NCT04037670

Brief Summary

Although previous studies investigated weight loss and improvement in comorbidities after SASI bypass, patients included in these studies had a BMI less than 50 Kg/m2. Therefore, the aim of the present study was to investigate the outcome of SASI bypass in patients with super obesity to assess the success of this novel bariatric procedure in this challenging group of patients in regards weight loss and improvement in associated comorbid conditions at 12 months postoperatively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2019

Completed
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

1.1 years

First QC Date

July 28, 2019

Last Update Submit

July 28, 2019

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (1)

  • percentage of excess weight loss

    \[preoperative weight - weight at 12 months\]/preoperative excess weight X 100

    at 12 months of follow-up

Secondary Outcomes (1)

  • Resolution of diabetes mellitus

    at 12 months of follow-up

Study Arms (1)

SASI bypass

EXPERIMENTAL

Patients with super obesity underwent SASI bypass

Procedure: SASI bypass

Interventions

SASI bypassPROCEDURE

Sleeve gastrectomy with single loop anastomosis between gastric antrum and ileum, 3 meters away from ileocecal junction

SASI bypass

Eligibility Criteria

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

You may qualify if:

  • Patients included to the present study were adult patients of both genders aging between 18 and 65 years with primary morbid obesity with BMI ≥50 kg/m2 with or without obesity-associated comorbidities such as hypertension, diabetes mellitus (DM), dyslipidemias, and gastroesophageal reflux disease (GERD).

You may not qualify if:

  • Pregnant women.
  • Patients unfit for general anasthesia (ASA 4, 5)
  • Endocrine or psychiatric disorders.
  • History of previous upper abdmominal laparotomy.
  • Alcoholic addiction
  • Liver cirrhosis
  • Coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Sameh H Emile, M.D.

    Mansoura University

    PRINCIPAL INVESTIGATOR

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
Lecturer of surgery

Study Record Dates

First Submitted

July 28, 2019

First Posted

July 30, 2019

Study Start

July 1, 2017

Primary Completion

July 20, 2018

Study Completion

July 20, 2019

Last Updated

July 30, 2019

Record last verified: 2019-07

Locations

EG(1)