Creating a Laparoscopic Banded Sleeve Gastrectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2026-03-01

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Morbid Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard SG

100 patients undergo a standard sleeve gastrectomy

Group Type ACTIVE_COMPARATOR

Standard SG

Intervention Type DEVICE

Standard SG

Banded SG

100 patients undergo a banded sleeve gastrectomy

Group Type EXPERIMENTAL

Banded Sleeve Gastrectomy

Intervention Type DEVICE

banded sleeve gastrectomy

Interventions

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Banded Sleeve Gastrectomy

banded sleeve gastrectomy

Intervention Type DEVICE

Standard SG

Intervention Type DEVICE

Other Intervention Names

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BSG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No