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
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.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | April 30, 2026 |
Est. primary completion date | April 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Up to 12 months after surgery | |
Secondary | Surgical site infection | Up to 90 days after surgery | ||
Secondary | Surgical site occurrence | Up to 90 days after surgery | ||
Secondary | Surgical site occurrence requiring procedural intervention | Up to 90 days after surgery | ||
Secondary | Postoperative complications | Post-operative infection, complication or pain will be assessed using Chi-squared test or Fisher's exact test. | Up to 90 days after surgery | |
Secondary | Need for reoperation | Up to 90 days after surgery | ||
Secondary | Need for reoperation secondary to complication of abdominal closure | Up to 90 days after surgery | ||
Secondary | Length of hospital stay (postoperatively) | Will be compared between the two arms using two-sample t-test or Wilcoxon rank sum test. | Up to 90 days after surgery | |
Secondary | Any readmission related to hernia repair | Up to 30 days after surgery | ||
Secondary | Health-related quality of life assessment | Will use linear mixed effect modeling to assess the effects of time, arm as well as the interaction between arm and time. | Up to 12 months after surgery | |
Secondary | Incidence of adverse events (AEs) | Will be summarized using descriptive statistics (frequency, percentage) by arm, AE type, severity and attribution. | Up to 90 days after surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
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