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

NCT04982653 | Recruiting Phase 2 DMC

• 2 other identifiers: 2021-0254NCI-2021-04402
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver and Intrahepatic Bile Duct Neoplasm; Metastatic Malignant Neoplasm in the Liver; Primary Malignant Liver Neoplasm

Outcome Measures

Primary Outcomes (1)

• Radiographic incidence rate of incisional hernia

  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 Outcomes (10)

• Surgical site infection

  Up to 90 days after surgery

• Surgical site occurrence

  Up to 90 days after surgery

• Surgical site occurrence requiring procedural intervention

  Up to 90 days after surgery

• Postoperative complications

  Up to 90 days after surgery

• Need for reoperation

  Up to 90 days after surgery

Study Arms (2)

Arm I (hepatectomy using small bites fascial closure)

EXPERIMENTAL

Patients undergo hepatectomy as planned using small bites fascial method for abdominal wall closure.

Other: Quality-of-Life Assessment; Procedure: Surgical Procedure

Arm II (hepatectomy using conventional fascial method)

ACTIVE COMPARATOR

Patients undergo hepatectomy as planned using conventional fascial method for abdominal wall closure.

Other: Quality-of-Life Assessment; Procedure: Surgical Procedure

Interventions

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (hepatectomy using small bites fascial closure); Arm II (hepatectomy using conventional fascial method)

Surgical Procedure PROCEDURE

Undergo hepatectomy using small bites fascial method for abdominal wall closure

Also known as: Operation, Surgery, Surgical, Surgical Intervention, Surgical Interventions, Surgical Procedures, Type of Surgery

Arm I (hepatectomy using small bites fascial closure)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective surgery
• Age \>= 18
• Planned midline laparotomy incision or inverted-L incision

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Timothy E Newhook, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy E Newhook, MD

CONTACT

713-792-6940; TNewhook@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: July 29, 2021
• Study Start: January 4, 2022
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)