Endometriosis
Conditions
Keywords
colorectal endometriosis, laparoscopy, laparotomy, gynecologic and digestive symptoms, quality of life (SF-36 questionnaire), morbidity, fertility
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.
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.
Interventions
PROCEDURElaparoscopy
colorectal resection
PROCEDURElaparotomy
colorectal resection
Sponsors
Tenon Hospital, Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of dyschesia at 6 months using a visual analogue scale | at 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 | at 6 months |
| Evaluation of quality of life at 6 months using SF-36 questionnaire | at 6 months |
| Morbidity | During 6 months |
| Postoperative fertility | during the study |
Countries
France
Outcome results
None listed