Colorectal Surgery Anastomotic Leakage C-Seal Drain
Conditions
Interventions
Use of the C-Seal drain.
The C-seal is a biodegradable thin-walled drain. It is compatible with the circular stapler used in almost all low anterior resections. It is developed to prevent extravasati
Sponsors
UMC Groningen, Dept. of Surgery
Eligibility
Inclusion criteria
Inclusion criteria: 1. Any colorectal disease requiring a colorectal anastomosis to be made by a circular stapler/cutter; 2. Elective surgery; 3. Age > 18 years; 4. American Society of Anesthesiologists (ASA) classification 1, 2 or 3; 5. No clinical signs of peritonitis; 6. No major surgical or interventional procedures within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study; 7. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial; 8. Written informed consent must be signed according to ICH/GCP and Dutch law, before patient registration and randomization; 9. Patients can only be randomized in this trial once.
Exclusion criteria
Exclusion criteria: No specific exclusion criteria other than the opposite of the inclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the incidence of anastomotic leakage leading to invasive treatment within 30 days after the primary operation. 1. Anastomotic leakage is defined as a communication between the intra- and extraluminal compartments owing to a defect of the integrity of the intestinal wall at the anastomosis; 2. An abscess in the proximity of the anastomosis is considered as AL; 3. Invasive treatment is defined as any invasive procedure after the primary operation: Surgical treatment in the operating theatre or radiological drainage. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of dismantled anastomoses; 2. Grade A, B or C AL within 30 days after the primary operation; 3. The interval between the primary operation and the diagnosis of AL; 4. Pain score at day 3 postoperatively on a Visual Analogue Scale; 5. The number of ostomies created; 6. Late anastomotic leakage (diagnosed ≥30 days and within 1 year postoperative); 7. The number of ostomies present after one year; 8. The total duration of hospital stay including readmissions for (serious) adverse events and/or stoma closure; 9. The interval between the primary operation and the excretion of the C-seal through the anus; 10. Interval between C-seal application and C-seal loss; 11. Other complications. | — |
Contacts
Public ContactI.S. Bakker
Afdeling Chirurgie Universitair Medisch Centrum Groningen Postbus 30001
Outcome results
None listed