Effect of Barbed Suture Fascia Closure on Incisional Hernia in Midline Laparotomy for Gynecological Diseases (BARBHER)

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Barbed Suture Fascia Closure on Incisional Hernia in Midline Laparotomy for Gynecological Disease (BARBHER)

Conditions
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Gynecologic Disease

Intervention / Treatment
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* Device: Barbed PDS suture (STRATAFIX Symmetric PDS Plus)
* Device: Non-barbed PDS suture (PDS Plus)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 2*2 factorial design Primary randomization: Barbed suture vs. Non-barbed suture in fascia closure Secondary randomization: subcutaneous drain insertion vs. non-insertion The effect of secondary randomization is one of secondary objectives.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental arm<br>Abdominal fascia will be closed with barbed suture. | Device: Barbed PDS suture (STRATAFIX Symmetric PDS Plus)<br>* STRATAFIX Symmetric PDS Plus is a barbed suture.<br>|
| Active Comparator: Control<br>Abdominal fascia will be closed with non-barbed suture. | Device: Non-barbed PDS suture (PDS Plus)<br>* Non-barbed suture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of incisional hernia | Incisional hernia till 1 year after surgery | from surgery to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Baseline, postoperative day 2, 4 | 
| Treatment related adverse event |  | from surgery to 1 year | 
| NRS | pain captured by NRS in nursing record, 0-10, higher score means more pain | from surgery to postoperative 4 day |