Intraoperative Antegrade Bowel Lavage for Ileostomy-Reversal vs. Standard-Ileostomy-Reversal – a prospective randomized multicenter trial
Phase 3
Recruiting
- Conditions
- Z93.2Ileostomy status
- Registration Number
- DRKS00028612
- Lead Sponsor
- niversitätsklinikum Freiburg, Department Chirurgie, Klinik für Allgemein- und Viszeralchirurgie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 204
Inclusion Criteria
Patient with protective loop-ileostomy scheduled for ileostomy reversal due to benign or malign underlying disease, Patient’s age = 18 years, Ability to understand the study and to participate in the trial examinations, ECOG-Performance-Status 0-2, Written informed consent
Exclusion Criteria
Simultaneous colon-, liver-, peritoeneal-, or multivisceral resection planned, Early stoma reversal (<28 days after initial operation), Pregnant women and nursing mothers, Expected non-compliance of the patient or language problems, Persons with any kind of dependency on the principal investigator or employed by the sponsor or principal investigator, Legally incapacitated persons or persons held in an institution by legal or official order
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time-to-first-flatus (TTFF) (Hours after end of surgery)
- Secondary Outcome Measures
Name Time Method Operationtime, Time-to-First-Bowel-Movement, Time-to-tolerate solid intake, Length of hospital stay, Re-Operation-Rate (at discharge and at day 30), Complications according to Clavien-Dindo-Classification (at discharge and at day 30), Rate of anastomotic leakages (at discharge and at day 30), Wound infection rate (at discharge and at day 30), Incidence of parenteral nutrition following surgery (at discharge and at day 30), Need for postoperative nasogastric tube placement (at discharge and at day 30)