Universität zu Köln

Bulian, Dirk Rolf ORCID: 0000-0002-1311-7326, Knuth, Juergen, Cerasani, Nicola, Sauerwald, Axel ORCID: 0000-0002-9451-7726, Lefering, Rolf and Heiss, Markus Maria (2015). Transvaginal/Transumbilical Hybrid-NOTES-Versus 3-Trocar Needlescopic Cholecystectomy: Short-term Results of a Randomized Clinical Trial. Ann. Surg., 261 (3). S. 451 - 459. PHILADELPHIA: LIPPINCOTT WILLIAMS & WILKINS. ISSN 1528-1140

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Abstract

Objective: For cholecystectomy, both the needlescopic cholecystectomy (NC) 3-trocar technique using 2 to 3 mm trocars and the umbilical-assisted transvaginal cholecystectomy (TVC) technique have found their way into clinical routine. This study compares these 2 techniques in female patients who are in need of an elective cholecystectomy. Background: Natural orifice transluminal endoscopic surgery (NOTES) is a surgical concept permitting scarless intra-abdominal operations through natural orifices, such as the vagina. Because of the lack of an adequately powered trial, we designed this first randomized controlled study for the comparison of TVC and NC. Methods: This prospective, randomized, nonblinded, single-center trial evaluates the safety and effectiveness of TVC (intervention), compared with NC (control) in female patients with symptomatic cholecystolithiasis. The primary endpoint was intensity of pain until the morning of postoperative day (POD) 2. Secondary outcomes were among others intra-and postoperative complications, procedural time, amount of analgesics used, pain intensity until POD 10, duration of hospital stay, satisfaction with the aesthetic result, and quality of life on POD 10 as quantified with the Eypasch Gastrointestinal Quality of Life Index (GIQLI). Results: Between February 2010 and June 2012, 40 patients were randomly assigned to the interventional or control group. All patients completed follow-up. Procedural time, length of postoperative hospital stay, and the rate of intra-and postoperative complications were similar in the 2 groups. However, significant advantages were found for the transvaginal access regarding pain until POD 2, but also until POD 10 (P = 0.043 vs P = 0.010) despite significantly less use of peripheral analgesics (P = 0.019). In the TVC group, patients were significantly more satisfied with the aesthetic result (P < 0.001) and had a significantly better GIQLI (P = 0.028). Conclusions: Although comparable in terms of safety, TVC caused less pain, increased satisfaction with the aesthetic result, and improved postoperative quality of life in the short term.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Bulian, Dirk Rolf UNSPECIFIED orcid.org/0000-0002-1311-7326 UNSPECIFIED Knuth, Juergen UNSPECIFIED UNSPECIFIED UNSPECIFIED Cerasani, Nicola UNSPECIFIED UNSPECIFIED UNSPECIFIED Sauerwald, Axel UNSPECIFIED orcid.org/0000-0002-9451-7726 UNSPECIFIED Lefering, Rolf UNSPECIFIED UNSPECIFIED UNSPECIFIED Heiss, Markus Maria UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-411339
DOI:	10.1097/SLA.0000000000000218
Journal or Publication Title:	Ann. Surg.
Volume:	261
Number:	3
Page Range:	S. 451 - 459
Date:	2015
Publisher:	LIPPINCOTT WILLIAMS & WILKINS
Place of Publication:	PHILADELPHIA
ISSN:	1528-1140
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language CONVENTIONAL LAPAROSCOPIC CHOLECYSTECTOMY; TRANSVAGINAL CHOLECYSTECTOMY; ENDOSCOPIC CHOLECYSTECTOMY; SURGICAL COMPLICATIONS; SURGERY; CLASSIFICATION; METAANALYSIS; PAIN Multiple languages Surgery Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/41133