NCT02870530

Brief Summary

The purpose of this study is to determine the efficacy of single anastomoses sleeve jejunal bypass as a treatment for morbid obesity

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 not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 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

First Submitted

Initial submission to the registry

August 10, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 17, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

March 11, 2022

Status Verified

February 1, 2022

Enrollment Period

5 months

First QC Date

August 10, 2016

Last Update Submit

February 25, 2022

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (3)

  • operative time

    the operative time from skin incision to skin closure

    the 1st 24 hours

  • intraoperative complications

    intraoperative complications like bleeding, other organs injuries

    the 1st 24 hours

  • the postoperative weight loss

    the percentage of weight loss from total excess body weight

    12 month

Secondary Outcomes (1)

  • effect on metabolic syndrome if present

    12 months

Other Outcomes (1)

  • postoperative biliary reflux

    3 months

Study Arms (1)

Single Anastomosis Sleeve Jejunal (SAS-J) Bypass

EXPERIMENTAL

Single Anastomosis Sleeve Jejunal (SAS-J) Bypass as A treatment for Morbid

Procedure: Single Anastomosis Sleeve Jejunal (SAS-J) Bypass

Interventions

Single Anastomosis Sleeve Jejunal (SAS-J) BypassPROCEDURE

Single Anastomosis Sleeve Jejunal (SAS-J) Bypass as A treatment for Morbid

Single Anastomosis Sleeve Jejunal (SAS-J) Bypass

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • obese patients with BMI more than 40
  • 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 50
  • patients with BMI less than 50
  • patient with previous upper abdominal surgery either for obesity or other diseases
  • patients with preoperative GERD clinically or by investigation

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 Officials

  • Alaa M Sewefy, MD

    Lecturer & consultant of general surgery, Department of surgery, Minia university hospital, Egypt.

    STUDY CHAIR

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
MD, Lecturer & consultant of general surgery, Department of surgery, Minia university hospital, Egypt

Study Record Dates

First Submitted

August 10, 2016

First Posted

August 17, 2016

Study Start

November 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

March 11, 2022

Record last verified: 2022-02

Locations

EG(1)