Systematic Reviews
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Oct 14, 2015; 21(38): 10915-10925
Published online Oct 14, 2015. doi: 10.3748/wjg.v21.i38.10915
Systematic analysis of the safety and benefits of transvaginal hybrid-NOTES cholecystectomy
Dirk R Bulian, Jurgen Knuth, Kai S Lehmann, Axel Sauerwald, Markus M Heiss
Dirk R Bulian, Jurgen Knuth, Markus M Heiss, Department of Abdominal, Vascular and Transplant Surgery, Cologne-Merheim Medical Center, Witten/Herdecke University, 51109 Cologne, Germany
Jurgen Knuth, Department of General, Visceral, Vascular and Thoracic Surgery, Hospital of Kempten, 87439 Kempten, Germany
Kai S Lehmann, Department of General, Visceral and Vascular Surgery, Charite? University Medical Center Berlin, Campus Benjamin Franklin, 12200 Berlin, Germany
Axel Sauerwald, Department for Obstetrics and Gynaecology Holweide, Holweide Hospital, 51067 Cologne, Germany
Author contributions: Bulian DR and Lehmann KS designed research; Bulian DR, Knuth J, Lehmann KS and Sauerwald A performed research; Bulian DR and Heiss MM checked the data analysis and reviewed the article; Bulian DR and Knuth J wrote the paper.
Conflict-of-interest statement: Bulian DR, Knuth J, Lehmann KS, Sauerwald A and Heiss MM do not report any conflict of interest.
Data sharing statement: The technical appendix, statistical code, and dataset are available from the corresponding author at buliand@kliniken-koeln.de. Participants gave informed consent for data sharing. No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Dirk R Bulian, MD, Department of Abdominal, Vascular and Transplant Surgery, Cologne-Merheim Medical Center, Witten/Herdecke University, Ostmerheimer Strasse 200, 51109 Cologne, Germany. buliand@kliniken-koeln.de
Telephone: +49-221-89073770 Fax: +49-221-89078561
Received: April 26, 2015
Peer-review started: April 27, 2015
First decision: June 23, 2015
Revised: July 21, 2015
Accepted: September 14, 2015
Article in press: September 14, 2015
Published online: October 14, 2015
Processing time: 170 Days and 17.8 Hours
Abstract

AIM: To evaluate transvaginal hybrid-NOTES cholecystectomy (TVC) during its clinical establishment and compare it with the traditional laparoscopic technique (LC).

METHODS: The specific problems and benefits of TVC were reviewed using a registry analysis, a comparative cohort study and a randomized clinical trial. At first, feasibility, safety and specific complications of the TVC were analyzed based on the first 488 data sets of the German NOTES Registry (GNR). Hereafter, we compared the early postoperative results of our first 50 TVC-patients with those of 50 female LC-patients matched by age, BMI and ASA classification. The same cohort was contacted an average of two years later to evaluate long-term results concerning pain and satisfaction with the aesthetic results and the overall postoperative results as well as sexual intercourse by means of two domains of the German version of the Female Sexual Function Index (FSFI-d). Consequently, we performed a randomized clinical trial comparing 20 TVC-patients with 20 needlescopic/3-trocar cholecystectomies (NC) also concerning the early postoperative results as well as pain, satisfaction and quality of life by means of the Eypasch Gastrointestinal Quality of Life Index (GIQLI) in the later course. Finally, we discussed the results in accordance with other published studies.

RESULTS: The complication (3.5%) and conversion rates (4.1%) for TVC were low in the GNR and comparable to those of the LC. Access related intraoperative complications included injuries to the bladder (n = 4; 0.8%) and bowel (n = 3; 0.6%). The study cohort revealed less postoperative pain after TVC comparing to the LC-patients on the day of surgery (NRS, 1.5/10 vs 3.1/10, P = 0.003), in the morning (NRS, 1.9/10 vs 2.8/10, P = 0.047) and in the evening (NRS, 1.1/10 vs 1.8/10, P = 0.025) of postoperative day (POD) one. The randomized clinical trial consistently found less cumulative pain until POD 2 (NRS, 8/40 vs 14/40, P = 0.043), as well as until POD 10 (NRS, 22/190 vs 41/190, P = 0.010). Furthermore, the TVC-patients had a better quality of life on POD 10 than did the LC-patients (GIQLI, 124/144 vs 107/144, P = 0.028). The complication rates were comparable and no specific problems were detected in the long-term follow-up for sexual intercourse for either group. The TVC-patients were more satisfied with the aesthetic result in the long-term course in the matched cohort analysis (1.00 vs 1.88, P < 0.001) as well as in the randomized clinical trial (1.00 vs 1.70, P < 0.001) when compared with the LC-patients.

CONCLUSION: TVC is a feasible procedure with a high safety profile and has advantages in regard to postoperative pain and aesthetic results when compared with LC or NC.

Keywords: NOTES; Cholecystolithiasis; Postoperative complications; Postoperative pain; Transvaginal hybrid-NOTES cholecystectomy

Core tip: Transvaginal hybrid-NOTES cholecystectomy (TVC) increased in popularity after its introduction in 2007. We systematically evaluated this new technique with regards to its specific complications and advantages compared with those of the laparoscopic technique (LC) using a registry analysis, a matched cohort analysis and a randomized clinical trial. TVC had a low conversion rate and complication rate. Injuries to the bladder and urinary tract infections were rare but access-specific complications. TVC-patients showed less postoperative pain and a better quality of life in the short-term course than did the LC-patients. TVC led to an improved satisfaction with the aesthetic results also in long-term course. No specific problems, not even for sexual intercourse, were detected.