Prevalence of Stool Outlet Obstruction After Laparoscopic Sacrocolpopexie

September 17, 2018 updated by: Dimitri Sarlos, Kantonsspital Aarau

Prospective Cross-sectional Study on the Prevalence of Stool Outlet Obstruction After Laparoscopic Sacrocolpopexie at the KSA

The aim was to evaluate the prevalence of stool outlet obstruction after laparoscopic sacrocolpopexie at the Kantonsspital Aarau in a prospective cross-sectional study.

Laparoscopic sacrocolpopexy techniques involving the dissection of the presacral space can compromise fibers of the superior hypogastric plexus. This can contribute to postoperative problems such as incomplete voiding, defecatory dysfunction, pain, and sensory problems. In 2010, the Kantonsspital Aarau has implemented a new nerve-sparing laparoscopic sacrocolpopexy technique. This technique has subjectively reduced the prevalence of stool outlet obstructions but this has not been tested systematically yet. The aim of this study is therefore to compare the patients' subjective conditions between these two surgical techniques using the investigator's standard-of-care German pelvic floor questionnaire.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The (pre-) sacral space is characterized by a complex neuroanatomy and surgical intervention in this part of the body is often associated with the dissection of nerve bundels, a procedure which may finally lead to transient defecatory dysfunction. In a earlier study we could show that ~17.8% of patient with laparoscopic sacrocolpopexie developed postoperative constipation within 3-6 months. In november 2010 the Frauenklinik Aarau introduced a novel, nerve-sparing technique of laparoscopic sacrocolpopexie. In this study we assess the pre-and postoperative differences in defecatory dysfunction between the two procedures trough the analysis of our standard of care pelvic floor questionnaire.

Study Type

Observational

Enrollment (Actual)

55

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

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

female patients who underwent laparoscopic sacrocolpopexy at the Kantonsspital Aarau

Description

Inclusion Criteria:

  • Women affected by symptomatic vault prolapse, who underwent laparoscopic sacrocolpopexy at the KSA
  • informed consent

Exclusion Criteria:

  • participation in other studies
  • Sacrocolpopexie done by Da Vinci Roboter
  • Patients who had a conversion to laparotomy perioperatively
  • Patients with a recurrence who had to undergo a second surgery
  • Patients who had a relaps operation

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
non-nerve-sparing laparaoscopic sacrocolpopexy.
nerve-sparing laparaoscopic sacrocolpopexy.
Procedure: nerve-sparing laparaoscopic sacrocolpopexy
nerve-sparing laparaoscopic sacrocolpopexy implemented after 2010

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the number of de novo or worsened obstructed defecation
Time Frame: 2003-2017
comparison of the number of de novo or worsened obstructed defecation of a cohort of patients who underwent nerve-sparing laparaoscopic sacrocolpopexy versus patients who underwent non-nerve-sparing laparaoscopic sacrocolpopexy
2003-2017

Collaborators and Investigators

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

Sponsor

Kantonsspital Aarau

Investigators

  • Principal Investigator: Dimitri Sarlos, PD Dr. med., Kantonsspital Aarau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

August 1, 2015

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

September 10, 2018

First Submitted That Met QC Criteria

September 11, 2018

First Posted (Actual)

September 12, 2018

Study Record Updates

Last Update Posted (Actual)

September 18, 2018

Last Update Submitted That Met QC Criteria

September 17, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • SACRO-GYN-KSA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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