A Phase 2 interventional study of Quality-of-Life Assessment and Surgical Procedure in Liver and Intrahepatic Bile Duct Neoplasm, Metastatic Malignant Neoplasm in the Liver and Primary Malignant Liver Neoplasm, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Prevention
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.
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.
3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.
This study's planned enrollment of 140 is above the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
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Exclusion Criteria:
Patients undergo hepatectomy as planned using small bites fascial method for abdominal wall closure.
Other: Quality-of-Life Assessment · Procedure: Surgical Procedure
Patients undergo hepatectomy as planned using conventional fascial method for abdominal wall closure.
Other: Quality-of-Life Assessment · Procedure: Surgical Procedure
Ancillary studies
Also known as: Quality of Life Assessment
Undergo hepatectomy using small bites fascial method for abdominal wall closure
Also known as: Operation, Surgery, Surgical, Surgical Intervention, Surgical Interventions, Surgical Procedures, Type of Surgery
Undergo hepatectomy using conventional fascial method for abdominal wall closure
Also known as: Operation, Surgery, Surgical, Surgical Intervention, Surgical Interventions, Surgical Procedures, Type of Surgery
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.
Time frame: Up to 12 months after surgery
Surgical site infection
Time frame: Up to 90 days after surgery
Surgical site occurrence
Time frame: Up to 90 days after surgery
Surgical site occurrence requiring procedural intervention
Time frame: Up to 90 days after surgery
Postoperative complications
Post-operative infection, complication or pain will be assessed using Chi-squared test or Fisher's exact test.
Time frame: Up to 90 days after surgery
Need for reoperation
Time frame: Up to 90 days after surgery
Need for reoperation secondary to complication of abdominal closure
Time frame: Up to 90 days after surgery
Length of hospital stay (postoperatively)
Will be compared between the two arms using two-sample t-test or Wilcoxon rank sum test.
Time frame: Up to 90 days after surgery
Any readmission related to hernia repair
Time frame: Up to 30 days after surgery
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.
Time frame: Up to 12 months after surgery
Incidence of adverse events (AEs)
Will be summarized using descriptive statistics (frequency, percentage) by arm, AE type, severity and attribution.
Time frame: Up to 90 days after surgery
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M.D. Anderson Cancer Center