NCT00645684

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 1998

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1998

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2001

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2002

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2008

Completed
Last Updated

March 28, 2008

Status Verified

March 1, 2008

Enrollment Period

3.4 years

First QC Date

March 25, 2008

Last Update Submit

March 25, 2008

Conditions

Gastrointestinal DiseasesLaparotomyAnastomosis, SurgicalAbsorbable, Coated Sutures

Keywords

Gastrointestinal AnastomosisMulticentreRandomized controlled single-blind studysynthetic, absorbable, braided and coated suture materialLaparotomy

Outcome Measures

Primary Outcomes (1)

  • Frequency of postoperative Complications

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

Secondary Outcomes (4)

  • handling characteristics

    intraoperative

  • Operation time to construct the first anastomosis

    intraoperative

  • length of hospitalization

    postoperative

  • costs of suture material

    intraoperative

Study Arms (2)

A

EXPERIMENTAL

one layer running suture technique

Procedure: Gastrointestinal Anastomosis

B

EXPERIMENTAL

two-layer suture technique

Procedure: Gastrointestinal Anastomosis

Interventions

Gastrointestinal AnastomosisPROCEDURE

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

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Bugat Pal Korhaz, Sebeszeti Osztaly

Gyöngyös, Hungary

Location

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

Miskolc, Hungary

Location

Medical School of University Pecs

Pécs, Hungary

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • György Weber, MD, PhD

    Medical School of University Pecs, Hungary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 25, 2008

First Posted

March 28, 2008

Study Start

April 1, 1998

Primary Completion

September 1, 2001

Study Completion

May 1, 2002

Last Updated

March 28, 2008

Record last verified: 2008-03

Locations

HU(3)