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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
123
Fascial closure using traditional surgical instruments and suture without laparoscopic guidance.
Fascial closure using a fascial closure device under direct laparoscopic guidance.
Erlanger Baroness Hospital
Chattanooga, Tennessee, United States
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.
Time frame: Through 2 weeks postoperatively
Quantity of narcotics consumed in postoperative period
Number of tablets of narcotics consumed in postoperative period
Time frame: Through 2 weeks postoperatively
Length of hospital stay
Length of hospital stay in days from day of surgery until discharge home
Time frame: Through study completion, up to 6 months
Postoperative complication
Postoperative incisional infection, postoperative incisional hernia
Time frame: 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.
Time frame: Duration of fascial closure operating time
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