NCT06857097

Brief Summary

This study was conducted aiming to assess the efficacy of SASJ bypass as a novel bariatric procedure in terms of operative time, weight loss, complications and effect on comorbidities compared to the outcomes of OAGB within two years after operation.

Trial Health

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Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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

Study Progress59%
Mar 2025Mar 2027

First Submitted

Initial submission to the registry

February 26, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Expected
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

February 26, 2025

Last Update Submit

March 7, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Weight loss parameters

    2 years

Study Arms (2)

single anastomosis sleeve jejunal bypass group

ACTIVE COMPARATOR
Procedure: single anastomosis sleeve jejunal bypass

one anastomosis gastric bypass

ACTIVE COMPARATOR

dissection started just distal to the crows' foot till reaching the lesser sac. A long narrow gastric pouch was created by the endostapler. After that, a longitudinal gastrojejunostomy (4-cm wide) was created at 200 cm distal to the Treitz ligament as the SASJ grou p.

Procedure: One anastomosis gastric bypass

Interventions

sleeve was created starting devascularization of greater gastric curve 6 cm proximal to pylorus. Devascularization was done via either a harmonic scalpel or a ligasure device. Dissection was continued proximally till reaching the left diaphragmatic crus. Afterwards that the stomach was resected along the greater curvature via an endostapler over a 36-Fr bougie. After creating the sleeve, two meters of the small bowel were counted starting from the ligament of Treitz, and an antecolic isoperistaltic gastrojejunostomy (4-cm wide) was created with the antrum via linear stapler, and the anterior wall defect was closed by sutures.

single anastomosis sleeve jejunal bypass group

dissection started just distal to the crows' foot till reaching the lesser sac. A long narrow gastric pouch was created by the endostapler. After that, a longitudinal gastrojejunostomy (4-cm wide) was created at 200 cm distal to the Treitz ligament as the SASJ group.

one anastomosis gastric bypass

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • body mass index of over 35 plus the comorbidity presence.
  • body mass index of over 40 with/without comorbidity.
  • patients' willingness to participate in the study.
  • patients' cooperation in follow-up researches.
  • lacking any psychiatric disease.

You may not qualify if:

  • Patients negating to change their lifestyle.
  • drug abuse and/or addiction.
  • eating disorder background (e.g., bulimia nervosa).
  • Patients with contraindications to laparoscopic surgery and (or) unfit for surgery.
  • pregnant patients.
  • previous upper abdominal procedures,
  • reflux symptoms
  • major unstable psychiatric illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, Egypt

Location

Study Officials

  • sohag university hospital

    Sohag University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer of general surgery at sohag university hospitals

Study Record Dates

First Submitted

February 26, 2025

First Posted

March 4, 2025

Study Start

March 1, 2025

Primary Completion

September 1, 2025

Study Completion (Estimated)

March 1, 2027

Last Updated

March 11, 2025

Record last verified: 2025-03

Locations