TerminatedNot Applicable

Stomach Intestinal Pylorus-Sparing Bariatric Surgery

Stopped: Recruitment barriers

United States2 participantsStarted 2018-05-17

Plain-language 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.

Who can participate

Age range18 Years – 89 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Safety as a primary procedure

Timeframe: Short-term (30 days)

Efficacy as a primary procedure

Timeframe: Long-term (5 years)

Trial details

NCT IDNCT05094830

SponsorBradley Needleman

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-01

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