Intraoperative Antegrade Bowel Lavage for Ileostomy-Reversal vs. Standard-Ileostomy-Reversal – a prospective randomized multicenter trial

Intraoperative Antegrade Bowel Lavage for Ileostomy-Reversal vs. Standard-Ileostomy-Reversal – a prospective randomized multicenter trial - ABRIL-Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00028612

Enrollment

204

Registered

2022-09-29

Start date

2022-10-28

Completion date

Unknown

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Z93.2

Interventions

Group 1: Experimental intervention: Ileostomy reversal with intraoperative antegrade bowel lavage (100 ml NaCl 0.9% or balanced cristalloids-solution (e.g. lactated Ringer’s solution) (ABL-IR) of the

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Time-to-first-flatus (TTFF) (Hours after end of surgery)	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Germany

Contacts

Public ContactHannes Neeff

Universitätsklinikum Freiburg, Department Chirurgie, Klinik für Allgemein- und Viszeralchirurgie

hannes.neeff@uniklinik-freiburg.de+49-761-270-25040

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026