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

M.D. Anderson Cancer Center

Status and phase: Enrolling; Phase 2

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04982653

NCI-2021-04402 (Registry Identifier)

2021-0254 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

Arm I (hepatectomy using small bites fascial closure)

Experimental group

Description:

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

Treatment:

Other: Quality-of-Life Assessment

Procedure: Surgical Procedure

Procedure: Surgical Procedure

Arm II (hepatectomy using conventional fascial method)

Active Comparator group

Description:

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

Treatment:

Other: Quality-of-Life Assessment

Procedure: Surgical Procedure

Procedure: Surgical Procedure