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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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02739724
Enrollment
108
Registered
2016-04-15
Start date
2016-04-30
Completion date
2019-04-30
Last updated
2016-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adnexal Pathology

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.

Interventions

PROCEDUREAdnexal surgery

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Postoperative pain measured with visual analog scalePostoperative pain evaluation at 24 hours

Secondary

MeasureTime frame
Postoperative pain measured with visual analog scale2 hours, 4 hours, 6 hours, 1 month
timing in minutes between incision and suture4 hours
Blood lost in milliliters (mls)1 hour
Inpatient numbers of days1 month
Non steroid anti inflammatory numbers of pills taken1 month
number of convertion to laparotomy, Postoperative hernia1 month
visual analog scale for cosmetic satisfaction1 year

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026