Well, well, well - I guess SADI/SIPS/LoopDS is experimental after all

[DianaCox]

https://clinicaltrials.gov/ct2/show/NCT02275208

"A Prospective, Multi-center, Single-arm Study of the Stomach, Intestinal and Pylorus Sparing (SIPS) Procedure"

Primary Outcome Measures:

• The primary endpoint is excess weight loss (EWL) at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

• SIPS-related adverse events at all timepoints [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
• Resolution of comorbidities at 1, 6, and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
• Quality of life (QOL) (SF-36 and gastroesophageal reflux disease - health related quality of life [GERD-HRQL]) at 6 and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:120
Study Start Date:November 2014
Estimated Study Completion Date:November 2016
Estimated Primary Completion Date:November 2016 (Final data collection date for primary outcome measure)

Detailed Description:

SIPS is a single-anastomosis duodeno-intestinal switch procedure. Preliminary data from Sanchez-Pernaute et al. (Surg Obes Relat Dis 2013;9:731) indicates that this procedure is safe, quick to perform, and offers good results for treatment of both morbid obesity and its metabolic comorbidities. CovidienTM plans to further investigate this procedure and has proposed a prospective clinical study to obtain data on subject outcomes through 12 months following the SIPS procedure.

Criteria
Inclusion Criteria:

• The subject must be 18-65 years of age
• The subject must be willing and able to participate in the study procedures and to understand and sign the informed consent
• The subject is under consideration for surgery for obesity or metabolic disease and elects to undergo a primary SIPS procedure
• The subject has a BMI of 35-40 kg/m2 with at least 1 obesity-related comorbidity or a BMI of 40-60 kg/m2

Exclusion Criteria:

• Any female subject who is pregnant, or is actively breast-feeding
• Any subject who is considered to be part of a vulnerable population (e.g. prisoners or those with psychological concerns or those without sufficient mental capacity)
• The procedure is an emergency procedure
• The procedure is a revision/reoperation for the same indication
• The subject is unable or unwilling to comply with the study requirements or follow-up schedule
• The subject has conditions which, in the opinion of the investigator, will not be appropriate for the study (e.g. severe cardiovascular disease, history of gastrointestinal (GI) malignancy, history of upper GI surgery, open cholecystectomy, history of intestinal surgery, immunosuppression, or non-ambulatory)
• The subject has an estimated life expectancy of less than 6 months
• The subject has participated in an investigational drug or device research study within 30 days of enrollment

Based on the study sites:

· Colorado: Metz

· NY, both Mt. Kisco and NYC: Roslin

· North Carolina:

o Cary is Enoch

o Durham is Sudan (?)​

· Utah: Cottam​

But hey, a clinical trial is a GOOD thing – real data, eventually. I’ll be interested in seeing the dietary recommendations.

Why do you suppose it is only a 12 month study?? That is WORTHLESS to prove anything – is this simply a PLOY to quickly get past the insurance companies’ refusal to cover it? Also, why is Medtronic/Covidien paying for the study? To sell more staples??

But most importantly for those who feel they were deceived by any of those surgeons, I think this clinical trial may be an admission at LEAST of the participating surgeons that the SIPS is experimental, and if this was not disclosed to you, especially after the start date for the clinical trial of November 2014, there may have been a serious violation of your rights. Your lawyer might want to know about this trial.

 

[unavidanueva]

Ok, I may be nuts here, but don't all experimental trials/studies require special consent forms to be signed by the patient, detailing exactly what he/she is signing up for?? At my surgeon's office, they are doing a psychological study of WLS patients and there was an entire sheaf of papers to be signed.

 

[southernlady]

Ok, I may be nuts here, but don't all experimental trials/studies require special consent forms to be signed by the patient, detailing exactly what he/she is signing up for?? At my surgeon's office, they are doing a psychological study of WLS patients and there was an entire sheaf of papers to be signed.

The ONE study I participated in about 15 years ago had a mass of papers...nothing like the ONE PAGE consent form I signed for my DS. I am talking about 25 plus pages of documents with initials EVERY damned page.

 

[DianaCox]

Ok, I may be nuts here, but don't all experimental trials/studies require special consent forms to be signed by the patient, detailing exactly what he/she is signing up for?? At my surgeon's office, they are doing a psychological study of WLS patients and there was an entire sheaf of papers to be signed.

That was what I meant by: "I think this clinical trial may be an admission at LEAST of the participating surgeons that the SIPS is experimental, and if this was not disclosed to you, especially after the start date for the clinical trial of November 2014, there may have been a serious violation of your rights."

 

[southernlady]

Estimated Study Completion Date:November 2016
Estimated Primary Completion Date:November 2016 (Final data collection date for primary outcome measure)

That part is flexible. They may extend it out.

 

[DianaCox]

My point was, anyone who received a SIPS from any of these surgeons after November 2014 who met the criteria should have been included in the clinical trial, and should have signed extensive consents to be IN the clinical trial.

 

[Larra]

@Diana would be better able to address this than I am, but would it be possible to find out if an individual who had SIPS with one of these surgeons had their surgery and results included in the clinical trial? If so, I think that would be even stronger evidence that that individual was subjected to an experimental procedure without your knowledge or consent.

 

[DianaCox]

Discovery in litigation. You can likely safely assume if she asks now, he's going to sanitize the record.

 

[Larra]

It is becoming harder to sanitize records these days as records are mostly electronic, and every access to the records leaves a trail. If course I have no idea whether or not these particular records are electronic. And see, I knew you would know the answer. Also, in addition to whatever records are kept locally, since this trial seems to involve multiple sites, there may be some kind of centralized records. I would think this is also something that could be requested during discovery, assuming such a record exists.

 

[DianaCox]

Yes - but if he hasn't entered her data into the trial site yet, he could theoretically try to retroactively remove her. I dunno - the last person I dealt with who tried to fabricate exculpatory evidence got caught red-handed and is facing felony charges.

 

[Larra]

Yep, the cover-up will always get you worse than the original offense.