NCT02739724|Unknown
Benefits of Laparoscopy by Single Port Access for Adnexal Surgery
Comparison Between Classic and Single Port Access Laparoscopy for Adnexal Surgery on Postoperative Pain: a Randomized Study.
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Comparison Between Classic and Single Port Access Laparoscopy for Adnexal Surgery on Postoperative Pain: a Randomized Study.
Sponsor study identifier
Secondary identifiers
OTHER · AP-HM
interventional
108
1 country
1
Study Start
April 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2016
Date type not reportedThis date has not been verified as actual or estimated.
April 12, 2016
Actual (reported)April 15, 2016
Actual (reported)April 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Postoperative pain measured with visual analog scale
Postoperative pain evaluation at 24 hours
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
Patients will undergo laparoscopy surgery with classic laparoscopy technic.
Patients will undergo laparoscopy surgery by single port access technic.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Assistance Publique Hopitaux de Marseille
Marseille, 13354, France
Schmitt A, Crochet P, Pivano A, Tourette C, Faust C, Baumstarck K, Agostini A. The Effects of a Laparoscopy by Single-Port Endoscopic Access in Benign Adnexal Surgery: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2024 May;31(5):397-405. doi: 10.1016/j.jmig.2024.01.017. Epub 2024 Feb 2.
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.
Urielle DESALBRES
AP-HM
First Submitted
April 12, 2016
First Posted
April 15, 2016
Study Start
April 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2018
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 15, 2016
Record last verified: 2016-04
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