Retrospective Analysis of Results of Surgery for Deep Bowel Endometriosis

December 9, 2020 updated by: Dr. med. Sebastian Daniel Schäfer, University Hospital Muenster

Retrospective Analysis of Outcomes After Surgery for Deep Infiltrating Endometriosis of the Bowel

identification of patients operated becaus of bowel endometriosis at the endometriosis center, University Hospital Muenster, Germany, starting 2009, Analysis of Patient history, surgical procedurie, intraoperative complications, postoperative complications, phone call assessing further complications, complaints after surgery, pregnancy, live birth, additional surgery, spontaneous conception, conception by IUI, ART

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

151

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

  • Germany
    • NRW
      • Münster, NRW, Germany, 48149
        • University Hospital Muenster

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 50 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

patients treated because of deep Infiltrating bowel endometriosis at the endometriosis Center, University Hospital Muenster, Germany starting 2009

Description

Inclusion Criteria:

  • deep Infiltrating endometriosis, surgery with complete or partial resection of bowel endometriosis or conservative Management, Treatment at endometriosis Center University Hospital Muenster, Germany, wants to participate

Exclusion Criteria:

  • declines participation

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
shaving
patients with DIE and shaving
Other: interview
telephone interview
disc resection
patients with DIE and Disc resection
Other: interview
telephone interview
segmental resection
patients with DIE and segmental resection
Other: interview
telephone interview
multifocal
patients with multifocal DIE having more than one bowel procedure
Other: interview
telephone interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications
Time Frame: up to 10 years
complications according to Clavien Dindo Classification
up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pregnancy rate
Time Frame: up to 10 years
pregancy after surgery
up to 10 years
live birth
Time Frame: up to 10 years
live birth after surgery
up to 10 years
pain recurrence
Time Frame: up to 10 years
pain recurrence after operation
up to 10 years
disease recurrence
Time Frame: up to 10 years
disease recurrence after operation
up to 10 years
recurrent surgery
Time Frame: up to 10 years
recurrent surgery after surgery for bowel endometriosis
up to 10 years
pregnancy rate with ongoing bowel endometriosis
Time Frame: up to 10 years
pregnancy rate with ongoing bowel endometriosis
up to 10 years
live birth with ongoing bowel endometriosis
Time Frame: up to 10 years
live birth with ongoing bowel endometriosis
up to 10 years

Collaborators and Investigators

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

Sponsor

University Hospital Muenster

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)

December 1, 2019

Primary Completion (ACTUAL)

May 1, 2020

Study Completion (ACTUAL)

December 4, 2020

Study Registration Dates

First Submitted

December 4, 2020

First Submitted That Met QC Criteria

December 9, 2020

First Posted (ACTUAL)

December 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 9, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Schäfer_Endo_DIE_Bowel_Com

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

will be shared upon reasonable request and according to regulations

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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