Introduction Single port access (SPA) is a recent laparoscopic technic evaluated in several pathologies. Benefits of this technic is poorly reported concerning adnexal surgical procedures. Results of both randomised studies including adnexectomy and ovarian cystectomy are discordants. So it seems interesting to conduct a new study about this technic. Aim of this study is to compare postoperative pain after laparoscopic surgery for adnexal pathology by SPA or classic laparoscopy (CL). Materiel and Methods We purpose a monocentric-randomised study. Inclusion criteria are women over 18 years requiring laparoscopic surgery for adnexal pathology with stratification for procedure (adnexectomy or ovarian cystectomy). After informed consent, patients will be randomised in two groups: laparoscopy with SPA and laparoscopy with CL. The main objective is postoperative pain evaluation at 24 hours. Secondary objectives are characteristics and perioperative complications, duration of procedure, postoperative quality of life and immediate postoperative pain. We hypothesis laparoscopy with SPA reduces postoperative pain at 24 hours of 2 pts (analogic scale 0-10). The estimated size of population number is 54 per group and 108 for the study. Expected results We expected a significant decrease of postoperative pain with SPA technic. This data will be interesting to promote use of SPA technic for adnexal surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Assistance Publique Hopitaux de Marseille
Marseille, France
Postoperative pain measured with visual analog scale
Time frame: Postoperative pain evaluation at 24 hours
Postoperative pain measured with visual analog scale
Time frame: 2 hours, 4 hours, 6 hours, 1 month
timing in minutes between incision and suture
Time frame: 4 hours
Blood lost in milliliters (mls)
Time frame: 1 hour
Inpatient numbers of days
Time frame: 1 month
Non steroid anti inflammatory numbers of pills taken
Time frame: 1 month
number of convertion to laparotomy, Postoperative hernia
Time frame: 1 month
visual analog scale for cosmetic satisfaction
Time frame: 1 year
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