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

Phase 2

Recruiting

Conditions: Metastatic Malignant Neoplasm in the Liver
Primary Malignant Liver Neoplasm
Liver and Intrahepatic Bile Duct Neoplasm

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

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.

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Arm II (hepatectomy using conventional fascial method)	Quality-of-Life Assessment	Patients undergo hepatectomy as planned using conventional fascial method for abdominal wall closure.
Arm I (hepatectomy using small bites fascial closure)	Surgical Procedure	Patients undergo hepatectomy as planned using small bites fascial method for abdominal wall closure.
Arm I (hepatectomy using small bites fascial closure)	Quality-of-Life Assessment	Patients undergo hepatectomy as planned using small bites fascial method for abdominal wall closure.
Arm II (hepatectomy using conventional fascial method)	Surgical Procedure	Patients undergo hepatectomy as planned using conventional fascial method for abdominal wall closure.

Primary Outcome Measures

Name	Time	Method
Radiographic incidence rate of incisional hernia	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 Outcome Measures

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