Laparoscopy Versus Laparotomy for Colorectal Endometriosis

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2009 by Tenon Hospital, Paris.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Tenon Hospital, Paris

ClinicalTrials.gov Identifier:

NCT00939861

First received: July 14, 2009

Last updated: NA

Last verified: July 2009

History: No changes posted

Tracking Information

First Received Date ^ICMJE

July 14, 2009

Last Updated Date

July 14, 2009

Start Date ^ICMJE

January 2006

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Evaluation of dyschesia at 6 months using a visual analogue scale [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]
Evaluation of quality of life at 6 months using SF-36 questionnaire [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]
Morbidity [ Time Frame: During 6 months ] [ Designated as safety issue: Yes ]
Postoperative fertility [ Time Frame: during the study ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Laparoscopy Versus Laparotomy for Colorectal Endometriosis

Official Title ^ICMJE

Study Comparing Laparoscopy Versus Laparotomy in the Treatment of Colorectal Endometriosis

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.

Detailed Description

For all patients, colorectal endometriosis will be confirmed preoperatively by clinical examination, transvaginal sonography, rectal endoscopic sonography and magnetic resonance imaging.Among patients with an indication of surgery, the intensity of dyschesia and other gynecological or digestive disorders will be evaluated pre-operatively using a visual analogue scale. Quality of life will be assessed using the SF-36 questionnaire. The allocation of the surgical route will be conducted by lottery the day before surgery. Patients will be reviewed postoperatively at 1 month and a new assessment of symptoms will be made at 6 months. The duration of the study will be 7 months for the patient and 24 months in total.If considering the two surgical routes as equivalent, with a delta score (after-before surgery) = ±2, standard deviation = 1.55, risk α=2.5%, risk β=10%, and taking into account that prevalence of dyschesia in the study population is 63%, 52 patients will be included.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Endometriosis

Intervention ^ICMJE

Procedure: laparoscopy
colorectal resection
Procedure: laparotomy
colorectal resection

Study Arm (s)

Experimental: 1
laparoscopy

Intervention: Procedure: laparoscopy
Experimental: 2
laparotomy

Intervention: Procedure: laparotomy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

September 2009

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

patients with prior colorectal surgery
patients with a contraindication to laparoscopy

Gender

Female

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00939861

Other Study ID Numbers ^ICMJE

13072009

Has Data Monitoring Committee

Responsible Party

Emile Daraï, Departement of Obstetrics and Gynecology, Tenon Hospital

Study Sponsor ^ICMJE

Tenon Hospital, Paris

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

emile Daraï, MD,PhD

AP-HP

Information Provided By

Tenon Hospital, Paris

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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