomy were eligible. Outcome: The papers had to specifically report results on sexual function, dyspareunia, vaginal pain, or discomfort in the result section or tables. Language restriction: only studies where full text was available in English were included.
Data Extraction Data extracted from the included papers were: year of publication, study design, total number of patients and respective allocation if relevant, means of measurement, postoperative follow-up/timing of measurements, and results on sexual function, dyspareunia, and vaginal pain or discomfort (Table 1). To identify and exclude possible publications based on the same surgical population, the following data were extracted: full author group, institution, country of origin, surgical period, and trial registration number. These parameters were only used in the exclusion process and are not presented in the results section or tables.
RESULTS After screening and removal of duplicates, a total of 71 potentially relevant papers were identified through PubMed
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Search terms. # 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22
Search terms NOTES NOTES surgery Hybrid NOTES Transvaginal NOTES NOTES transvaginal Pure NOTES Natural orifice Natural orifice translumenal Natural orifice translumenal endoscopic Natural orifice translumenal endoscopic surgery Natural orifice translumenal endoscopy Natural orifice translumenal endoscopy surgery Natural orifice surgery Natural orifice translumenal Natural orifice translumenal endoscopic Natural orifice translumenal endoscopic surgery Natural orifice translumenal surgery Transvaginal natural orifice Natural orifice endoscopic surgery 1 OR 2 OR 3 OR 4 OR 5 OR 6 OR 7 OR 8 OR 9 OR 10 OR 11 OR 12 OR 13 OR 14 OR 15 OR 16 OR 17 OR 18 OR 19 Transvaginal 20 AND 21 For EMBASE: 22 AND "Journal: Article" [Publication Type]
PubMed 32,446 5,929 204 247 247 174 1,483 670 667 1,265 1,268 1,268 1,408 333 330 329 332 261 515 33,066
EMBASE 34,402 33 129 115 72 87 1,916 1,474 1,454 1,445 8 4 187 490 473 467 14 48 24 34,961
8,897 288
16,922 526 275
FIGURE 1. Search terms used and number of hits in PubMed and EMBASE.
and EMBASE. Of these, 19 were included in the final review. Reasons for exclusion are presented in the flow diagram (Fig. 2). The included papers comprised 1 randomized clinical trial,18 3 prospective controlled studies,10,19,20 14 prospective or case series,21–34 and 1 postoperative survey.35
Dyspareunia and Vaginal Pain or Discomfort Seventeen papers reported on dyspareunia and vaginal pain or discomfort.18–34 One prospective series reported de novo vaginal pain in 3 patients (3/80, 3.8%).26 The same study reported altered intravaginal feeling during intercourse for 4% of patients. Of these, 3% reported worse and 1% reported better intravaginal feeling. A small case series reported a single case of dyspareunia (1/8, 12.5%).31 This resolved after antibiotic treatment, which was given because of vaginal inflammation. The last paper reporting a change in dyspareunia was a prospective series with 85 sexually active patients.27 This paper reported a nonsignificant reduction in the rate of painful sexual intercourse postoperatively measured on a Likert scale. The remaining 14 papers reported no incidents of dyspareunia and vaginal pain or discomfort.18–25,28–30,32–34
Sexual Function Eight papers reported on sexual function.10,20,21,25–28,35 Three papers used validated questionnaires.10,20,27 Two papers used the Gastrointestinal Quality Of Life Index (GIQLI).10,27 One was a prospective series that found a significant reduction in sexual life impairment postoperatively.27 This paper also used the Female Sexual Function Index (FSFI) and found the total score to be comparable to that of population-based studies. A prospective controlled study also found an improvement in sexual function on GIQLI without any differences between traditional laparoscopy and transvaginal cholecystectomy.10 A small prospective controlled study used the Sexual Function Questionnaire (SFQ).20 This study r
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found better scores after the procedure compared with before, although this change was not significant. Compared with traditional laparoscopy, the transvaginal group had worse sexual health in 2 of 7 domains (desire and orgasm) after the operation. Overall, there was an improvement in the transvaginal group as this group had significantly worse sexual health in 6 of 7 domains compared with the laparoscopic group before operation. A prospective series using a nonvalidated questionnaire found that 11% had altered libido and frequency of sexual intercourse.26 Of these, 1% had better and 10% had worse sexual function. The reasons for this alteration were not specified in the paper. The remaining papers also used nonvalidated questionnaires,21,25,28,35 and all reported no alteration in sexual function after transvaginal cholecystectomy. Three papers reported that they had contacted the patients who were not sexually active.22,27,28 None of the patients blamed the transvaginal procedure for their sexual abstinence.
DISCUSSION Overall, the reported rate of postoperative de novo dyspareunia and vaginal pain or discomfort was between 0% and 12.5%. Regarding sexual function, a significant reduction in sexual life impairment (item 26, GIQLI) was found. Using validated questionnaires, total FSFI score was found comparable to that of the general public, and the use of SFQ did not find impaired sexual function after transvaginal cholecystectomy. With nonvalidated questionnaires, one paper reported worse sexual behavior for 10% of the patients. Of the patients who were not sexually active, no one blamed transvaginal cholecystectomy as the reason for their sexual abstinence. Besides cholecystectomy, transvaginal NOTES has been shown to be feasible in human series for a wide variety of procedures.36–45 Despite complication rates comparable to that of laparoscopy, and with the benefit of reduced postoperative pain, patients, partners, and professionals www.surgical-laparoscopy.com |
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TABLE 1. Results on Dyspareunia, Vaginal Pain or Discomfort, and Sexual Function Extracted From Included Papers
References
Study Design
Mofid et al28
Prospective series
Linke et al27
Prospective series
Brescia et al21 Nijhawan et al29
Prospective series Prospective series
Borchert et al10
Prospective controlled study Randomized clinical trial
Noguera et al18
Total Number (N)
Timing and/or Follow-up
220
Questionnaire Median, 6 mo and (3-10 mo) interview 149 GIQLI, FSFI, GIQOL Likert preoperative and 1 y / FSFI 1 y 21 — POD 7, 30, and 1y 27 Interview Mean, 3.32 mo (0.0612.2 mo) TV 128/ GIQLI Preoperative LAP 147 and 4 wk TV 20/U — 20/LAP 20 TV 7/ SFQ LAP 7
Santos et al20
Prospective controlled study
Buess et al22 Hensel et al26
Case series
6
Prospective series
80
Hensel et al26
Prospective controlled study Case series
Noguera et al30 CuadradoGarcia et al23 Hackethall et al25 Tsin et al35 Pugliese et al.32 Decarli et al24 Palanivelu et al.31 Ramos et al.33 Zorron et al34
Measuring Method
—
3 and 6 mo
3 mo
Sexual Function
No dyspareunia
No sexual dysfunction
Painful sexual intercourse reduced
Sexual function improved; FSFI score comparable to population-based studies
No vaginal discomfort
No sexual dysfunction
No dyspareunia
—
—
Sexual function improved with no differences between groups
Preoperative, No dyspareunia POD 30 mo, 6 mo, and 1 y Preoperative No dyspareunia and 3 mo
Questionnaire 3 mo and interview
TV 30/ Interview LAP 30
Dyspareunia, Vaginal Pain or Discomfort
— Sexual function improved; worse sexual health in “desire” and “orgasm” compared with LAP —
No dyspareunia Vaginal pain 3/80; intravaginal feeling during intercourse: 3% worse, 1% better No dyspareunia
Altered libido and frequency of sexual intercourse: 10 % worse, 1% better —
6
—
Mean, 10.6 mo No dyspareunia
—
Prospective series
25
—
Mean, 180 d
—
Case series
10
Questionnaire Mean, 8.5 mo
Survey Retrospectively analyzed Prospective series Case series
44 18
Questionnaire — — No sexual dysfunction — Mean, 12 mo No vaginal discomfort — (1-22 mo) — POD 15, 30, No dyspareunia, vaginal pain — and 6 mo or discomfort — 1 wk, 1, 2, 3 mo dyspareunia 1/8 —
Prospective series Case series
32
12 8
Questionnaire 30 d
4
—
30 d
No dyspareunia No dyspareunia
No sexual dysfunction
No dyspareunia
—
No dyspareunia
—
Overview of included papers. FSFI indicates Female Sexual Function Index; GIQLI, Gastrointestinal Quality of Life Index; LAP, laparoscopic; POD, postoperative day; SFQ, Sexual Function Questionnaire; TV, Transvaginal; U, umbilical; (—), data not available.
express concerns on the risk of postoperative sexual dysfunction.14–16,46,47 Excluding the small series with a case of dyspareunia caused by vaginal inflammation, this review found a low incidence of de novo dyspareunia and vaginal pain or discomfort of between 0% and 3.8%, and some patients even reported better intravaginal feeling after the operation. The largest series included in this review comprised 161 sexually active participants without postoperative complaints of dyspareunia or sexual dysfunction.28 The same population
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has also been compared with a group subjected to conventional laparoscopy in a matched pair analysis. No difference in sexual activity or function was reported.48 Data from a prospectively collected database support a low incidence of dyspareunia with a single case in 240 (0.5%) transvaginal procedures.9 With respect to sexual function, 2 studies reported a significant improvement in sexual life on GIQLI.10,27 This improvement correlates well with the general improvement in quality of life including sexual life reported after r
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Screening Identification
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288 papers identified through PubMed
275 papers identified through EMBASE
65 relevant papers from title or abstract
64 relevant papers from title or abstract
Eligibility
71 relevant papers after duplicates have been removed
58 full text papers assessed for eligibility
13 papers excluded based on language other than English. Spanish (6) German (4) Czech (1) Dutch (2)
30 papers excluded Not reporting sexual function or dyspareunia (14) Case reports on 1 patient (12)
28 papers eligible for inclusion
Video abstract or short communication (4)
Included
9 papers excluded Reported on the same surgical population (9)
19 papers included in the review
FIGURE 2. Flowchart depicting the selection process of included papers.
laparoscopic cholecystectomy.49 One paper found that FSFI scores on the prevalence of sexual dysfunction measured 1 year after the procedure were comparable to the results in population-based studies.27 The FSFI has also been used in a prospective case-control study of transvaginal versus laparoscopic appendectomy.50 There were no differences between baseline scores and FSFI scores measured >60 days postoperatively. Moreover, there were no differences between the groups. Two papers reported impairment of sexual function with decreased desire/orgasm and libido/frequency.20,26 In the case of lower desire and orgasm, the 2 study groups were not comparable at baseline. The transvaginal group had significantly worse sexual health in 6/7 domains on a validated questionnaire.20 Selection bias could explain this difference. Larger sample size or stratified allocation with respect to preoperative scores could be used to ensure the 2 groups comparability at baseline. The other paper reported decreased libido and frequency for 10%.26 Deceased frequency could be caused by pain during intercourse; however, the incidence of pain was much lower in this study. With regard to decreased libido, it is difficult to assess how transvaginal access can influence this emotional aspect of sexual function without the use of comprehensive and validated instruments. The techniques used for access in the included studies are most often blunt trocar perforation under visual guidance or culdotomy with electrocautery and/or scissors. Access is acquired through the posterior vaginal fornix. Closure is achieved through transvaginal suturing with absorbable thread. These techniques have been used r
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for years in gynecological surgery with minimal risk of complications.51–53 Because of the differences in surgical trauma to the urogenital region, it is difficult to compare transvaginal cholecystectomy to gynecological procedures. The reported incidence of dyspareunia after radical hysterectomy is as high as 44%. This high incidence is thought to be multifactorial and caused by a drop in estrogen level, shortening and/or narrowing of the vagina because of resection of the vaginal cuff, and decreased vaginal lubrication.54 Transvaginal access itself does not increase the risk of postoperative sexual function as compared with laparoscopic hysterectomy.55 The incidence of de novo dyspareunia after transvaginal repair of a pelvic organ prolapse is much lower (4% to 8%).56,57 These procedures are performed through the anterior vaginal wall, thus making comparison with posterior access for transvaginal cholecystectomy difficult. The underlying disease itself could also account for sexual dysfunction. The most comparable data are from a study evaluating long-term complications after transvaginal ovarian cyst removal, where 5% of the women experienced temporary dyspareunia 1 month after surgery, whereas none developed permanent dyspareunia. The conclusion was that transvaginal access did not cause permanent dyspareunia.58 The primary limitation of the current review is the level of evidence on which this review is based. Because of the many small prospective series, there is a potential for selection bias as eligibility criteria were only mentioned in just over half of the included papers. Only 3 papers reported on whether or not the occurrence of postoperative www.surgical-laparoscopy.com |
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sexual abstinence was related to transvaginal surgical access. This aspect of postoperative follow-up is necessary to assess if sexual inactivity is because of procedure-related complications such as dyspareunia. Nonvalidated questionnaires/interviews without a clear definition of sexual dysfunction and dyspareunia were applied in many of the studies. Only one study reported on the prevalence of dyspareunia before operation (5/80, 6.3%).26 The prevalence of dyspareunia in the general public is between 7% and 60%, depending on definition and selection criteria of the study population.59 The use of nonvalidated questionnaires could account for the low postoperative incidence of de novo symptoms presented in this review. This emphasizes the need for validated questionnaires on sexual function in future studies to fully assess sexual dysfunction when the etiology may be both organic, emotional, and psychological.60 GIQLI can be used to evaluate the quality of life after surgery but the questionnaire has only 1 question regarding sexual function (item 26, sexual life impairment). To fully evaluate what effect transvaginal procedures have on all aspects of sexual function, comprehensive questionnaires have to be applied. The FSFI 19 items questionnaire is made up of 6 domains assessing desire, arousal, lubrication, orgasm, satisfaction, and pain.61 SFQ is a 34 item questionnaire made up of 7 domains assessing desire, enjoyment, orgasm, arousal sensation, arousal lubrication, pain, and partner.62 Future studies must report on prolonged follow-up on the patients who develop dyspareunia and sexual dysfunction to establish whether the complications have a treatable etiology or are permanent chronic conditions. In conclusion, the evidence presented here suggests a low rate of dyspareunia and sexual dysfunction after transvaginal cholecystectomy, thus supporting the use of the transvaginal route for cholecystectomy in clinical practice. To fully assess the safety profile of transvaginal cholecystectomy, well-designed randomized clinical trials are warranted to evaluate not only postoperative pain and reconvalescence but also sexual function using validated questionnaires, both preoperatively and postoperatively. REFERENCES 1. Rattner D, Kalloo A. ASGE/SAGES Working Group on Natural Orifice Translumenal Endoscopic Surgery. Surg Endosc. 2006;20:329–333. 2. Catenacci M, Goldberg JM. Transvaginal hydrolaparoscopy. Semin Reprod Med. 2011;29:95–100. 3. Christian J, Barrier BF, Schust D, et al. Culdoscopy: a foundation for natural orifice surgery—past, present, and future. J Am Coll Surg. 2008;207:417–422. 4. Gordts S, Campo R, Rombauts L, et al. Transvaginal salpingoscopy: an office procedure for infertility investigation. Fertil Steril. 1998;70:523–526. 5. Gordts S, Puttemans P, Brosens I, et al. Transvaginal laparoscopy. Best Pract Res Clin Obstet Gynaecol. 2005; 19:757–767. 6. Nieboer TE, Johnson N, Lethaby A, et al. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009;8:CD003677. 7. Lehmann KS, Ritz JP, Wibmer A, et al. The German registry for natural orifice translumenal endoscopic surgery: report of the first 551 patients. Ann Surg. 2010;252:263–270. 8. Pollard JS, Fung AK, Ahmed I. Are natural orifice transluminal endoscopic surgery and single-incision surgery viable techniques for cholecystectomy? J Laparoendosc Adv Surg Tech A. 2012;22:1–14.
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9. Zorron R, Palanivelu C, Galvao Neto MP, et al. International multicenter trial on clinical natural orifice surgery—NOTES IMTN study: preliminary results of 362 patients. Surg Innov. 2010;17:142–158. 10. Borchert D, Federlein M, Ruckbeil O, et al. Prospective evaluation of transvaginal assisted cholecystectomy. Surg Endosc. 2012;26:3597–3604. 11. Bulian DR, Trump L, Knuth J, et al. Less pain after transvaginal/transumbilical cholecystectomy than after the classical laparoscopic technique: short-term results of a matched-cohort study. Surg Endosc. 2013;27:580–586. 12. Kilian M, Raue W, Menenakos C, et al. Transvaginal-hybrid vs. single-port-access vs.‘conventional’ laparoscopic cholecystectomy: a prospective observational study. Langenbecks Arch Surg. 2011;396:709–715. 13. Solomon D, Shariff AH, Silasi DA, et al. Transvaginal cholecystectomy versus single-incision laparoscopic cholecystectomy versus four-port laparoscopic cholecystectomy: a prospective cohort study. Surg Endosc. 2012;26:2823–2827. 14. Bucher P, Ostermann S, Pugin F, et al. Female population perception of conventional laparoscopy, transumbilical LESS, and transvaginal NOTES for cholecystectomy. Surg Endosc. 2011;25:2308–2315. 15. Peterson CY, Ramamoorthy S, Andrews B, et al. Women’s positive perception of transvaginal NOTES surgery. Surg Endosc. 2009;23:1770–1774. 16. Strickland AD, Norwood MG, Behnia-Willison F, et al. Transvaginal natural orifice translumenal endoscopic surgery (NOTES): a survey of women’s views on a new technique. Surg Endosc. 2010;24:2424–2431. 17. Moher D, Liberati A, Tetzlaff J, et al. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Int J Surg. 2010;8:336–341. 18. Noguera JF, Cuadrado A, Dolz C, et al. Prospective randomized clinical trial comparing laparoscopic cholecystectomy and hybrid natural orifice transluminal endoscopic surgery (NOTES) (NCT00835250). Surg Endosc. 2012;26: 3435–3441. 19. Hensel M, Schernikau U, Schmidt A, et al. Transvaginal cholecystectomy is associated with reduced pain and decreased analgetic requirements compared to laparoscopic cholecystectomy. Eur Surg. 2011;43:135–139. 20. Santos BF, Teitelbaum EN, Arafat FO, et al. Comparison of short-term outcomes between transvaginal hybrid NOTES cholecystectomy and laparoscopic cholecystectomy. Surg Endosc. 2012;26:3058–3066. 21. Brescia A, Masoni L, Gasparrini M, et al. Laparoscopic assisted transvaginal cholecystectomy: single centre preliminary experience. Surgeon. 2013;11:S1–S5. 22. Buess GF, Misra MC, Bhattacharjee HK, et al. Single-port surgery and NOTES: from transanal endoscopic microsurgery and transvaginal laparoscopic cholecystectomy to transanal rectosigmoid resection. Surg Laparosc Endosc Percutan Tech. 2011;21:e110–e119. 23. Cuadrado-Garcia A, Noguera JF, Olea-Martinez JM, et al. Hybrid natural orifice transluminal endoscopic cholecystectomy: prospective human series. Surg Endosc. 2011;25:19–22. 24. Decarli LA, Zorron R, Branco A, et al. New hybrid approach for NOTES transvaginal cholecystectomy: preliminary clinical experience. Surg Innov. 2009;16:181–186. 25. Hackethal A, Sucke J, Oehmke F, et al. Establishing transvaginal NOTES for gynecological and surgical indications: benefits, limits, and patient experience. Endoscopy. 2010; 42:875–878. 26. Hensel M, Schernikau U, Schmidt A, et al. Surgical outcome and midterm follow-up after transvaginal NOTES hybrid cholecystectomy: analysis of a prospective clinical series. J Laparoendosc Adv Surg Tech A. 2011;21:101–106. 27. Linke GR, Luz S, Janczak J, et al. Evaluation of sexual function in sexually active women 1 year after transvaginal NOTES: a prospective cohort study of 106 patients. Langenbecks Arch Surg. 2013;398:139–145. r
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28. Mofid H, Emmermann A, Alm M, et al. Is the transvaginal route appropriate for intra-abdominal NOTES procedures? Experience and follow-up of 222 cases. Surg Endosc. 2013; 27:2807–2812. 29. Nijhawan S, Barajas-Gamboa JS, Majid S, et al. NOTES transvaginal hybrid cholecystectomy: the United States human experience. Surg Endosc. 2013;27:514–517. 30. Noguera JF, Cuadrado A, Sanchez-Margallo FM, et al. Emergency transvaginal hybrid natural orifice transluminal endoscopic surgery. Endoscopy. 2011;43:442–444. 31. Palanivelu C, Rajan PS, Rangarajan M, et al. NOTES: Transvaginal endoscopic cholecystectomy in humans-preliminary report of a case series. Am J Gastroenterol. 2009;104: 843–847. 32. Pugliese R, Forgione A, Sansonna F, et al. Hybrid NOTES transvaginal cholecystectomy: operative and long-term results after 18 cases. Langenbecks Arch Surg. 2010;395:241–245. 33. Ramos AC, Murakami A, Galvao Neto M, et al. NOTES transvaginal video-assisted cholecystectomy: first series. Endoscopy. 2008;40:572–575. 34. Zorron R, Maggioni LC, Pombo L, et al. NOTES transvaginal cholecystectomy: preliminary clinical application. Surg Endosc. 2008;22:542–547. 35. Tsin DA, Castro-Perez R, Davila MR, et al. Postoperative patient attitudes and perceptions of transvaginal cholecystectomy. J Laparoendosc Adv Surg Tech A. 2010;20:119–121. 36. Alba Mesa F, Amaya Cortijo A, Romero Fernandez JM, et al. Transvaginal sigmoid cancer resection: first case with 12 months of follow-up—technique description. J Laparoendosc Adv Surg Tech A. 2012;22:587–590. 37. Alcaraz A, Peri L, Molina A, et al. Feasibility of transvaginal NOTES-assisted laparoscopic nephrectomy. Eur Urol. 2010; 57:233–237. 38. Fischer LJ, Jacobsen G, Wong B, et al. NOTES laparoscopicassisted transvaginal sleeve gastrectomy in humans— description of preliminary experience in the United States. Surg Obes Relat Dis. 2009;5:633–636. 39. Michalik M, Orlowski M, Bobowicz M, et al. The first report on hybrid NOTES adjustable gastric banding in human. Obes Surg. 2011;21:524–527. 40. Panait L, Wood SG, Bell RL, et al. Transvaginal natural orifice transluminal endoscopic surgery in the morbidly obese. Surg Endosc. 2013;27:2625–2629. 41. Roberts KE, Solomon D, Mirensky T, et al. Pure transvaginal appendectomy versus traditional laparoscopic appendectomy for acute appendicitis: a prospective cohort study. Ann Surg. 2012;255:266–269. 42. Targarona EM, Gomez C, Rovira R, et al. NOTES-assisted transvaginal splenectomy: the next step in the minimally invasive approach to the spleen. Surg Innov. 2009;16:218–222. 43. Truong T, Arnaoutakis D, Awad ZT. Laparoscopic hybrid NOTES liver resection for metastatic colorectal cancer. Surg Laparosc Endosc Percutan Tech. 2012;22:e5–e7. 44. Yoshiki N, Okawa T, Kubota T. Hybrid transvaginal and transumbilical laparoendoscopic adnexal surgery. J Laparoendosc Adv Surg Tech A. 2012;22:992–995. 45. Zou X, Zhang G, Xiao R, et al. Transvaginal natural orifice transluminal endoscopic surgery (NOTES)-assisted laparo-
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58. 59. 60. 61. 62.
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scopic adrenalectomy: first clinical experience. Surg Endosc. 2011;25:3767–3772. Kobiela J, Stefaniak T, Dobrowolski S, et al. Transvaginal NOTES cholecystectomy in my partner? No way! Wideochir Inne Tech Malo Inwazyjne. 2011;6:236–241. Thele F, Zygmunt M, Glitsch A, et al. How do gynecologists feel about transvaginal NOTES surgery? Endoscopy. 2008;40: 576–580. Zornig C, Siemssen L, Emmermann A, et al. NOTES cholecystectomy: matched-pair analysis comparing the transvaginal hybrid and conventional laparoscopic techniques in a series of 216 patients. Surg Endosc. 2011;25:1822–1826. Mentes BB, Akin M, Irkorucu O, et al. Gastrointestinal quality of life in patients with symptomatic or asymptomatic cholelithiasis before and after laparoscopic cholecystectomy. Surg Endosc. 2001;15:1267–1272. Solomon D, Lentz R, Duffy AJ, et al. Female sexual function after pure transvaginal appendectomy: a cohort study. J Gastrointest Surg. 2012;16:183–186. Gordts S, Campo R, Puttemans P, et al. Transvaginal access: a safe technique for tubo-ovarian exploration in infertility? Review of the literature. Gynecol Surg. 2008;5:187–191. Tolcher MC, Kalogera E, Hopkins MR, et al. Safety of culdotomy as a surgical approach: implications for natural orifice transluminal endoscopic surgery. Jsls. 2012;16: 413–420. Uccella S, Ceccaroni M, Cromi A, et al. Vaginal cuff dehiscence in a series of 12,398 hysterectomies: effect of different types of colpotomy and vaginal closure. Obstet Gynecol. 2012;120:516–523. Vrzackova P, Weiss P, Cibula D. Sexual morbidity following radical hysterectomy for cervical cancer. Expert Rev Anticancer Ther. 2010;10:1037–1042. Long CY, Fang JH, Chen WC, et al. Comparison of total laparoscopic hysterectomy and laparoscopically assisted vaginal hysterectomy. Gynecol Obstet Invest. 2002;53:214–219. Cao Q, Chen YS, Ding JX, et al. Long-term treatment outcomes of transvaginal mesh surgery versus anteriorposterior colporrhaphy for pelvic organ prolapse. Aust N Z J Obstet Gynaecol. 2013;53:79–85. El Haddad R, Svabik K, Masata J, et al. Women’s quality of life and sexual function after transvaginal anterior repair with mesh insertion. Eur J Obstet Gynecol Reprod Biol. 2013;167:110–113. Tanaka M, Sagawa T, Yamazaki R, et al. Evaluation of transvaginal peritoneal surgery in young female patients. Surg Endosc. 2013;27:2619–2624. Heim LJ. Evaluation and differential diagnosis of dyspareunia. Am Fam Physician. 2001;63:1535–1544. Tunuguntla HS, Gousse AE. Female sexual dysfunction following vaginal surgery: myth or reality? Curr Urol Rep. 2004;5:403–411. Wiegel M, Meston C, Rosen R. The female sexual function index (FSFI): cross-validation and development of clinical cutoff scores. J Sex Marital Ther. 2005;31:1–20. Quirk FH, Heiman JR, Rosen RC, et al. Development of a sexual function questionnaire for clinical trials of female sexual dysfunction. J Womens Health Gend Based Med. 2002;11:277–289.
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Sexual Function After Transvaginal Cholecystectomy: A Systematic Review Anders M. Donatsky, MD,* Lars N. Jørgensen, MD, DMSc,w Søren Meisner, MD,w Peter Vilmann, MD, DMSc,* and Jacob Rosenberg, MD, DMSc*
Introduction: Despite several benefits, patients are concerned that transvaginal cholecystectomy has a negative impact on sexual health. The objective of this systematic review was to assess the impact of transvaginal cholecystectomy on postoperative dyspareunia and sexual function. Method: A literature search was performed in the PubMed and EMBASE databases. Papers reporting on postoperative dyspareunia, vaginal pain or discomfort, and sexual function were included. Results: Seventeen papers reported on dyspareunia and vaginal pain or discomfort. Two papers reported a rate of de novo dyspareunia of 3.8% and 12.5%, respectively. One study reported a nonsignificant reduction in painful sexual intercourse and the remaining 14 reported no incidents of dyspareunia. Eight papers reported on sexual function. One paper using a nonvalidated questionnaire found impaired sexual function. The papers that used validated questionnaires found no impairment of sexual function. Conclusions: The risk of sexual dysfunction and dyspareunia after transvaginal cholecystectomy seems minimal. Well-designed studies using validated questionnaires are necessary to fully assess these types of complications. Key Words: transvaginal, cholecystectomy, NOTES, sexual function, dyspareunia
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S
everal barriers for the implementation of Natural Orifice Translumenal Endoscopic Surgery (NOTES) in clinical practice have been identified.1 Specifically, worries about safe access, reliable closure, and prevention of infectious complications have prolonged clinical implementation, with the exception of the transvaginal route. Transvaginal access to the abdomen has been used in gynecological surgery for years, thus making clinical implementation easier.2–6
Received for publication May 27, 2013; accepted June 8, 2013. From the *Department of Surgery, Herlev Hospital; and wDepartment of Surgery, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark. L.N.J. has received a travel grant from Olympus and lecture fees from Covidien. S.M. is a consultant with Boston Scientific, Olympus Europa, and Coloplast Denmark. P.V. has received consultantship honorarium from MediGlobe GmbH, Grassau, Germany and reimbursed travel from Olympus, Denmark. J.R. has received payment for expert testimony from Baxter Healthcare, research support from Covidien and Baxter Healthcare, and has had travel/ accommodation expenses for international meetings covered by Johnson & Johnson. A.M.D. declares no conflicts of interest. Reprints: Anders M. Donatsky, MD, Department of Surgery, Herlev Hospital, Herlev Ringvej 75, Herlev 2730, Denmark (e-mail: [email protected]). Copyright r 2014 by Lippincott Williams & Wilkins
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Complication rates for transvaginal cholecystectomy have been found comparable to traditional laparoscopy.7–9 Furthermore, transvaginal cholecystectomy seems preferable to laparoscopy with respect to reduced postoperative pain.10–13 However, patients may be skeptical of this new technique, primarily because of concerns of a potential negative impact on sexual function.14–16 The objective of this systematic review was to assess the reported risk of postoperative sexual dysfunction and dyspareunia after transvaginal cholecystectomy.
METHODS This systematic review was conducted in accordance with the PRISMA guidelines.17 The literature search was completed in February 2013. The PubMed and Excerpta Medica (EMBASE) databases were used for the search. The exact search terms used are shown in Figure 1. The terms were used as free text and MeSH terms in PubMed. In EMBASE, the search was restricted to publication type “Journal: Article” to exclude conference abstracts. There were no restrictions on the year of publication. Titles and abstracts were screened to identify potential relevant papers for inclusion. Final inclusion was decided based on full text review. The potentially relevant papers were screened for inclusion based on the following eligibility criteria: Study Design: All study designs were eligible except case reports based on a single patient. Surgical Procedure: Both pure and hybrid transvaginal cholecystectomy were eligible. Outcome: The papers had to specifically report results on sexual function, dyspareunia, vaginal pain, or discomfort in the result section or tables. Language restriction: only studies where full text was available in English were included.
Data Extraction Data extracted from the included papers were: year of publication, study design, total number of patients and respective allocation if relevant, means of measurement, postoperative follow-up/timing of measurements, and results on sexual function, dyspareunia, and vaginal pain or discomfort (Table 1). To identify and exclude possible publications based on the same surgical population, the following data were extracted: full author group, institution, country of origin, surgical period, and trial registration number. These parameters were only used in the exclusion process and are not presented in the results section or tables.
RESULTS After screening and removal of duplicates, a total of 71 potentially relevant papers were identified through PubMed
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Search terms. # 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22
Search terms NOTES NOTES surgery Hybrid NOTES Transvaginal NOTES NOTES transvaginal Pure NOTES Natural orifice Natural orifice translumenal Natural orifice translumenal endoscopic Natural orifice translumenal endoscopic surgery Natural orifice translumenal endoscopy Natural orifice translumenal endoscopy surgery Natural orifice surgery Natural orifice translumenal Natural orifice translumenal endoscopic Natural orifice translumenal endoscopic surgery Natural orifice translumenal surgery Transvaginal natural orifice Natural orifice endoscopic surgery 1 OR 2 OR 3 OR 4 OR 5 OR 6 OR 7 OR 8 OR 9 OR 10 OR 11 OR 12 OR 13 OR 14 OR 15 OR 16 OR 17 OR 18 OR 19 Transvaginal 20 AND 21 For EMBASE: 22 AND "Journal: Article" [Publication Type]
PubMed 32,446 5,929 204 247 247 174 1,483 670 667 1,265 1,268 1,268 1,408 333 330 329 332 261 515 33,066
EMBASE 34,402 33 129 115 72 87 1,916 1,474 1,454 1,445 8 4 187 490 473 467 14 48 24 34,961
8,897 288
16,922 526 275
FIGURE 1. Search terms used and number of hits in PubMed and EMBASE.
and EMBASE. Of these, 19 were included in the final review. Reasons for exclusion are presented in the flow diagram (Fig. 2). The included papers comprised 1 randomized clinical trial,18 3 prospective controlled studies,10,19,20 14 prospective or case series,21–34 and 1 postoperative survey.35
Dyspareunia and Vaginal Pain or Discomfort Seventeen papers reported on dyspareunia and vaginal pain or discomfort.18–34 One prospective series reported de novo vaginal pain in 3 patients (3/80, 3.8%).26 The same study reported altered intravaginal feeling during intercourse for 4% of patients. Of these, 3% reported worse and 1% reported better intravaginal feeling. A small case series reported a single case of dyspareunia (1/8, 12.5%).31 This resolved after antibiotic treatment, which was given because of vaginal inflammation. The last paper reporting a change in dyspareunia was a prospective series with 85 sexually active patients.27 This paper reported a nonsignificant reduction in the rate of painful sexual intercourse postoperatively measured on a Likert scale. The remaining 14 papers reported no incidents of dyspareunia and vaginal pain or discomfort.18–25,28–30,32–34
Sexual Function Eight papers reported on sexual function.10,20,21,25–28,35 Three papers used validated questionnaires.10,20,27 Two papers used the Gastrointestinal Quality Of Life Index (GIQLI).10,27 One was a prospective series that found a significant reduction in sexual life impairment postoperatively.27 This paper also used the Female Sexual Function Index (FSFI) and found the total score to be comparable to that of population-based studies. A prospective controlled study also found an improvement in sexual function on GIQLI without any differences between traditional laparoscopy and transvaginal cholecystectomy.10 A small prospective controlled study used the Sexual Function Questionnaire (SFQ).20 This study r
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found better scores after the procedure compared with before, although this change was not significant. Compared with traditional laparoscopy, the transvaginal group had worse sexual health in 2 of 7 domains (desire and orgasm) after the operation. Overall, there was an improvement in the transvaginal group as this group had significantly worse sexual health in 6 of 7 domains compared with the laparoscopic group before operation. A prospective series using a nonvalidated questionnaire found that 11% had altered libido and frequency of sexual intercourse.26 Of these, 1% had better and 10% had worse sexual function. The reasons for this alteration were not specified in the paper. The remaining papers also used nonvalidated questionnaires,21,25,28,35 and all reported no alteration in sexual function after transvaginal cholecystectomy. Three papers reported that they had contacted the patients who were not sexually active.22,27,28 None of the patients blamed the transvaginal procedure for their sexual abstinence.
DISCUSSION Overall, the reported rate of postoperative de novo dyspareunia and vaginal pain or discomfort was between 0% and 12.5%. Regarding sexual function, a significant reduction in sexual life impairment (item 26, GIQLI) was found. Using validated questionnaires, total FSFI score was found comparable to that of the general public, and the use of SFQ did not find impaired sexual function after transvaginal cholecystectomy. With nonvalidated questionnaires, one paper reported worse sexual behavior for 10% of the patients. Of the patients who were not sexually active, no one blamed transvaginal cholecystectomy as the reason for their sexual abstinence. Besides cholecystectomy, transvaginal NOTES has been shown to be feasible in human series for a wide variety of procedures.36–45 Despite complication rates comparable to that of laparoscopy, and with the benefit of reduced postoperative pain, patients, partners, and professionals www.surgical-laparoscopy.com |
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TABLE 1. Results on Dyspareunia, Vaginal Pain or Discomfort, and Sexual Function Extracted From Included Papers
References
Study Design
Mofid et al28
Prospective series
Linke et al27
Prospective series
Brescia et al21 Nijhawan et al29
Prospective series Prospective series
Borchert et al10
Prospective controlled study Randomized clinical trial
Noguera et al18
Total Number (N)
Timing and/or Follow-up
220
Questionnaire Median, 6 mo and (3-10 mo) interview 149 GIQLI, FSFI, GIQOL Likert preoperative and 1 y / FSFI 1 y 21 — POD 7, 30, and 1y 27 Interview Mean, 3.32 mo (0.0612.2 mo) TV 128/ GIQLI Preoperative LAP 147 and 4 wk TV 20/U — 20/LAP 20 TV 7/ SFQ LAP 7
Santos et al20
Prospective controlled study
Buess et al22 Hensel et al26
Case series
6
Prospective series
80
Hensel et al26
Prospective controlled study Case series
Noguera et al30 CuadradoGarcia et al23 Hackethall et al25 Tsin et al35 Pugliese et al.32 Decarli et al24 Palanivelu et al.31 Ramos et al.33 Zorron et al34
Measuring Method
—
3 and 6 mo
3 mo
Sexual Function
No dyspareunia
No sexual dysfunction
Painful sexual intercourse reduced
Sexual function improved; FSFI score comparable to population-based studies
No vaginal discomfort
No sexual dysfunction
No dyspareunia
—
—
Sexual function improved with no differences between groups
Preoperative, No dyspareunia POD 30 mo, 6 mo, and 1 y Preoperative No dyspareunia and 3 mo
Questionnaire 3 mo and interview
TV 30/ Interview LAP 30
Dyspareunia, Vaginal Pain or Discomfort
— Sexual function improved; worse sexual health in “desire” and “orgasm” compared with LAP —
No dyspareunia Vaginal pain 3/80; intravaginal feeling during intercourse: 3% worse, 1% better No dyspareunia
Altered libido and frequency of sexual intercourse: 10 % worse, 1% better —
6
—
Mean, 10.6 mo No dyspareunia
—
Prospective series
25
—
Mean, 180 d
—
Case series
10
Questionnaire Mean, 8.5 mo
Survey Retrospectively analyzed Prospective series Case series
44 18
Questionnaire — — No sexual dysfunction — Mean, 12 mo No vaginal discomfort — (1-22 mo) — POD 15, 30, No dyspareunia, vaginal pain — and 6 mo or discomfort — 1 wk, 1, 2, 3 mo dyspareunia 1/8 —
Prospective series Case series
32
12 8
Questionnaire 30 d
4
—
30 d
No dyspareunia No dyspareunia
No sexual dysfunction
No dyspareunia
—
No dyspareunia
—
Overview of included papers. FSFI indicates Female Sexual Function Index; GIQLI, Gastrointestinal Quality of Life Index; LAP, laparoscopic; POD, postoperative day; SFQ, Sexual Function Questionnaire; TV, Transvaginal; U, umbilical; (—), data not available.
express concerns on the risk of postoperative sexual dysfunction.14–16,46,47 Excluding the small series with a case of dyspareunia caused by vaginal inflammation, this review found a low incidence of de novo dyspareunia and vaginal pain or discomfort of between 0% and 3.8%, and some patients even reported better intravaginal feeling after the operation. The largest series included in this review comprised 161 sexually active participants without postoperative complaints of dyspareunia or sexual dysfunction.28 The same population
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has also been compared with a group subjected to conventional laparoscopy in a matched pair analysis. No difference in sexual activity or function was reported.48 Data from a prospectively collected database support a low incidence of dyspareunia with a single case in 240 (0.5%) transvaginal procedures.9 With respect to sexual function, 2 studies reported a significant improvement in sexual life on GIQLI.10,27 This improvement correlates well with the general improvement in quality of life including sexual life reported after r
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Screening Identification
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288 papers identified through PubMed
275 papers identified through EMBASE
65 relevant papers from title or abstract
64 relevant papers from title or abstract
Eligibility
71 relevant papers after duplicates have been removed
58 full text papers assessed for eligibility
13 papers excluded based on language other than English. Spanish (6) German (4) Czech (1) Dutch (2)
30 papers excluded Not reporting sexual function or dyspareunia (14) Case reports on 1 patient (12)
28 papers eligible for inclusion
Video abstract or short communication (4)
Included
9 papers excluded Reported on the same surgical population (9)
19 papers included in the review
FIGURE 2. Flowchart depicting the selection process of included papers.
laparoscopic cholecystectomy.49 One paper found that FSFI scores on the prevalence of sexual dysfunction measured 1 year after the procedure were comparable to the results in population-based studies.27 The FSFI has also been used in a prospective case-control study of transvaginal versus laparoscopic appendectomy.50 There were no differences between baseline scores and FSFI scores measured >60 days postoperatively. Moreover, there were no differences between the groups. Two papers reported impairment of sexual function with decreased desire/orgasm and libido/frequency.20,26 In the case of lower desire and orgasm, the 2 study groups were not comparable at baseline. The transvaginal group had significantly worse sexual health in 6/7 domains on a validated questionnaire.20 Selection bias could explain this difference. Larger sample size or stratified allocation with respect to preoperative scores could be used to ensure the 2 groups comparability at baseline. The other paper reported decreased libido and frequency for 10%.26 Deceased frequency could be caused by pain during intercourse; however, the incidence of pain was much lower in this study. With regard to decreased libido, it is difficult to assess how transvaginal access can influence this emotional aspect of sexual function without the use of comprehensive and validated instruments. The techniques used for access in the included studies are most often blunt trocar perforation under visual guidance or culdotomy with electrocautery and/or scissors. Access is acquired through the posterior vaginal fornix. Closure is achieved through transvaginal suturing with absorbable thread. These techniques have been used r
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for years in gynecological surgery with minimal risk of complications.51–53 Because of the differences in surgical trauma to the urogenital region, it is difficult to compare transvaginal cholecystectomy to gynecological procedures. The reported incidence of dyspareunia after radical hysterectomy is as high as 44%. This high incidence is thought to be multifactorial and caused by a drop in estrogen level, shortening and/or narrowing of the vagina because of resection of the vaginal cuff, and decreased vaginal lubrication.54 Transvaginal access itself does not increase the risk of postoperative sexual function as compared with laparoscopic hysterectomy.55 The incidence of de novo dyspareunia after transvaginal repair of a pelvic organ prolapse is much lower (4% to 8%).56,57 These procedures are performed through the anterior vaginal wall, thus making comparison with posterior access for transvaginal cholecystectomy difficult. The underlying disease itself could also account for sexual dysfunction. The most comparable data are from a study evaluating long-term complications after transvaginal ovarian cyst removal, where 5% of the women experienced temporary dyspareunia 1 month after surgery, whereas none developed permanent dyspareunia. The conclusion was that transvaginal access did not cause permanent dyspareunia.58 The primary limitation of the current review is the level of evidence on which this review is based. Because of the many small prospective series, there is a potential for selection bias as eligibility criteria were only mentioned in just over half of the included papers. Only 3 papers reported on whether or not the occurrence of postoperative www.surgical-laparoscopy.com |
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sexual abstinence was related to transvaginal surgical access. This aspect of postoperative follow-up is necessary to assess if sexual inactivity is because of procedure-related complications such as dyspareunia. Nonvalidated questionnaires/interviews without a clear definition of sexual dysfunction and dyspareunia were applied in many of the studies. Only one study reported on the prevalence of dyspareunia before operation (5/80, 6.3%).26 The prevalence of dyspareunia in the general public is between 7% and 60%, depending on definition and selection criteria of the study population.59 The use of nonvalidated questionnaires could account for the low postoperative incidence of de novo symptoms presented in this review. This emphasizes the need for validated questionnaires on sexual function in future studies to fully assess sexual dysfunction when the etiology may be both organic, emotional, and psychological.60 GIQLI can be used to evaluate the quality of life after surgery but the questionnaire has only 1 question regarding sexual function (item 26, sexual life impairment). To fully evaluate what effect transvaginal procedures have on all aspects of sexual function, comprehensive questionnaires have to be applied. The FSFI 19 items questionnaire is made up of 6 domains assessing desire, arousal, lubrication, orgasm, satisfaction, and pain.61 SFQ is a 34 item questionnaire made up of 7 domains assessing desire, enjoyment, orgasm, arousal sensation, arousal lubrication, pain, and partner.62 Future studies must report on prolonged follow-up on the patients who develop dyspareunia and sexual dysfunction to establish whether the complications have a treatable etiology or are permanent chronic conditions. In conclusion, the evidence presented here suggests a low rate of dyspareunia and sexual dysfunction after transvaginal cholecystectomy, thus supporting the use of the transvaginal route for cholecystectomy in clinical practice. To fully assess the safety profile of transvaginal cholecystectomy, well-designed randomized clinical trials are warranted to evaluate not only postoperative pain and reconvalescence but also sexual function using validated questionnaires, both preoperatively and postoperatively. REFERENCES 1. Rattner D, Kalloo A. ASGE/SAGES Working Group on Natural Orifice Translumenal Endoscopic Surgery. Surg Endosc. 2006;20:329–333. 2. Catenacci M, Goldberg JM. Transvaginal hydrolaparoscopy. Semin Reprod Med. 2011;29:95–100. 3. Christian J, Barrier BF, Schust D, et al. Culdoscopy: a foundation for natural orifice surgery—past, present, and future. J Am Coll Surg. 2008;207:417–422. 4. Gordts S, Campo R, Rombauts L, et al. Transvaginal salpingoscopy: an office procedure for infertility investigation. Fertil Steril. 1998;70:523–526. 5. Gordts S, Puttemans P, Brosens I, et al. Transvaginal laparoscopy. Best Pract Res Clin Obstet Gynaecol. 2005; 19:757–767. 6. Nieboer TE, Johnson N, Lethaby A, et al. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009;8:CD003677. 7. Lehmann KS, Ritz JP, Wibmer A, et al. The German registry for natural orifice translumenal endoscopic surgery: report of the first 551 patients. Ann Surg. 2010;252:263–270. 8. Pollard JS, Fung AK, Ahmed I. Are natural orifice transluminal endoscopic surgery and single-incision surgery viable techniques for cholecystectomy? J Laparoendosc Adv Surg Tech A. 2012;22:1–14.
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9. Zorron R, Palanivelu C, Galvao Neto MP, et al. International multicenter trial on clinical natural orifice surgery—NOTES IMTN study: preliminary results of 362 patients. Surg Innov. 2010;17:142–158. 10. Borchert D, Federlein M, Ruckbeil O, et al. Prospective evaluation of transvaginal assisted cholecystectomy. Surg Endosc. 2012;26:3597–3604. 11. Bulian DR, Trump L, Knuth J, et al. Less pain after transvaginal/transumbilical cholecystectomy than after the classical laparoscopic technique: short-term results of a matched-cohort study. Surg Endosc. 2013;27:580–586. 12. Kilian M, Raue W, Menenakos C, et al. Transvaginal-hybrid vs. single-port-access vs.‘conventional’ laparoscopic cholecystectomy: a prospective observational study. Langenbecks Arch Surg. 2011;396:709–715. 13. Solomon D, Shariff AH, Silasi DA, et al. Transvaginal cholecystectomy versus single-incision laparoscopic cholecystectomy versus four-port laparoscopic cholecystectomy: a prospective cohort study. Surg Endosc. 2012;26:2823–2827. 14. Bucher P, Ostermann S, Pugin F, et al. Female population perception of conventional laparoscopy, transumbilical LESS, and transvaginal NOTES for cholecystectomy. Surg Endosc. 2011;25:2308–2315. 15. Peterson CY, Ramamoorthy S, Andrews B, et al. Women’s positive perception of transvaginal NOTES surgery. Surg Endosc. 2009;23:1770–1774. 16. Strickland AD, Norwood MG, Behnia-Willison F, et al. Transvaginal natural orifice translumenal endoscopic surgery (NOTES): a survey of women’s views on a new technique. Surg Endosc. 2010;24:2424–2431. 17. Moher D, Liberati A, Tetzlaff J, et al. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Int J Surg. 2010;8:336–341. 18. Noguera JF, Cuadrado A, Dolz C, et al. Prospective randomized clinical trial comparing laparoscopic cholecystectomy and hybrid natural orifice transluminal endoscopic surgery (NOTES) (NCT00835250). Surg Endosc. 2012;26: 3435–3441. 19. Hensel M, Schernikau U, Schmidt A, et al. Transvaginal cholecystectomy is associated with reduced pain and decreased analgetic requirements compared to laparoscopic cholecystectomy. Eur Surg. 2011;43:135–139. 20. Santos BF, Teitelbaum EN, Arafat FO, et al. Comparison of short-term outcomes between transvaginal hybrid NOTES cholecystectomy and laparoscopic cholecystectomy. Surg Endosc. 2012;26:3058–3066. 21. Brescia A, Masoni L, Gasparrini M, et al. Laparoscopic assisted transvaginal cholecystectomy: single centre preliminary experience. Surgeon. 2013;11:S1–S5. 22. Buess GF, Misra MC, Bhattacharjee HK, et al. Single-port surgery and NOTES: from transanal endoscopic microsurgery and transvaginal laparoscopic cholecystectomy to transanal rectosigmoid resection. Surg Laparosc Endosc Percutan Tech. 2011;21:e110–e119. 23. Cuadrado-Garcia A, Noguera JF, Olea-Martinez JM, et al. Hybrid natural orifice transluminal endoscopic cholecystectomy: prospective human series. Surg Endosc. 2011;25:19–22. 24. Decarli LA, Zorron R, Branco A, et al. New hybrid approach for NOTES transvaginal cholecystectomy: preliminary clinical experience. Surg Innov. 2009;16:181–186. 25. Hackethal A, Sucke J, Oehmke F, et al. Establishing transvaginal NOTES for gynecological and surgical indications: benefits, limits, and patient experience. Endoscopy. 2010; 42:875–878. 26. Hensel M, Schernikau U, Schmidt A, et al. Surgical outcome and midterm follow-up after transvaginal NOTES hybrid cholecystectomy: analysis of a prospective clinical series. J Laparoendosc Adv Surg Tech A. 2011;21:101–106. 27. Linke GR, Luz S, Janczak J, et al. Evaluation of sexual function in sexually active women 1 year after transvaginal NOTES: a prospective cohort study of 106 patients. Langenbecks Arch Surg. 2013;398:139–145. r
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Transvaginal Surgery and Sexual Function
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