Laparoscopy Versus Laparotomy for Colorectal Endometriosis

Tenon Hospital, Paris

Status and phase: Unknown; Phase 3

Conditions: Endometriosis

Treatments: Procedure: laparotomy; Procedure: laparoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT00939861

13072009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

1

Experimental group

Description:

laparoscopy

Treatment:

Procedure: laparoscopy

2

Experimental group

Description:

laparotomy

Treatment:

Procedure: laparotomy