Laparoscopy Versus Laparotomy for Colorectal Endometriosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Tenon Hospital, Paris

July 14, 2009
July 15, 2009
July 15, 2009
January 2006
May 2009   (Final data collection date for primary outcome measure)
Evaluation of dyschesia at 6 months using a visual analogue scale [ Time Frame: at 6 months ]
Same as current
No Changes Posted
  • 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 ]
  • Evaluation of quality of life at 6 months using SF-36 questionnaire [ Time Frame: at 6 months ]
  • Morbidity [ Time Frame: During 6 months ]
  • Postoperative fertility [ Time Frame: during the study ]
Same as current
Not Provided
Not Provided
Laparoscopy Versus Laparotomy for Colorectal Endometriosis
Study Comparing Laparoscopy Versus Laparotomy in the Treatment of Colorectal Endometriosis
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.
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.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Procedure: laparoscopy
    colorectal resection
  • Procedure: laparotomy
    colorectal resection
  • Experimental: 1
    Intervention: Procedure: laparoscopy
  • Experimental: 2
    Intervention: Procedure: laparotomy
Touboul C, Ballester M, Dubernard G, Zilberman S, Thomin A, Daraï 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
September 2009
May 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Emile Daraï, Departement of Obstetrics and Gynecology, Tenon Hospital
Tenon Hospital, Paris
Not Provided
Principal Investigator: emile Daraï, MD,PhD Assistance Publique - Hôpitaux de Paris
Tenon Hospital, Paris
July 2009

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