Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Direct Fascial Closure | Active Comparator | 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. |
|
| Fascial Closure Device | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional Direct Fascial Closure | Device | Fascial closure using traditional surgical instruments and suture without laparoscopic guidance. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Todd Boren, MD | University of Tennessee College of Medicine Gynecology Oncology | Principal Investigator |
| Jessica G Putman, MD | University of Tennessee Chattanooga Minimally Invasive Gynecologic Surgery Fellow | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erlanger Baroness Hospital | Chattanooga | Tennessee | 37403 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
| Fascial Closure Device | Device | Fascial closure using a fascial closure device under direct laparoscopic guidance. |
|
| 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 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |