The Efficacy of a Topical Anti-adhesive Film for Decreasing Perihepatic Adhesions in Repeat Hepatic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Incidence of peri-hepatic adhesions at the time of repeat liver surgery
研究概览
简要总结
There has been an increase in the need for repeat hepatic surgery, especially for patients with colorectal liver metastasis and hepatocellular carcinoma. Adhesions at the time of repeat surgery can lead to increased operative times, higher blood loss and even increased perioperative morbidity. Not much data exists regarding use of anti-adhesion barriers at the time of index hepatectomy and their effect on adhesions at repeat hepatectomy. This randomized controlled trial aims to evaluate the effectiveness of the use of a hyaluronan and cellulose based antiadhesive topical film at index hepatectomy in reducing perihepatic adhesions at the time of repeat hepatic surgery.
详细描述
Peritoneal adhesions develop in up to 93% of patients following abdominal surgery.1 Mesothelial injury, inflammation and unbalanced fibrinolysis have been described as the primary factors leading to adhesion formation.2 Within hepatic surgery, the degree to which adhesions pose a significant challenge at the time of repeat resection often depends upon the extent of hepatectomy, hilar dissection, number of preceding liver resections, and the location of the proposed repeat partial hepatectomy. More specifically, peri-hepatic adhesions can lead to increased operative time, an increased risk of bleeding, injury to adjacent intra-abdominal organs and even higher perioperative morbidity.3 Similar to other diseases, repeat hepatectomy is often required in instances of both primary and metastatic liver cancers. This need will likely only increase in the future with continuously improving systemic chemotherapy and novel multimodality treatments. Not surprisingly, the necessary lysis of peri-hepatic adhesions has also been shown to increase operative times, by consuming as much as 50% of the operative procedure, during a repeat hepatectomy as well.4
Numerous anti-adhesion materials and barriers have been studied in colorectal,5,6,7 gynecological,8,9 neurosurgery,10 cardiac surgery,11 and otolaryngology.12 There is some data that these barriers can also be helpful in reducing operative times for repeat hepatectomy as well.13 More specifically, in a rat model, an Alg bilayer sponge application was effective in preventing peri-hepatic adhesions following a crush hepatectomy model.14 Unfortunately, there has been limited data regarding the effectiveness of any antiadhesion barriers in reducing peri-hepatic adhesions to date. SEPRA-C2T15 concluded that barrier film is helpful in reducing abdominal and perihepatic adhesions. This was done in patients with unresectable colorectal liver metastasis who underwent two stage hepatectomy and the median time to second hepatectomy was only 2 months.
The primary aim of this study is to evaluate the efficacy of a topical anti-adhesion barrier film in reducing the severity of subsequent peri-hepatic adhesions at the time of repeat hepatic surgery.
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
- Single (Participant)
盲法说明
Once eligibility has been determined, participants will be randomized with a 1:1 ratio using a block randomization model. The randomization tool will be located on a password-protected website. In order to maintain allocation concealment, the assigned intervention (i.e. Seprafilm use) will be provided to the surgeon in an opaque, sealed envelope immediately before surgery by the research assistant. Patients and data analysts will be blinded to treatment allocation status.
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 partial hepatectomy with high likelihood of needing repeat hepatectomy (e.g. those with colorectal liver metastasis and hepatocellular carcinoma)
- •Patients ≥ 18 years of age.
排除标准
- •Patients unable to provide informed consent.
- •Patients with hypersensitivity to Seprafilm and/or to any components of the Seprafilm.
- •Patients who are found to have unresectable disease during surgery (additional hepatic lesions or extrahepatic metastatic disease precluding liver resection
结局指标
主要结局
Incidence of peri-hepatic adhesions at the time of repeat liver surgery
时间窗: 0-4 years from initial surgery, time of repeat surgery will vary from patient to patient
Evaluation will be performed at second surgery as follows: Calgary Scoring System Grade1-No adhesions, Grade2-Mild, Grade3-Moderate, Grade4-Severe adhesions, Grade5-severe adhesions with injury to other organs TORanomon Adhesion score (TORAD score): * Hepatic Hilum * 1-Easy: Easy for encircling the hepatoduodenal ligament (HDL) * 2-Hard: Additional maneuver for encircling HDL * 3-Extreme: Safe encircling of HDL is impossible * Liver Surface * 1-Easy: No adhesion * 2-Hard: Presence of dense fibrosis or scarring tissue- hard dissection * 3-Extreme): Dense scar with unclear boundary with the surrounding organs.
次要结局
- Operating time(0-4 years from initial surgery, unpredictable - time of repeat surgery will vary from patient to patient)
- Transfusion of blood or blood products(0-4 years from initial surgery, unpredictable - time of repeat surgery will vary from patient to patient)
- Duration of hepatic pedicle clamping(0-4 years from initial surgery, unpredictable - time of repeat surgery will vary from patient to patient)
- Estimated blood loss(0-4 years from initial surgery, unpredictable - time of repeat surgery will vary from patient to patient)
- Postoperative length of stay(0-4 years from initial surgery, unpredictable - time of repeat surgery will vary from patient to patient)
- 30-day mortality and morbidity(30 days after the repeat surgery which may be anywhere from 0-4 months after initial surgery)
研究者
Dr. Chad G. Ball
Professor of Surgery and Oncology
University of Calgary