NCT00939861

Brief Summary

Study hypothesis: equivalency of laparoscopic compared to laparotomic colorectal resection for endometriosis on digestive, gynaecologic, general symptoms and quality of life. Morbidity and fertility outcomes will also be evaluated.Primary purpose of the protocol is the evaluation of dyschesia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2006

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

July 15, 2009

Status Verified

July 1, 2009

Enrollment Period

3.3 years

First QC Date

July 14, 2009

Last Update Submit

July 14, 2009

Conditions

Endometriosis

Keywords

colorectal endometriosis, laparoscopy, laparotomygynecologic and digestive symptomsquality of life (SF-36 questionnaire)morbidityfertility

Outcome Measures

Primary Outcomes (1)

  • Evaluation of dyschesia at 6 months using a visual analogue scale

    at 6 months

Secondary Outcomes (4)

  • Evaluation of gynaecologic symptoms (dysmenorrhea, dyspareunia), digestive symptoms (diarrhea, constipation , intestinal cramps) and general symptoms (asthenia, back pain) at 6 months using visual analogue scale

    at 6 months

  • Evaluation of quality of life at 6 months using SF-36 questionnaire

    at 6 months

  • Morbidity

    During 6 months

  • Postoperative fertility

    during the study

Study Arms (2)

1

EXPERIMENTAL

laparoscopy

Procedure: laparoscopy

2

EXPERIMENTAL

laparotomy

Procedure: laparotomy

Interventions

laparoscopyPROCEDURE

colorectal resection

1
laparotomyPROCEDURE

colorectal resection

2

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients over 18 years old
  • patients with colorectal endometriosis
  • patients affiliated to the French Health Care system
  • patients having signed the inform consent.
  • patients who can speak and read French

You may not qualify if:

  • patients with prior colorectal surgery
  • patients with a contraindication to laparoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tenon Hospital, Departement of Obstetrics and Gynecology

Paris, Paris, 75020, France

Location

Related Publications (1)

  • Touboul C, Ballester M, Dubernard G, Zilberman S, Thomin A, Darai E. Long-term symptoms, quality of life, and fertility after colorectal resection for endometriosis: extended analysis of a randomized controlled trial comparing laparoscopically assisted to open surgery. Surg Endosc. 2015 Jul;29(7):1879-87. doi: 10.1007/s00464-014-3880-4. Epub 2014 Oct 8.

    PMID: 25294552DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

LaparoscopyLaparotomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • emile Daraï, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 14, 2009

First Posted

July 15, 2009

Study Start

January 1, 2006

Primary Completion

May 1, 2009

Study Completion

September 1, 2009

Last Updated

July 15, 2009

Record last verified: 2009-07

Locations

FR(1)