This study aims to assess the long-term impact of the POSE-2 procedure on weight loss, specifically focusing on the percentage of total weight loss (%TWL) over a 5-year follow-up period. Additionally, the durability and safety of the procedure will…
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
- Medical device
N.a.
Outcome measures
Primary outcome
<p>Primarily, the percentage of total weight loss (%TWL) at a 5-year follow-up</p>
Secondary outcome
<p>secondary the long-term durability and safety of the POSE-2 assessed by<br />
gastroscopy and barium swallow. Tertiary the quality of life and overall<br />
patient satisfaction, assessed by questionnaires</p>
Background summary
In the context of rising obesity rates, various interventions have been
developed to address weight loss, from non-invasive options such as lifestyle
intervention and anti-obesity drugs to more invasive options such as Bariatric
Metabolic Surgery (BMS). BMS effectively reduces weight up to 30% total weight
loss (TWL) within the first year, but it also results in complications in up to
10% of patients. These complications include serious short- and long-term
consequences, such as anastomotic leaks or pulmonary embolisms, which can pose
substantial risks to patients. Endoscopic procedures have emerged as a middle
ground between non-invasive therapies and traditional BMS. An endoscopic
approach has fewer risks, demonstrating a TWL of 13% at 3-6 months and 13% at
12-15 months, while maintaining a low complication rate of 3%.
One of the endoscopic options is, primary obesity surgery endoluminal (POSE),
which utilizes an incisionless approach aimed at modifying gastric
accommodation and motility through full-thickness plications. More recently a
modified version of the POSE is introduced in clinical practice, the POSE-2.
Despite promising short-term results, there is a lack of information on the
long-term effects of POSE-2, particularly beyond two years post-procedure.
Existing studies adequately cover outcomes up to two years, but data on its
sustained efficacy and safety over five years are sparse. This study aims to
address this gap by assessing long-term outcomes over five years, thereby
providing valuable insights into the procedure's sustained effectiveness and
safety. Such findings are crucial for informing clinical practices and
enhancing patient care in obesity management.
Study objective
This study aims to assess the long-term impact of the POSE-2 procedure on
weight loss, specifically focusing on the percentage of total weight loss
(%TWL) over a 5-year follow-up period. Additionally, the durability and safety
of the procedure will be examined. Finally, this study will explore the
influence of the POSE-2 procedure on patients' quality of life.
Study design
This long-term study will prospectively collect patient data at their 5-year
post-POSE-2 procedure mark to examine clinical outcomes.
Intervention
POSE 2
Study burden and risks
The burden of a gastroscopy and barium swallow includes the preparation and
potential discomfort associated with these procedures. For a gastroscopy,
patients typically need to fast for several hours beforehand, and although
sedation is often used to minimize discomfort, they might experience a sore
throat or mild discomfort afterward. The barium swallow requires ingestion of a
barium contrast, which some might find unpleasant, and may lead to temporary
constipation. The burden of the questionnaires will be minimal. A clinically
validated questionnaire, the OBESI-q, will be utilised with additional
questions.
Despite these burdens, a significant benefit is that these procedures provide
the patient with a comprehensive assessment of their upper gastrointestinal
health. This offers an additional check-up of their medical condition without
the extra cost, potentially identifying issues early and preventing further
complications, thus contributing positively to their overall health management.
GHJM Verkoulen
Henri Dunantstraat 5
Heerlen 6419PC
Netherlands
088 459 7777
bwo@zuyderland.nl
GHJM Verkoulen
Henri Dunantstraat 5
Heerlen 6419PC
Netherlands
088 459 7777
bwo@zuyderland.nl
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
- Patients who underwent a POSE-2 procedure
- Patient is >18 years old
- The patient is capable of understanding, reading, and signing the informed
consent.
Exclusion criteria
- Death
- Psychiatric Disorders
- Substance abuse
- Malignancy
- Women who are currently pregnant or within 6 months postpartum at the time of
the 5-year follow-up.
- Allergic reaction to oral barium contrast
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
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 | NL88701.096.24 |
Research portal | NL-009111 |