Clinical trial NCT04610099: Creating a Laparoscopic Banded Sleeve Gastrectomy
Official title: Creating a Laparoscopic Banded Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Morbid Obesity
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Sleeve Gastrectomy (SG) is on the long term not always successful in every patient because weight regain can occur. An intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the sleeve (Banded-Sleeve Gastrectomy: BSG) which increases weight loss and decreases weight regain on the longer term. The question is whether primary application of a banded sleeve gives a greater weight loss and / or prevent weight regain in the future versus a standard sleeve gastrectomy.

Detailed description: A Sleeve Gastrectomy (SG) is on the long term not always successful in every patient because weight regain can occur. An intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the sleeve (Banded-Sleeve Gastrectomy: BSG) which increases weight loss and decreases weight regain on the longer term. The question is whether primary application of a banded sleeve gives a greater weight loss and / or prevent weight regain in the future versus a standard sleeve gastrectomy.

Study is a prospective, randomized, multi centre trial.

Study population: patients who qualify for a SG are eligible to participate. The primary SG patients may participate if there is a BMI of 35 kg / m2 with a morbidly obesity-related comorbidity or a BMI of 40kg / m2 or higher.

Intervention: The standard SG is compared with a banded-SG (BSG)

Eligibility criteria: Inclusion Criteria:

* Alle patients who are eligible for a primary SG

Exclusion Criteria:

* Bariatric surgery in medical history
* BMI \> 60kg/m2 or a planned two-stage procedure.
* Patients with a language barrier which may affect the compliance with medical advice
* Patients with a disease not related to morbid obesity, such as Cushing or drug related.
* Chronic bowel disease for example Crohn's disease or colitis Colitis.
* Renal impairment (MDRD \<30) or hepatic dysfunction (liver function twice the normal values)
* Pregnancy during follow-up
* Patients with treatment-resistant reflux symptoms. Defined as reflux persistent symptoms despite the use of a minimum dose of proton-pump inhibitors

Primary outcomes:
measure: Percentage Total Body Weight loss (%TBWL)
timeFrame: 3 years
Secondary outcomes:
measure: Percentage Excess Weight Loss (%EWL)
timeFrame: 3 years
measure: Quality of life due to questionnaire
timeFrame: 3 years
measure: Quality of life due to questionnaire
timeFrame: 3 years
measure: Quality of life due to questionnaire
timeFrame: 3 years
measure: Gastroesophageal reflux disease
timeFrame: 3 years
measure: Reduction of comorbidities
timeFrame: 3 years
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
city: Heerlen
country: Netherlands
facility: Zuyderland Medisch Centrum
state: Limburg
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
state: Utrecht
Study officials:
affiliation: Rijnstate Hospital
name: Hazebroek
role: PRINCIPAL_INVESTIGATOR
References: