Liver and Intrahepatic Bile Duct Neoplasm, Metastatic Malignant Neoplasm in the Liver, Primary Malignant Liver Neoplasm
Conditions
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.
Interventions
OTHERQuality-of-Life Assessment
Ancillary studies
PROCEDURESurgical Procedure
Undergo hepatectomy using small bites fascial method for abdominal wall closure
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic incidence rate of incisional hernia | Up to 12 months after surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Surgical site infection | Up to 90 days after surgery | — |
| Surgical site occurrence | Up to 90 days after surgery | — |
| Surgical site occurrence requiring procedural intervention | Up to 90 days after surgery | — |
| Postoperative complications | Up to 90 days after surgery | Post-operative infection, complication or pain will be assessed using Chi-squared test or Fisher's exact test. |
| Need for reoperation | Up to 90 days after surgery | — |
| Need for reoperation secondary to complication of abdominal closure | Up to 90 days after surgery | — |
| Length of hospital stay (postoperatively) | Up to 90 days after surgery | Will be compared between the two arms using two-sample t-test or Wilcoxon rank sum test. |
| Any readmission related to hernia repair | Up to 30 days after surgery | — |
| Health-related quality of life assessment | Up to 12 months after surgery | Will use linear mixed effect modeling to assess the effects of time, arm as well as the interaction between arm and time. |
| Incidence of adverse events (AEs) | Up to 90 days after surgery | Will be summarized using descriptive statistics (frequency, percentage) by arm, AE type, severity and attribution. |
Countries
United States
Contacts
CONTACTTimothy E Newhook, MD
PRINCIPAL_INVESTIGATORTimothy E Newhook, MD
M.D. Anderson Cancer Center
Outcome results
None listed