Spanish research institute conducts the clinical trial of pelvic drain
Hospital Universitari Vall d'Hebron Research Institute in Spain is recruiting patients for the clinical trial of pelvic drain after rectal resection for mid-low rectal cancer (GECO1).
This RCT aims at assessing the effects of a pelvic drain after total mesorectal excision for mid-low rectal cancer on the rates of pelvic sepsis and anastomotic leaks.
Patients undergoing total mesorectal excision for mid-low rectal cancer will be randomly assigned into two groups:
- pelvic drain;
- no pelvic drain. Patients will be followed-up to assess the rates of anastomotic leaks, pelvic sepsis and secondary outcomes.
The assessor will not know whether the patient received a drain or not.
The researchers think that October 2020 will be the study start date. The indicative completion of the clinical trial will be September 2022.
Among primary outcome measures are number of participants with pelvic sepsis and anastomotic leak or pelvic collections clinically or radiologically detected.
The study will take place at the Hospital General Universitario Vall d´Hebron in Barcelona, Spain.
Male or female (18 year-of-age or above) participants with mid or low rectal cancer, anastomosis below the peritoneal reflection and total mesorectal excision (TME) can be involved in this process.
There are a number of indicators that do not allow participation, such as:
- pregnancy;
- chronic kidney failure or hepatic failure, immunodepression, malnoutrition;
- life expectancy < 6 months;
- partial mesorectal excision;
- abdominoperineal excision;
- ultivisceral resections;
- emergency surgery.
