Clinical Use of an Absorbable Coated Suture Material in Surgery (Safil)

Aesculap

Status and phase

Completed

Phase 4

Conditions

Laparotomy

Gastrointestinal Diseases

Anastomosis, Surgical

Absorbable, Coated Sutures

Treatments

Procedure: Gastrointestinal Anastomosis

Study type

Interventional

Funder types

Industry

Identifiers

NCT00645684

BBS-WV-H-0219

Details and patient eligibility

About

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 of the strand material used in two suture techniques (2-layer suture technique vs. 1-layer running) are to be tested on the basis of handling characteristics, the operative time consumed for the construction of the 1st anastomosis, the average time of the hospital duration for both patient groups, and the frequency of postoperative complications after discharge, 1 month and a maximum of 3-4 months. The used suture units are counted and the length of sutures determined which will be an indirect measurement of the costs of suture material for the two techniques.

Enrollment

210 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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