Laparoscopic Gastric Bypass as Metabolic Surgery in Obesity Class 1

NCT ID: NCT04595396

Last Updated: 2020-10-20

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

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-01

Study Completion Date

2019-12-31

Brief Summary

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Prospective study including Mexican patients diagnosed with type 2 diabetes and class 1 obesity, undergoing laparoscopic gastric bypass. The objective was to determine short, mid-and long-term outcomes (weight loss, metabolic, morbidity and diabetes remission). A subanalysis was included, based on preoperative usage of one (Group A) or more antidiabetics ± insulin (Group B).

Detailed Description

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Conditions

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Type2 Diabetes Bariatric Surgery Candidate Laparoscopic Gastric Bypass Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Laparoscopic Gastric Bypass

The LGBP was performed using a classic Roux-en-Y procedure. Briefly, a gastric pouch of 30-50 cc was constructed with an antecolic calibrated gastro-jejunal anastomosis (mechanical anastomosis using a 2.5 mm load). The biliary and alimentary limbs measured ≈70 cm and ≈150 cm, respectively, and the jejuno-jejunal anastomosis was also performed in a latero-lateral fashion (mechanical anastomosis using a 2.5 mm load). Mesenteric defects were closed with running non-absorbable sutures and the omentum was divided in every case

Intervention Type PROCEDURE

Other Intervention Names

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Roux-en-y gastric bypass

Eligibility Criteria

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Inclusion Criteria

Inclusion criteria Any sex \>18 years-old \<60 years-old Class 1 obesity (BMI 30-34.9 kg/m2) Type-2 diabetes mellitus diagnosis (with or without medication) Submitted to laparoscopic gastric bypass

Exclusion criteria Other bariatric surgery Revisional surgery Incomplete charts
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CARLOS ZERRWECK LOPEZ

OTHER_GOV

Sponsor Role lead

Responsible Party

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CARLOS ZERRWECK LOPEZ

Professor and Head of Department.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hospital General Tlahuac

Mexico City, , Mexico

Site Status

Countries

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Mexico

References

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Cevallos L, Rodriguez FM, Herrera A, Sepulveda EM, Donatini G, Guilbert L, Zerrweck C. Metabolic Surgery and Class 1 Obesity (< 35 kg/m2): a Prospective Study with Short-, Mid-, and Long-term Results Among Latinos. Obes Surg. 2021 Jun;31(6):2401-2409. doi: 10.1007/s11695-021-05275-3. Epub 2021 Feb 17.

Reference Type DERIVED
PMID: 33598844 (View on PubMed)

Other Identifiers

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CONBIOETICA09-CEI-001-20160404

Identifier Type: -

Identifier Source: org_study_id

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