Fascial Closure Technique After Gynecologic Laparoscopic Surgery and Postoperative Pain

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04765306
• Other study ID #: 21-004
• Status: Completed
• Phase: N/A
• Start date: March 5, 2021
• Est. completion date: April 14, 2022

Study information

• Verified date: May 2022
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: April 14, 2022
• Est. primary completion date: March 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Device:
• Traditional Direct Fascial Closure
Fascial closure using traditional surgical instruments and suture without laparoscopic guidance.
• Fascial Closure Device
Fascial closure using a fascial closure device under direct laparoscopic guidance.

Locations

Country	Name	City	State
United States	Erlanger Baroness Hospital	Chattanooga	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Jessica G Putman

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quantity of narcotics consumed in postoperative period	Number of tablets of narcotics consumed in postoperative period	Through 2 weeks postoperatively
Secondary	Length of hospital stay	Length of hospital stay in days from day of surgery until discharge home	Through study completion, up to 6 months
Secondary	Postoperative complication	Postoperative incisional infection, postoperative incisional hernia	Through 6 weeks postoperatively
Secondary	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