Surg Endosc DOI 10.1007/s00464-014-3784-3

and Other Interventional Techniques

Standardized laparoscopic NOSE-colectomy is feasible with low morbidity Albert M. Wolthuis • Anthony de Buck van Overstraeten Steffen Fieuws • Katrien Boon • Andre´ D’Hoore



Received: 27 May 2014 / Accepted: 28 July 2014 Ó Springer Science+Business Media New York 2014

Abstract Background In laparoscopic colorectal surgery, extraction site laparotomy can be avoided by natural orifice specimen extraction (NOSE) resulting in less postoperative pain, shorter length of stay, and less morbidity such as wound complications. To date, short-term outcome of a large prospective cohort of patients has not been studied. The aim of this prospective cohort study was to assess short-term outcome of laparoscopic left-sided NOSE-colectomy. Methods Prospectively collected data of patients who had undergone elective laparoscopic NOSE-colectomy between July 2009 and December 2013 were analyzed retrospectively. Primary endpoint was short-term morbidity. Results A total of 110 patients were included in this study. Median age was 38 years (IQR: 32–56), median BMI was 23 kg/m2 (IQR: 21–25), and 88 % of the patients were female. Sixty-three patients (57 %) underwent resection for endometriosis, 29 patients (26 %) for diverticular disease, 16 patients (15 %) for a tumor, and 2 patients for other indications. Median operating time was 85 min (IQR: 70–100) and median length of the extracted specimen was 20 cm (IQR: 16–25). Overall, 14 patients had a postoperative complication (13 %), of which 9 were Clavien-Dindo grade 1 or 2 (8 %). Four patients (3.6 %) had an intraluminal bleeding from the anastomosis, which was treated endoscopically. There was 1 anastomotic leak A. M. Wolthuis (&)  A. de Buck van Overstraeten  K. Boon  A. D’Hoore Department of Abdominal Surgery, University Hospital Gasthuisberg Leuven, Herestraat 49, 3000 Louvain, Belgium e-mail: [email protected]; [email protected] S. Fieuws Interuniversity Centre for Biostatistics and Statistical Bioinformatics, University Hospital Leuven, Louvain, Belgium

(1 %), treated by emergency laparotomy and creation of a new colorectal anastomosis (grade 3b). The median hospital stay was 5 days (IQR: 4–6). Conclusion Laparoscopic NOSE-colectomy is safe and feasible with good short-term outcome. This study concerning a standardized operative technique is the first in literature reporting on a large group of patients. Keywords Laparoscopic NOSE-colectomy  Transrectal specimen extraction  NOSE In laparoscopic colorectal surgery, extraction site laparotomy can be avoided by natural orifice specimen extraction (NOSE) [1]. This might reduce postoperative pain, length of stay, and morbidity. Laparoscopic NOSE-colectomy for left-sided disease involves transrectal or transvaginal specimen extraction and intracorporeal colorectal anastomosis formation. To date, short-term outcome of a large prospective cohort of patients has not been studied and the learning curve to perform laparoscopic NOSE-colectomy safely is still ill-defined. Only one randomized controlled trial could be found, showing less postoperative pain and wound complications [2]. We hypothesized that a standardized laparoscopic left-sided NOSE-colectomy is feasible with low morbidity. The aim of this prospective cohort study was to study short-term outcome in a large group of patients. We here report an original experience in a series of 110 laparoscopic left-sided NOSE-colectomies. Materials and methods Study population All consecutive laparoscopic NOSE-colectomies performed at the University Hospital Leuven, Belgium from

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July 2009 to December 2013 were reviewed. Patients who underwent transrectal specimen extraction were included in the study. All patients included were older than 18 years and had been diagnosed with benign or malignant sigmoid colon disease, such as, diverticular disease (elective sigmoid resections for recurrent diverticulitis), endometriosis, a benign adenoma or lipoma or a non-transmural carcinoma smaller than 4 cm in diameter. Some criteria to exclude patients from NOSE were derived from specific patient and pathology aspects. Patient-specific exclusion criteria were pregnancy, body mass index (BMI)[35 kg/m2, being on immunosuppressive medication or immunocompromised, abnormal blood coagulation, undergoing peritoneal dialysis, and history of anal surgery. Pathologyspecific exclusion criteria were diverticulitis of the proximal sigmoid colon, acute diverticulitis including Hinchey stages 1–4, and advanced colon carcinoma, defined as cT3 or cT4 tumors. All perioperative clinical data were collected prospectively, reviewed and analyzed retrospectively in December 2013. Complications were classified according to Dindo et al. [3] Grades 1 and 2 were considered minor complications, and grades 3 and 4 were considered major complications. The study was approved by the local ethical committee. Operative technique The technical aspects of standardized laparoscopic NOSEcolectomy have been reported, previously [4, 5]. Briefly, after admission on the day before surgery, patients underwent mechanical bowel preparation. Although bowel preparation is not recommended for colectomy, we used it in patients undergoing NOSE-colectomy, because of concerns of perioperative peritoneal contamination with solid stool. In our current practice, we abandoned bowel preparation and patients had a fleet-enema on the day before surgery. After administration of preoperative intravenous antibiotic prophylaxis (cefuroxime 2 g and metronidazole 1.5 g), general anesthesia was induced. The patient was placed in modified Lloyd-Davies position on a moldable beanbag to allow a steep Trendelenburg position. The peritoneal cavity was entered in the left hypochondric region subcostally with a Veress needle, and pneumoperitoneum was established to a pressure of 15 mmHg. Three 5-mm trocars were placed in the right and left flanks and slightly right laterally above the umbilicus. A 12-mm trocar was placed in the right iliac fossa for stapling. We only used standard straight laparoscopic instruments and a 30° 5-mm laparoscope. A medial-to-lateral approach was performed. The inferior mesenteric artery and vein were clipped and divided, safeguarding the left ureter, the gonadal vessels, and the autonomic hypogastric nerves. The sigmoid colon was mobilized by incising Toldt’s

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fascia. A partial mesorectal excision was performed to clean the upper part of the rectum, allowing the rectal ampulla and reservoir function to be saved and leaving rectal capacity intact. After the proximal and distal margins had been established, the sigmoid mesentery was divided with a vessel-sealing device. The devascularized specimen was isolated and both the proximal sigmoid colon and proximal rectum were tied off with a non-absorbable suture, determining the proximal and distal resection margins. A rectotomy was then performed to deliver the anvil from a circular stapler (Fig. 1). The spike from the circular stapler contained a prefabricated hole and was connected to a monofilament suture. A colotomy was made at the level of the transition between descending colon and proximal sigmoid colon, and the anvil was introduced into the descending colon. The suture on the spike was used to place an antimesenterial stitch and gentle pulling on the suture retrieved the anvil. The spike was disconnected from the anvil and removed via the 12-mm trocar. The colon was closed and divided with a 60-mm endoscopic linear stapler. The proximal part of the anastomosis was ready for use. The rectum was transected completely and the specimen was extracted transrectally in a specimen retrieval pouch. The rectum was closed at the level of the promontory with a 60-mm endoscopic linear stapler and the rim of proximal rectum was extracted through the 12-mm trocar. An end-toend triple-stapled colorectal anastomosis was made using the circular stapler and an air leak test was routinely performed. No drain was placed. Statistical analysis Data were presented as median (IQR, interquartile range, and range). A Spearman correlation was used to evaluate the relation between case number and operative time. The postoperative evolution of the C-reactive protein (CRP) values was described using a linear mixed model on the logtransformed CRP values, assuming a linear change after day 1 and between baseline and day 1. A random intercept and random linear slopes were used to take into account the correlation. All analyses were performed using SAS software, version 9.2 of the SAS System for Windows.

Results Overall, 115 laparoscopic NOSE-colectomies, including 110 transrectal specimen extractions and 5 transvaginal specimen extractions, were performed at our institution in the study period. Only data from patients with transrectal NOSE were analyzed. Patients were predominantly female (n = 97, 88.2 %) with a median age of 38 years (IQR, 32–56, range, 25–80 years) and median BMI of 23 kg/m2

Surg Endosc Fig. 1 Critical steps of laparoscopic transrectal NOSEcolectomy. A Anvil insertion into the abdominal cavity via proximal rectotomy. B Anvil insertion into the descending colon. C Anvil retrieval by pulling on the anti-mesenterially placed stitch after the colon has been stapled. D Specimen inserted into the specimen retrieval pouch and extracted transrectally

(IQR, 21–25, range, 17–35 kg/m2). Six patients (5.5 %) were obese (BMI C30 kg/m2). Nine patients (8.2 %) were considered American Society of Anesthesiologists (ASA) class III, whereas the remaining patients were classified ASA class I (n = 45, 40.9 %) or ASA class II (n = 56, 50.9 %). The preoperative diagnosis was endometriosis (n = 63, 57.3 %), diverticular disease (n = 29, 26.4 %), colonic carcinoma (n = 14, 12.7 %), sarcoma (n = 1, 0.9 %), lipoma (n = 1, 0.9 %), ischemic stricture (n = 1, 0.9 %), and volvulus (n = 1, 0.9 %). Median operative time was 85 min (IQR, 70–100, range, 45–180 min). Operative time decreased significantly with increasing experience over time (Fig. 2). To further assess this learning curve, technical difficulties during the operation were noted. The procedure was technically difficult in five patients (4.6 %). Technical difficulties included re-stapling of the rectum (n = 2, 1.8 %), specimen extraction without a specimen retrieval pouch (n = 2, 1.8 %) and conversion to specimen extraction via left iliac fossa utility incision (n = 1, 0.9 %). Median length of the extracted specimen was 20 cm (IQR, 16–25, range, 6–50 cm). For colonic tumors, median tumor diameter was 2.4 cm (IQR, 1–3.7, range, 1–4.5 cm). Overall, complication rate was 12.7 % (CI: 5.8–23.0 %). Ninety-six patients (87.3 %) had no complications. Five major (4.6 %) and 9 minor (8.1 %) complications were encountered. Anastomotic leakage occurred in a 51-year-old female patient (BMI = 26 kg/ m2) on the second postoperative day. She underwent emergency laparotomy and repeat colorectal anastomosis

without defunctioning ileostomy. The patient received therapeutic antibiotics intravenously. She was discharged on day 11. Five patients experienced intraluminal bleeding at the anastomosis. One patient was observed without intervention (grade 1). In two patients, the anastomotic bleeding was controlled by flexible endoscopy performed at the bedside in the recovery room (grade 3a). In the remaining two patients, flexible endoscopy was necessary under general anesthesia (grade 3b). Eight patients had a grade 2 complication. Four patients (3.6 %) developed a urinary tract infection, which was successfully treated with oral antibiotics. Three patients (2.7 %) developed a fever [38.5 °C postoperatively and were treated with a short course of antibiotics. Paralytic ileus occurred in a 63-yearold patient (BMI = 20 kg/m2). A nasogastric tube was inserted for 3 days. He was discharged on postoperative day 7. None of the patients required a temporary defunctioning stoma, and there was no postoperative mortality. Inflammatory response, measured by C-reactive protein (CRP), peaked on the second postoperative day and decreased quickly thereafter (Fig. 3). Postoperative pain scores measured by a visual analogous scale (VAS) decreased after the first postoperative day (Fig. 4). Postoperatively, median length of hospital stay was 5 days (IQR, 4–6, range, 2–19 days). In the group of patients enrolled in a fast-track program, median length of hospital stay was 4 days (IQR, 3–6, range 2–19 days). Seven patients (6.4 %) were readmitted within 30 days. Two patients in this series required reoperation. One patient

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Fig. 2 Operative time over the study period in all patients

Fig. 3 Evolution of geometric mean CRP-levels over the study period in all patients. Dashed lines represent pointwise 99 % confidence interval

suffered from a small bowel obstruction due to a singleband adhesion requiring laparoscopic adhesiolysis. Another patient developed a pelvic abscess, which required transrectal drainage. This occurred in the female patient who had had an anastomotic leak. Four patients were observed for 1 night without intervention, because of nausea and vomiting (n = 2), and anal bleeding (n = 2). One patient was treated as an outpatient for constipation.

Discussion Soon after the introduction of laparoscopic colorectal surgery in the early 1990s, the concept and technique of transrectal NOSE-colectomy was developed [6, 7]. NOSE could be the key to further reduce abdominal wall trauma and seems to be an attractive option to improve postoperative outcome. Our single-center experience in 110

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Fig. 4 Evolution of geometric mean postoperative pain score (VAS) over the study period in all patients. Dashed lines represent pointwise 99 % confidence interval

consecutive patients who had standardized laparoscopic NOSE-colectomy shows that this procedure performed for different indications is feasible and only has minimal morbidity. Moreover, the learning curve showed a significant decrease of duration of surgery over time. Although the learning curve may be shown on the basis of operative times, it is important to investigate and report surgical morbidity, when safety and feasibility of newly implemented techniques are evaluated. This study shows safety of a triple-stapled anastomosis and transrectal specimen extraction without rectal injury. Intraluminal anastomotic bleeding occurred in 4.5 % of patients and might be a drawback of triple-stapled techniques. Another possible concern could be intraperitoneal opening of both the colon and rectum for anvil insertion, preparation of the anastomosis, and specimen extraction. Theoretically, this could lead to peritoneal contamination. One study showed polybacterial growth in all peritoneal culture samples, without affecting infectious morbidity [8]. It is worth emphasizing that in this NOSE-colectomy series, nosocomial infections hardly occurred. Only 4 patients (3.6 %) had a urinary tract infection and 3 patients (2.7 %) had transient fever postoperatively, treated by a short course of antibiotics. Moreover, there were no wound infections. Improvement of postoperative outcome by reducing abdominal wall trauma is an important goal of laparoscopic NOSE-surgery. Together with avoidance of an incision for specimen extraction from the abdominal cavity, fast-track programs have been developed to improve postoperative outcome. These fast-track programs or so-called enhanced recovery after surgery (ERAS) protocols, pioneered by Kehlet, aim to improve surgical stress response, organ dysfunction and morbidity [9]. Postoperative recovery is enhanced by a multimodality set of measures proposed by the different stakeholders in postoperative care [10]. With the

2011

2011

2012

2013

2013

Wolthuis [4]

Wolthuis [5]

Costantino [17]

Christoforidis [16]

Franklin [12]

RCT

Case series

Case series

Case series

Casematched

Casematched

Case series

Casematched

Case series

Case series

Case series

Case series

Case series

Type of study

35

34

15

277

11

17

21

21

16

16

8

10

16

N

Malignant

Malignant

Benign

Benign and malignant

Benign

Benign

Benign and malignant

Endometriosis

Malignant

Diverticulitis

Benign and malignant

Malignant

Malignant

Indication

4

5

3

4

4

3

4

4

5

3

4

5

4

Ports (N)

TEO

TEM and bag

TEA

Retrieval bag

Camera sleeve

None

Retrieval bag

Retrieval bag

Wound retractor

McCarteny Tube None

TEO

None

Protection

DS

DS

TS

TS

TS

TS

TS

TS

DS

TS

TS

TS

TS

Anastomosis

a

Leakage (6, 3b) None

105a

Bleeding (1, 1), ileus (1, 2)

Leakage (3, 3b) 151.6

131

164.7

Abscess (1, 3a), leakage (3b) and trocar hernia (3b)

200a

Leakage (1, 3b)

105*

Bleeding (1, 1), fever (2, 2), abscess (1, 2), leakage (1, 3b)

Urinary tract infection (1, 2)

122

Leakage (1, 2)

241

Transient epigastric pain (1, 1), fever (3, 2)

None

None

Woundinfection (1, 1)

Morbidity (N, Clavien–Dindo grade)

90a

Range 95–180 120.9

127.5

180

Mean OR time (min)

5

9

NA

6.9b

6

7.2b

6

6

6

6.1b

range 4–8

7

11b

Median LOS (days)

b

a

Mean LOS

Median OR time

DS double-stapled, LOS length of stay, NA not available, N number, OR operating room, RCT randomized controlled trial, TEA transanal endoscopic applicator, TEM transanal endoscopic microsurgery, TEO transanal endoscopic operation, TS triple-stapled

2013

2011

Nishimura [20]

Leung [2]

2011

Leroy [8]

2013

2010

Saad [21]

2013

2009

Cheung [15]

Han [19]

2009

Akamatsu [14]

Fuchs [18]

Year

Author

Table 1 Studies that describe outcome of transrectal NOSE-Colectomy

Surg Endosc

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introduction of enhanced recovery protocols, hospital stay after a laparoscopic colorectal resection has been further reduced [9, 11]. In the LAFA-trial, median hospital stay was 5 days in the laparoscopic resection with a fast-track program group [11]. We also observed a median hospital stay of 5 days in the present study, with non-standardized postoperative care. Hospital stay was further reduced to a median of 4 days within an ERAS-protocol. If postoperative care is standardized using an ERAS-protocol, hospital stay may be reduced after laparoscopic NOSE-colectomy. The strengths of this study include the substantial number of consecutive patients and the complete short-term followup. Although this is a retrospective study, data collection was prospective and included all relevant perioperative events. The procedure was performed in a standardized way and operative set-up was the same in all patients. It was standardized in such a way that, apart from a tailored approach to resection margins for benign and malignant disease, the sequence of the steps for NOSE was identical in every patient, thus standardizing the technique and making it teachable and reproducible. A drawback of the present series is that laparoscopic NOSE-colectomy was applied to a young, predominantly female population suffering from endometriosis (57 %) with a low median BMI, indicating that the group of patients was highly selected. Another possible limitation could be that the present study has no comparative arm or is not a randomized controlled trial. However, before randomization becomes possible, feasibility and reproducibility of laparoscopic NOSEcolectomy should be shown in a large case series. Moreover, the primary goal of this study was to demonstrate that laparoscopic NOSE-colectomy is feasible with low morbidity on short-term. Only Franklin et al. [12] have reported their experience with transvaginal- and transanal NOSE-colectomy in a large cohort of patients, but results cannot be compared to our series, because transvaginal, transrectal, and transanal approaches were included in that study. No difference was made between transanal and transrectal specimen extraction. In our opinion, the difference between transrectal and transanal specimen extraction lies in the level at which the bowel is opened exactly [13]. A transrectal NOSE implies that the rectal ampulla is saved and rectal capacity remains intact. A transanal NOSE involves total mesorectal excision, and this often involves rectal cancer surgery. The largest cohort study comprised 277 patients, but results of both transanal and transrectal NOSE-colectomies were presented. It is unclear how many sigmoid resection and how many (low) anterior resections were included. Hence, the difference between the results presented and the results from Franklin et al. is that only our experience with transrectal NOSE-colectomy was analyzed. In literature, smaller studies have shown equivalent results with regard to postoperative morbidity and

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length of hospital stay (Table 1) [2, 4, 5, 8, 12, 14–21]. Due to heterogeneity among studies regarding operative technique, it is impossible to compare postoperative outcome in a meta-analysis [13]. These were studies with different surgical approaches (3 operating ports-23 %, 4 ports-54 %, 5 ports-23 %), rectal protection (none-24 %, rigid rectoscope-38 %, camera sleeve or retrieval bag-38 %), and anastomotic technique (double-stapled-23 %, triple-stapled-77 %). Only one randomized controlled trial and three case-matched studies could be found comparing laparoscopic NOSE-colectomy to conventional laparoscopic colectomy. In 3 studies, there were significantly fewer analgesic requirements in the NOSE-colectomy group [2, 4, 17]. In future, well-designed randomized controlled trials should focus on the presumed benefits of laparoscopic NOSEcolectomy compared to conventional laparoscopic resection. Moreover, long-term outcome regarding patient satisfaction, cosmetic outcome, incisional hernias, and anal function needs to be studied in a prospective way using validated tools. Finally, the findings with this series further pave the way to natural orifice transluminal endoscopic surgery and other minimally abdominal access trauma techniques.

Conclusions Elective laparoscopic NOSE-colectomy for left-sided colonic pathology can be performed safely. Standardization of technique leads to a safe and reproducible procedure with an acceptable learning curve. The present experience is representative of the expected learning curve of adopting laparoscopic NOSE-colectomy to surgical practice, with a low overall complication rate of 12.7 %. Moreover, a median hospital stay of 5 days and readmission rate of 6 % is promising. These favorable results are encouraging and clearly merit further use of this procedure.

Disclosures Drs. A. Wolthuis, A. de Buck van Overstraeten, K. Boon, and A. D’Hoore, and Mr. S. Fieuws have no conflicts of interest and no financial ties to disclose.

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13. Wolthuis AM, Van Geluwe B, Fieuws S, Penninckx F, D’Hoore A (2012) Laparoscopic sigmoid resection with transrectal specimen extraction: a systematic review. Colorectal Dis 14:1183–1188 14. Akamatsu H, Omori T, Oyama T, Tori M, Ueshima S, Nakahara M, Abe T, Nishida T (2009) Totally laparoscopic sigmoid colectomy: a simple and safe technique for intracorporeal anastomosis. Surg Endosc 23:2605–2609 15. Cheung HY, Leung AL, Chung CC, Ng DC, Li MK (2009) Endolaparoscopic colectomy without mini-laparotomy for left-sided colonic tumors. World J Surg 33:1287–1291 16. Christoforidis D, Clerc D, Demartines N (2013) Transrectal specimen extraction after laparoscopic left colectomy: a casematched study. Colorectal Dis 15:347–353 17. Costantino FA, Diana M, Wall J, Leroy J, Mutter D, Marescaux J (2012) Prospective evaluation of peritoneal fluid contamination following transabdominal vs. transanal specimen extraction in laparoscopic left-sided colorectal resections. Surg Endosc 26:1495–1500 18. Fuchs KH, Breithaupt W, Varga G, Schulz T, Reinisch A, Josipovic N (2013) Transanal hybrid colon resection: from laparoscopy to NOTES. Surg Endosc 27:746–752 19. Han Y, He YG, Zhang HB, Lv KZ, Zhang YJ, Lin MB, Yin L (2013) Total laparoscopic sigmoid and rectal surgery in combination with transanal endoscopic microsurgery: a preliminary evaluation in China. Surg Endosc 27:518–524 20. Nishimura A, Kawahara M, Suda K, Makino S, Kawachi Y, Nikkuni K (2011) Totally laparoscopic sigmoid colectomy with transanal specimen extraction. Surg Endosc 25:3459–3463 21. Saad S, Hosogi H (2010) Natural orifice specimen extraction for avoiding laparotomy in laparoscopic left colon resections: a new approach using the McCartney tube and the tilt top anvil technique. J Laparoendosc Adv Surg Tech A 20:689–692

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Standardized laparoscopic NOSE-colectomy is feasible with low morbidity.

In laparoscopic colorectal surgery, extraction site laparotomy can be avoided by natural orifice specimen extraction (NOSE) resulting in less postoper...
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