Laparoscopic Transvaginal Hybrid Anterior Resection: a Prospective Data Collection

Completed

• Conditions: Sigmoid Diverticulitis (Hinchey I and II); Sigmoid Diverticulosis With Two or More Attacks of Diverticulitis
• Interventions: Procedure: Laparoscopic transvaginal hybrid anterior resection

• Registration Number: NCT01043731
• Lead Sponsor: Cantonal Hospital of St. Gallen

Brief Summary

Transvaginal hybrid procedures are of interest as an available NOTES-Procedure for the clinical routine. Few authors have demonstrated the feasibility and safety of such procedures (e.g. cholecystectomy) in selected patient collectives. In 2008 Lacy at al. published the experience with a transvaginal sigmoidectomy as a first in human report. The aim of this prospective data collection is to evaluate the feasibility and safety of the transvaginal hybrid anterior resection in the clinical routine.

Therefore all patients giving the informed consent to the transvaginal hybrid anterior resection will be included and assessed concerning feasibility to perform the transvaginal approach and complete the operation transvaginally.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2010-01-06
• Study First Submitted QC: 2010-01-06
• Study First Posted: 2010-01-07
• Status Verified: 2010-07
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Last Update Submitted: 2010-12-09
• Last Update Posted: 2010-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

• given informed consent
• sigmoid diverticulosis (two or more attacks)
• sigmoid diverticulitis (Hinchey I and II)

Exclusion Criteria

• ASA IV
• emergency surgery
• liver-malfunction or coagulation disorders
• acute diverticulitis (Hinchey III and IV)
• malignancy
• acute vaginal infection
• refusal of mandatory preoperative gynecological examination
• pregnancy
• endometriosis
• previous surgery of colon and rectum
• strongly retroflexed uterus
• acute pelvic disorders, infection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ginven indication for laparoscopic anterior resection	Laparoscopic transvaginal hybrid anterior resection	-

Primary Outcome Measures

Name	Time	Method
Feasibility and safety of the transvaginal operation	30 days

Secondary Outcome Measures

Name	Time	Method
Long-term life quality and sexual dysfunction	3 year

Trial Locations

Locations (1)

Department of surgery; 🇨🇭 St. Gallen, Switzerland