Absorbable, Coated Sutures, Anastomosis, Surgical, Gastrointestinal Diseases, Laparotomy
Conditions
Keywords
Gastrointestinal Anastomosis, Multicentre, Randomized controlled single-blind study, synthetic, absorbable, braided and coated suture material, Laparotomy
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 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.
Interventions
PROCEDUREGastrointestinal Anastomosis
Gastrointestinal Anastomosis with synthetic, absorbable, coated suture material using two different suture-techniques
Sponsors
Aesculap AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of postoperative Complications | discharge, 1 month and a maximum of 3-4 months |
Secondary
| Measure | Time frame |
|---|---|
| handling characteristics | intraoperative |
| Operation time to construct the first anastomosis | intraoperative |
| length of hospitalization | postoperative |
| costs of suture material | intraoperative |
Countries
Hungary
Outcome results
None listed