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

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

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Diseases; Laparotomy; Anastomosis, Surgical; Absorbable, Coated Sutures
• Intervention / Treatment: Procedure: Gastrointestinal Anastomosis

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 4

Contacts and Locations

Study Locations

• Hungary
  • Gyöngyös, Hungary
    • Bugat Pal Korhaz, Sebeszeti Osztaly
  • Miskolc, Hungary
    • B.-A.-Z. Megyei Korhaz, Sebeszeti Osztaly
  • Pecs, Hungary
    • Medical School of University PECS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; one layer running suture technique	Procedure: Gastrointestinal Anastomosis; Gastrointestinal Anastomosis with synthetic, absorbable, coated suture material using two different suture-techniques; Other Names: SAFIL®: is a mid-term braided and coated synthetic absorbable suture made of; pure polyglycolic acid.
Experimental: B; two-layer suture technique	Procedure: Gastrointestinal Anastomosis; Gastrointestinal Anastomosis with synthetic, absorbable, coated suture material using two different suture-techniques; Other Names: SAFIL®: is a mid-term braided and coated synthetic absorbable suture made of; pure polyglycolic acid.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Aesculap AG
• Investigators: Principal Investigator: György Weber, MD, PhD, Medical School of University Pecs, Hungary

Study record dates

Study Major Dates

• Study Start: April 1, 1998
• Primary Completion (Actual): September 1, 2001
• Study Completion (Actual): May 1, 2002

Study Registration Dates

• First Submitted: March 25, 2008
• First Submitted That Met QC Criteria: March 25, 2008
• First Posted (Estimate): March 28, 2008

Study Record Updates

• Last Update Posted (Estimate): March 28, 2008
• Last Update Submitted That Met QC Criteria: March 25, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Keywords: Laparotomy; Multicentre; Gastrointestinal Anastomosis; Randomized controlled single-blind study; synthetic, absorbable, braided and coated suture material
• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: BBS-WV-H-0219