Volumetric Pouch Study After Laparoscopic Sleeve Gastrectomy

NCT ID: NCT04880902

Last Updated: 2021-05-11

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

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2020-11-01

Brief Summary

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This study aimed to evaluate Laparoscopic Sleeve Gastrectomy in the treatment of morbidly obese patients pre and post-operatively after 3 months, 6 months, and 1-year follow-up and assess the volumetric changes of the gastric reservoir 1 year after LSG using multi-slice computer tomography.

Detailed Description

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Conditions

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Bariatric Surgery Candidate Obesity, Morbid

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sleeve gastrectomy followed by volumetric assessment

Group Type EXPERIMENTAL

sleeve gastrectomy

Intervention Type PROCEDURE

Laparoscopic sleeve gastrectomy had evident therapeutic effects on preexisting obesity-related comorbidities. All patients were referred for abdominal MSCT with a volumetric assessment of gastric pouch within 1 month of surgery and 1 year postoperatively

Interventions

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sleeve gastrectomy

Laparoscopic sleeve gastrectomy had evident therapeutic effects on preexisting obesity-related comorbidities. All patients were referred for abdominal MSCT with a volumetric assessment of gastric pouch within 1 month of surgery and 1 year postoperatively

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* BMI of \> 40 kg/m 2 or \> 35 kg/m2 with comorbidities e.g. hypertension and type 2 DM.
* All patients failed in supervised conservative management for obesity for at least 2 years.

Exclusion Criteria

* BMI \> 60
* previous bariatric surgery
* symptomatic reflux oesophagitis disease, gastric pathology (tumor, active peptic ulcer)
* Significant psychological disorder, active alcohol or substance abuse
* severe eating disorders (bulimia)
* severe systemic disease making anesthesia or surgery prohibitively risky (American Society of Anesthesiologists (ASA) class IV
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kafrelsheikh University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Ahmed Elkhoby

Dr, assistant lecturer of General Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kafrelsheikh university

Kafr ash Shaykh, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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01006786978123

Identifier Type: -

Identifier Source: org_study_id

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