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An International, Multicentric, Prospective, Observational Study to Evaluate Monosyn® Suture Material for Anastomoses in the Gastrointestinal Tract

NCT02080702 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 106

Last updated 2018-07-02

No results posted yet for this study

Summary

The aim of this non-interventional study is to evaluate the efficacy of a monofilament, mid-term absorbable suture material (Monosyn®) for anastomosis performed in the gastrointestinal tract using the frequency of anastomosis leakage as a primary parameter.

Postoperative complication rate, length of hospital stay, costs, time to perform the anastomosis and handling will serve as secondary endpoints.

The question is addressed, whether a monofilament suture material is as effective as a braided suture material for anastomosis construction within the gastrointestinal tract.

Conditions

  • C.Surgical Procedure; Digestive System
  • Symptomatic Disorders of the Gastrointestinal Tract
  • Gastric Anastomosis (Site)
  • Gastrointestinal Neoplasms

Interventions

DEVICE

Monosyn

Monosyn will be used to perform the gastrointestinal anastomoses

Sponsors & Collaborators

  • B.Braun Surgical SA

    collaborator INDUSTRY

  • Aesculap AG

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Malaysia
  • Philippines
  • South Korea
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02080702 on ClinicalTrials.gov