Short Stitch Versus Traditional Suture for the Prevention of Incisional Hernia After Open Hepatectomy
NCT ID: NCT04982653
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
140 participants
INTERVENTIONAL
2022-01-04
2026-04-30
Brief Summary
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Detailed Description
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I. To assess whether small bites abdominal wall closure reduces the risk of developing incisional hernia following liver surgery.
SECONDARY OBJECTIVES:
I. To compare short-term perioperative outcomes between small bites and typical fascial closure technique.
II. To assess the hernia incidence rate of short stich versus (vs.) standard closure in subgroups of patients with inverted-L or midline incisions.
III. To assess the hernia incidence rate of Kawaguchi-Gayet hepatectomy complexity classifications I/II vs. III (hernia rate by extent of hepatectomy).
IV. To assess the hernia incidence rate of preoperative chemotherapy or no preoperative chemotherapy (hernia rate by exposure to preoperative chemotherapy).
V. To assess impact of small bites abdominal wall closure on health care quality of life following liver surgery.
VI. To assess safety of small tissue bites fascial closure suture technique versus conventional fascial closure following hepatectomy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (INTERVENTION): Patients undergo hepatectomy as planned using small bites fascial method for abdominal wall closure.
ARM II (CONTROL): Patients undergo hepatectomy as planned using conventional fascial method for abdominal wall closure.
After completion of study, patients are followed up at 1-4 weeks, and then at 3, 6, and 12 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Arm I (hepatectomy using small bites fascial closure)
Patients undergo hepatectomy as planned using small bites fascial method for abdominal wall closure.
Quality-of-Life Assessment
Ancillary studies
Surgical Procedure
Undergo hepatectomy using small bites fascial method for abdominal wall closure
Arm II (hepatectomy using conventional fascial method)
Patients undergo hepatectomy as planned using conventional fascial method for abdominal wall closure.
Quality-of-Life Assessment
Ancillary studies
Surgical Procedure
Undergo hepatectomy using conventional fascial method for abdominal wall closure
Interventions
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Quality-of-Life Assessment
Ancillary studies
Surgical Procedure
Undergo hepatectomy using small bites fascial method for abdominal wall closure
Surgical Procedure
Undergo hepatectomy using conventional fascial method for abdominal wall closure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Elective surgery
* Age \>= 18
* Planned midline laparotomy incision or inverted-L incision
Exclusion Criteria
* History of mesh placement at prior laparotomy
* Pregnant women
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Timothy E Newhook, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Timothy E. Newhook
Role: primary
Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2021-04402
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-0254
Identifier Type: OTHER
Identifier Source: secondary_id
2021-0254
Identifier Type: -
Identifier Source: org_study_id