Study on the Performance of Symmcora® Mid-term Suture Versus Novosyn® Suture in Patients Undergoi… (NCT05433688) | Clinical Trial Compass
CompletedNot Applicable
Study on the Performance of Symmcora® Mid-term Suture Versus Novosyn® Suture in Patients Undergoing Robotic Assisted Gastric Bypass Surgery
Germany150 participantsStarted 2022-10-12
Plain-language summary
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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.