NCT05145205

Brief Summary

This is a retrospective work on 200 morbid obese patients randomized and categorized into 2 groups according to the treatment method: the laparoscopic sleeve gastrectomy (LSG) and LRYGB groups, within the period from 2014 to 2019 and matched weight dissipation, complications, life quality, and negative events

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

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

Study Start

First participant enrolled

January 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 6, 2021

Completed
Last Updated

December 6, 2021

Status Verified

November 1, 2021

Enrollment Period

1 year

First QC Date

November 23, 2021

Last Update Submit

November 23, 2021

Conditions

Laparoscopic Surgery

Outcome Measures

Primary Outcomes (1)

  • weight dissipation

    decrease the body mass index by 1 or more

    12 months

Study Arms (2)

LSG

Procedure: Sleeve gastrectomy

RYGB

Procedure: Laparoscopic Roux-en-Y gastric bypass

Interventions

Sleeve gastrectomyPROCEDURE

Bougie was applied over the lower curvature to adjust the gastric tube then longitudinal amputation of the stomach was performed for about 4 to 6 cm per pecker of the pylorus to the corner of His. No supportive materials were used, and over-suturing of the basic line performed only over the points of bleeding. All resected specimens were sent to histopathology laboratory for examination.

LSG
Laparoscopic Roux-en-Y gastric bypassPROCEDURE

An antecolic and antegastric RYGB become executed with a 150 cm alimentary limb with both a linearly or circularly kink (25 mm) gastrojejunostomy in step with the desire of the surgeon. A 50-cm-lengthy biliopancreati

RYGB

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study included Egyptian patients with age ranging from 18 to 70 seeking surgical operation for obesity.

You may qualify if:

  • All patients of (Body Mass Index) more than 40, with at least 1 comorbidity

You may not qualify if:

  • All patients of (Body Mass Index) less than 40,
  • No comorbidities
  • Patients who refused the surgical procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azhar faculty of medicine

Cairo, 11884, Egypt

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

November 23, 2021

First Posted

December 6, 2021

Study Start

January 1, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

December 6, 2021

Record last verified: 2021-11

Locations

EG(1)