Short Stitch Versus Traditional Suture for the Prevention of Incisional Hernia After Open Hepatectomy

May 22, 2026 updated by: M.D. Anderson Cancer Center

Incisional Hernia Prevention After Open Hepatectomy by Small Tissue Bite Fascial Closure: A Randomized Clinical Trial

This clinical trial compares two different kinds of surgical closing techniques, short stitch suture or traditional suture, in patients who are having liver tumor surgery. This study may help researchers learn if one technique can lower the chances of developing a hole in the wall of the abdomen (an abdominal hernia) at the incision site better than the other.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

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.

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Timothy E. Newhook

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing hepatectomy for malignant diagnosis (primary or secondary) from 5/1/2021 through 11/1/2024 will be eligible for inclusion in this study
  • Elective surgery
  • Age >= 18
  • Planned midline laparotomy incision or inverted-L incision

Exclusion Criteria:

  • Pre-existing abdominal hernia
  • History of mesh placement at prior laparotomy
  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (hepatectomy using small bites fascial closure)
Patients undergo hepatectomy as planned using small bites fascial method for abdominal wall closure.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Procedure: Surgical Procedure
Undergo hepatectomy using small bites fascial method for abdominal wall closure
Other Names:
  • Operation
  • Surgery
  • Surgical
  • Surgical Intervention
  • Surgical Interventions
  • Surgical Procedures
  • Type of Surgery
Procedure: Surgical Procedure
Undergo hepatectomy using conventional fascial method for abdominal wall closure
Other Names:
  • Operation
  • Surgery
  • Surgical
  • Surgical Intervention
  • Surgical Interventions
  • Surgical Procedures
  • Type of Surgery
Active Comparator: Arm II (hepatectomy using conventional fascial method)
Patients undergo hepatectomy as planned using conventional fascial method for abdominal wall closure.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Procedure: Surgical Procedure
Undergo hepatectomy using small bites fascial method for abdominal wall closure
Other Names:
  • Operation
  • Surgery
  • Surgical
  • Surgical Intervention
  • Surgical Interventions
  • Surgical Procedures
  • Type of Surgery
Procedure: Surgical Procedure
Undergo hepatectomy using conventional fascial method for abdominal wall closure
Other Names:
  • Operation
  • Surgery
  • Surgical
  • Surgical Intervention
  • Surgical Interventions
  • Surgical Procedures
  • Type of Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic incidence rate of incisional hernia
Time Frame: Up to 12 months after surgery
Definition of incisional hernia will be based on the European Hernia Society: Any abdominal wall gap with or without a bulge in the area of a postoperative scar perceptible or palpable by clinical examination or imaging. Assessment of the primary outcome will occur at 3, 6, and 12 months with a computed tomography scan/magnetic resonance imaging. Scans will be read and assessed for incisional hernia by 3 independent assessors blinded to the allocation. A correlation coefficient will be determined for their assessments. The cumulative incidence rate of incisional hernia at 12 months will be estimated, along with the 95% confidence interval.
Up to 12 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical site infection
Time Frame: Up to 90 days after surgery
Up to 90 days after surgery
Surgical site occurrence
Time Frame: Up to 90 days after surgery
Up to 90 days after surgery
Surgical site occurrence requiring procedural intervention
Time Frame: Up to 90 days after surgery
Up to 90 days after surgery
Postoperative complications
Time Frame: Up to 90 days after surgery
Post-operative infection, complication or pain will be assessed using Chi-squared test or Fisher's exact test.
Up to 90 days after surgery
Need for reoperation
Time Frame: Up to 90 days after surgery
Up to 90 days after surgery
Need for reoperation secondary to complication of abdominal closure
Time Frame: Up to 90 days after surgery
Up to 90 days after surgery
Length of hospital stay (postoperatively)
Time Frame: Up to 90 days after surgery
Will be compared between the two arms using two-sample t-test or Wilcoxon rank sum test.
Up to 90 days after surgery
Any readmission related to hernia repair
Time Frame: Up to 30 days after surgery
Up to 30 days after surgery
Health-related quality of life assessment
Time Frame: Up to 12 months after surgery
Will use linear mixed effect modeling to assess the effects of time, arm as well as the interaction between arm and time.
Up to 12 months after surgery
Incidence of adverse events (AEs)
Time Frame: Up to 90 days after surgery
Will be summarized using descriptive statistics (frequency, percentage) by arm, AE type, severity and attribution.
Up to 90 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Timothy E Newhook, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2022

Primary Completion (Estimated)

February 2, 2027

Study Completion (Estimated)

February 2, 2027

Study Registration Dates

First Submitted

June 18, 2021

First Submitted That Met QC Criteria

July 20, 2021

First Posted (Actual)

July 29, 2021

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0254 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2021-04402 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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