Gastrointestinal Anastomosis Using MonoPlus® Suture

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-31

Study Completion Date

2023-12-31

Brief Summary

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The primary aim of this study is to collect clinical data on the performance of MonoPlus® suture applied in routine clinical practice. Diverse parameters are to be used to assess the safety and efficacy of MonoPlus® suture for gastrointestinal anastomosis construction.

This study has been designed to implement an action within the framework of a proactive Post Market Clinical Follow up (PMCF) activity.

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Detailed Description

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Conditions

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Gastrointestinal Stromal Tumors Gastrointestinal Neoplasms Digestive System Neoplasm Stomach Tumor Small Intestine Tumor Colon Tumor Rectum Tumor

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Monoplus®

Adult patients undergoing an elective, primary surgery within the gastrointestinal tract with the need for anastomosis.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult patients undergoing an elective open or laparoscopic primary tumor resection within GI tract (stomach, small intestine, large intestine , colon and rectum.
* Age ≥ 18 years
* ASA ≤ III
* Written informed consent

Exclusion Criteria

* ASA ≥IV
* Emergency operations
* Peritonitis
* Surgical interventions in the pancreas, oesophagus
* Patients with traumatic perforations
* Pregnant and/or breast-feeding women
* Patients who had received chemotherapy within the last 4 weeks or radiotherapy on the treated region within the last 2 weeks
* Patients who were receiving immunosuppressant therapy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No