To determine whether UGI series is a feasible technique for 2D and 3D gastric pouch and gastroenterostomy size measurements after Roux-en-Y gastric bypass surgery.
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters are pouch volume and gastroenterostomy area and diameter
and sleeve volume on CT scan and UGI series.
Secondary outcome
nvt
Background summary
Morbid obesity is a global and imminent health issue. The Roux-en-Y gastric
bypass (RYGB) and sleeve gastrectomy (SG) are effective and sustainable methods
for weight loss. Although the advantages of bariatric surgery have been widely
shown, insufficient weight loss, weight regain and malnutrition are important
adverse long-term outcomes. It has been discussed if, and to what extent
gastric pouch size and gastroenterostomy size or sleeve size influence the
outcomes of bariatric surgery in terms of weight loss. The inability of
revealing a relationship between pouch or anastomosis size in RYGB and sleeve
size in SG and weight loss may be due to the (suboptimal) methods that have
been used for size measurements. Computed tomography (CT) and upper
gastrointestinal (UGI) series have been used for size measurements after RYGB
or SG surgery. Although size measurements can be accurately performed on CT
scans, the use of UGI series has several advantages over CT, such as lower
costs, easier accessibility and lower radiation dose. We aim to validate an
optimized UGI examination for size measurements of the gastric pouch and
gastroenterostomy after RYGB or SG surgery.
Study objective
To determine whether UGI series is a feasible technique for 2D and 3D gastric
pouch and gastroenterostomy size measurements after Roux-en-Y gastric bypass
surgery.
Study design
This study will be a prospective pilot study. Size measurements on a newly
developed standardized method using UGI examination (including fluoroscopy)
will be compared to CT as a gold standard.
Study burden and risks
In this pilot study, subjects will receive an additional radiation dose of
about 2 mSv. On average, an acute dose of 10 mSv of this type of radiation
leads to an additional risk of cancer of about 1 in 1750 (~1 in 2000 for males,
~1 in 1500 for females) for a 50-year old subject, based on the linear no
threshold model. The standard diagnosing tool for inventorying weight regain
after RYGB is the CT scan. However, UGI examination has several advantages over
CT that could prove to be useful for pouch and gastroenterostomy measurements.
Wagnerlaan 55
Arnhem 6815AD
NL
Wagnerlaan 55
Arnhem 6815AD
NL
Listed location countries
Age
Inclusion criteria
The patient should have undergone laparoscopic RYGB or SG surgery (standard procedure);
The patient must have a CT scan planned, for example for evaluation of upper abdominal complaints or weight regain.
Exclusion criteria
The patient is suspected to have a leakage of the gastric pouch, gastric sleeve or gastroenterostomy;
The patient has an age below 18;
The patient is incompetent to decide;
The patient is pregnant or gives breast feeding;
One or more scans have insufficient scan quality;
The patient has a contra-indication for the administration of IV contrast;
The patient is not able to tolerate effervescent granules.
Design
Recruitment
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 | NL60384.091.16 |