NCT03465956

Brief Summary

Laparoscopic Sleeve Gastrectomy (LSG), Also known as longitudinal or vertical gastrectomy. LSG was initially considered a first-stage operation in high-risk patients before bilio-pancreatic diversion or Roux-en-Y gastric bypass surgery. However, LSG was subsequently found to be effective as a single procedure for treatment of morbid obesity.LSG functions mainly as a restrictive procedure in which about 75 % of the stomach is removed leaving a narrow gastric tube or sleeve. So, it limits the amount of food that can be eaten at one time via inducing early satiety after eating a small amount of food due to early distension of the fashioned gastric sleeve giving a sense of satiety, consequently losing excess body weight by time.Sleeve gastrectomy may also cause a decrease in appetite by reducing the amount of Ghrelin (hunger hormone) produced by the stomach.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 21, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 15, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

March 20, 2018

Status Verified

March 1, 2018

Enrollment Period

1.9 years

First QC Date

February 21, 2018

Last Update Submit

March 16, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of excess weight loss

    Assessment of excess weight loss six months after the operation.

    First six months after surgery

Study Arms (1)

Laparoscopic Sleeve Gastrectomy

OTHER

Laparoscopic sleeve gastrectomy for patients with morbid obesity using the gastro-intestinal anastomosis stapler.

Procedure: Laparoscopic Sleeve Gastrectomy

Interventions

Laparoscopic Sleeve Gastrectomy using the gastro-intestinal anastomosis stapler.

Laparoscopic Sleeve Gastrectomy

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All patients,males and females with age (20-50 years old) with morbid obesity (BMI ≥ 40 kg/m2 or \> 35 kg/m2 associated with co-morbidity), and are fit for laparoscopic surgery.

You may not qualify if:

  • Patients having severe co-morbidity who are not fit for surgery or general anaesthesia.
  • Patients with age below 20 years or above 50 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AssiutU

Asyut, Egypt

RECRUITING

Related Publications (1)

  • Nosso G, Angrisani L, Saldalamacchia G, Cutolo PP, Cotugno M, Lupoli R, Vitolo G, Capaldo B. Impact of sleeve gastrectomy on weight loss, glucose homeostasis, and comorbidities in severely obese type 2 diabetic subjects. J Obes. 2011;2011:340867. doi: 10.1155/2011/340867. Epub 2011 Mar 8.

    PMID: 21423553BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Mohamed Gamal

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All patients,males and females with age (20-50 years old) with morbid obesity (BMI ≥ 40 kg/m2 or \> 35 kg/m2 associated with co-morbidity).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 21, 2018

First Posted

March 15, 2018

Study Start

April 1, 2018

Primary Completion

March 1, 2020

Study Completion

July 1, 2020

Last Updated

March 20, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations