M D Anderson Cancer Center
Houston, Texas, 77030, United States
Location status: Recruiting
NCT Number: NCT04982653
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Houston, Texas, 77030, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ancillary studies
Other names: Quality of Life Assessment
Undergo hepatectomy using small bites fascial method for abdominal wall closure
Other names: Operation, Surgery, Surgical, Surgical Intervention, Surgical Interventions, Surgical Procedures, Type of Surgery
Time frame: 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.
Time frame: Up to 90 days after surgery
Time frame: Up to 90 days after surgery
Time frame: Up to 90 days after surgery
Time frame: Up to 90 days after surgery
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
Time frame: Up to 90 days after surgery
Time frame: Up to 90 days after surgery
Will be compared between the two arms using two-sample t-test or Wilcoxon rank sum test.
Time frame: Up to 30 days after surgery
Time frame: 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.
Time frame: Up to 90 days after surgery
Will be summarized using descriptive statistics (frequency, percentage) by arm, AE type, severity and attribution.
Contact information is provided by the study sponsor or research team.
M.D. Anderson Cancer Center
Other
Incisional Hernia Prevention After Open Hepatectomy by Small Tissue Bite Fascial Closure: A Randomized Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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