An interventional study of Adnexal surgery in Adnexal Pathology, sponsored by Assistance Publique Hopitaux De Marseille. Status unknown at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-15.
Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Treatment
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.
Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Patients will undergo laparoscopy surgery with classic laparoscopy technic.
Procedure: Adnexal surgery
Patients will undergo laparoscopy surgery by single port access technic.
Procedure: Adnexal surgery
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
Plan to share: No
This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Assistance Publique Hopitaux De Marseille