Incisional Hernia Prevention After Open Hepatectomy by Small Tissue Bite Fascial Closure: A Randomized 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.
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.
Arms & interventions
- OtherQuality-of-Life Assessment
Ancillary studies
- ProcedureSurgical Procedure
Undergo hepatectomy using small bites fascial method for abdominal wall closure
- ProcedureSurgical Procedure
Undergo hepatectomy using conventional fascial method for abdominal wall closure
Outcome measures
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.
Time frame: Up to 12 months after surgery
Secondary
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
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)
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
Time frame: Up to 12 months after surgery
Incidence of adverse events (AEs)
Time frame: Up to 90 days after surgery
Eligibility criteria
Study locations (1)
M D Anderson Cancer Center
Houston, Texas, 77030