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

Primary Purpose

Gastrointestinal Diseases, Laparotomy, Anastomosis, Surgical

Status

Completed

Phase

Phase 4

Locations

Hungary

Study Type

Interventional

Intervention

Gastrointestinal Anastomosis

About this trial

This is an interventional treatment trial for Gastrointestinal Diseases focused on measuring Gastrointestinal Anastomosis, Multicentre, Randomized controlled single-blind study, synthetic, absorbable, braided and coated suture material, Laparotomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Bugat Pal Korhaz, Sebeszeti Osztaly
B.-A.-Z. Megyei Korhaz, Sebeszeti Osztaly
Medical School of University Pecs

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

one layer running suture technique

two-layer suture technique

Outcomes

Primary Outcome Measures

Frequency of postoperative Complications

Secondary Outcome Measures

handling characteristics

Operation time to construct the first anastomosis

length of hospitalization

costs of suture material

Full Information

NCT ID

NCT00645684

First Posted

March 25, 2008

Last Updated

March 25, 2008

Sponsor

Aesculap AG

1. Study Identification

Unique Protocol Identification Number

NCT00645684

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Completed

Study Start Date

April 1998 (undefined)

Primary Completion Date

September 2001 (Actual)

Study Completion Date

May 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Aesculap AG

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Gastrointestinal Anastomosis, Multicentre, Randomized controlled single-blind study, synthetic, absorbable, braided and coated suture material, Laparotomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

210 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

one layer running suture technique

Arm Title

Arm Type

Experimental

Arm Description

two-layer suture technique

Intervention Type

Procedure

Intervention Name(s)

Gastrointestinal Anastomosis

Other Intervention Name(s)

SAFIL®: is a mid-term braided and coated synthetic absorbable suture made of, pure polyglycolic acid.

Intervention Description

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

Primary Outcome Measure Information:

Title

Frequency of postoperative Complications

Time Frame

discharge, 1 month and a maximum of 3-4 months

Secondary Outcome Measure Information:

Title

handling characteristics

Time Frame

intraoperative

Title

Operation time to construct the first anastomosis

Time Frame

intraoperative

Title

length of hospitalization

Time Frame

postoperative

Title

costs of suture material

Time Frame

intraoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

György Weber, MD, PhD

Organizational Affiliation

Medical School of University Pecs, Hungary

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bugat Pal Korhaz, Sebeszeti Osztaly

City

Gyöngyös

Country

Hungary

Facility Name

B.-A.-Z. Megyei Korhaz, Sebeszeti Osztaly

City

Miskolc

Country

Hungary

Facility Name

Medical School of University Pecs

City

Pecs

Country

Hungary

12. IPD Sharing Statement

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

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