NCT03821688

Brief Summary

150 morbidly obese patients divided into to equal groups, group A underwent single anastomosis sleeve jejunal bypass and group B underwent mini gastric bypass, group C underwent sleeve gastrectomy. All patients were followed for at least one year. all cases were evaluated as regard BMI, complications, nutritional status and obesity-related comorbidities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

March 15, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2020

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

1.4 years

First QC Date

January 19, 2019

Last Update Submit

December 26, 2021

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (1)

  • percentage of excess weight loss

    percentage of excess weight loss in kilogram

    12 months

Secondary Outcomes (3)

  • the incidence of nutritional deficiency

    2 years

  • the rate of improved co morbidity

    2 years

  • the incidence of early operative complications

    one month

Study Arms (3)

SAS-JB

EXPERIMENTAL

laparoscopic single anastomosis sleeve jejunal bypass

Procedure: SAS-JB

MGB

ACTIVE COMPARATOR

laparoscopic mini gastric bypass

Procedure: OAGB

LSG

ACTIVE COMPARATOR

laparoscopic sleeve gastrectomy

Procedure: LSG

Interventions

SAS-JBPROCEDURE

single anastomosis sleeve jejunal bypass

SAS-JB
OAGBPROCEDURE

one anastomosis gastric bypass

MGB
LSGPROCEDURE

laproscopic sleeve gastrectomy

LSG

Eligibility Criteria

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

You may qualify if:

  • obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
  • patients fit for laparoscopic surgery
  • give approval to share in the study

You may not qualify if:

  • patients refused to share in the study
  • patients unfit for surgery
  • patients aged less than 18 and older than 60
  • patient with previous upper abdominal surgery either for obesity or other diseases
  • revisional bariatric procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

Minya, 61511, Egypt

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Alaa M Sewefy, MD

    Minia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 19, 2019

First Posted

January 30, 2019

Study Start

March 15, 2019

Primary Completion

August 10, 2020

Study Completion

August 10, 2020

Last Updated

January 11, 2022

Record last verified: 2021-12

Locations

EG(1)