International Journal of Gynecology and Obstetrics 125 (2014) 86–88

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SURGERY AND TECHNOLOGY

Pure natural orifice transluminal endoscopic surgery (NOTES) involving peroral endoscopic salpingo-oophorectomy (POESY) Amadeus Hornemann a,⁎, Marc Suetterlin a, Marcus J. Trunk b, Axel Gerhardt a, Georg Kaehler c a b c

Department of Obstetrics and Gynecology, University Medical Centre Mannheim, University of Heidelberg, Mannheim, Germany Institute for Pathology, University Medical Centre Mannheim, University of Heidelberg, Mannheim, Germany Central Interdisciplinary Endoscopy, University Medical Centre Mannheim, University of Heidelberg, Mannheim, Germany

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Article history: Received 23 May 2013 Received in revised form 14 September 2013 Accepted 22 December 2013 Keywords: Bilateral salpingo-oophorectomy BRCA mutation Natural orifice transluminal endoscopic surgery Peroral endoscopic salpingo-oophorectomy Transgastric

a b s t r a c t Objective: Natural orifice transluminal endoscopic surgery (NOTES) is a surgical approach that uses natural orifices to gain access to areas of the body. In the present article, we describe the first transgastric pure NOTES salpingo-oophorectomy, which we call peroral endoscopic salpingo-oophorectomy (POESY). Methods: A woman with BRCA1 mutation presented for prophylactic bilateral salpingo-oophorectomy. We offered her the transgastric approach, having performed more than 25 transgastric appendectomies. After gastroscopic incision in the corpus wall, we advanced the gastroscope into the abdominal cavity. Salpingo-oophorectomy was performed with the help of an intrauterine manipulator and a transvaginally introduced 5-mm trocar. The posterior colpotomy was dilated and the specimens were extracted. The gastrotomy was closed with an over-the-scope clip, and the colpotomy with a running suture. Results: The gastroscope provided excellent optical control and good tissue preparation. Prophylactic bilateral salpingo-oophorectomy was performed successfully via POESY. The patient recovered quickly and was discharged on the third day, with an uneventful follow-up. Conclusion: The present case demonstrates the feasibility of transgastric access. The gastroscope provided excellent optical control and good tissue preparation. Therefore, we expect an increasing role of transgastric procedures for diseases in the pelvic region, particularly if new endoscopic platforms with better means of instrumentation and tissue management become available. © 2013 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

1. Introduction Women with BRCA1 or BRCA2 mutations are at risk of developing breast and/or ovarian cancer. After extensive counseling and identification of the genetic alteration, these patients are advised to undergo prophylactic bilateral salpingo-oophorectomy (PBSO) after the age of 40 [1,2]. Just a few decades ago, abdominal laparotomy had to be performed for this operation, whereas laparoscopy is the standard procedure today. Recently, physicians have been trying to further reduce the abdominal access trauma by using a single umbilical port for salpingo-oophorectomy [3]. For removing the adnexa, a pure transvaginal approach can be used if additional hysterectomy is performed. In young patients with BRCA1 or BRCA2 mutations, however, hysterectomy is normally not indicated. Postulating that the transgastric approach does not produce more surgical risks than the transabdominal route, our goal was to demonstrate the feasibility, safety, and patient acceptance of transgastric bilateral salpingo-oophorectomy. ⁎ Corresponding author at: Department of Obstetrics and Gynecology, University Medical Centre Mannheim, University of Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany. Tel.: +49 621 383 5188; fax: +49 621 383 3814. E-mail address: [email protected] (A. Hornemann).

Since 2010, 35 transgastric procedures in pigs and more than 25 transgastric appendectomies in patients with acute appendicitis have been performed at the University Medical Centre Mannheim, Mannheim, Germany [4,5]. Based on this success, we planned a feasibility study for peroral endoscopic salpingo-oophorectomy (POESY). In the present paper, we describe the technique and report the first results. 2. Methods In May 2013, an online literature review was carried out using PubMed and the keywords “transgastric,” “NOTES,” and “bilateral salpingo-oophorectomy.” The search did not reveal any published investigations on the subject. A 42-year-old woman with verified BRCA1 mutation presented for PBSO. Her past medical history revealed left-sided breast cancer at 27 years of age (treated with breast-conserving surgery) followed by a second, right-sided breast cancer at 35 years (treated with mastectomy and reconstruction). In both cases, adjuvant chemotherapy was given. At the time of adnexal surgery, there were no signs of breast tumor recurrence. The ovaries had bilateral cysts with no indication of malignancy and there was little fluid in the pouch of Douglas. The patient’s height was 170 cm and her weight was 80 kg; her body mass index (calculated as weight in kilograms divided by the square of height in meters) was 27.7.

0020-7292/$ – see front matter © 2013 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijgo.2013.08.024

A. Hornemann et al. / International Journal of Gynecology and Obstetrics 125 (2014) 86–88

Screening for contraindications to POESY was unsuspicious (no peptic ulcer, no suspected obstruction in the upper gastrointestinal tract, no current proton pump inhibitor treatment). The patient experienced severe psoriasis. The transgastric approach was offered within the trial as a new minimally invasive operation without a transcutaneous incision but with the risk of gastric and vaginal wound-healing problems. The study protocol was approved by the Heidelberg University Human Investigations Committee II (ClinicalTrials.gov identifier: NCT01566955). Informed consent was obtained from the patient. Before transfer to the operating theater, the patient received oral lavage with the antiseptic agent octenidine HCL. After anesthesia was established with endotracheal intubation, the patient was placed in a low lithotomy position on a vacuum mattress in order to facilitate extreme head-down positioning during the procedure. Single-shot antibiotic prophylaxis (2.0 g of cefazolin and 500 mg of metronidazole) was administered immediately before the operation. The endoscopic surgeon was located behind the patient’s head; the gynecologist was situated between the patient’s legs. There were 2 endoscopic screens on each side of the patient. The abdomen, pelvis, and vagina were disinfected with povidoneiodine scrub solution, and the patient was covered with sterile draping. A speculum was introduced into the vagina for visualization of the cervix, and an intrauterine manipulator (Quinones-Neubüser, Karl Storz, Tuttlingen, Germany) was inserted. 3. Results The procedure began with routine gastroscopy to exclude abnormalities in the esophagus and stomach. After identification of the middle third of the anterior wall of the corpus by “fingertip trial” from the left epigastrium (similar to endoscopic percutanous gastrotomy application), the puncture region was marked with 5 coagulation marks. This was done to locate the insertion, in case the endoscope had to be removed during the operation. Via gastroscope, the gastric wall was then punctured with a high-frequency electrosurgical needle knife (Needle Papillotome; MTW Endoskopie, Wesel, Germany/ICC 200 high-frequency generator; Erbe Elektromedizin, Tübingen, Germany), and a 450-cm guide wire (Jagwire; Boston Scientific, Ratingen, Germany) was inserted. After removal of the needle knife, a dilation balloon (Rigiflex 18-1920 mm; Boston Scientific) was introduced and the hole in the gastric wall was dilated. As the balloon was deflating, the gastroscope was advanced into the peritoneum, and a capnoperitoneum with standard laparoscopy pressure of 12 mm Hg was established and maintained with an automatic insufflator (Laparoflator, Karl Storz), followed by endoscopic orientation of the abdomen. The patient was then moved into a steep Trendelenburg position. The pouch of Douglas was inspected, and the fluid aspirated and preserved for cytologic examination. The uterus was moved to the left using the manipulator in order to gain traction of the tissue of the right adnexa. The right fallopian tube was grasped close to the uterus with hemostatic forceps (Coagrasper FD-410LR; Olympus, Tokyo, Japan) and coagulated. Dissection of the fallopian tube was performed with an endoscopic electrosurgical knife (Hook Knife KD-620LR; Olympus, Hamburg, Germany). The ovarian ligament was then coagulated and cut in the same manner, followed by coagulation and dissection of the infundibulopelvic ligament. There was almost no bleeding. The right adnexa were then placed in the pouch of Douglas. The uterus was moved to the right side but, owing to lack of visibility, the sigmoid had to be mobilized to gain access to the left adnexa. Without opening the retroperitoneum, the physiologic sigmoid adhesions were dissected until the left ureter was visible. Despite moving the uterus to the right side, it was not possible to reach the infundibulopelvic ligament safely. Therefore, a posterior colpotomy was performed and a 5-mm trocar with a grasper was inserted. The left adnexa were then grasped transvaginally and moved

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to the right. Next, the left fallopian tube, ovarian ligament, and infundibulopelvic ligament were dissected—without complication— with monopolar electrocautery. Because of the ovarian size (4 cm), transgastric removal was not possible. Therefore, the posterior colpotomy was dilated to 4 cm, the specimen was removed in an endobag (Endo Cath; Covidien, Mansfield, MA, USA), and the colpotomy was repaired with a running suture. After fixation of an over-the-scope clip (OTSC 12/6a-220; Ovesco Endoscopy, Tübingen, Germany), a twin grasper was applied to the tip of the gastroscope. This instrument enabled grasping of both edges of the gastric lesion with subsequent independent locking. After fullthickness grasping of the gastric wall, the tissue was pulled into the transparent hood of the gastroscope and the clip was then released. Tightness of the gastric closure was controlled by gastroscopic inspection. The procedure was performed using a double-channel therapeutic gastroscope (PV-TG 2; Karl Storz) with a modern endoscopy system (light source, Xenon 100; video processor, Telecam SL II; documentation system, Aida; all Karl Storz). The gastroscope was sterilized with ethylene oxide and provided in a sterile box. One of the channels was connected to a CO2 insufflator (Thermoflator; Karl Storz) with a flow of 6 L/min CO2 and a pressure of 15 mm Hg; the other was used for instrumentation. Because this was the first operation of its kind, preparation was carried out very slowly and carefully. Therefore, the procedure lasted 241 minutes; however, the patient recovered quickly. Oral intake of 1000 mL of liquid was allowed on the first postoperative day, and normal food on the second day. After the operation, the patient received double the standard dose of proton pump inhibitor (2 × 40 mg of pantoprazole) for 8 days. She was discharged on the third postoperative day. The adnexa were completely removed and the tissues were examined following the “sectioning and extensively examining the fimbriated end (SEE-FIM)” protocol [6]. There was no evidence of malignant transformation. 4. Discussion Based on our extensive experience with interventional endoluminal endoscopy and laparoscopic gynecologic surgery, a study on the feasibility of transgastric PBSO was planned. The aim was to evaluate the effectiveness, safety, and patient acceptance of POESY according to the NOTES philosophy. Since the first report of transgastric appendectomy in India [7], many other NOTES approaches such as transvaginal cholecystectomy and transvesical thoracoscopy have been performed [8,9]. However the procedures in humans were not pure NOTES operations because they required an additional transumbilical trocar, resulting in a skin incision. New methods are not always welcomed at the first time of presentation. When the German gynecologist Kurt Semm first reported advanced operative laparoscopy [10], he received much criticism. Nevertheless, it developed into a routine procedure for most gynecologic, and even some oncologic, resections. To begin with, the researchers were confronted with many technical problems and had to develop new instruments. For the transgastric approach, the available instruments—although able to perform well—leave a great deal of room for improvement, which should lead to increased flexibility, faster and safer procedures, and shorter recovery times. An example is suturing the gastrotomy at the end of the operation. After intensive research, the over-the-scope clip was developed, leading to a safe and fast procedure for this important step. When the procedure is performed well, peritonitis caused by insufficient closure should be extremely rare. During the operation, we realized that several steps could be changed to improve the efficiency of POESY in the future. For example, the transvaginal trocar makes the operation much easier and should be used from the beginning to save time. We also encountered sigmoid adhesions during the procedure and were surprised that even difficult adhesiolysis was possible with just the gastroscope and the uterus manipulator. However, it remains to be determined whether salpingooophorectomy would also be feasible with POESY after hysterectomy

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and, therefore, possible altered anatomy. After closing the gastrotomy and the colpotomy, we realized that there was still some gas in the abdomen, which was causing postoperative abdominal pain. For the next patient, it might be useful to insert a drain temporarily through the vagina into the abdomen, initially closing the stomach and then suturing the vagina when all the gas is gone after a few minutes. Given that this operation was a fundamentally new surgical procedure, the time needed was acceptable for the team. An interdisciplinary approach between interventional endoscopy and gynecology is fundamental for this procedure. Importantly, POESY appears to be safe. Further advantages are expected from flexible endoscopes with multiple instrumentation channels and the ability to move these instruments independently from the entire scope. Another advance would be the ability to remove the adnexa transgastrically via suction after isolation and encapsulation. With improvements in instrumentation, POESY may become an effective procedure that has a faster recovery time compared with current methods. Conflict of interest G.K. received research support from Karl Storz and from Erbe Elektromedizin. The other authors have no conflicts of interest.

References [1] Kauff ND, Domchek SM, Friebel TM, Robson ME, Lee J, Garber JE, et al. Risk-reducing salpingo-oophorectomy for the prevention of BRCA1- and BRCA2-associated breast and gynecologic cancer: a multicenter, prospective study. J Clin Oncol 2008;26(8): 1331–7. [2] Domchek SM, Friebel TM, Singer CF, Evans DG, Lynch HT, Isaacs C, et al. Association of risk-reducing surgery in BRCA1 or BRCA2 mutation carriers with cancer risk and mortality. JAMA 2010;304(9):967–75. [3] Romanelli JR, Earle DB. Single-port laparoscopic surgery: an overview. Surg Endosc 2009;23(7):1419–27. [4] Schoenberg MB, Ströbel P, von Renteln D, Eickhoff A, Kähler GF. Absorbable ligation loops for flexible endoscopy: a necessary tool for natural orifice transluminal endoscopic surgery. Gastrointest Endosc 2011;73(4):791–7. [5] Eickhoff A, Vetter S, von Renteln D, Caca K, Kähler G, Eickhoff JC, et al. Effectivity of current sterility methods for transgastric NOTES procedures: results of a randomized porcine study. Endoscopy 2010;42(9):748–52. [6] Crum CP, Drapkin R, Miron A, Ince TA, Muto M, Kindelberger DW, et al. The distal fallopian tube: a new model for pelvic serous carcinogenesis. Curr Opin Obstet Gynecol 2007;19(1):3–9. [7] ASGE, SAGES. ASGE/SAGES Working Group on Natural Orifice Translumenal Endoscopic Surgery White Paper October 2005. Gastrointest Endosc 2006;63(2): 199–203. [8] Lima E, Henriques-Coelho T, Rolanda C, Pêgo JM, Silva D, Carvalho JL, et al. Transvesical thoracoscopy: a natural orifice translumenal endoscopic approach for thoracic surgery. Surg Endosc 2007;21(6):854–8. [9] Marescaux J, Dallemagne B, Perretta S, Wattiez A, Mutter D, Coumaros D. Surgery without scars: report of transluminal cholecystectomy in a human being. Arch Surg 2007;142(9):823–7. [10] Semm K. Endoscopic appendectomy. Endoscopy 1983;15(2):59–64.

Pure natural orifice transluminal endoscopic surgery (NOTES) involving peroral endoscopic salpingo-oophorectomy (POESY).

Natural orifice transluminal endoscopic surgery (NOTES) is a surgical approach that uses natural orifices to gain access to areas of the body. In the ...
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