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Laparoscopy Versus Laparotomy for Colorectal Endometriosis

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ClinicalTrials.gov Identifier: NCT00939861
Recruitment Status : Unknown
Verified July 2009 by Tenon Hospital, Paris.
Recruitment status was:  Active, not recruiting
First Posted : July 15, 2009
Last Update Posted : July 15, 2009
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Endometriosis Procedure: laparoscopy Procedure: laparotomy Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study Comparing Laparoscopy Versus Laparotomy in the Treatment of Colorectal Endometriosis
Study Start Date : January 2006
Primary Completion Date : May 2009
Estimated Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
laparoscopy
Procedure: laparoscopy
colorectal resection
Experimental: 2
laparotomy
Procedure: laparotomy
colorectal resection


Outcome Measures

Primary Outcome Measures :
  1. Evaluation of dyschesia at 6 months using a visual analogue scale [ Time Frame: at 6 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. Evaluation of quality of life at 6 months using SF-36 questionnaire [ Time Frame: at 6 months ]
  3. Morbidity [ Time Frame: During 6 months ]
  4. Postoperative fertility [ Time Frame: during the study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Assistance Publique - Hôpitaux de Paris
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Emile Daraï, Departement of Obstetrics and Gynecology, Tenon Hospital
ClinicalTrials.gov Identifier: NCT00939861     History of Changes
Other Study ID Numbers: 13072009
First Posted: July 15, 2009    Key Record Dates
Last Update Posted: July 15, 2009
Last Verified: July 2009

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