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Gastric bypass banding for post bariatric dumping and post bariatric late hypoglycaemia

Gastric bypass banding for post bariatric dumping and post bariatric late hypoglycaemia - CARB study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49962
Enrollment
36
Registered
2020-10-12
Start date
2022-12-19
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dumping syndroom Dumping syndrome late postprandial hypoglycaemia.

Interventions

Placement of a MiniMizer around the pouch.

Sponsors

Rijnstate Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Age > 18 - RYGB or OAGB in medical history - Dumping related symptoms - Failed treatment of dumping symptoms with dietary adjustments. - The intention to fully follow the postoperative program.

Exclusion criteria

Exclusion criteria: - Symptoms of early dumping and late hypoglycaemia. - Pregnancy - Patiënts with a language barrier which can have effect on medical follow-up and treatment - Patients with endocrine disorders that may have influence on gastric emptying (such as diabetes, hypo- or hyperthyreoidism)

Design outcomes

Primary

MeasureTime frame
Frequency of early dumping; Frequency of late hypoglycaemia.

Secondary

MeasureTime frame
- Frequency of starting medication - Complications and reoperations - Quality of Life; BAROS, SF-36 and BODY-Q - Reflux and dysphagia; GERD-HRQL.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)