Clinical trial NCT02739724: Benefits of Laparoscopy by Single Port Access for Adnexal Surgery
Official title: Comparison Between Classic and Single Port Access Laparoscopy for Adnexal Surgery on Postoperative Pain: a Randomized Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adnexal Pathology
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

Presumed benign adnexal disease Adnexal pathologies treated between 7:00 AM and 10:00 PM Signed informed consent Patient presenting no contraindication to laparoscopy

Exclusion Criteria:

Salpingitis and twist annexes. The patient does not fluently read French.

Primary outcomes:
measure: Postoperative pain measured with visual analog scale
timeFrame: Postoperative pain evaluation at 24 hours
Secondary outcomes:
measure: Postoperative pain measured with visual analog scale
timeFrame: 2 hours, 4 hours, 6 hours, 1 month
measure: timing in minutes between incision and suture
timeFrame: 4 hours
measure: Blood lost in milliliters (mls)
timeFrame: 1 hour
measure: Inpatient numbers of days
timeFrame: 1 month
measure: Non steroid anti inflammatory numbers of pills taken
timeFrame: 1 month
measure: number of convertion to laparotomy, Postoperative hernia
timeFrame: 1 month
measure: visual analog scale for cosmetic satisfaction
timeFrame: 1 year
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: AP-HM
name: Urielle DESALBRES
role: STUDY_DIRECTOR
References:
citation: Schmitt A, Crochet P, Baumstark K, Tourette C, Poizac S, Pivano A, Boubli L, Cravello L, Agostini A. Effect of laparoscopy by single-port endoscopic access in benign adnexal surgery: study protocol for a randomized controlled trial. Trials. 2018 Jan 15;19(1):38. doi: 10.1186/s13063-017-2429-y.