Trials / Terminated
TerminatedNCT02080702
An International, Multicentric, Prospective, Observational Study to Evaluate Monosyn® Suture Material for Anastomoses in the Gastrointestinal Tract
An International, Multicentric, Prospective, Observational Study to Evaluate Monosyn® Suture Material for Anastomoses in the Gastrointestinal Tract.
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 106 (actual)
- Sponsor
- Aesculap AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DEVICE | Monosyn | Monosyn will be used to perform the gastrointestinal anastomoses |
Timeline
- Start date
- 2014-08-01
- Primary completion
- 2016-06-01
- Completion
- 2016-06-01
- First posted
- 2014-03-06
- Last updated
- 2018-07-02
Locations
5 sites across 4 countries: Malaysia, Philippines, South Korea, Taiwan
Source: ClinicalTrials.gov record NCT02080702. Inclusion in this directory is not an endorsement.