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
  Purpose

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.


Condition Intervention Phase
Endometriosis
Procedure: laparoscopy
Procedure: laparotomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study Comparing Laparoscopy Versus Laparotomy in the Treatment of Colorectal Endometriosis

Resource links provided by NLM:


Further study details as provided by Tenon Hospital, Paris:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 52
Study Start Date: January 2006
Estimated Study Completion Date: September 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
laparoscopy
Procedure: laparoscopy
colorectal resection
Experimental: 2
laparotomy
Procedure: laparotomy
colorectal resection

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939861

Locations
France
Tenon Hospital, Departement of Obstetrics and Gynecology
Paris, France, 75020
Sponsors and Collaborators
Tenon Hospital, Paris
Investigators
Principal Investigator: emile Daraï, MD,PhD AP-HP
  More Information

No publications provided

Responsible Party: Emile Daraï, Departement of Obstetrics and Gynecology, Tenon Hospital
ClinicalTrials.gov Identifier: NCT00939861     History of Changes
Other Study ID Numbers: 13072009
Study First Received: July 14, 2009
Last Updated: July 14, 2009
Health Authority: France: French Data Protection Authority

Keywords provided by Tenon Hospital, Paris:
colorectal endometriosis, laparoscopy, laparotomy
gynecologic and digestive symptoms
quality of life (SF-36 questionnaire)
morbidity
fertility

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 16, 2014