Benefits of Laparoscopy by Single Port Access for Adnexal Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Comparison Between Classic and Single Port Access Laparoscopy for Adnexal Surgery on Postoperative Pain: a Randomized Study.

Conditions
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Adnexal Pathology

Intervention / Treatment
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* Procedure: Adnexal surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Classic laparoscopy<br>Patients will undergo laparoscopy surgery with classic laparoscopy technic. | Procedure: Adnexal surgery<br> <br> |
| Experimental: Laparoscopy single port access<br>Patients will undergo laparoscopy surgery by single port access technic. | Procedure: Adnexal surgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain measured with visual analog scale |  | Postoperative pain evaluation at 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain measured with visual analog scale |  | 2 hours, 4 hours, 6 hours, 1 month | 
| timing in minutes between incision and suture |  | 4 hours | 
| Blood lost in milliliters (mls) |  | 1 hour | 
| Inpatient numbers of days |  | 1 month | 
| Non steroid anti inflammatory numbers of pills taken |  | 1 month | 
| number of convertion to laparotomy, Postoperative hernia |  | 1 month | 
| visual analog scale for cosmetic satisfaction |  | 1 year |