Bariatric Surgery CandidateNCT03236142
DS vs SIPS-Bariatric Surgery Comparasion
A study testing SIPS Operation and Standard Duodenal Switch Operation in people with Bariatric Surgery Candidate, run by Reading Health System at 1 site in United States.
Trial summary
The aim of this study is to answer the question of whether the single anastomosis, 300 cm loop, duodenal switch (SIPS) is an equally effective, safe, simpler operation with less nutritional and surgical risks than the standard duodenal switch (DS) operation. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- SIPS Operation and Standard Duodenal Switch Operation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) of 40 to 65
- Agree to not use weight loss medications for the length of the study
- Compliance with standards of surgical program
Who cannot join
- Patients with a history of previous bariatric surgery except for patients who have had a previous gastric sleeve
- Previous complex abdominal surgery
- Poorly controlled medical or psychiatric disease
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Reading Health Physician Network Weight Management Center
West Reading, Pennsylvania, 19611
Malissa Sullivan Bariatric Coordinator, 484-628-3141, Malissa.Sullivan@towerhealth.org
Stephan Myers Principal Investigator, 484-628-3064, stephan.myers@towerhealth.org
About this study
Official title: The Single Anastomosis, 300 cm Loop, Duodenal Switch (SIPS) Results in Less Nutritional Deficiencies Than the Standard Duodenal Switch (DS) Operation: A Multicenter, Randomized Controlled Trial
The aim of this study is to answer the question of whether the single anastomosis, 300 cm loop, duodenal switch (SIPS) is an equally effective, safe, simpler operation with less nutritional and surgical risks than the standard duodenal switch (DS) operation. Please note, this study does not provide a stipend or coverage for surgery.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- SIPS Operation, Standard Duodenal Switch Operation
- Keywords
- bariatric, duodenal switch, DS, weight loss surgery, SIPS, Single Anastomosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIPS OperationProcedure or surgery
The SIPS modification of the DS operation entails one less division of the small intestine and one less anastomosis, thereby reducing the time of the procedure.
Standard Duodenal Switch OperationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Standard Duodenal Switch (DS) | Active comparator | Not described Receives: Procedure: Standard Duodenal Switch Operation |
| Single Anastomosis, 300 cm Loop, Duodenal Switch (SIPS) | Experimental | Not described Receives: Procedure: SIPS Operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin A Deficiency
Proportion of patients with a vitamin A deficiency
Measured: 36 months post surgery
Secondary outcomes (5)
Vitamin D, zinc, copper, and albumin
Proportion of patients with vitamin D, zinc, copper, and albumin deficiency
Measured: 36 months post surgery
Frequency of stools
Amount of stools per day
Measured: 36 months post surgery
Length of Operation
Length of surgical procedure in time
Measured: Date of operation
Percentage of excess weight lost
Weight in excess of a body mass index (BMI) of 25.0 lost
Measured: 36 months post surgery
Body Mass Index (BMI)
Body mass index (weight in kilograms divided by height in meters squared
Measured: 36 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study startJan 2017
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reading Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephan Myers, MD, Reading Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236142
- Sponsor's protocol ID
- IRB 016-16
- Status last verified
- Aug 2018
- First submitted
- 30 Jun 2017
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Single Anastomosis, 300 cm Loop, Duodenal Switch (SIPS) Results in Less Nutritional Deficiencies Than the Standard Duodenal Switch (DS) Operation: A Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03236142
- Acronym / sponsor ID
- IRB 016-16
- Conditions
- Bariatric Surgery Candidate
- Keywords
- bariatric, duodenal switch, DS, weight loss surgery, SIPS, Single Anastomosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Reading Health SystemUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 1 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to answer the question of whether the single anastomosis, 300 cm loop, duodenal switch (SIPS) is an equally effective, safe, simpler operation with less nutritional and surgical risks than the standard duodenal switch (DS) operation. Please note, this study does not provide a stipend or coverage for surgery.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Duodenal Switch (DS) | Active comparator | Procedure: Standard Duodenal Switch Operation |
| Single Anastomosis, 300 cm Loop, Duodenal Switch (SIPS) | Experimental | Procedure: SIPS Operation |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) of 40 to 65
- Agree to not use weight loss medications for the length of the study
- Compliance with standards of surgical program
Key exclusion criteria (3 listed)
- Patients with a history of previous bariatric surgery except for patients who have had a previous gastric sleeve
- Previous complex abdominal surgery
- Poorly controlled medical or psychiatric disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIPS OperationThe SIPS modification of the DS operation entails one less division of the small intestine and one less anastomosis, thereby reducing the time of the procedure. | Procedure or surgery | Single Anastomosis, 300 cm Loop, Duodenal Switch (SIPS) |
| Standard Duodenal Switch Operation | Procedure or surgery | Standard Duodenal Switch (DS) |
Primary outcome
Vitamin A Deficiency
Time frame: 36 months post surgery
Proportion of patients with a vitamin A deficiency
5 secondary outcomes
Vitamin D, zinc, copper, and albumin
Time frame: 36 months post surgery
Frequency of stools
Time frame: 36 months post surgery
Length of Operation
Time frame: Date of operation
Percentage of excess weight lost
Time frame: 36 months post surgery
Body Mass Index (BMI)
Time frame: 36 months post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reading Health Physician Network Weight Management Center
West Reading, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIPS Operation and Standard Duodenal Switch Operation in people with Bariatric Surgery Candidate, run by Reading Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin A Deficiency (time frame: 36 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.