Short Stitch Versus Traditional Suture for the Prevention of Incisional Hernia After Open Hepatectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Quality-of-Life Assessment, Surgical Procedure, Surgical Procedure.
- Who it may be relevant to
- Registry conditions: Liver and Intrahepatic Bile Duct Neoplasm, Metastatic Malignant Neoplasm in the Liver, Primary Malignant Liver Neoplasm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Incisional Hernia Prevention After Open Hepatectomy by Small Tissue Bite Fascial Closure: A Randomized Clinical Trial
Overview
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.
Interventions
- Other Quality-of-Life Assessment
Ancillary studies - Procedure Surgical Procedure
Undergo hepatectomy using small bites fascial method for abdominal wall closure - Procedure Surgical Procedure
Undergo hepatectomy using conventional fascial method for abdominal wall closure
Primary outcome measures
- Radiographic incidence rate of incisional hernia [Time frame: Up to 12 months after surgery]
Secondary outcome measures (10)
- 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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- M D Anderson Cancer Center — Houston
Identifiers
NCT: NCT04982653 · 2021-0254 · NCI-2021-04402 · 2021-0254