An interventional study of Stomach Intestinal Pylorus-Sparing (SIPS) Procedure in Obesity, sponsored by Bradley Needleman. Terminated at 1 site in United States. Open to participants aged 18 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-27.
Sponsored by Bradley Needleman · Not applicable, Interventional, and Treatment
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.
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.
This is the only study on the registry with Bradley Needleman as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients undergoing SIPS procedure as their bariatric surgery of choice.
Procedure: Stomach Intestinal Pylorus-Sparing (SIPS) Procedure
The SIPS procedure will be performed as an investigational bariatric surgery. 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.
Safety as a primary procedure
Complication rates
Time frame: Short-term (30 days)
Efficacy as a primary procedure
Excess weight loss achieved post-surgery
Time frame: Long-term (5 years)
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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