NCT05591833

Brief Summary

to compare the results of SASI to SAS-J in treatment of morbid obesity

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 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

May 7, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 24, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2023

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

1.2 years

First QC Date

May 7, 2022

Last Update Submit

September 20, 2023

Conditions

Obesity, Morbid

Outcome Measures

Primary Outcomes (1)

  • nutritional deficiency

    the effect of the 2 procedures on nutritional status by doing the following investigations to collectively give idea about deficiency this investigation including: Hb% ( in mg/dL), vitamin D (in ng/mL) , vitamin B ( in pg/mL), Serum Ca (in mg/dL) serum Zinc (in μg/dL) serum Iron ( in mcg/dL) serum Folate (in μg/L) and serum albumin ( in g/dL)

    12 months

Secondary Outcomes (3)

  • comorbidities

    1 year

  • complications

    1 year

  • weight loss

    12 months

Study Arms (2)

SASI

ACTIVE COMPARATOR
Procedure: SASI

SAS-J

EXPERIMENTAL
Procedure: SAS-J

Interventions

SASIPROCEDURE

Single-Anastomosis Sleeve ileal (SASI) Bypass

SASI
SAS-JPROCEDURE

Single-Anastomosis Sleeve Jejunal (SAS-J) 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

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, 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
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor & Consultant of General Surgery and laparo-endoscopy

Study Record Dates

First Submitted

May 7, 2022

First Posted

October 24, 2022

Study Start

July 1, 2022

Primary Completion

September 1, 2023

Study Completion

September 20, 2023

Last Updated

September 22, 2023

Record last verified: 2023-09

Locations

EG(1)