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Sleeve Gastrectomy Versus One-anastomosis Gastric Bypass: Randomized Trial

M

Mansoura University

Status

Unknown

Conditions

Morbid Obesity

Treatments

Procedure: sleeve gastrectomy
Procedure: one anastomosis gastric bypass

Study type

Interventional

Funder types

Other

Identifiers

NCT04134156
Mansoura105

Details and patient eligibility

About

Hormonal changes after SG and OAGB involve alterations in the levels of many enteric hormones, among these hormones are ghrelin and glucagon-like peptide-1 (GLP-1). Ghrelin is an orexigenic hormone that stimulates food intake and has a documented role in the development of obesity. While ghrelin levels decrease significantly after SG as the fundus, which is the main source of that hormone, is completely removed, they tend to increase after OAGB GLP-1 plays an important role in glucose homeostasis via affecting food intake and satiety. It enhances insulin secretion, stimulates the proliferation and growth of pancreatic beta cells, inhibits food and water intake, and promotes satiety. Some studies reported that both OAGB and SG are followed by increased GLP-1 levels. We conducted this randomized study to compare SG and OAGB with regards to weight loss, comorbidity resolution, changes in ghrelin and GLP-1 hormones, and complications.

Enrollment

40 patients

Sex

All

Ages

16 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult patients of both genders with morbid obesity (defined as BMI > 40 kg/m2 or > 35 Kg/m2 with at least one associated comorbidity) were included. Patients who underwent previous surgery for morbid obesity were also included.

Exclusion criteria

  • patients ageing more than 60 years
  • patients with endocrine disorders
  • patients with psychiatric disorders that influence perception of the study protocol
  • patients unfit for general anesthesia.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Sleeve gastrectomy
Active Comparator group
Description:
5-port standard sleeve gastrectomy was conducted
Treatment:
Procedure: sleeve gastrectomy
one anastomosis gastric bypass
Active Comparator group
Description:
5-port standard one-anastomosis gastric bypass was performed
Treatment:
Procedure: one anastomosis gastric bypass

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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