Catheter ileostomy versus conventional loop-ileostomy in elective low anterior rectal resection and total mesorectal excision for protection of anastomosis

Catheter ileostomy versus conventional loop-ileostomy in elective low anterior rectal resection and total mesorectal excision for protection of anastomosis - CICERO-Pilot

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00010708

Enrollment

Registered

2016-06-22

Start date

2016-08-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

K91.4 K91.88

Interventions

Group 1: Control group: Loop-Ileostomie Group 2: Intervention group: catheter ileostomy

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients scheduled for elective low anterior rectal resection and total mesorectal excision for rectal cancer of the mid and lower third are eligible for the Pilot-Trial. The inculsion criteria are: • Age greater than 18 years • Expectancy of life greater than 12 months • Written informed consent

Exclusion criteria

Exclusion criteria: Exclusion criteria are: • Chronic inflammatory bowl disease • Participation in another interventional trial with interfering outcome measures • Neurophysiologic deficiencies • Severe psychiatric or neurologic disorders • Inability to understand patients` information and/or informed consent

Design outcomes

Primary

Measure	Time frame
The occurance of anastomotic leaks within 10 days after surgery is defined as primary endpoint. Primary safety events are defined as: •Occurrence of anastomotic leaks within 10 days after the removal of the catheter •Occurrence of catheter associated complications: leakage, blockage, bowel obstruction •Occurrence of catheter associated complications within 10 days after removal of the catheter: leakage, blockage, bowel obstruction •Occurrence of infections of the former catheter site within 10 days after removal of the catheter Abortion of the trial will occur if at least one of the safety events occurs at least seven patients. The determination is based on a binominal test with an alpha-niveau of 0.05 and an assumed leakage rate of 15%.	—

Measure

Time frame

The occurance of anastomotic leaks within 10 days after surgery is defined as primary endpoint. Primary safety events are defined as: •Occurrence of anastomotic leaks within 10 days after the removal of the catheter •Occurrence of catheter associated complications: leakage, blockage, bowel obstruction •Occurrence of catheter associated complications within 10 days after removal of the catheter: leakage, blockage, bowel obstruction •Occurrence of infections of the former catheter site within 10 days after removal of the catheter Abortion of the trial will occur if at least one of the safety events occurs at least seven patients. The determination is based on a binominal test with an alpha-niveau of 0.05 and an assumed leakage rate of 15%.

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Secondary

Measure	Time frame
Secondary endpoints are: •The occurrence of anastomotic leaks within 90 (+5) days postoperative in the control group •The occurance of the ileostomy-related complications: surgical site infection, retraction, prolapse, skin alteration within 90 (+5) days postoperative in the control group •The occurrence of surgical site infections and incisional hernias within 30 (+5) days after closure of ileostomy in the control group •The feasibility of the intervention and •The feasibility of trial the aspects: recruitment, randomization and allocation	—

Measure

Time frame

Secondary endpoints are: •The occurrence of anastomotic leaks within 90 (+5) days postoperative in the control group •The occurance of the ileostomy-related complications: surgical site infection, retraction, prolapse, skin alteration within 90 (+5) days postoperative in the control group •The occurrence of surgical site infections and incisional hernias within 30 (+5) days after closure of ileostomy in the control group •The feasibility of the intervention and •The feasibility of trial the aspects: recruitment, randomization and allocation

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Countries

Germany

Contacts

Public ContactKatja Maschuw

Klinik für Viszeral-, Thorax- und Gefäßchirurgie Universitätsklinikum Gießen und Marburg GmbH- Standort Marburg

maschuw@med.uni-marburg.de06421-58-69897

Outcome results

None listed

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