Back to resultsFascial Closure Technique After Gynecologic Laparoscopic Surgery and Postoperative Pain
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Traditional Direct Fascial Closure
Fascial Closure Device
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
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.
Sites / Locations
- Erlanger Baroness Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Traditional Direct Fascial Closure
Fascial Closure Device
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Quantity of narcotics consumed in postoperative period
Number of tablets of narcotics consumed in postoperative period
Length of hospital stay
Length of hospital stay in days from day of surgery until discharge home
Postoperative complication
Postoperative incisional infection, postoperative incisional hernia
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04765306
Brief Title
Fascial Closure Technique After Gynecologic Laparoscopic Surgery and Postoperative Pain
Official Title
Fascial Closure Technique After Gynecologic Laparoscopic Surgery and Postoperative Pain: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
March 17, 2022 (Actual)
Study Completion Date
April 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jessica G Putman
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
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.
Allocation
Randomized
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional Direct Fascial Closure
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Fascial Closure Device
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Traditional Direct Fascial Closure
Intervention Description
Fascial closure using traditional surgical instruments and suture without laparoscopic guidance.
Intervention Type
Device
Intervention Name(s)
Fascial Closure Device
Intervention Description
Fascial closure using a fascial closure device under direct laparoscopic guidance.
Primary Outcome Measure Information:
Title
Postoperative pain scores via Visual Analog Scale
Description
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
Secondary Outcome Measure Information:
Title
Quantity of narcotics consumed in postoperative period
Description
Number of tablets of narcotics consumed in postoperative period
Time Frame
Through 2 weeks postoperatively
Title
Length of hospital stay
Description
Length of hospital stay in days from day of surgery until discharge home
Time Frame
Through study completion, up to 6 months
Title
Postoperative complication
Description
Postoperative incisional infection, postoperative incisional hernia
Time Frame
Through 6 weeks postoperatively
Title
Fascial closure operating time
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd Boren, MD
Organizational Affiliation
University of Tennessee College of Medicine Gynecology Oncology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jessica G Putman, MD
Organizational Affiliation
University of Tennessee Chattanooga Minimally Invasive Gynecologic Surgery Fellow
Official's Role
Study Director
Facility Information:
Facility Name
Erlanger Baroness Hospital
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Fascial Closure Technique After Gynecologic Laparoscopic Surgery and Postoperative Pain
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