Laparoscopic Sleeve Gastrectomy Short Term Follow up

NCT ID: NCT03465956

Last Updated: 2018-03-20

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-30

Study Completion Date

2020-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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) randomly admitted to Assiut University Hospital-General Surgery Department.

Pre-operative: Assessment of; BMI (Body Mass Index), Fasting Blood Glucose level (FBG), Associated Co-morbidities (as hypertensions \& sleep apnea).

Operative (During Operation):

All patients undergo LSG by single team work with intra-operative oesophageal bougie 36 french with use of laparoscopic gastro-intestinal anastomosis(GIA) stapler.

Post-operative:

Patients are discharged from the hospital after they can start oral diet.

Post-operative evaluation of:

1. Complications:

1. Early complications: during the first 2 weeks after surgery,which include hemorrhage (intra-luminal or extra-luminal), staple line leak, vomiting and infection (surgical site infection or intra- abdominal abscess formation)
2. Late complications: from 2 weeks to 6 months post-operative, which include stricture of the gastric sleeve, gastro-esophageal reflux disease (GERD) and nutritional deficiencies.
2. Excess weight loss (EWL) by using BMI Follow up of patients at fifteen days, one month, two months, three months and six months after surgery.
3. Assessment of Blood Glucose level during visits.
4. Measurement of blood pressure during visits (if there is associated hypertension).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Morbid Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Laparoscopic Sleeve Gastrectomy

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

Group Type OTHER

Laparoscopic Sleeve Gastrectomy

Intervention Type PROCEDURE

Laparoscopic Sleeve Gastrectomy using the gastro-intestinal anastomosis stapler.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Laparoscopic Sleeve Gastrectomy

Laparoscopic Sleeve Gastrectomy using the gastro-intestinal anastomosis stapler.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

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

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role collaborator

Mohamed Gamal Thabet

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohamed Gamal Thabet

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mohamed Gamal

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

AssiutU

Asyut, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mohamed Gamal

Role: primary

01026674177

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21423553 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Mohamed gamal

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Weight Loss and Aggression
NCT05654584 UNKNOWN
Naturally Banded Sleeve Gastrectomy
NCT05603338 COMPLETED NA