Short Stitch Versus Traditional Suture for the Prevention of Incisional Hernia After Open Hepatectomy

Metastatic Malignant Neoplasm in the Liver Clinical Trial

Official title:

Incisional Hernia Prevention After Open Hepatectomy by Small Tissue Bite Fascial Closure: A Randomized Clinical Trial

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
• 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
• 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

Related Conditions & MeSH terms

• Bile Duct Neoplasms
• Incisional Hernia
• Liver Neoplasms
• Metastatic Malignant Neoplasm in the Liver
• Neoplasms
• Primary Malignant Liver Neoplasm

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

External Links

•   MD Anderson Cancer Center