Fascial Closure Technique After Gynecologic Laparoscopic Surgery and Postoperative Pain

Overview

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.

Full Title of Study: “Fascial Closure Technique After Gynecologic Laparoscopic Surgery and Postoperative Pain: a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: September 2021

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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Postoperative pain scores via Visual Analog Scale
    • Time Frame: Through 2 weeks postoperatively
    • 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.

Secondary Measures

  • Quantity of narcotics consumed in postoperative period
    • Time Frame: Through 2 weeks postoperatively
    • Number of tablets of narcotics consumed in postoperative period
  • Length of hospital stay
    • Time Frame: Through study completion, up to 6 months
    • Length of hospital stay in days from day of surgery until discharge home
  • Postoperative complication
    • Time Frame: Through 6 weeks postoperatively
    • Postoperative incisional infection, postoperative incisional hernia
  • Fascial closure operating time
    • Time Frame: Duration of 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.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Jessica G Putman
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Jessica G Putman, Fellow Investigator – University of Tennessee
  • Overall Official(s)
    • Todd Boren, MD, Principal Investigator, University of Tennessee College of Medicine Gynecology Oncology
    • Jessica G Putman, MD, Study Director, University of Tennessee Chattanooga Minimally Invasive Gynecologic Surgery Fellow
  • Overall Contact(s)
    • Jessica G Putman, MD, (423) 778-2531, jessica.putman@erlanger.org

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