Protection of colorectal anastomoses with a biodegradable device: The C-SEAL feasibility study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25108

Enrollment

Registered

2008-06-06

Start date

2005-01-01

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

COLORECTAL CANCER ANASTOMOTIC LAEKAGE

Interventions

Prior to performing a colorectal anastomosis, a biodegradable sheath was glued to the anvil of the circular stapler. in doing so, firing the circular stapler resulted in a fixation of the protective d

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18-80. 2. Patient requires anastomosis, maximally 15 cm from the anus. 3. Patient will recieve a colorectal anatomosis by means of stapling. 4. Patient is willing and able to comply with the specified follow-ip evaluation. 5. Patient or legally representative has given written consent.

Exclusion criteria

Exclusion criteria: See inclusion, if not, than exclusion

Design outcomes

Primary

Measure	Time frame
Position of sheath after one week, demonstrated by water-soluble contrast enema imaging.	—

Secondary

Measure	Time frame
- Userfriendliness - Compatibility with stapler device - Patient confort - Duration of degradation - Anastomotic leakage	—

Contacts

Public ContactJ.L.P. Kolkert

University Medical Center Groningen Department of Surgery PO Box 30 001

j.l.p. kolkert@chir.umcg.nl+31 (0)50 3616161

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)