Reduction of gastrojejunal anastomosis with a novel endoscopic clipping device in bariatric patients with gastric bypass for treatment of dumping syndrome - an observation study

Recruiting

Conditions: K91.1
Postgastric surgery syndromes

Registration Number: DRKS00022042

Lead Sponsor: IVERSITÄTSKLINIKUM FREIBURG Klinik für Innere Medizin II Gastroenterologie, Hepatologie, Endokrinologie und Infektiologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

Patients treated with Bariatric Reduction System. This means: Proven Dumping syndrome by Sigstad Score >7 and pathologic modified oGTT and refractory to dietary restrictions.

Exclusion Criteria

According to contraindications for BARS:
- Esophageal or pharyngeal stenosis
- no obtainable informed consent
- age <18 years
- insulin-dependant diabetes mellitus
- esophageal varices

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical success (=successful reduction of the anastomotic diameter and/or reduction of the surface area to 20-30%)

Secondary Outcome Measures

Name	Time	Method
Clinical success: <br>- 50% reduction of sigstad score or below 7 points 4 and 12 weeks after BARS<br>- Change in AUC glucose and insulin in modified oral glucose tolerance test after 4 and 12 weeks<br>- change of heart rate in the modified oral glucose tolerance test after 4 and 12 weeks<br><br>Quality of life measured with questionnaire (SF-36) before and after 12 weeks<br><br>Complications<br><br>Procedure time and intervention time<br><br>Reduction in gastric emptying via scintigraphy