Fascial Closure Technique After Gynecologic Laparoscopic Surgery and Postoperative Pain

Jessica G Putman

Status: Completed

Conditions: Pain, Postoperative

Treatments: Device: Fascial Closure Device; Device: Traditional Direct Fascial Closure

Study type: Interventional

Funder types: Other

Identifiers

NCT04765306

21-004

Details and patient eligibility

About

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.

Enrollment: 123 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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123 participants in 2 patient groups

Traditional Direct Fascial Closure

Active Comparator group

Description:

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.

Treatment:

Device: Traditional Direct Fascial Closure

Fascial Closure Device

Active Comparator group

Description:

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.

Treatment:

Device: Fascial Closure Device