Clinical trial NCT04982653: Short Stitch Versus Traditional Suture for the Prevention of Incisional Hernia After Open Hepatectomy
Official title: Incisional Hernia Prevention After Open Hepatectomy by Small Tissue Bite Fascial Closure: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Liver and Intrahepatic Bile Duct Neoplasm
Metastatic Malignant Neoplasm in the Liver
Primary Malignant Liver Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Radiographic incidence rate of incisional hernia
timeFrame: Up to 12 months after surgery
Secondary outcomes:
measure: Surgical site infection
timeFrame: Up to 90 days after surgery
measure: Surgical site occurrence
timeFrame: Up to 90 days after surgery
measure: Surgical site occurrence requiring procedural intervention
timeFrame: Up to 90 days after surgery
measure: Postoperative complications
timeFrame: Up to 90 days after surgery
measure: Need for reoperation
timeFrame: Up to 90 days after surgery
measure: Need for reoperation secondary to complication of abdominal closure
timeFrame: Up to 90 days after surgery
measure: Length of hospital stay (postoperatively)
timeFrame: Up to 90 days after surgery
measure: Any readmission related to hernia repair
timeFrame: Up to 30 days after surgery
measure: Health-related quality of life assessment
timeFrame: Up to 12 months after surgery
measure: Incidence of adverse events (AEs)
timeFrame: Up to 90 days after surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Timothy E Newhook, MD
role: PRINCIPAL_INVESTIGATOR
References: