NCT05269420

Brief Summary

single anastomosis sleeve jejunal bypass as a revisional procedure after weight regain or failure after laparoscopic sleeve gastrectomy, gastric plications or laparoscopic adjustable gastric band

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

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 12, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2020

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
Last Updated

March 8, 2022

Status Verified

February 1, 2022

Enrollment Period

3.9 years

First QC Date

February 25, 2022

Last Update Submit

February 25, 2022

Conditions

Obesity, Morbid

Outcome Measures

Primary Outcomes (1)

  • weight loss

    percentage of excess weight loss in kilogram

    12 months

Secondary Outcomes (3)

  • the rate of improved co morbidity

    12 months

  • the incidence of nutritional deficiency

    12-24 months

  • the incidence of early operative complications the incidence of early operative complications the incidence of early operative complications the incidence of complications

    12-24 months

Study Arms (1)

SAS-J

EXPERIMENTAL

single anastomosis sleeve Jejunal Bypass as a revisional bariatric procedure after restrictive bariatric procedures

Procedure: SAS-J

Interventions

SAS-JPROCEDURE

Single Anastomosis Sleeve Jejunal Bypass

SAS-J

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
  • previous restrictive bariatric procedure

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia university hospital

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
Assistant professor & consultant of general surgery, Department of Surgery

Study Record Dates

First Submitted

February 25, 2022

First Posted

March 8, 2022

Study Start

January 12, 2017

Primary Completion

December 8, 2020

Study Completion

January 4, 2021

Last Updated

March 8, 2022

Record last verified: 2022-02

Locations

EG(1)