Obesity Clinical Trial - Stomach Intestinal Pylorus-Sparing Bariatric

Status Recruiting

Clinical Trial Summary

This study will evaluate the safety and efficacy of Stomach Intestinal Pylorus Sparing (SIPS) as a primary bariatric surgery. In addition, we will evaluate the safety and efficacy of SIPS performed as a revisional surgery following sleeve gastrectomy (SG) in which adequate weight loss was not achieved.

Clinical Trial Description

This is a prospective study of an interventional procedure. Results of patients selecting to undergo the Stomach Intestinal Pylorus Sparing (SIPS) procedure will be prospectively collected. In addition to the currently offered bariatric weight loss procedures, patients who present to our bariatric clinic will be presented with information on the SIPS procedure. All patients interested in pursuing bariatric surgery will undergo a standardized bariatric surgery evaluation process as standard of care. Patients interested in undergoing SIPS must meet the following inclusion/exclusion criteria in addition to the established criteria for bariatric surgery. The SIPS procedure will be performed as an investigational procedure. The SIPS procedure involves the creation of a standard sleeve gastrectomy over a 36-40 bougie. Division of the duodenum post-pylorus is performed, followed by the creation of a common channel 300 cm from the ileo-cecal valve. A hand-sewn anti-side duodenoileostomy is performed and the anastomosis tested for leaks through use of endoscopic insufflation and under water air leak test. Incisions are then closed in standard fashion. The SIPS procedure itself is not a separate surgery but rather a modification to the standard of care surgery. All patients electing to enroll in this study will experience the same pre- and postoperative care provided as standard of care to all bariatric surgery patients. A pre-operative evaluation is performed to confirm appropriateness for bariatric surgery and includes: Psychological evaluation, dietary counseling, and testing of cardiovascular, pulmonary, and gastrointestinal health. Pre-operative evaluation also consists of blood work to identify or confirm obesity-related comorbid conditions. Post-operative care provided following bariatric surgery ensures that patients progress with adequate pain control and appropriate diet tolerance before hospital discharge while evaluating and monitoring manifestations of potential complications. ;

Study Design

Related Conditions & MeSH terms

Obesity

Clinical Trial Details

NCT number	NCT05094830
Study type	Interventional
Source	Ohio State University
Contact	Kayla Diaz
Phone	614-293-8549
Email	kayla.diaz@osumc.edu
Status	Recruiting
Phase	N/A
Start date	May 17, 2018
Completion date	December 31, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Stomach Intestinal Pylorus-Sparing Bariatric Surgery — SIPS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms