NCT05590208

Brief Summary

in this study the investigators will test anew technique to mange patients with morbid obesity and GERD by doing sleeve gastrectomy plus cruroplasty and omental rape around the gastroesophageal junction

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

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

October 1, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

October 12, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 21, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
Last Updated

January 17, 2024

Status Verified

December 1, 2022

Enrollment Period

1.2 years

First QC Date

October 1, 2022

Last Update Submit

January 13, 2024

Conditions

Obesity, MorbidGERD

Outcome Measures

Primary Outcomes (1)

  • the effect on GERD

    change in GERD symptoms using either upper GIT endoscopy or GERDQ questionnaire

    6 months

Secondary Outcomes (2)

  • weight loss

    12 months

  • comorbidities

    12 months

Study Arms (1)

sleeve gastrectomy+ cruroplasty + omental rape

EXPERIMENTAL

sleeve gastrectomy+ cruroplasty + omental rape

Procedure: sleeve gastrectomy+ cruroplasty+ omental rap

Interventions

sleeve gastrectomy+ cruroplasty+ omental rapPROCEDURE

sleeve gastrectomy+ cruroplasty+ omental rap

sleeve gastrectomy+ cruroplasty + omental rape

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Minia university hospital

Minya, 61511, Egypt

Location

MeSH Terms

Conditions

Obesity, MorbidGastroesophageal Reflux

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

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
assistant professor of general surgery

Study Record Dates

First Submitted

October 1, 2022

First Posted

October 21, 2022

Study Start

October 12, 2022

Primary Completion

December 20, 2023

Study Completion

December 20, 2023

Last Updated

January 17, 2024

Record last verified: 2022-12

Locations

EG(1)