Fascial Closure Technique After Gynecologic Laparoscopic Surgery and Postoperative Pain

NCT04765306 | Completed FDA Device

• 1 other identifier: 21-004
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Quantity of narcotics consumed in postoperative period

  Through 2 weeks postoperatively

• Length of hospital stay

  Through study completion, up to 6 months

• Postoperative complication

  Through 6 weeks postoperatively

• Fascial closure operating time

  Duration of fascial closure operating time

Study Arms (2)

Traditional Direct Fascial Closure

ACTIVE COMPARATOR

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 Device

ACTIVE COMPARATOR

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

Interventions

Traditional Direct Fascial Closure DEVICE

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

Traditional Direct Fascial Closure

Fascial Closure Device DEVICE

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

Fascial Closure Device

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jessica G Putman: lead

Study Sites (1)

Erlanger Baroness Hospital

Chattanooga, Tennessee, 37403, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Todd Boren, MD

  University of Tennessee College of Medicine Gynecology Oncology

  PRINCIPAL INVESTIGATOR

• Jessica G Putman, MD

  University of Tennessee Chattanooga Minimally Invasive Gynecologic Surgery Fellow

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Fellow Investigator

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 21, 2021
• Study Start: March 5, 2021
• Primary Completion: March 17, 2022
• Study Completion: April 14, 2022
• Last Updated: May 12, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)