AdiposityBARGASTRONCT05433688
Study on the Performance of Symmcora® Mid-term Suture Versus Novosyn® Suture in Patients Undergoing Robotic Assisted Gastric Bypass Surgery
An observational study of Adiposity, run by Aesculap AG at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adiposity
- What is being tested?
- Robotic assisted gastric bypass surgery
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 12 Oct 2022to 11 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing elective primary, robotic assisted gastric bypass surgery with the need to close the gastro-jejunal anastomosis and the jejuno-jejunal anastomosis.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, 24105
About this study
Official title: 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
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).
- Conditions
- Adiposity
- Being tested
- Robotic assisted gastric bypass surgery
- Keywords
- gastro-jejunal anastomosis, jejuno-jejunal anastomosis, robotic assisted gastric bypass surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic assisted gastric bypass surgeryDevice
The product under investigation and the conventional suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).
| Study group | Role | What they receive |
|---|---|---|
| UBS | unidirectional barbed suture (Symmcora® mid term, UBS) Receives: Device: Robotic assisted gastric bypass surgery | |
| CS | conventional suture (Novosyn®, CS) Receives: Device: Robotic assisted gastric bypass surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to perform the anastomosis
Time to perform the gastro-jejunal anastomosis and the jejuno-jejunal anastomosis
Measured: intraoperatively
Secondary outcomes (16)
Anastomotic leak rate over postoperative period
Number of patients having Anastomotic leak at each examination
Measured: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively
Anastomosis stenosis rate over postoperative period
Number of patients having Anastomosis stenosis at each examination
Measured: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively
Gastric fistula rate over postoperative period
Number of patients having Gastric fistula at each examination
Measured: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively
Rate of Obstruction over postoperative period
Number of patients having obstruction of the anastomosis at each examination
Measured: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively
Rate of Anastomosis bleeding over postoperative period
Number of patients having anastomosis bleeding at each examination
Measured: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively
Cumulative Frequency of other complications according to "Clavien-Dindo" over postoperative period
Number of other complications classified according to "Clavien-Dindo" classification in order to rank a complication in an objective and reproducible manner. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study. Complications that have the potential for long-lasting disability after patient's discharge (e.g.: paralysis of a voice cord after thyroid surgery) are highlighted in the present classification by a suffix ("d" for disability). This suffix indicates that a follow-up is required to comprehensively evaluate the outcome and related long-term quality of life
Measured: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively
Rate of Re-anastomosis over postoperative period
Number of re-anastomosis at each examination
Measured: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively
Total operation duration
time from cut to closure in minutes. The time is rounded up and only whole numbers are used
Measured: intraoperatively
Total procedure costs
Costs (15 Euro / Operation minute; suture material, number of used sutures, costs / Hospital day)
Measured: until discharge approximately 10 days after surgery
Length of postoperative stay
Number of days after surgery until the patient is discharged from hospital
Measured: until discharge approximately 10 days after surgery
Patient satisfaction (VAS)
With the Visual Analogue Scale from 0 mm - 100 mm the satisfaction of the patient will be evaluated with 0 (not satisfied at all) to 100 (very satisfied).
Measured: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively
Patient pain (VAS)
With the Visual Analogue Scale from 0 mm - 100 mm the pain of the patient will be evaluated with 0 (no pain) to 100 (worst pain).
Measured: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively
Bariatric Analysis and Reporting Outcome System (BAROS)
questionnaire a common tool to evaluate patient's outcome and quality of life before and after bariatric surgeries. Three main parameters are evaluated with this tool, the weight, the medical conditions and the quality of life. The weight and the medical conditions will be evaluated by the physician. The questions regarding the quality of life will be answered directly by the patients. The six categories (felling, sexual activities, physical activities, work, food and social contacts) can be answered on scale with 10 steps from very good to very bad.
Measured: preoperative, 30 days and 12 months post-surgery
Course of Health Status measured with EQ-5D-5L Score
EQ-5D-5L is a Quality of Life Score introduced by the EuroQol Group. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
Descriptive system comprises five dimensions (5D): mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels (5L): no problems, slight problems, moderate problems, severe problems, extreme problems. Each answer results in a 1-digit number. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Measured: preoperative, 30 days and 12 months post-surgery
Assessment of the handling of the unidirectional barbed suture
intra-operatively including different dimensions with 5 evaluations levels (excellent, very good, good, satisfied, poor).
Measured: intraoperatively
Assessment of the barbed suture compared to a conventional suture
Handling of barbed suture compared to a conventional suture (degree of difficulties and ease of handling) measured in two categories with a 5 point scale (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree)
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start12 Oct 2022
- Primary completion11 Mar 2026
- Study completion11 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AdiposityStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Responsible party
- Sponsor
- Investigators
- Jan H Beckmann, Dr., Principal investigator, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433688
- Sponsor's protocol ID
- AAG-O-H-1932
- Acronym
- BARGASTRO
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2022
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beckmann JH, Baumann P, Jackisch C, Richter F, Mehdorn AS, Becker T, Taivankhuu T, von Schonfels W. Assessment of a new unidirectional barbed suture versus a conventional suture for anastomosis during robotic-assisted Roux-en-Y gastric bypass surgery in obese patients: BARGASTRO - study protocol for a German randomized active-controlled trial. Trials. 2026 Jan 6;27(1):87. doi: 10.1186/s13063-025-09401-9.
PubMed 41495768
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05433688
- Acronym / sponsor ID
- BARGASTRO / AAG-O-H-1932
- Conditions
- Adiposity
- Keywords
- gastro-jejunal anastomosis, jejuno-jejunal anastomosis, robotic assisted gastric bypass surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 11 Mar 2026 (actual)
- Study completion
- 11 Mar 2026 (actual)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UBS | – | Device: Robotic assisted gastric bypass surgeryunidirectional barbed suture (Symmcora® mid term, UBS) |
| CS | – | Device: Robotic assisted gastric bypass surgeryconventional suture (Novosyn®, CS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective primary, robotic assisted gastric bypass surgery with the need to close the gastro-jejunal anastomosis and the jejuno-jejunal anastomosis.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Emergency surgery
- Previous gastric surgery
- History of chronic steroid use
- Pregnancy or breastfeeding
- Patients with hypersensitivity or allergy to the suture material
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic assisted gastric bypass surgeryThe product under investigation and the conventional suture material will be used in routine clinical practice and according to the Instructions for Use (IfU). | Device | CS, UBS |
Primary outcome
Time to perform the anastomosis
Time frame: intraoperatively
Time to perform the gastro-jejunal anastomosis and the jejuno-jejunal anastomosis
16 secondary outcomes
Anastomotic leak rate over postoperative period
Time frame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively
Anastomosis stenosis rate over postoperative period
Time frame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively
Gastric fistula rate over postoperative period
Time frame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively
Rate of Obstruction over postoperative period
Time frame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively
Rate of Anastomosis bleeding over postoperative period
Time frame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively
Cumulative Frequency of other complications according to "Clavien-Dindo" over postoperative period
Time frame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively
Rate of Re-anastomosis over postoperative period
Time frame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively
Total operation duration
Time frame: intraoperatively
Total procedure costs
Time frame: until discharge approximately 10 days after surgery
Length of postoperative stay
Time frame: until discharge approximately 10 days after surgery
Patient satisfaction (VAS)
Time frame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively
Patient pain (VAS)
Time frame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively
Bariatric Analysis and Reporting Outcome System (BAROS)
Time frame: preoperative, 30 days and 12 months post-surgery
Course of Health Status measured with EQ-5D-5L Score
Time frame: preoperative, 30 days and 12 months post-surgery
Assessment of the handling of the unidirectional barbed suture
Time frame: intraoperatively
Assessment of the barbed suture compared to a conventional suture
Time frame: intraoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Background: PubMed 41495768Beckmann JH, Baumann P, Jackisch C, Richter F, Mehdorn AS, Becker T, Taivankhuu T, von Schonfels W. Assessment of a new unidirectional barbed suture versus a conventional suture for anastomosis during robotic-assisted Roux-en-Y gastric bypass surgery in obese patients: BARGASTRO - study protocol for a German randomized active-controlled trial. Trials. 2026 Jan 6;27(1):87. doi: 10.1186/s13063-025-09401-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan H Beckmann, Dr. principal investigator
University Hospital Schleswig-Holstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adiposity, run by Aesculap AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to perform the anastomosis (time frame: intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05433688, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.