About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pre-existing abdominal hernia
History of mesh placement at prior laparotomy
Pregnant women
Trial design
Parallel
Treatments tested in this trial
Quality-of-Life Assessment
Other interventionAncillary studies
Surgical Procedure
Procedure/SurgeryUndergo hepatectomy using small bites fascial method for abdominal wall closure
Surgical Procedure
Procedure/SurgeryUndergo hepatectomy using conventional fascial method for abdominal wall closure
Treatment groups
Trial outcomes
Primary outcomes
Radiographic incidence rate of incisional hernia
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 outcomes
Surgical site infection
Surgical site occurrence
Surgical site occurrence requiring procedural intervention
Postoperative complications
Post-operative infection, complication or pain will be assessed using Chi-squared test or Fisher's exact test.
Sponsors and contacts
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