Adiposity
Conditions
Keywords
gastro-jejunal anastomosis, jejuno-jejunal anastomosis, robotic assisted gastric bypass surgery
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).
Interventions
DEVICERobotic assisted gastric bypass surgery
The product under investigation and the conventional suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).
Sponsors
Aesculap AG
B.Braun Surgical SA
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to perform the anastomosis | intraoperatively | Time to perform the gastro-jejunal anastomosis and the jejuno-jejunal anastomosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anastomotic leak rate over postoperative period | until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively | Number of patients having Anastomotic leak at each examination |
| Anastomosis stenosis rate over postoperative period | until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively | Number of patients having Anastomosis stenosis at each examination |
| Gastric fistula rate over postoperative period | until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively | Number of patients having Gastric fistula at each examination |
| Rate of Obstruction over postoperative period | until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively | Number of patients having obstruction of the anastomosis at each examination |
| Rate of Anastomosis bleeding over postoperative period | until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively | Number of patients having anastomosis bleeding at each examination |
| Cumulative Frequency of other complications according to "Clavien-Dindo" over postoperative period | until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively | 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 |
| Rate of Re-anastomosis over postoperative period | until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively | Number of re-anastomosis at each examination |
| Total operation duration | intraoperatively | time from cut to closure in minutes. The time is rounded up and only whole numbers are used |
| Total procedure costs | until discharge approximately 10 days after surgery | Costs (15 Euro / Operation minute; suture material, number of used sutures, costs / Hospital day) |
| Length of postoperative stay | until discharge approximately 10 days after surgery | Number of days after surgery until the patient is discharged from hospital |
| Patient satisfaction (VAS) | until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively | 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). |
| Patient pain (VAS) | until discharge (approximately 10 days after surgery), at 30 days and at 12 months postoperatively | 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). |
| Bariatric Analysis and Reporting Outcome System (BAROS) | preoperative, 30 days and 12 months post-surgery | 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. |
| Course of Health Status measured with EQ-5D-5L Score | preoperative, 30 days and 12 months post-surgery | 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'. |
| Assessment of the handling of the unidirectional barbed suture | intraoperatively | intra-operatively including different dimensions with 5 evaluations levels (excellent, very good, good, satisfied, poor). |
| Assessment of the barbed suture compared to a conventional suture | intraoperatively | 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) |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORJan H Beckmann, Dr.
University Hospital Schleswig-Holstein
Outcome results
None listed