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Suture Techniques for Preventing Incisional Hernia After Liver Surgery

Phase 2
Recruiting
Led By Timothy E Newhook
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Elective surgery
Planned midline laparotomy incision or inverted-L incision
Must not have
Pre-existing abdominal hernia
History of mesh placement at prior laparotomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 90 days after surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial compares two different kinds of surgical closing techniques for patients having liver tumor surgery. One technique may help lower the chances of developing a hole in the wall of the abdomen at the incision site.

Who is the study for?
This trial is for adults over 18 who are scheduled for elective liver tumor surgery (hepatectomy) due to cancer, between May 2021 and November 2024. They must be planning to have a specific type of incision made. Pregnant women, those with prior mesh placement from past surgeries, or pre-existing abdominal hernias cannot participate.
What is being tested?
The study is testing two surgical techniques used to close the incision after liver surgery: short stitch suture versus traditional suture. The goal is to determine which method better prevents an incisional hernia—a bulge through the site where the skin was cut.
What are the potential side effects?
While not drug-related, side effects may include discomfort at the incision site, risk of infection, potential complications leading to hernia with either technique, and varying recovery times based on individual healing processes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am planning to have elective surgery.
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I am scheduled for surgery with a specific type of incision.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a hernia in my abdomen.
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I have had mesh placed in a previous abdominal surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 90 days after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Radiographic incidence rate of incisional hernia
Secondary study objectives
Health-related quality of life assessment
Incidence of adverse events (AEs)
Length of hospital stay (postoperatively)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (hepatectomy using small bites fascial closure)Experimental Treatment2 Interventions
Patients undergo hepatectomy as planned using small bites fascial method for abdominal wall closure.
Group II: Arm II (hepatectomy using conventional fascial method)Active Control2 Interventions
Patients undergo hepatectomy as planned using conventional fascial method for abdominal wall closure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Surgical Procedure
2020
Completed Phase 2
~160

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,068 Previous Clinical Trials
1,802,539 Total Patients Enrolled
22 Trials studying Liver Cancer
9,398 Patients Enrolled for Liver Cancer
Timothy E NewhookPrincipal InvestigatorM.D. Anderson Cancer Center
Timothy E Newhook, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Short Stitch Suture Clinical Trial Eligibility Overview. Trial Name: NCT04982653 — Phase 2
Liver Cancer Research Study Groups: Arm I (hepatectomy using small bites fascial closure), Arm II (hepatectomy using conventional fascial method)
Liver Cancer Clinical Trial 2023: Short Stitch Suture Highlights & Side Effects. Trial Name: NCT04982653 — Phase 2
Short Stitch Suture 2023 Treatment Timeline for Medical Study. Trial Name: NCT04982653 — Phase 2
~47 spots leftby Apr 2026
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