Incisional Hernia Prevention After Open Hepatectomy by Small Tissue Bite Fascial Closure: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Radiographic incidence rate of incisional hernia
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Pre-existing abdominal hernia
- •History of mesh placement at prior laparotomy
- •Pregnant women
研究组 & 干预措施
Arm I (hepatectomy using small bites fascial closure)
Patients undergo hepatectomy as planned using small bites fascial method for abdominal wall closure.
干预措施: Quality-of-Life Assessment (Other)
Arm I (hepatectomy using small bites fascial closure)
Patients undergo hepatectomy as planned using small bites fascial method for abdominal wall closure.
干预措施: Surgical Procedure (Procedure)
Arm II (hepatectomy using conventional fascial method)
Patients undergo hepatectomy as planned using conventional fascial method for abdominal wall closure.
干预措施: Quality-of-Life Assessment (Other)
Arm II (hepatectomy using conventional fascial method)
Patients undergo hepatectomy as planned using conventional fascial method for abdominal wall closure.
干预措施: Surgical Procedure (Procedure)
结局指标
主要结局
Radiographic incidence rate of incisional hernia
时间窗: 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.
次要结局
- Surgical site occurrence requiring procedural intervention(Up to 90 days after surgery)
- Postoperative complications(Up to 90 days after surgery)
- Length of hospital stay (postoperatively)(Up to 90 days after surgery)
- Need for reoperation(Up to 90 days after surgery)
- Health-related quality of life assessment(Up to 12 months after surgery)
- Need for reoperation secondary to complication of abdominal closure(Up to 90 days after surgery)
- Any readmission related to hernia repair(Up to 30 days after surgery)
- Surgical site infection(Up to 90 days after surgery)
- Surgical site occurrence(Up to 90 days after surgery)
- Incidence of adverse events (AEs)(Up to 90 days after surgery)