Fascial Closure Technique After Gynecologic Laparoscopic Surgery and Postoperative Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-05

Study Completion Date

2022-04-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Traditional Direct Fascial Closure

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Fascial Closure Device

Intervention Type DEVICE

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

Interventions

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Traditional Direct Fascial Closure

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

Intervention Type DEVICE

Fascial Closure Device

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes