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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04982653
Other study ID # 2021-0254
Secondary ID NCI-2021-0440220
Status Recruiting
Phase Phase 2
First received
Last updated
Start date January 4, 2022
Est. completion date April 30, 2026

Study information

Verified date June 2024
Source M.D. Anderson Cancer Center
Contact Timothy E Newhook, MD
Phone 713-792-6940
Email TNewhook@mdanderson.org
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Quality-of-Life Assessment
Ancillary studies
Procedure:
Surgical Procedure
Undergo hepatectomy using small bites fascial method for abdominal wall closure
Surgical Procedure
Undergo hepatectomy using conventional fascial method for abdominal wall closure

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

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
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