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

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: Metastatic Malignant Neoplasm in the Liver; Primary Malignant Liver Neoplasm; Liver and Intrahepatic Bile Duct Neoplasm
• Intervention / Treatment: Other: Quality-of-Life Assessment; Procedure: Surgical Procedure; Procedure: Surgical Procedure

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

• Study Contact: Name: Timothy E Newhook, MD; Phone Number: 713-792-6940; Email: TNewhook@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Timothy E. Newhook; Phone Number: 713-792-6940; Email: tnewhook@mdanderson.org
      • Principal Investigator: Timothy E. Newhook

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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		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	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		Up to 90 days after surgery
Need for reoperation secondary to complication of abdominal closure		Up to 90 days after surgery
Length of hospital stay (postoperatively)	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		Up to 30 days after surgery
Health-related quality of life assessment	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)	Will be summarized using descriptive statistics (frequency, percentage) by arm, AE type, severity and attribution.	Up to 90 days after surgery

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2022
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026

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 (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Site; Postoperative Complications; Digestive System Neoplasms; Liver Diseases; Pathological Conditions, Anatomical; Biliary Tract Diseases; Hernia; Bile Duct Diseases; Biliary Tract Neoplasms; Neoplasms; Liver Neoplasms; Incisional Hernia; Bile Duct Neoplasms
• 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