Effect of Barbed Suture Fascia Closure on Incisional Hernia in Midline Laparotomy for Gynecological Diseases (BARBHER)
Not Applicable
- Conditions
- Gynecologic Disease
- Interventions
- Device: Barbed PDS suture (STRATAFIX Symmetric PDS Plus)Device: Non-barbed PDS suture (PDS Plus)
- Registration Number
- NCT04643197
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Investigators will compare the incidence of incisional hernia in women who underwent midline laparotomy whose abdominal fascia was closed with barbed suture vs. conventional non-barbed suture.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 174
Inclusion Criteria
- Anticipating midline laparotomy for gynecologic diseases
- ECOG performance status 0 - 2
Exclusion Criteria
- Previous or current abdominal incisional hernia
- Pregnant
- Previous radiation on abdomen area
- Allergy to PDS or irgacare MP
- Having disease affecting wound healing such as uncontrolled DM, autoimmune vasculitis, liver cirrhosis, coagulopathy
- BMI > 35
- Current or anticipated use of drugs affecting wound healing such as bevacizumab (with 4 week drug free period, bevacizumab user is eligible)
- Abdominal midline laparotomy within 6 months
- Surgery for infection control
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Experimental arm Barbed PDS suture (STRATAFIX Symmetric PDS Plus) Abdominal fascia will be closed with barbed suture. Control Non-barbed PDS suture (PDS Plus) Abdominal fascia will be closed with non-barbed suture.
- Primary Outcome Measures
Name Time Method Cumulative incidence of incisional hernia from surgery to 1 year Incisional hernia till 1 year after surgery
- Secondary Outcome Measures
Name Time Method Time-event curve of incisional hernia from surgery to 1 year Cumulative incidence of surgical site infection from surgery to 4weeks Incidence of wound dehiscence post-surgery 4weeks Brief Pain Inventory - Korean (BPI-K) score Baseline, postoperative day 2, 4 Pain measured with BPI-K Specifically score (0-10 all domain, higher score mean worse outcome) in domain of worst pain, least pain, average pain, current pain, impact of pain in general activity, mood, work, relationship, ambulation, sleep and happiness
Treatment related adverse event from surgery to 1 year NRS from surgery to postoperative 4 day pain captured by NRS in nursing record, 0-10, higher score means more pain