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

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Use of an Absorbable Coated Suture Material in Surgery (Safil) One Layer Running(A) vs. Two-Layer Suture Technique (B)

Conditions
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Gastrointestinal Diseases, Laparotomy, Anastomosis, Surgical, Absorbable, Coated Sutures

Intervention / Treatment
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* Procedure: Gastrointestinal Anastomosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>one layer running suture technique | Procedure: Gastrointestinal Anastomosis<br>* Gastrointestinal Anastomosis with synthetic, absorbable, coated suture material using two different suture-techniques<br>* Other names: pure polyglycolic acid.;|
| Experimental: B<br>two-layer suture technique | Procedure: Gastrointestinal Anastomosis<br>* Gastrointestinal Anastomosis with synthetic, absorbable, coated suture material using two different suture-techniques<br>* Other names: pure polyglycolic acid.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of postoperative Complications |  | discharge, 1 month and a maximum of 3-4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| handling characteristics |  | intraoperative | 
| Operation time to construct the first anastomosis |  | intraoperative | 
| length of hospitalization |  | postoperative | 
| costs of suture material |  | intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrointestinal Anastomosis, Multicentre, Randomized controlled single-blind study, synthetic, absorbable, braided and coated suture material, Laparotomy