Colorectal anastomosis protected by a biodegradable drain fixed to the anastomosis by a circular stapler: a randomised, controlled, multicenter trial.

Colorectal anastomosis protected by a biodegradable drain fixed to the anastomosis by a circular stapler: a randomised, controlled, multicenter trial. - The C-Seal Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00005123

Enrollment

616

Registered

2013-07-02

Start date

2011-10-15

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

Anastomotic Leakage after colorectal surgery

Interventions

Group 1: The Sponsor wants to enroll overall 616 patients in this study. Each group (Intervention group vs. Control group) should include 313 patients. Procedure: After the physician has decided to ma

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - The patient will receive a colorectal anastomosis by means of stapling - Elective surgery - Age: 18 or older - American Society of Anesthesiologist (ASA) classification 1,2 or 3 - The patient did receive preoperative oral mechanical bowel preparation

Exclusion criteria

Exclusion criteria: - There are clinical signs of peritonitis - The patient underwent major surgical or interventional procedures in the last 30 days prior to this study or surgical or interventional procedures are planned within 30 days of entry in this study - There are psychological, familial, sociological conditions which could hampering compliance with the study protocol or follow-up schedule - Patient is randomized in this trial before

Design outcomes

Primary

Measure	Time frame
The primary outcome is the incidence of anastomotic leakage leading to invasive treatment within 30 days after the primary operation.	—

Secondary

Measure	Time frame
Secondary Outcomes: - Number of dismantled anastomoses - Grade A, B or C Anastomotic Leakage - Interval between the primary operation and the diagnosis of Anastomotic Leakage - Pain Score at day 3 postoperatively on a visual analogue scale - Number of ostomies created - Late anastomotic leakage (diagnosed 30 days after the primary operation) - Number of ostomies present after one year - Total duration of hospital stay including readmissions for (serious) adverse events and/or stoma closure - Interval between the primary operation and the excretion of the C-Seal through the anus - Other complications	—

Measure

Time frame

Secondary Outcomes: - Number of dismantled anastomoses - Grade A, B or C Anastomotic Leakage - Interval between the primary operation and the diagnosis of Anastomotic Leakage - Pain Score at day 3 postoperatively on a visual analogue scale - Number of ostomies created - Late anastomotic leakage (diagnosed 30 days after the primary operation) - Number of ostomies present after one year - Total duration of hospital stay including readmissions for (serious) adverse events and/or stoma closure - Interval between the primary operation and the excretion of the C-Seal through the anus - Other complications

—

Countries

Austria, France, Germany, Italy, Netherlands, Portugal, Spain, United Kingdom

Contacts

Public ContactIlsalien Bakker

University Medical Center Groningen Department of Abdominal Surgery

i.s.bakker@umcg.nl+316-31623612; +3150-3611505

Outcome results

None listed

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