Status:
UNKNOWN
Treatment of Anastomotic Leakage After Rectal Cancer Resection
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Anastomotic Leak Rectum
Rectal Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The TENTACLE: Rectum study is a multinational retrospective cohort study that includes patients with anastomotic leakage after rectal cancer resection. The study aims to develop an anastomotic leakag...
Detailed Description
Rationale: Anastomotic leakage occurs in up to 20% after low anterior resection for rectal cancer. It is a severe complication with high associated morbidity, ICU admission, prolonged hospital stay a...
Eligibility Criteria
Inclusion
- Aged 18 years or older;
- Cancer located in the rectum, defined according to the international definition of the rectum consensus \[D'Souza 2019\];
- Rectal cancer resection with primary anastomosis (with or without diverting loop ileostomy) for either primary cancer, completion after local excision or salvage resection for regrowth after watch \& wait or local excision;
- Postoperative anastomotic leakage according to the following definition: "a breach in a surgical join between two hollow viscera, with or without active leak of luminal contents" \[Peel 1991\].
Exclusion
- Rectal resection for benign disease;
- Rectal resection for recurrent rectal cancer after previous low anterior resection or other primary malignancies;
- Multivisceral resection (lateral lymph node dissection can be included)
- Emergency resection;
Key Trial Info
Start Date :
April 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2021
Estimated Enrollment :
1246 Patients enrolled
Trial Details
Trial ID
NCT04127734
Start Date
April 1 2020
End Date
September 30 2021
Last Update
October 21 2019
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