Retrospective Analysis of Results of Surgery for Deep Bow... | NCT04669769

Studies
Retrospective Analysis of Results of Surgery for Deep Bowel Endometriosis

NCT04669769

Sponsor

University Hospital Muenster

Status

Completed

Last Update Posted

Dec 17, 2020Actual

Enrollment

151Actual

Phase

Not provided

Conditions

Endometriosis
Deep Endometriosis
Bowel Endometriosis
Reproductive Issues
Complication

Interventions

interview

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2019Actual

Primary Completion Date

May 1, 2020Actual

Completion Date

Dec 4, 2020Actual

First Submitted Date

Dec 4, 2020

First Submission Date that Met QC Criteria

Dec 9, 2020

First Posted Date

Dec 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2020

Last Update Posted Date

Dec 17, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. med. Sebastian Daniel Schäfer, Head of Gynecology, University Hospital MuensterPrincipal Investigator

Lead Sponsor

University Hospital MuensterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

151Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
interview	Other	telephone interview	disc resection multifocal segmental resection shaving

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
pregnancy rate	pregancy after surgery	up to 10 years
live birth	live birth after surgery	up to 10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sebastian D Schaefer, MD PhD	University Hospital Muenster, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Muenster		Münster	North Rhine-Westphalia	48149	Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

will be shared upon reasonable request and according to regulations

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004715	Endometriosis

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007407	Interviews as Topic

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided