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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Monosyn

Construction of a gastrointestinal anastomoses

Monosyn

Intervention Type DEVICE

Monosyn will be used to perform the gastrointestinal anastomoses

Interventions

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Monosyn

Monosyn will be used to perform the gastrointestinal anastomoses

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age 18 years and older
* ASA I-III
* Indication for an elective tumor surgery within the GI tract (stomach, small intestine, large intestine)
* Written informed consent

Exclusion Criteria

* Emergency surgery
* Peritonitis
* Patients undergoing an operation due to a tumour within the pancreas, rectum, esophagus
* Pregnant women and breast-feeding women
* Chemotherapy
* Current immunosuppressive therapy
* Radiotherapy on the treated region within the last 2 months

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No