The C-seal study.

Colorectal anastomosis protected by a biodegradable drain fixed to the anastomosis by a circular stapler: A phase II study.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28405

Enrollment

Registered

2010-04-19

Start date

2010-02-08

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Low anterior resection, anastomotic leakage, anastomotic dehiscence, rectal cancer, surgery In Dutch: naadlekkage, rectumcarcinoom, laag anterior resectie, chirurgie

Interventions

Placement of the C-seal in a stapled colorectal anastomosis. C-seal is a biofragmentable drain, which is stapled to the anastomosis with a circular stapler. It covers the luminal side of the colorecta

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age > 18 years; 2. The patient requires an anastomosis, maximally 15 cm proximal from the anus; 3. The patient will receive a colorectal anastomosis by means of stapling; 4. The patient is willing and able to comply with the specified follow-up evaluation; 5. The patient must provide written informed consent prior to the procedure.

Exclusion criteria

Exclusion criteria: 1. Patient treatment is acute (not elective); 2. Patient is associated with infections at the time of intervention (peritonitis); 3. 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; 4. Patients with ASA classification > 3.

Design outcomes

Primary

Measure	Time frame
To estimate the occurrence of anastomotic leakage when the C-seal is used.	—

Secondary

Measure	Time frame
1. The assessment of technical feasibility defined as technical success, determined by a gastrografin enema X-ray of the rectum one week after the operation; 2. The successful clearance of the C-seal at 6 weeks without the occurrence of a serious adverse event; 3. Estimation of patient friendliness of the drain, at one week and 6 weeks; 4. Technical success: The Technical success is defined as the successful application of the C-seal; 5. Acute procedural success: Acute procedural success is defined as the successful application of the C-seal without the occurrence of a Serious Adverse Effects (SAE) caused by the drain/protector during or directly after the procedure; 6. Procedural success: The successful placement of the C-seal and the successful clearance of the C-seal with absence of any serious adverse events up to 30 days.	—

Measure

Time frame

1. The assessment of technical feasibility defined as technical success, determined by a gastrografin enema X-ray of the rectum one week after the operation; 2. The successful clearance of the C-seal at 6 weeks without the occurrence of a serious adverse event; 3. Estimation of patient friendliness of the drain, at one week and 6 weeks; 4. Technical success: The Technical success is defined as the successful application of the C-seal; 5. Acute procedural success: Acute procedural success is defined as the successful application of the C-seal without the occurrence of a Serious Adverse Effects (SAE) caused by the drain/protector during or directly after the procedure; 6. Procedural success: The successful placement of the C-seal and the successful clearance of the C-seal with absence of any serious adverse events up to 30 days.

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Contacts

Public ContactA.N. Morks

Hanzeplein 1

a.n.morks@chir.umcg.nl+31 (0)50 3611294

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)