NCT06530212

Brief Summary

sleeve gastrectomy with jejunoileal bypass (SGJIB) is a novel technique for the surgical treatment of obesity. The aim of the study is to compare this maneuver with single anastomosis sleeve jejunal bypass (SAS-JB)

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 28, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2025

Completed
Last Updated

March 4, 2025

Status Verified

September 1, 2024

Enrollment Period

1.1 years

First QC Date

July 17, 2024

Last Update Submit

February 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Stoma complications

    any complication due to sleeve jejunal anastomosis

    one year

Secondary Outcomes (2)

  • weight loss at one year

    one year

  • improvement of comorbidities

    one year

Study Arms (2)

SGJIB

EXPERIMENTAL
Procedure: SGJIB

SAS-JB

ACTIVE COMPARATOR
Procedure: SAS-JB

Interventions

SGJIBPROCEDURE

sleeve gastrectomy with jejunoileal bypass with anastomosis between the jejunum at about 100 cm from the duodeno-jejunal flexure and the ileum at 250 cm from the ileocaecal junction.

SGJIB
SAS-JBPROCEDURE

single anastomosis sleeve jejunal bypass (SAS-JB) with biliary limb equal one third of total intestinal length.

SAS-JB

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)

Faculty of medicine

Minya, 61511, Egypt

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alaa Sewefy, professor

    Minia University, faculty of medicine

    PRINCIPAL INVESTIGATOR
  • Taha Kayed, MD

    Minia University, faculty of medicine

    STUDY DIRECTOR

Central Study Contacts

Alaa sewefy, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of general and bariatric surgery

Study Record Dates

First Submitted

July 17, 2024

First Posted

July 31, 2024

Study Start

September 28, 2024

Primary Completion

October 20, 2025

Study Completion

November 20, 2025

Last Updated

March 4, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations