Status:
UNKNOWN
Anastomotic Leakage and Enhanced Recovery Pathways After Colorectal Surgery
Lead Sponsor:
Ospedale C & G Mazzoni
Conditions:
Colorectal Neoplasms
Anastomotic Leak
Eligibility:
All Genders
Brief Summary
Prospective observational multicenter study on the influence of adherence to enhanced recovery pathways on early outcomes (anastomotic leakage, morbidity, mortality, readmission, reoperation rates and...
Detailed Description
BACKGROUND Anastomotic leakage (AL) is a dreaded major complication after colorectal surgery. The overall incidence of anastomotic dehiscence and subsequent leaks is 2 to 7 percent when performed by ...
Eligibility Criteria
Inclusion
- Patients submitted to laparoscopic/robotic/open/converted ileo-colo-rectal resection with anastomosis (both intra- and extra-corporeal), including planned Hartmann's reversals.
- American Society of Anesthesiologists' (ASA) class I, II or III
- Elective or delayed urgency surgery
- Patients' written acceptance to be included in the study.
Exclusion
- American Society of Anesthesiologists' (ASA) class IV-V
- Patients with stoma before or at operation
- Simple stoma closure
- Transanal procedure
- Pregnancy
- Hyperthermic intraperitoneal chemotherapy for carcinomatosis.
Key Trial Info
Start Date :
January 7 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
1748 Patients enrolled
Trial Details
Trial ID
NCT03771456
Start Date
January 7 2019
End Date
December 31 2019
Last Update
December 11 2018
Active Locations (41)
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1
UOC Chirurgia Generale - Ospedale Profili - Fabriano (AN) - ASUR MARCHE AV2
Fabriano, AN, Italy
2
UOC Chirurgia Generale - Ospedale "C. Urbani" Jesi - AV2 - ASUR Marche
Iesi, AN, Italy
3
UOC Chirurgia Generale e d'Urgenza - Ospedale Regionale "U. Parini" - Aosta
Aosta, AO, Italy
4
UOC Chirurgia Generale - Ascoli Piceno - AV5 - ASUR Marche
Ascoli Piceno, AP, Italy