Fascial Closure Technique After Gynecologic Laparoscopic Surgery and Postoperative Pain

• Sponsor: Jessica G Putman (Other)
• Overall Status: Completed
• CT.gov ID: NCT04765306
• Collaborator: (none)
• Enrollment: 123
• Location: 1
• Arms: 2
• Actual Duration (Months): 13.3
• Patients Per Site Per Month: 9.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Device: Traditional Direct Fascial Closure; Device: Fascial Closure Device	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 123 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Masking Description: This will be a prospective, singled-blinded, randomized controlled study. Eligible patients who provide consent will be randomized into one of two arms either undergoing fascial closure with a fascial closure device or traditional direct closure on the day of surgery. Every patient will have equal probability of being assigned to either study arm. The patients will be blinded to which study arm they have been assigned to, but providers will be aware due to the nature of study topic.
• Primary Purpose: Treatment
• Official Title: Fascial Closure Technique After Gynecologic Laparoscopic Surgery and Postoperative Pain: a Randomized Controlled Trial
• Actual Study Start Date: Mar 5, 2021
• Actual Primary Completion Date: Mar 17, 2022
• Actual Study Completion Date: Apr 14, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Quantity of narcotics consumed in postoperative period [Through 2 weeks postoperatively]

   Number of tablets of narcotics consumed in postoperative period

2. Length of hospital stay [Through study completion, up to 6 months]

   Length of hospital stay in days from day of surgery until discharge home

3. Postoperative complication [Through 6 weeks postoperatively]

   Postoperative incisional infection, postoperative incisional hernia

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Erlanger Baroness Hospital	Chattanooga	Tennessee	United States	37403

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jessica G Putman, Fellow Investigator, University of Tennessee
• ClinicalTrials.gov Identifier: NCT04765306
• Other Study ID Numbers: 21-004
• First Posted: Feb 21, 2021
• Last Update Posted: May 12, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of May 12, 2022