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Fascial Closure Technique After Gynecologic Laparoscopic Surgery and Postoperative Pain

NCT04765306 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2022-05-12

No results posted yet for this study

Summary

Our study aims to determine postoperative pain outcomes when comparing port site \> 10 mm fascial closure with traditional direct closure versus use of laparoscopic fascial closure device in patients undergoing minimally invasive gynecologic surgery via laparoscopic or robotic techniques. Pain outcomes will be measured using the visual analog scale.

Conditions

  • Pain, Postoperative

Interventions

DEVICE

Traditional Direct Fascial Closure

Fascial closure using traditional surgical instruments and suture without laparoscopic guidance.

DEVICE

Fascial Closure Device

Fascial closure using a fascial closure device under direct laparoscopic guidance.

Sponsors & Collaborators

  • Jessica G Putman

    lead OTHER

Principal Investigators

  • Todd Boren, MD · University of Tennessee College of Medicine Gynecology Oncology

  • Jessica G Putman, MD · University of Tennessee Chattanooga Minimally Invasive Gynecologic Surgery Fellow

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-05
Primary Completion
2022-03-17
Completion
2022-04-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04765306 on ClinicalTrials.gov