Spots Global Cancer Trial Database for Short Stitch Versus Traditional Suture for the Prevention of Incisional Hernia After Open Hepatectomy

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

Official Title: Incisional Hernia Prevention After Open Hepatectomy by Small Tissue Bite Fascial Closure: A Randomized Clinical Trial

Study ID: NCT04982653

Conditions

Liver and Intrahepatic Bile Duct Neoplasm

Metastatic Malignant Neoplasm in the Liver

Primary Malignant Liver Neoplasm

Interventions

Quality-of-Life Assessment

Surgical Procedure

Study Description

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.