NCT04880902

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2021

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

1.9 years

First QC Date

May 6, 2021

Last Update Submit

May 10, 2021

Conditions

Bariatric Surgery CandidateObesity, Morbid

Keywords

Laparoscopic Sleeve Gastrectomygastric reservoirMulti-slice computer tomography

Outcome Measures

Primary Outcomes (1)

  • Gastric volume after surgery

    gastric reservoir volume after performance of laparoscopic sleeve gastrectomy

    1 month

Study Arms (1)

sleeve gastrectomy followed by volumetric assessment

EXPERIMENTAL
Procedure: sleeve gastrectomy

Interventions

sleeve gastrectomyPROCEDURE

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

sleeve gastrectomy followed by volumetric assessment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh university

Kafr ash Shaykh, 33516, Egypt

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr, assistant lecturer of General Surgery

Study Record Dates

First Submitted

May 6, 2021

First Posted

May 11, 2021

Study Start

November 1, 2018

Primary Completion

October 1, 2020

Study Completion

November 1, 2020

Last Updated

May 11, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)