NCT04823767

Brief Summary

single anastomosis sleeve jejunal bypass with hiatal repair for morbid obesity with reflux manifestations

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

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

April 12, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2021

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

11 months

First QC Date

March 22, 2021

Last Update Submit

March 28, 2021

Conditions

Obesity, Morbid

Outcome Measures

Primary Outcomes (1)

  • the effect of sleeve jejunal bypass on reflux manifestations

    evaluation of the effect of sleeve jejunal bypass on reflux manifestations

    2 months

Secondary Outcomes (2)

  • EWL

    one year

  • treatment of comorbidities

    one year

Study Arms (1)

Single anastomosis sleeve jejunal bypass with hiatal repair

EXPERIMENTAL

Single anastomosis sleeve jejunal bypass with hiatal repair

Other: Single anastomosis sleeve jejunal bypass with hiatal repair

Interventions

Single anastomosis sleeve jejunal bypass with hiatal repairOTHER

Single anastomosis sleeve jejunal bypass with hiatal repair

Single anastomosis sleeve jejunal bypass with hiatal repair

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 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
Proffessor

Study Record Dates

First Submitted

March 22, 2021

First Posted

April 1, 2021

Study Start

April 12, 2020

Primary Completion

March 10, 2021

Study Completion

March 15, 2021

Last Updated

April 1, 2021

Record last verified: 2021-03

Locations

EG(1)