Fascial Closure Technique After Gynecologic Laparoscopic Surgery and Postoperative Pain

Study Overview
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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.

Official Title
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Fascial Closure Technique After Gynecologic Laparoscopic Surgery and Postoperative Pain: a Randomized Controlled Trial

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Device: Traditional Direct Fascial Closure
* Device: Fascial Closure Device


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional Direct Fascial Closure<br>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<br>* Fascial closure using traditional surgical instruments and suture without laparoscopic guidance.<br>|
| Active Comparator: Fascial Closure Device<br>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<br>* Fascial closure using a fascial closure device under direct laparoscopic guidance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity of narcotics consumed in postoperative period | Number of tablets of narcotics consumed in postoperative period | Through 2 weeks postoperatively | 
| Length of hospital stay | Length of hospital stay in days from day of surgery until discharge home | Through study completion, up to 6 months | 
| Postoperative complication | Postoperative incisional infection, postoperative incisional hernia | Through 6 weeks postoperatively | 
| 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. | Duration of fascial closure operating time |