Laparoscopic Transvaginal Hybrid Anterior Resection: a Prospective Data Collection

December 9, 2010 updated by: Cantonal Hospital of St. Gallen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • St. Gallen, Switzerland, 9007
        • Department of Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Given indication for laparoscopic anterior resection

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ginven indication for laparoscopic anterior resection
Procedure: Laparoscopic transvaginal hybrid anterior resection
Transvaginal Hybrid Anterior Resection: three 5mm trocars are placed transabdominally (one trans-umbilical, the other two in the lower abdomen). Identification of the inferior mesenteric vein and artery. Clipping of the vein. Then placement of a 12mm trocar through the posterior fornix of the vagina for stapling of the inferior mesenteric artery. After mobilisation of the colon descendens and the splenic flexure stapling of the proximal rectum through the 12mm trocar placed vaginally. Afterwards the colpotomy is performed and the mobilised left hemi-colon is extracted transvaginally. The proximal colonic resection is performed extracorporeally in the conventional fashion with placement of a purse-string suture and insertion of the circular stapling anvil into the proximal end of the bowel. The bowel is then replaced into the abdominal cavity. The colpotomy is then closed. A circular stapler is inserted transanally and the end-to-end anastomosis is performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility and safety of the transvaginal operation
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Long-term life quality and sexual dysfunction
Time Frame: 3 year
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cantonal Hospital of St. Gallen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

January 6, 2010

First Submitted That Met QC Criteria

January 6, 2010

First Posted (ESTIMATE)

January 7, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 10, 2010

Last Update Submitted That Met QC Criteria

December 9, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKSG09/151/2B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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