Clinical trial NCT05094830: Stomach Intestinal Pylorus-Sparing Bariatric Surgery
Official title: Stomach Intestinal Pylorus Sparing (SIPS) As a Primary and Revisional Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Keywords: Weight Loss Surgery
Bariatric Surgery
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety as a primary procedure
timeFrame: Short-term (30 days)
measure: Efficacy as a primary procedure
timeFrame: Long-term (5 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: The Ohio State University College of Medicine
name: Bradley Needleman, MD
role: PRINCIPAL_INVESTIGATOR
References: