Status:
UNKNOWN
Enhanced Perioperative Care for the Prevention of Colorectal Anastomotic Leakage
Lead Sponsor:
Amsterdam UMC, location VUmc
Conditions:
Anastomotic Leak Small Intestine
Anastomotic Leak Large Intestine
Eligibility:
All Genders
Phase:
NA
Brief Summary
This multicenter open-label trial is designed to evaluate if the implementation of an enhanced peri-operative care protocol results in an optimal intraoperative condition of the patient and in a decre...
Detailed Description
Rationale Colorectal anastomotic leakage (CAL) remains a severe complication following surgery with a reported incidence of 3-19% worldwide. Recent research has identified several modifiable peri-oper...
Eligibility Criteria
Inclusion
- Age 18 and above
- Bowel (small intestine/colon/rectal) resection with creation of a primary anastomosis
- Ability to give informed consent
Exclusion
- The need for emergency surgery
- Scheduled operation concerning a reoperation for complications from recent surgery (within 3 months after the initial procedure).
- The inability to read or understand informed consent material
Key Trial Info
Start Date :
September 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
1600 Patients enrolled
Trial Details
Trial ID
NCT05250882
Start Date
September 5 2021
End Date
December 1 2023
Last Update
February 22 2022
Active Locations (9)
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1
UZA
Antwerp, Belgium
2
Elkerliek
Helmond, Limburg, Netherlands
3
Maastricht UMC+
Maastricht, Limburg, Netherlands
4
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant, Netherlands