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NCT Number: NCT04982653

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Timothy E. Newhook

CONTACT

[email protected]

713-792-6940

Timothy E. Newhook

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Surgical Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Surgical site infection

    Time frame: Up to 90 days after surgery

  2. Surgical site occurrence

    Time frame: Up to 90 days after surgery

  3. Surgical site occurrence requiring procedural intervention

    Time frame: Up to 90 days after surgery

  4. 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.

  5. Need for reoperation

    Time frame: Up to 90 days after surgery

  6. Need for reoperation secondary to complication of abdominal closure

    Time frame: Up to 90 days after surgery

  7. 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.

  8. Any readmission related to hernia repair

    Time frame: Up to 30 days after surgery

  9. 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.

  10. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Timothy E Newhook, MD

CONTACT

[email protected]

713-792-6940

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jul 29, 2021
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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