Study on the Performance of Symmcora® Mid-term Suture Versus Novosyn® Suture in Patients Undergoing Robotic Assisted Gastric Bypass Surgery

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

ACTIVE_NOT_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-12

Study Completion Date

2027-01-31

Brief Summary

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The study is designed as a prospective, mono-centric, randomized, patient blinded comparison of unidirectional barbed suture (Symmcora® mid term, UBS) vs. a conventional suture (Novosyn®, CS). Patient will be randomly allocated in a 1:1 ratio to either the UBS group or the CS group to perform the gastro-jejunal anastomosis (GJA) and the jejuno-jejunal anastomosis (JJA).

The product under investigation and the conventional suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).

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Detailed Description

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Conditions

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Adiposity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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UBS

unidirectional barbed suture (Symmcora® mid term, UBS)

Robotic assisted gastric bypass surgery

Intervention Type DEVICE

The product under investigation and the conventional suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).

CS

conventional suture (Novosyn®, CS)

Robotic assisted gastric bypass surgery

Intervention Type DEVICE

The product under investigation and the conventional suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).

Interventions

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Robotic assisted gastric bypass surgery

The product under investigation and the conventional suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing an elective, primary robotic, assisted gastric bypass surgery (with a BMI ≥40 kg/m2 or with a BMI ≥35 kg/m2) with one or more of the following comorbidities: refractory arterial hypertension, type 2 diabetes mellitus and/or proven sleep apnea) with the need to close the gastro-jejunal anastomosis (GJA) and jejuno-jejunal anastomosis (JJA).
* Age ≥18 years
* Written informed consent

Exclusion Criteria

* Emergency surgery
* Previous gastric surgery
* History of chronic steroid use
* Pregnancy or breastfeeding
* Patients with hypersensitivity or allergy to the suture material
* Non compliance
* Participation in another randomized controlled trial

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No