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Completed

NCT Number: NCT04880902

Volumetric Pouch Study After Laparoscopic Sleeve Gastrectomy

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.

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Key information

Conditions

Bariatric Surgery Candidate Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh university

Kafr ash Shaykh, 33516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleeve gastrectomy

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

Primary outcomes

  1. Gastric volume after surgery

    Time frame: 1 month

    gastric reservoir volume after performance of laparoscopic sleeve gastrectomy

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

Volumetric Pouch Study After Laparoscopic Sleeve Gastrectomy: Effect of the Pouch Size on Excessive Weight Loss and Weight Regain

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 11, 2021
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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