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

Metastatic Malignant Neoplasm in the Liver Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04982653
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Timothy E Newhook, MD
Phone 713-792-6940
Email TNewhook@mdanderson.org
Status Recruiting
Phase Phase 2
Start date January 4, 2022
Completion date April 30, 2026
View Details
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