Midterm Follow up Outcomes of (SASJ) in Management of Morbid Obesity

July 18, 2025 updated by: Mahmoud Sayed Khalaf, Sohag University

Midterm Follow up Outcomes of Single Anastomosis Sleeve Jejunal Bypass (SASJ) in Management of Morbid Obesity

Obesity is a critical health problem associated with an increased risk of cardiovascular disease, diabetes, and cancers, affecting both the quality of life and life expectancy . The increasing prevalence of obesity and comorbid conditions requires effective treatment and prevention . Previous evidence has demonstrated that bariatric surgery is associated with greater and longer-term weight loss than non-surgical management Thus, in patients with a body mass index of ≥ 40 or ≥ 35 kg/m2 with co-morbidities, bariatric surgery is the most effective treatment option that not only promotes weight loss but also improves comorbid conditions . However, like any surgical procedure, several complications can occur . The development of nutritional deficiencies is a complication which may be life-threatening; therefore, bariatric surgery requires careful consideration .

The most frequently performed surgery for obesity worldwide is the laparoscopic sleeve gastrectomy (LSG), the Roux-en-Y gastric bypass (RYGB), and more recently, the one anastomosis gastric bypass (OAGB) .

One newly developed weight loss procedure, the single sleeve ileal anastomosis bypass (SASI), has been developed as a modification to Santoro's operation (sleeve gastrectomy with transit bipartition SG + TB) . Since no duodenal division or manual anastomosis is required, the procedure allows easy endoscopic access to the duodenum . noted that SASI has the following advantages over other bariatric procedures: SASI has a shorter operative time compared to other procedures; 2) easy access to the duodenum and biliary tree endoscopically; 3) SASI does not divide the duodenum, thus eliminating the possibility of duodenal stump leakage, a serious complication with an incidence range between; 4) the tension on the anastomosis lower than other techniques; 5) there are no blind loops, excluded segments, or foreign bodies; 6) SASI is completely reversible .

Single anastomosis sleeve jejunal (SASJ) bypass, which is the focus of this study, is a modification of SASI using a shorter biliopancreatic limb length compared to SASI to prevent long-term nutritional complications . The SASJ bypass appears to be safer than the SASI procedure in patients with excessive weight loss and nutritional deficiencies and is simpler due to its improved surgical ergonomics .

Aim of the Work This study aims to evaluate the three-year outcomes of SASJ bypass as a primary bariatric procedure in a tertiary bariatric center for weight loss, comorbidity resolution, and both early and late complications.

Study Overview

Status

Active, not recruiting

Detailed Description

A retrospective study with prospective collected data included a case series of consecutive bariatric patients who underwent SASJ bypass in Sohag university hospitals between the 1st of January 2019 and the 31st of june 2023. The analysis in the present study included data of all the patients who underwent SASJ as bariatric procedure. All patients were approved as candidates for bariatric surgery by a multidisciplinary screening team, between 18 and 65 years of age and a BMI more than 40 kg/m2 or BMI of more than 35 kg/m2 combined with comorbidities.

All the required data have been collected from the patients' files at Sohag university hospitals out-patient clinic. To update follow up data for missing patients, a postal questionnaire will be sent to all patients to retrieve the latest outcome. Patients who will not respond will receive a phone call and email if applicable. The postal questionnaire contained questions about:

  1. Current and lowest weight after surgery.
  2. Current comorbidities and medication.
  3. Possible complaints / complications.
  4. Any surgical intervention related to the SASJ bypass. In case of non-response, the data of the last visit either in hospital or out-patient clinic were used as a final outcome.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Sohag, Egypt, 82515
        • Sohag Hospital University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Sohag University Hospitals

Description

Inclusion Criteria:

  • Age from 18 to 65 years old.
  • Both sexes.
  • Body mass index (BMI) > 35 with comorbidities or BMI > 40 with or without comorbidities.
  • Primary bariatric procedure.
  • Follow up period 2 years or more after SASJ.

Exclusion Criteria:

  • Follow up period less than 2 years.
  • Previous laparoscopic metabolic surgery
  • Patients with huge anterior abdominal wall hernias.
  • Cirrhotic patients.
  • Pregnant or lactating females.
  • Unfit patients for anesthesia.
  • patients requiring revisional bariatric surgery.
  • Patients with any contraindications to laparoscopic surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight loss outcomes
Time Frame: 2 years
  • Percentage of excess weight loss
  • Percentage of total weight loss
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comorbidities readmission reoperation
Time Frame: 2 years
  • Comorbidity resolution
  • readmission
  • reoperation.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

June 30, 2023

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

July 10, 2025

First Submitted That Met QC Criteria

July 18, 2025

First Posted (Actual)

July 28, 2025

Study Record Updates

Last Update Posted (Actual)

July 28, 2025

Last Update Submitted That Met QC Criteria

July 18, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Soh-Med--25-6-9MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Morbid Obesity Requiring Bariatric Surgery

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