Stomach Intestinal Pylorus-Sparing Bariatric Surgery

Not Applicable

Terminated

• Conditions: Obesity
• Interventions: Procedure: Stomach Intestinal Pylorus-Sparing (SIPS) Procedure

• Registration Number: NCT05094830
• Lead Sponsor: Bradley Needleman

Brief 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.

Detailed 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 Timeline

• Study Start: 2018-05-17
• Study First Submitted: 2018-05-23
• Study First Submitted QC: 2021-10-15
• Study First Posted: 2021-10-26
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01
• Status Verified: 2023-10
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stomach Intestinal Pylorus Sparing (SIPS)	Stomach Intestinal Pylorus-Sparing (SIPS) Procedure	Patients undergoing SIPS procedure as their bariatric surgery of choice.

Primary Outcome Measures

Name	Time	Method
Efficacy as a primary procedure	Long-term (5 years)	Excess weight loss achieved post-surgery
Safety as a primary procedure	Short-term (30 days)	Complication rates

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States