Stomach Intestinal Pylorus-Sparing Bariatric Surgery

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    25
  • sponsor
    Bradley Needleman
Updated on 2 November 2021
bariatric surgery
sleeve gastrectomy
Accepts healthy volunteers

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.

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.

Details
Condition adiposity, Obesity
Treatment Stomach Intestinal Pylorus-Sparing (SIPS) Procedure
Clinical Study IdentifierNCT05094830
SponsorBradley Needleman
Last Modified on2 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18-89
Primary: Satisfies established NIH criteria for bariatric surgery
Revision of sleeve gastrectomy: Sleeve gastrectomy performed at least two years prior but the patient did not reach 50% excess weight loss (EWL), has regained 20% of EWL since sleeve gastrectomy, or has current BMI > 40
Willing and able to provide his/her own consent for the surgery

Exclusion Criteria

Contraindication to bariatric surgery
Current pregnancy/breast feeding or plans for pregnancy
Prisoners
Previous history of gastrectomy other than sleeve gastrectomy for weight loss
History of small bowel resection
History of any kind of surgery to treat gastroesophageal reflux disease (GERD)
History of or current Barrett's esophagus
History of or any kind of cancer diagnosis in last 5 years
Large hiatal hernia > 5 cm
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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