ESG vs LSG: Short-term Nutritional Outcomes

NCT ID: NCT04264364

Last Updated: 2020-02-11

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

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-16

Study Completion Date

2019-11-25

Brief Summary

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To assess endoscopic sleeve gastroplasty in comparison to laparoscopic sleeve gastrectomy before and 3 months after the procedure in terms of multiple nutrition-related factors, quality of life, weight and other related parameters.

Detailed Description

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This will be a short-term prospective cohort study, single-center study (NewYou clinical center - Riyadh). A total of 15 endoscopic sleeve gastroplasty patients will be matched with 15 laparoscopic sleeve gastrectomy patients by age, gender and BMI. Total sample size is 30 patients. Sample size was selected based on literature, considering the sample will be surgical patients and based on booked patients in the clinic. A multidisciplinary team will provide post-procedure care (including post-surgery diet stages protocol given by the center).

Conditions

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Endoscopic Sleeve Gastroplasty Laparoscopic Sleeve Gastrectomy Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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laparoscopic sleeve gastrectomy

Patients who underwent laparoscopic sleeve gastrectomy

Laparoscopic sleeve gastrectomy

Intervention Type PROCEDURE

Bariatric surgical intervention

endoscopic sleeve gastroplasty

Patients who underwent endoscopic sleeve gastroplasty

Endoscopic sleeve gastroplasty

Intervention Type PROCEDURE

Endoscopic bariatric procedure

Interventions

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Laparoscopic sleeve gastrectomy

Bariatric surgical intervention

Intervention Type PROCEDURE

Endoscopic sleeve gastroplasty

Endoscopic bariatric procedure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adult (≥ 18 years old)
* Willingness and ability to participate
* Males and females
* Non-pregnant

Exclusion Criteria

* Children (\<18 years old)
* Pregnant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Saud Medical City

OTHER_GOV

Sponsor Role collaborator

King Saud University

OTHER

Sponsor Role lead

Responsible Party

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Ghadah AlGhafees

Clinical Nutrition Master's Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ghadah M AlGhafees, BSc

Role: PRINCIPAL_INVESTIGATOR

King Saud University

Locations

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New You Medical Center

Riyadh, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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ESGvsLSG

Identifier Type: -

Identifier Source: org_study_id

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