NCT01953250

Brief Summary

Questionnaire To assess the functional outcome in patients that underwent laparoscopic sigmoid and/or rectum resection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
143

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

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

June 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 30, 2013

Completed
Last Updated

September 30, 2013

Status Verified

April 1, 2012

Enrollment Period

1 year

First QC Date

February 19, 2013

Last Update Submit

September 25, 2013

Conditions

Endometriosis

Keywords

Deep infiltrating endometriosisLaparoscopic sigmoid resectionlaparoscopic rectum resectionColorectal surgery

Outcome Measures

Primary Outcomes (1)

  • ColoRectal Functional Outcome

    Operation: between 1997 and 2011 Questionnaire to assess the colorectal function sent once in 2012

    1 day

Study Arms (1)

Infiltrating endometriosis

272 patients that underwent laparoscopic sigmoid and/or rectum resection with the indication of deep infiltrating endometriosis, in the department of Abdominal Surgery, University Hospital Leuven, between the year 1997 and September 2011.

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

272 patients that underwent laparoscopic sigmoid and/or rectum resection with the indication of deep infiltrating endometriosis

You may qualify if:

  • Patients that underwent laparoscopic sigmoid and/or rectum resection with the indication of deep infiltrating endometriosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinics Gasthuisberg

Leuven, Flemish Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • André JL D'Hoore, PhD

    University Clinics Gasthuisberg Department of Abdominal Surgery

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 19, 2013

First Posted

September 30, 2013

Study Start

June 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

September 30, 2013

Record last verified: 2012-04

Locations

BE(1)