Comparison of two types of sutures in robotic gastric bypass surgery
Prospective, Mono-center, Randomized, Single-blinded, Controlled Study on the Performance of Symmcora® Mid-term Suture Versus Novosyn® Suture in Patients Undergoing Robotic Assisted Gastric Bypass Surgery
This study is testing whether a new type of suture works better than a standard one for patients having robotic gastric bypass surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aesculap AG Industry-sponsored |
| Locations | 1 site (Kiel, Schleswig-Holstein) |
| Trial ID | NCT05433688 on ClinicalTrials.gov |
What this trial studies
This study compares the performance of Symmcora® mid-term suture and Novosyn® conventional suture in patients undergoing robotic-assisted gastric bypass surgery. It is a prospective, mono-centric, randomized, and patient-blinded trial where participants will be allocated to one of the two suture groups for the gastro-jejunal and jejuno-jejunal anastomoses. The goal is to evaluate the effectiveness and outcomes of these sutures in routine clinical practice.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a BMI of 35 or higher and related comorbidities, undergoing elective robotic-assisted gastric bypass surgery.
Not a fit: Patients who are undergoing emergency surgery or have a history of previous gastric surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and recovery for patients undergoing gastric bypass surgery.
How similar studies have performed: Other studies have shown promising results with similar approaches in surgical suturing techniques, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Kiel, Schleswig-Holstein
- Universitätsklinikum Schleswig-Holstein — Kiel, Schleswig-Holstein, Germany (Recruiting)
Study contacts
- Principal investigator: Jan H Beckmann, Dr. — University Hospital Schleswig-Holstein
- Study coordinator: Petra Baumann, Dr.
- Email: petra.baumann@aesculap.de
- Phone: +49746195
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.