Trials Sponsors Conditions Drugs Pricing

Conditions

Endometriosis Endometriosis; Bowel Endometriosis, Rectum Endometriosis-related Pain

Outcome Measures

Primary Outcomes (2)

The proportion of patients experiencing one of the following symptoms at 12 months postoperatively:
* constipation (1 stool/\>5 consecutive days) * frequent bowel movement (≥3 stools/day) * defecation pain * anal incontinence (involuntary loss of gas or stools) * dysuria * bladder atony requiring self-catheterization
12 months postoperatively
The determination of possible risk factors for radical surgery.
based on patient complaints, preoperative imaging techniques and intra operative finding
3 months postoperatively

Study Arms (2)

Conservative surgery

Other: PROMS

Radical surgery (segmental resection)

Other: PROMS

Interventions

PROMSOther

Patient Reported Outcomes after different types of surgery for rectal endometriosis

Conservative surgeryRadical surgery (segmental resection)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 45 Years

Sexfemale

Age GroupsAdult (18-64)

Sampling MethodProbability Sample

Study Population

Women scheduled for a multidisciplinary laparoscopic surgery for rectal endometriosis.

You may qualify if:

Age: 18 - 45 years (both inclusive)

Sponsors & Collaborators

Universitaire Ziekenhuizen KU Leuven
Otherlead
Semmelweis University
Othercollaborator

Study Sites (2)

UZ Leuven

Leuven, 3000, Belgium

Semmelweis University Hospital

Budapest, Hungary

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

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

Study Officials

Carla Tomassetti, MD, PhD
UZ Leuven
PRINCIPAL INVESTIGATOR

Enrollment

294 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 16, 2019

First Posted

December 19, 2019

Study Start

December 9, 2019

Actual (reported)

Patient Reported Outcomes After Surgery for Rectal Endometriosis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Conservative surgery

Radical surgery (segmental resection)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Conservative surgery

Radical surgery (segmental resection)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations