Pain, Postoperative
Conditions
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.
Interventions
DEVICETraditional Direct Fascial Closure
Fascial closure using traditional surgical instruments and suture without laparoscopic guidance.
DEVICEFascial Closure Device
Fascial closure using a fascial closure device under direct laparoscopic guidance.
Sponsors
Jessica G Putman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain scores via Visual Analog Scale | Through 2 weeks postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantity of narcotics consumed in postoperative period | Through 2 weeks postoperatively | Number of tablets of narcotics consumed in postoperative period |
| Length of hospital stay | Through study completion, up to 6 months | Length of hospital stay in days from day of surgery until discharge home |
| Postoperative complication | Through 6 weeks postoperatively | Postoperative incisional infection, postoperative incisional hernia |
| Fascial closure operating time | Duration of 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. |
Countries
United States
Outcome results
None listed