Obsidian in Anastomotic Healing After Rectal Cancer Resection: A Prospective Clinical Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The rate of successful use and application of Obsidian as a supplemental procedure in the creation of rectal anastomosis with minimal invasive technique
研究概览
简要总结
Rectal cancer is one of the most frequent cancer diseases, with more than 1500 new cases per year in Denmark. Fortunately, if the tumor is discovered early, surgeons can remove the part of the intestine that is afflicted, and they can often sew the intestine-ends back together, forming what is known as an anastomosis. However, in 10-15% of cases, this anastomosis doesn't heal completely, leading to anastomotic leakage. This is a serious complication, with detrimental effects for the individual patient. Previous measures to avoid this complication, have proven unsuccessful.
Obsidian is a mixture derived from the patients' own blood, that contains components of blood normally responsible for stopping bleeding and kickstarting the healing process. It is already used in other clinical settings and preliminary, yet unpublished, results from a pilot study have shown its promise in decreasing the risk of anastomotic leakage in rectal anastomosis. However, its use has not been examined when performing surgery for rectal cancer with minimally invasive technique, which is today's standard.
The main clinical hypothesis of this feasibility study is that it is possible for colorectal surgeons to apply Obsidian successfully on the anastomotic area with minimal invasive technique, as a supplement during rectal cancer resection with anastomosis.
This study will be conducted at the Department of Surgery, Aarhus University Hospital. 50 patients will be included, who will undergo minimally invasive rectal cancer surgery with an anastomosis. Right after the onset of anaesthesia, 120 ml of blood will be collected from the patient and will be processed, making a 5-6 ml Obsidian concentrate. When the tumor-bearing part of the rectum has been removed, Obsidian will be applied, according to a pre-specified protocol.
If the application is deemed successful (based on predefined assessment criteria) in at least 90% of our included patients, then this study will serve as a stepping stone for a bigger study, the aim of which will be to assess if this method can indeed bring down the rate of anastomotic leakage in such patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Primary rectal cancer (adenocarcinoma) with the lower boarder within 15 cm from the anal verge assessed by rigid proctoscopy
- •Clinical UICC stage I-III at time of rectal cancer diagnosis
- •Deemed suitable for intended curative rectal cancer resection at MDT either by total mesorectal excision (TME) or partial mesorectal excision (PME)
- •Scheduled for elective, minimal invasive surgery
- •ECOG performance status 0-2
- •Age at least 18 years
- •Written and orally informed consent
排除标准
- •Distant metastatic disease
- •Locally advanced rectal cancer requiring extended resection
- •Open surgery
- •Benign lesions of the rectum
- •Inflammatory bowel disease
- •Another malignant disease within previous 2 years
- •Inability and unwillingness to give informed consent
- •Pregnant (positive pregnancy test) or breast feeding women
结局指标
主要结局
The rate of successful use and application of Obsidian as a supplemental procedure in the creation of rectal anastomosis with minimal invasive technique
时间窗: This outcome is measured during the intervention.
Defined as the surgeon being able re-inforce the anastomosis with Obsidian as described in our protocol. Assessment of the Obsidian application must be graded using the following rating assessment scale: 'Complete' 'Almost complete' 'Incomplete' Each of these are detailed in the study protocol. To be able to view the use of Obsidian application as a successful method, then the application should be rated as 'Complete' or 'Almost complete' in at least 45 out of 50 (90%) patients.
次要结局
- The surgeon's self-assessment of the user-friendliness of using Obsidian(This outcome is measured immediately after the intervention.)
- Re-hospitalization within 30 days after surgery(Measured within 30 days after surgery)
- Time spent for creating a rectal anastomosis with application of Obsidian(This outcome is measured during the intervention.)
- Length of hospital stay(From, and including, day of surgery to, and including, day of discharge, or up to 90 days after surgery.)
- 2-year mortality(Within 2 years after surgery)
- Anastomotic leak rate(Measured within 30 days after surgery)
- Morbidity within 30 days after surgery graded ≥3 severity according to the Clavien-Dindo classification(Measured within 30 days after surgery)