Intraoperative Testing of Colorectal Anastomosis - Air or Water (Methylene Blue)?
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 主要终点
- the predictive value of intraoperative anastomosis testing on anastomotic leak.
研究概览
简要总结
A leak from a colorectal anastomosis is a post-operative complication surgeons fear the most, following colonic resection. Over the years, there have been multiple suggestions for intraoperative tests for the integrity of the colorectal anastomosis.
Two of the most common tests that are performed routinely are:
- Air tight leak test - filling the pelvis with saline and insufflating air trans anal - looking for air bubbles in the saline filled pelvis.
- Injecting diluted dye (methylene blue) trans anal, and looking for blue dye stains on gauze pads covering the outer side of anastomosis.
The aim of the study is to compare the two methods, and to assess if there is a superior method. A secondary aim is to establish standards to perform the test, mainly to assess the appropriate pressure to apply on the anastomosis.
In this prospective study patients scheduled to undergo colonic resection of their distal part of the colon/ rectum with colorectal anastomosis, will have both testing methods performed sequentially and will be followed post-operative to assess the yield and sensitivity of the testing methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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 over the age of 18 undergoing elective colonic resection of their distal part of the colon/ rectum with colorectal anastomosis in a laparoscopic or open approach for a benign or malignant colonic disease.
排除标准
- •Emergent colonic resections,
- •Colonic resections with no colorectal anastamosis
研究组 & 干预措施
colorectal resection and anastamosis
Intraoperative testing of colorectal anastomoses
- Insert a Foley catheter through the anus into the rectum.
- Insufflate the Foley balloon with 5 cc of air.
- fill the pelvic space with 500 CC of warm saline
- Insufflate air into the rectum up to a pressure of 35 mmH2o as measured by external manometer
- Remove the saline from the pelvic space.
- Inject methylene blue in to the rectum up to a pressure of 35 mmH2o measured by external manometer
- Remove the methylene blue from rectum.
NB the above procedures are standard practice for assessing the quality of colorectal anastomoses during colorectal surgery.
The purpose of the study is to compare these standard methods of evaluation to determinant which method is superior
干预措施: Intraoperative testing of colorectal anastomoses (Procedure)
colorectal resection and anastamosis
Intraoperative testing of colorectal anastomoses
- Insert a Foley catheter through the anus into the rectum.
- Insufflate the Foley balloon with 5 cc of air.
- fill the pelvic space with 500 CC of warm saline
- Insufflate air into the rectum up to a pressure of 35 mmH2o as measured by external manometer
- Remove the saline from the pelvic space.
- Inject methylene blue in to the rectum up to a pressure of 35 mmH2o measured by external manometer
- Remove the methylene blue from rectum.
NB the above procedures are standard practice for assessing the quality of colorectal anastomoses during colorectal surgery.
The purpose of the study is to compare these standard methods of evaluation to determinant which method is superior
干预措施: Stapled colorectal anastomoses (Procedure)
结局指标
主要结局
the predictive value of intraoperative anastomosis testing on anastomotic leak.
时间窗: 30 days
The presence or absence of a post-operative clinical anastomotic leak
次要结局
- The sensitivity of the 2 methods of intraoperative anastomosis testing.(Both findings will be obvious (if present) immediately after the test is performed)