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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

July 14, 2009
July 14, 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 ] [ Designated as safety issue: Yes ]
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 ] [ 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 ]
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Endometriosis
  • Procedure: laparoscopy
    colorectal resection
  • Procedure: laparotomy
    colorectal resection
  • Experimental: 1
    laparoscopy
    Intervention: Procedure: laparoscopy
  • Experimental: 2
    laparotomy
    Intervention: Procedure: laparotomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
52
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
Female
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00939861
13072009
No
Emile Daraï, Departement of Obstetrics and Gynecology, Tenon Hospital
Tenon Hospital, Paris
Not Provided
Principal Investigator: emile Daraï, MD,PhD AP-HP
Tenon Hospital, Paris
July 2009

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