NCT04669769

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

5 months

First QC Date

December 4, 2020

Last Update Submit

December 9, 2020

Conditions

Keywords

endometriosisdeep endometriosisbowel endometriosisconceptionARTspontaneous conceptionpregnancy rate

Outcome Measures

Primary Outcomes (1)

  • complications

    complications according to Clavien Dindo Classification

    up to 10 years

Secondary Outcomes (7)

  • pregnancy rate

    up to 10 years

  • live birth

    up to 10 years

  • pain recurrence

    up to 10 years

  • disease recurrence

    up to 10 years

  • recurrent surgery

    up to 10 years

  • +2 more secondary outcomes

Study Arms (4)

shaving

patients with DIE and shaving

Other: interview

disc resection

patients with DIE and Disc resection

Other: interview

segmental resection

patients with DIE and segmental resection

Other: interview

multifocal

patients with multifocal DIE having more than one bowel procedure

Other: interview

Interventions

telephone interview

disc resectionmultifocalsegmental resectionshaving

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • declines participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Muenster

Münster, North Rhine-Westphalia, 48149, Germany

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Sebastian D Schaefer, MD PhD

    University Hospital Muenster, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Gynecology

Study Record Dates

First Submitted

December 4, 2020

First Posted

December 17, 2020

Study Start

December 1, 2019

Primary Completion

May 1, 2020

Study Completion

December 4, 2020

Last Updated

December 17, 2020

Record last verified: 2020-12

Locations