Stomach Intestinal Pylorus-Sparing Bariatric Surgery

NCT05094830 | Terminated

• 1 other identifier: 2017H0400
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Weight Loss Surgery; Bariatric Surgery

Outcome Measures

Primary Outcomes (2)

• Safety as a primary procedure

  Complication rates

  Short-term (30 days)

• Efficacy as a primary procedure

  Excess weight loss achieved post-surgery

  Long-term (5 years)

Study Arms (1)

Stomach Intestinal Pylorus Sparing (SIPS)

EXPERIMENTAL

Patients undergoing SIPS procedure as their bariatric surgery of choice.

Procedure: Stomach Intestinal Pylorus-Sparing (SIPS) Procedure

Interventions

Stomach Intestinal Pylorus-Sparing (SIPS) Procedure 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.

Stomach Intestinal Pylorus Sparing (SIPS)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bradley Needleman: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bradley Needleman, MD

  The Ohio State University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: October 26, 2021
• Study Start: May 17, 2018
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: March 27, 2025

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)