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

Not Applicable

• Conditions: Gynecologic Disease

• 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

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-11
• Study First Submitted QC: 2020-11-23
• Last Update Submitted: 2020-11-23
• Study First Posted: 2020-11-25
• Last Update Posted: 2020-11-25
• Study Start: 2020-12-01
• Primary Completion: 2023-05-30
• Study Completion: 2023-05-31

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

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
Cumulative incidence of surgical site infection	from surgery to 4weeks
Time-event curve of incisional hernia	from surgery to 1 year
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