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临床试验/NCT05831956
NCT05831956已完成不适用

Taipei Medical University Shuang-Ho Hospital

Taipei Medical University Shuang Ho Hospital1 个研究点 分布在 1 个国家目标入组 241 人开始时间: 2022年9月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
241
试验地点
1
主要终点
Bowel function recovery

研究概览

简要总结

In order to investigate the effects of collagen wound dressing on colonic anastomosis during colectomy, we conducted a retrospective cohort study. The goal of study was to determine whether the use of collagen wound dressing results in improving clinical outcomes for patients undergoing laparoscopic colectomy.

详细描述

Wound healing occurs in four distinct phases: hemostasis, inflammation, proliferation, and tissue remodeling. Numerous factors can influence these phases, which can be classified as either local or systemic. Local factors include infection, presence of foreign bodies, inadequate oxygenation, and other issues affecting the wound itself, while systemic factors encompass a wide range of considerations such as age, gender, presence of systemic disease, ischemia, stress, medication use, obesity, cigarette and alcohol use, nutritional status, and immunocompromised conditions.

Anastomotic healing in the colon is similar to the healing process in skin while there's still some differences. While the cellular and histological processes involved in colonic healing are well known, the pathophysiological process is not fully understood and requires further studies . Unlike skin healing, the process of patients undergoing colonic resection and anastomosis healing can only be inferred by observing certain parameters, such as amount of drainage, time to first flatus and defecation and the patient's symptoms. These parameters are used to guide the patient's recovery program. Complications such as anastomotic leakage, bleeding or stricture would lead to longer hospital stay, mortality and morbidity. The most devastating one is anastomotic leakage. Although we have found some strategies to lower the rate in colorectal surgery such as colon preparation or antibiotics administration, the leakage still bothers a lot.

Besides controlling the local and systemic factors, several biomaterial products have been designed to progress the healing. Collagen plays crucial roles in all of the four healing phases. As a result, collagen wound dressing, derived from bovine, equine, avian or porcine, has been applied in different sites of wound to promote healing. Several studies have concluded that collagen wound dressing resulted in better outcomes but limited to in vitro studies or animal based research. Pantelis D. concluded that fibrin in combination with the collagen patch can improve healing in high-risk mice that underwent colonic anastomosis surgery. Pommergaard HC. also concluded that the collagen wound dressing can lower the leakage rate in mouse colon anastomosis surgery.

Another limitation is that most studies have small sample sizes and lack of long term observation. Parker et al designed a non-randomized study and concluded that collagen wound dressing is safe and easy to apply in human colorectal surgery. Marano et al compared the complication rate of two cohorts and revealed that collagen wound dressing can lower the complication rate in the patients who underwent upper gastrointestinal surgery. As of now, it is premature to conclude that collagen wound dressing is effective in human colonic anastomosis due to the lack of human studies and larger sample size. In order to investigate the effects of collagen wound dressing on colonic anastomosis during colectomy, we conducted a retrospective cohort study. Our goal was to determine whether the use of collagen wound dressing results in improving clinical outcomes for patients undergoing laparoscopic colectomy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who underwent laparoscopic colectomy.

排除标准

  • Patients who underwent open surgery, emergent surgery, or had prior chemotherapy or concurrent chemoradiotherapy were excluded from the study

结局指标

主要结局

Bowel function recovery

时间窗: 0-30 days after colectomy

The primary outcome measurements were the number of days until first flatus and defecation after surgery, which were recorded as the number of days from surgery to the first occurrence of each event.

次要结局

未报告次要终点

研究者

发起方
Taipei Medical University Shuang Ho Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tungcheng Chang

Chief of Colorectal Surgery

Taipei Medical University Shuang Ho Hospital

研究点 (1)

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