Adnexal Pathology Clinical Trial
Official title:
Comparison Between Classic and Single Port Access Laparoscopy for Adnexal Surgery on Postoperative Pain: a Randomized Study.
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.
| Status | Active, not recruiting |
| Enrollment | 108 |
| Est. completion date | April 2019 |
| Est. primary completion date | April 2018 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique Hopitaux de Marseille | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Postoperative pain measured with visual analog scale | Postoperative pain evaluation at 24 hours | No | |
| Secondary | Postoperative pain measured with visual analog scale | 2 hours, 4 hours, 6 hours, 1 month | No | |
| Secondary | timing in minutes between incision and suture | 4 hours | No | |
| Secondary | Blood lost in milliliters (mls) | 1 hour | Yes | |
| Secondary | Inpatient numbers of days | 1 month | No | |
| Secondary | Non steroid anti inflammatory numbers of pills taken | 1 month | Yes | |
| Secondary | number of convertion to laparotomy, Postoperative hernia | 1 month | Yes | |
| Secondary | visual analog scale for cosmetic satisfaction | 1 year | No |