Status:
COMPLETED
Clinical Use of an Absorbable Coated Suture Material in Surgery (Safil)
Lead Sponsor:
Aesculap AG
Conditions:
Gastrointestinal Diseases
Laparotomy
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The purpose is to test a coated polyglycolic acid multifilament suture in gastrointestinal surgery as part of a controlled randomized single blinded parallel group trial. The applicability and safety ...
Eligibility Criteria
Inclusion
- Patients of both sexes, undergoing a gastrointestinal hand made one-layer running (A) or two-layer (B) anastomotic procedure where the use of synthetic absorbable surgical suture material is indicated.
- Written consent to participate in the study
Exclusion
- Emergency patients that cannot be properly informed about the clinical trial and cannot give their written consent
- Pregnancy or lactation period
- Patients suffering from a diffuse purulent peritonitis or generalized diseases, which can have consequences for the healing of the asnastomosis (e.g. ubalanced diabetes, progressed uremia, massive hypoproteinaemia, sever jaundice, generalized intraabdominal tumor metastases, severe tumorous cachexia, severe avitaminosis, chronic liver disease.
- Patients who are undergoing a therapeutic procedure, which can have consequences for the healing of the anastomosis (e.g. treatment with corticosteroids or cytostatics, local radiation in the operating area)
- Laparoscopial Procedures
- Patients who are not willing to cooperate and legally incapacitated people
Key Trial Info
Start Date :
April 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2002
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT00645684
Start Date
April 1 1998
End Date
May 1 2002
Last Update
March 28 2008
Active Locations (3)
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1
Bugat Pal Korhaz, Sebeszeti Osztaly
Gyöngyös, Hungary
2
B.-A.-Z. Megyei Korhaz, Sebeszeti Osztaly
Miskolc, Hungary
3
Medical School of University Pecs
Pécs, Hungary