Survey: Clinical Outcome After Bowel Resection in Women Due to Endometriosis

October 5, 2023 updated by: Klugsberger Bettina, Kepler University Hospital
Endometriosis is one of the most frequent benign diseases that can affect women in their reproductive age. In severe form, the colon or rectum may be involved. It has been shown that the surgical treatment improve typical symptoms like pain and dyspareunia. The investigators evaluated the functional results and quality of life after laparoscopic colonic resection for endometriosis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A clinical analysis of thirty women with typical symptoms including pelvic pain, infertility and endometriotic bowel lesions who underwent laparoscopic surgery including colonic resection performed from 2009 to 2012. Quality of life and pain was documented postoperatively. We conduct a telephone survey, which starts at May 2014.

Study Type

Observational

Enrollment (Actual)

30

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

  • Austria
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • 2nd Surgical Department, Academic Teaching Hospital, AKH Linz

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 to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

women with typical symptoms including pelvic pain, infertility and endometriotic bowel lesions who underwent laparoscopic surgery including colonic resection performed from 2009 to 2012

Description

Inclusion Criteria:

  • •Clinical diagnosis of endometriosis

Exclusion Criteria:

  • Unwillingness to participate on the survey

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
bowel endometriosis
laparoscopic colonic resection
Procedure: laparoscopic colonic surgery
women with typical symptoms including pelvic pain, infertility and endometriotic bowel lesions who underwent laparoscopic surgery including colonic resection performed from 2009 to 2012

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual analog scala for pain
Time Frame: one year after the operation
comparison of pain before and after the operation (one year later), value 0 til 10; 0= no pain, 10= strong pain
one year after the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dyspareunia
Time Frame: one year after the operation
comparison of dyspareunia before and one year after the operation
one year after the operation
dysuria
Time Frame: one year after operation
comparison of dysuria before and one year after the operation
one year after operation
obstipation
Time Frame: one year after operation
comparison of obstipation before and one year after the operation
one year after operation
pain during defecation
Time Frame: one year after operation
comparison of pain during defecation before and one year after the operation
one year after operation
rectal bleeding
Time Frame: one year after operation
comparison of rectal bleeding during menstruation before and one year after the operation
one year after operation

Collaborators and Investigators

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

Sponsor

Kepler University Hospital

Investigators

  • Study Chair: Andreas Shamiyeh, Univ-Prof.Dr, Ludwig Boltzmann Institute for Operative Laparoscopy, 2nd Surgical Department, Academic Teaching Hospital, AKH Linz

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

April 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

March 30, 2014

First Submitted That Met QC Criteria

April 2, 2014

First Posted (Estimated)

April 3, 2014

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENCO-014 (Other Identifier: 2nd Surgical Department, General Hospital, Linz)

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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