Fascial Closure Technique After Gynecologic Laparoscopic Surgery and Postoperative Pain

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Device: Traditional Direct Fascial Closure; Device: Fascial Closure Device

• Registration Number: NCT04765306
• Lead Sponsor: Jessica G Putman

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-19
• Study First Posted: 2021-02-21
• Study Start: 2021-03-05
• Primary Completion: 2022-03-17
• Study Completion: 2022-04-14
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-10
• Last Update Posted: 2022-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 123

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Direct Fascial Closure	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.
Fascial Closure Device	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.

Primary Outcome Measures

Name	Time	Method
Postoperative pain scores via Visual Analog Scale	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 Outcome Measures

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

Trial Locations

Locations (1)

Erlanger Baroness Hospital; 🇺🇸 Chattanooga, Tennessee, United States