Fascial Closure Technique After Gynecologic Laparoscopic Surgery and Postoperative Pain

Fascial Closure Technique After Gynecologic Laparoscopic Surgery and Postoperative Pain: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Device: Traditional Direct Fascial Closure; Device: Fascial Closure Device

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Baroness Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients aged 18 or older.
• Any patient undergoing laparoscopic gynecologic surgery with one left upper quadrant port site > 10 mm via either robotic or traditional laparoscopic techniques for any indication including abnormal bleeding, pelvic pain, gynecologic cancer, uterine fibroids, etc. Procedures performed will include but not be limited to hysterectomy, bilateral or unilateral salpingoophorectomy, ovarian cystectomy, and pelvic floor support procedures.
• Patients willing and able to give informed consent.
• Patients capable and willing to return for follow up and complete pain diaries.

Exclusion Criteria:

• Patients unable to return for follow up.
• Patients undergoing laparoscopic surgery that requires conversion to laparotomy.
• Patients undergoing laparoscopic surgery that does not require a port site >10 mm.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional Direct Fascial Closure; At the beginning of the laparoscopic procedure, all patients will receive 5 mL of 0.5% ropivacaine into each laparoscopic incision site. Patients in this group will have fascia closed under traditional direct visualization without laparoscopic guidance using a single interrupted suture of 0-vicryl.	Device: Traditional Direct Fascial Closure; Fascial closure using traditional surgical instruments and suture without laparoscopic guidance.
Active Comparator: Fascial Closure Device; At the beginning of the laparoscopic procedure, all patients will receive 5 mL of 0.5% ropivacaine into each laparoscopic incision site. Patients in this group will have fascia closed using direct laparscopic visualization with the Carter-Thomason fascial closure device with a single interrupted suture of 0-vicryl.	Device: Fascial Closure Device; Fascial closure using a fascial closure device under direct laparoscopic guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain scores via Visual Analog Scale	A 20 mm difference in VAS score and a 2-unit difference on a 10-point pain scale have been described as a clinically significant difference between treatment groups.	Through 2 weeks postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantity of narcotics consumed in postoperative period	Number of tablets of narcotics consumed in postoperative period	Through 2 weeks postoperatively
Length of hospital stay	Length of hospital stay in days from day of surgery until discharge home	Through study completion, up to 6 months
Postoperative complication	Postoperative incisional infection, postoperative incisional hernia	Through 6 weeks postoperatively
Fascial closure operating time	Timing of fascial closure will start when the surgeon or surgical assistant reports s/he is beginning the fascial closure and stop after the suture is cut after tying.	Duration of fascial closure operating time

Collaborators and Investigators

• Sponsor: Jessica G Putman
• Investigators: Principal Investigator: Todd Boren, MD, University of Tennessee College of Medicine Gynecology Oncology; Study Director: Jessica G Putman, MD, University of Tennessee Chattanooga Minimally Invasive Gynecologic Surgery Fellow

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2021
• Primary Completion (Actual): March 17, 2022
• Study Completion (Actual): April 14, 2022

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: February 19, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 21-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes