Clinical trial NCT05433688: Study on the Performance of Symmcora® Mid-term Suture Versus Novosyn® Suture in Patients Undergoing Robotic Assisted Gastric Bypass Surgery
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adiposity
Keywords: gastro-jejunal anastomosis
jejuno-jejunal anastomosis
robotic assisted gastric bypass surgery
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2022-06-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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.

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).


Eligibility 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

Primary outcomes:
measure: Time to perform the anastomosis
timeFrame: intraoperatively
Secondary outcomes:
measure: Anastomotic leak rate over postoperative period
timeFrame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively
measure: Anastomosis stenosis rate over postoperative period
timeFrame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively
measure: Gastric fistula rate over postoperative period
timeFrame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively
measure: Rate of Obstruction over postoperative period
timeFrame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively
measure: Rate of Anastomosis bleeding over postoperative period
timeFrame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively
measure: Cumulative Frequency of other complications according to "Clavien-Dindo" over postoperative period
timeFrame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively
measure: Rate of Re-anastomosis over postoperative period
timeFrame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively
measure: Total operation duration
timeFrame: intraoperatively
measure: Total procedure costs
timeFrame: until discharge approximately 10 days after surgery
measure: Length of postoperative stay
timeFrame: until discharge approximately 10 days after surgery
measure: Patient satisfaction (VAS)
timeFrame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively
measure: Patient pain (VAS)
timeFrame: until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively
measure: Bariatric Analysis and Reporting Outcome System (BAROS)
timeFrame: preoperative, 30 days and 12 months post-surgery
measure: Course of Health Status measured with EQ-5D-5L Score
timeFrame: preoperative, 30 days and 12 months post-surgery
measure: Assessment of the handling of the unidirectional barbed suture
timeFrame: intraoperatively
measure: Assessment of the barbed suture compared to a conventional suture
timeFrame: intraoperatively
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
Study officials:
affiliation: University Hospital Schleswig-Holstein
name: Jan H Beckmann, Dr.
role: PRINCIPAL_INVESTIGATOR
References: