NCT05433688

Brief 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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Oct 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Oct 2022Jan 2027

First Submitted

Initial submission to the registry

June 22, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

October 12, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

3.6 years

First QC Date

June 22, 2022

Last Update Submit

April 10, 2026

Conditions

Adiposity

Keywords

gastro-jejunal anastomosisjejuno-jejunal anastomosisrobotic assisted gastric bypass surgery

Outcome Measures

Primary Outcomes (1)

  • Time to perform the anastomosis

    Time to perform the gastro-jejunal anastomosis and the jejuno-jejunal anastomosis

    intraoperatively

Secondary Outcomes (16)

  • Anastomotic leak rate over postoperative period

    until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively

  • Anastomosis stenosis rate over postoperative period

    until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively

  • Gastric fistula rate over postoperative period

    until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively

  • Rate of Obstruction over postoperative period

    until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively

  • Rate of Anastomosis bleeding over postoperative period

    until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively

  • +11 more secondary outcomes

Study Arms (2)

UBS

unidirectional barbed suture (Symmcora® mid term, UBS)

Device: Robotic assisted gastric bypass surgery

CS

conventional suture (Novosyn®, CS)

Device: Robotic assisted gastric bypass surgery

Interventions

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).

CSUBS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, 24105, Germany

Location

Related Publications (1)

  • 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.

    PMID: 41495768BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jan H Beckmann, Dr.

    University Hospital Schleswig-Holstein

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2022

First Posted

June 27, 2022

Study Start

October 12, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)