Research with human participants

Overview of medical research in the Netherlands

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

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Explore if the MiniMizer has effect on gastric emptying and on patients with symptoms of early dumping or late hypoglycaemia.

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Ethical review
Approved WMO
Status
Recruiting
Health condition type
Other condition
Study type
Interventional

ID

NL-OMON49962

Source

ToetsingOnline

Brief title

CARB study

Condition

  • Other condition
  • Gastrointestinal therapeutic procedures

Synonym

Dumping syndrome, late postprandial hypoglycaemia.

Health condition

Dumping syndroom

Research involving

Human

Sponsors and support

Primary sponsor :
Rijnstate Ziekenhuis
Source(s) of monetary or material Support :
Eigen financiering

Intervention

Keyword :
Banding, Bariatric Surgery, Dumping syndrome, Late hypoglycaemia

Outcome measures

Primary outcome

Frequency of early dumping; Frequency of late hypoglycaemia.

Secondary outcome

- Frequency of starting medication

- Complications and reoperations

- Quality of Life; BAROS, SF-36 and BODY-Q

- Reflux and dysphagia; GERD-HRQL.

Background summary

Moribid obesity is a worldwide problem. The Roux-en-Y Gastric Bypass (RYGB) and
one anatomosis gastric bypass (OAGB) are an effective treatment for this
problem. But 15 - 20% of the patients after a RYGB/ OAGB has dumping related
symptoms. A possible explanation is rapid gastric emptying of food which is
rich on carbohydrates. To slow the speed of emptying a MiniMizer around the
pouch could be a solution.

Study objective

Explore if the MiniMizer has effect on gastric emptying and on patients with
symptoms of early dumping or late hypoglycaemia.

Study design

Prospective multicentre pilot study

Intervention

Placement of a MiniMizer around the pouch.

Study burden and risks

- More dysfagia
- More reflux complaints
- Removal of the ring

Public
Rijnstate Ziekenhuis

Wagnerlaan 55
Arnhem 6800TA
NL
Scientific
Rijnstate Ziekenhuis

Wagnerlaan 55
Arnhem 6800TA
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)

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

- 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

Study type :
Interventional
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruiting
Start date (anticipated) :
Enrollment :
36
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
CCMO NL73179.091.20