NCT04982653

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Quality-of-Life Assessment	Ancillary studies
PROCEDURE	Surgical Procedure	Undergo hepatectomy using small bites fascial method for abdominal wall closure
PROCEDURE	Surgical Procedure	Undergo hepatectomy using conventional fascial method for abdominal wall closure

Timeline

• Start date: 2022-01-04
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2021-07-29
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States