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

Gastrointestinal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00645684
• Other study ID #: BBS-WV-H-0219
• Status: Completed
• Phase: Phase 4
• First received: March 25, 2008
• Last updated: March 25, 2008
• Start date: April 1998
• Est. completion date: May 2002

Study information

• Verified date: March 2008
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: Regional Research Ethics Committee of Pote
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: May 2002
• Est. primary completion date: September 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Absorbable, Coated Sutures
• Anastomosis, Surgical
• Digestive System Diseases
• Gastrointestinal Diseases
• Laparotomy

Intervention

Procedure:
• Gastrointestinal Anastomosis
Gastrointestinal Anastomosis with synthetic, absorbable, coated suture material using two different suture-techniques

Locations

Country	Name	City	State
Hungary	Bugat Pal Korhaz, Sebeszeti Osztaly	Gyöngyös
Hungary	B.-A.-Z. Megyei Korhaz, Sebeszeti Osztaly	Miskolc
Hungary	Medical School of University Pecs	Pecs

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of postoperative Complications		discharge, 1 month and a maximum of 3-4 months	Yes
Secondary	handling characteristics		intraoperative	No
Secondary	Operation time to construct the first anastomosis		intraoperative	No
Secondary	length of hospitalization		postoperative	No
Secondary	costs of suture material		intraoperative	No