ObesityNCT02671331
Loop Duodenal Switch Surgery in Morbidly Obese Patients
An observational study of Obesity and Type-2 Diabetes Mellitus, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The loop duodenal switch (L-DS) is a single-anastomosis biliopancreatic diversion with duodenal switch (BPD-DS) procedure. The original BPD-DS has two-anastomosis and is an accepted and approved bariatric procedure by the American Society of Metabolic and Bariatric Surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Type-2 Diabetes Mellitus
- What is being tested?
- Loop duodenal switch
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jul 2016
- Phase
- Observational
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are candidates for bariatric surgery and meet inclusion criteria for the Loop duodenal swith surgery with be approached for study consent.
Who may be able to join
- The subject must be 18-70 years of age at time of enrollment.
- 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 loop duodenal switch procedure or as a conversion procedure for failed, sustained weight loss after a sleeve gastrectomy or laparoscopic adjustable gastric band performed more than 12 months prior to time of evaluation.
- The subject has a BMI of greater than or equal to 40 kg/m2 at time of surgical consultation.
Who cannot join
- Subjects under 18 years of age or older than 70 years of age.
- Subject is not willing or able to participate in the study procedures and understand the informed consent.
- The subject wishes to under a different bariatric procedure other than the loop duodenal switch.
- The subject has a BMI of less than 40 kg/m2 at the time of surgical consultation.
- Any female subject who is pregnant, or is actively breast-feeding
- Any subject who is considered to be part of a vulnerable population (eg. prisoners or those with psychological concerns or those without sufficient mental capacity)
Show all 12Show fewer
- The procedure is an emergency procedure
- The subject is unable to unwilling to comply with the study requirements or follow-up schedule.
- The subject has comorbidities which, in the opinion of the investigator, will not be appropriate for the study (eg. severe cardiovascular disease or history of gastrointestinal malignancy, history of upper GI gastric surgery, history of intestinal surgery, open cholecystectomy, immunosuppression, and 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.
- The subject's insurance company does not cover a duodenal switch operation as treatment for morbid obesity.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: The Effect of Loop Duodenal Switch Surgery in Morbidly Obese Patients on Weight Loss at One Year
The loop duodenal switch (L-DS) is a single-anastomosis biliopancreatic diversion with duodenal switch (BPD-DS) procedure. The original BPD-DS has two-anastomosis and is an accepted and approved bariatric procedure by the American Society of Metabolic and Bariatric Surgery. Preliminary data from Sanchez-Pernaute et al. (2013) indicates that the L-DS procedure is safer and easier to perform as it only requires one anastomosis compared to the BPD-DS, and offers good results for treatment of both morbid obesity and its metabolic comorbidities, including type-2 diabetes mellitus. However, the initial publications of the loop DS still resulted in a small number of patients with total protein malnutrition. For this reason, the investigators will study the loop DS with a modification of the originally published technique with a longer common channel limb (300 cm) to reduce the risk of protein malnutrition For patients with a BMI >50, many are limited to just a sleeve gastrectomy as other bariatric procedures are technically challenging with increased operative risk. A loop duodenal switch may be a safer operation with improved weight loss for the super-morbidly obese patient.
Read the detailed description
Screening and Informed Consent
Subjects will be screened on a weekly basis for eligibility of enrollment. If eligible, patients will be approached by study staff at the initial surgical consultation. The purpose of the study and risks of the procedures will be explained to the subject and the consent process must be documented accordingly in the medical record. Subjects who agree to study participation must sign an IRB-approved informed consent form. Subjects will be informed that their participation in this study is voluntary and they may refuse to participate or discontinue from the study at any time. Subjects will be given the opportunity to ask the investigator questions so that they are adequately informed about the research. A copy of the signed informed consent must be provided to the subject and the informed consent process will be documented in source documents. If new information becomes available that may affect a subject's decision to continue to take part in the study, this information will be discussed with the subject by the investigator.
Failure to meet submission requirements:
Each patient will be required to meet their individual insurance companies requirements for submission of bariatric surgery approval. Subjects who provide study consent but then do not submit for insurance approval or are denied will be considered "discontinued" and will not require additional study follow-up visits. The reason for the discontinuation will be clearly delineated on the applicable case report form. Subjects in who the loop duodenal switch procedure is begun but not completed will be considered "discontinued" once discharged from the hospital and not require any additional study follow-up visits. Reasons for discontinuation will be recorded in the case report form.
Additionally, female patients of child bearing age will undergo a standard of care pregnancy test at the time of the pre-operative surgical testing (2/3 weeks before surgery) and always the morning of surgery by urine HCG.
Surgical Procedures:
The operation will be performed per standard of care and as previously described (1-3), with the exception that in this protocol the duodeno-intestinal anastomosis will be performed at approximately 300 cc with moderate stretch from the ileocecal valve, rather than 200 cm or 250 cm, as in previous reports (Cottam et al, 2015). The purpose of this change is to allow greater nutrient absorption since a previous report observed no difference in mean excess weight loss between 200 cm and 250 cm (3). In addition, the sleeve gastrectomy will be performed over a 40 French bougie. The duodeno-intestinal anastomosis will be hand-sewn.
Subjects will be maintained on a low-calorie diet for the first post-operative month, as per standard of care. In addition, multivitamin supplements, calcium, and iron should be prescribed and maintained per standard of care.
- Conditions
- Obesity, Type-2 Diabetes Mellitus
- Being tested
- Loop duodenal switch
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loop duodenal switchProcedure or surgery
The loop duodenal switch (L-DS) is a single anastomosis duodeno-intestinal bypass. In this simplified version of a BPD-DS, a sleeve gastrectomy is followed by a single anastomosis of the duodenum to the ileum in a loop fashion. The proposed benefits of this are to reproduce the excellent weight loss seen after a BPD-DS (an accepted and utilized bariatric procedure in the USA) but with the potential for reduced complications. With one anastomoses in the L-DS over two in the BPD-DS there is a theoretical lower probability of leaks, strictures, reduced anesthesia with shorter operative times, and decreased risk of internal hernia.
What is being measured
The primary outcome is the main question the study is designed to answer.
Excess weight loss (EWL)
Excess weight loss is a common metric for reporting weight loss after bariatric surgery. The EWL is calculated from an ideal body mass index (BMI) of 25 kg/m^2 and considers weight before surgery and at 12 months post-procedure.
Measured: 12 months post-procedure
Secondary outcomes (6)
Loop duodenal switch related adverse events
Surgery related events such as hospital re-admission, re-operation, complications, etc.
Measured: 12 months post-procedure
Resolution rate of obesity related co-morbidities
Resolution of obesity related co-morbidities including type 2 diabetes mellitus, hypertension, sleep apnea, hyperlipidemia, and other obesity-associated co-morbidities.
Measured: 12 months post-procedure
SF-36 Quality of Life Survey
Quality of life will be measured using the SF-36 Quality of Life Survey.
Measured: 12 months post-procedure
Gastro-esophageal Reflux Disease Health Related Quality of Life Survey
GERD related quality of life will be measured using the Gastro-esophageal Reflux Disease Health Related Quality of Life Survey.
Measured: 12 months post-procedure
Gastrointestinal Symptoms Rating
Gastrointestinal Symptoms will be measured using the Gastrointestinal Symptoms Rating Scale.
Measured: 12 months post-procedure
Protein malnutrition
Protein malnutrition will be assess by albumin level (hypoalbuminemia, <3.5 g/dL) and serum total protein levels (<6.1 g/dL) when oral intake is adequate ( protein intake of 60g +per day).
Measured: 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2016
- Study completionJul 2016
Why it stopped: Principal investigator terminated study due to low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tammy Kindel, Medical College of Wisconsin
- Investigators
- Tammy Kindel, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671331
- Sponsor's protocol ID
- PRO25874
- Status last verified
- Jul 2016
- First submitted
- 29 Dec 2015
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sanchez-Pernaute A, Rubio Herrera MA, Perez-Aguirre E, Garcia Perez JC, Cabrerizo L, Diez Valladares L, Fernandez C, Talavera P, Torres A. Proximal duodenal-ileal end-to-side bypass with sleeve gastrectomy: proposed technique. Obes Surg. 2007 Dec;17(12):1614-8. doi: 10.1007/s11695-007-9287-8. Epub 2007 Nov 27.
PubMed 18040751Sanchez-Pernaute A, Herrera MA, Perez-Aguirre ME, Talavera P, Cabrerizo L, Matia P, Diez-Valladares L, Barabash A, Martin-Antona E, Garcia-Botella A, Garcia-Almenta EM, Torres A. Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S). One to three-year follow-up. Obes Surg. 2010 Dec;20(12):1720-6. doi: 10.1007/s11695-010-0247-3.
PubMed 20798995Sanchez-Pernaute A, Rubio MA, Perez Aguirre E, Barabash A, Cabrerizo L, Torres A. Single-anastomosis duodenoileal bypass with sleeve gastrectomy: metabolic improvement and weight loss in first 100 patients. Surg Obes Relat Dis. 2013 Sep-Oct;9(5):731-5. doi: 10.1016/j.soard.2012.07.018. Epub 2012 Aug 7.
PubMed 22963820Cottam A, Cottam D, Medlin W, Richards C, Cottam S, Zaveri H, Surve A. A matched cohort analysis of single anastomosis loop duodenal switch versus Roux-en-Y gastric bypass with 18-month follow-up. Surg Endosc. 2016 Sep;30(9):3958-64. doi: 10.1007/s00464-015-4707-7. Epub 2015 Dec 22.
PubMed 26694182
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Loop Duodenal Switch Surgery in Morbidly Obese Patients on Weight Loss at One Year
- ClinicalTrials.gov ID
- NCT02671331
- Acronym / sponsor ID
- PRO25874
- Conditions
- Obesity, Type-2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal investigator terminated study due to low enrollment.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 2 Feb 2016 (estimated)
- 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 loop duodenal switch (L-DS) is a single-anastomosis biliopancreatic diversion with duodenal switch (BPD-DS) procedure. The original BPD-DS has two-anastomosis and is an accepted and approved bariatric procedure by the American Society of Metabolic and Bariatric Surgery. Preliminary data from Sanchez-Pernaute et al. (2013) indicates that the L-DS procedure is safer and easier to perform as it only requires one anastomosis compared to the BPD-DS, and offers good results for treatment of both morbid obesity and its metabolic comorbidities, including type-2 diabetes mellitus. However, the initial publications of the loop DS still resulted in a small number of patients with total protein malnutrition. For this reason, the investigators will study the loop DS with a modification of the originally published technique with a longer common channel limb (300 cm) to reduce the risk of protein malnutrition For patients with a BMI >50, many are limited to just a sleeve gastrectomy as other bariatric procedures are technically challenging with increased operative risk. A loop duodenal switch may be a safer operation with improved weight loss for the super-morbidly obese patient.
Detailed description
Screening and Informed Consent
Subjects will be screened on a weekly basis for eligibility of enrollment. If eligible, patients will be approached by study staff at the initial surgical consultation. The purpose of the study and risks of the procedures will be explained to the subject and the consent process must be documented accordingly in the medical record. Subjects who agree to study participation must sign an IRB-approved informed consent form. Subjects will be informed that their participation in this study is voluntary and they may refuse to participate or discontinue from the study at any time. Subjects will be given the opportunity to ask the investigator questions so that they are adequately informed about the research. A copy of the signed informed consent must be provided to the subject and the informed consent process will be documented in source documents. If new information becomes available that may affect a subject's decision to continue to take part in the study, this information will be discussed with the subject by the investigator.
Failure to meet submission requirements:
Each patient will be required to meet their individual insurance companies requirements for submission of bariatric surgery approval. Subjects who provide study consent but then do not submit for insurance approval or are denied will be considered "discontinued" and will not require additional study follow-up visits. The reason for the discontinuation will be clearly delineated on the applicable case report form. Subjects in who the loop duodenal switch procedure is begun but not completed will be considered "discontinued" once discharged from the hospital and not require any additional study follow-up visits. Reasons for discontinuation will be recorded in the case report form.
Additionally, female patients of child bearing age will undergo a standard of care pregnancy test at the time of the pre-operative surgical testing (2/3 weeks before surgery) and always the morning of surgery by urine HCG.
Surgical Procedures:
The operation will be performed per standard of care and as previously described (1-3), with the exception that in this protocol the duodeno-intestinal anastomosis will be performed at approximately 300 cc with moderate stretch from the ileocecal valve, rather than 200 cm or 250 cm, as in previous reports (Cottam et al, 2015). The purpose of this change is to allow greater nutrient absorption since a previous report observed no difference in mean excess weight loss between 200 cm and 250 cm (3). In addition, the sleeve gastrectomy will be performed over a 40 French bougie. The duodeno-intestinal anastomosis will be hand-sewn.
Subjects will be maintained on a low-calorie diet for the first post-operative month, as per standard of care. In addition, multivitamin supplements, calcium, and iron should be prescribed and maintained per standard of care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are candidates for bariatric surgery and meet inclusion criteria for the Loop duodenal swith surgery with be approached for study consent.
Key inclusion criteria (4 listed)
- The subject must be 18-70 years of age at time of enrollment.
- 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 loop duodenal switch procedure or as a conversion procedure for failed, sustained weight loss after a sleeve gastrectomy or laparoscopic adjustable gastric band performed more than 12 months prior to time of evaluation.
- The subject has a BMI of greater than or equal to 40 kg/m2 at time of surgical consultation.
Key exclusion criteria (12 listed)
- Subjects under 18 years of age or older than 70 years of age.
- Subject is not willing or able to participate in the study procedures and understand the informed consent.
- The subject wishes to under a different bariatric procedure other than the loop duodenal switch.
- The subject has a BMI of less than 40 kg/m2 at the time of surgical consultation.
- Any female subject who is pregnant, or is actively breast-feeding
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 |
|---|---|---|
| Loop duodenal switchThe loop duodenal switch (L-DS) is a single anastomosis duodeno-intestinal bypass. In this simplified version of a BPD-DS, a sleeve gastrectomy is followed by a single anastomosis of the duodenum to the ileum in a loop fashion. The proposed benefits of this are to reproduce the excellent weight loss seen after a BPD-DS (an accepted and utilized bariatric procedure in the USA) but with the potential for reduced complications. With one anastomoses in the L-DS over two in the BPD-DS there is a theoretical lower probability of leaks, strictures, reduced anesthesia with shorter operative times, and decreased risk of internal hernia. | Procedure or surgery | – |
Primary outcome
Excess weight loss (EWL)
Time frame: 12 months post-procedure
Excess weight loss is a common metric for reporting weight loss after bariatric surgery. The EWL is calculated from an ideal body mass index (BMI) of 25 kg/m^2 and considers weight before surgery and at 12 months post-procedure.
6 secondary outcomes
Loop duodenal switch related adverse events
Time frame: 12 months post-procedure
Resolution rate of obesity related co-morbidities
Time frame: 12 months post-procedure
SF-36 Quality of Life Survey
Time frame: 12 months post-procedure
Gastro-esophageal Reflux Disease Health Related Quality of Life Survey
Time frame: 12 months post-procedure
Gastrointestinal Symptoms Rating
Time frame: 12 months post-procedure
Protein malnutrition
Time frame: 12 months post-procedure
Results and safety
The study was stopped early (reason given: Principal investigator terminated study due to low enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
- Background: PubMed 18040751Sanchez-Pernaute A, Rubio Herrera MA, Perez-Aguirre E, Garcia Perez JC, Cabrerizo L, Diez Valladares L, Fernandez C, Talavera P, Torres A. Proximal duodenal-ileal end-to-side bypass with sleeve gastrectomy: proposed technique. Obes Surg. 2007 Dec;17(12):1614-8. doi: 10.1007/s11695-007-9287-8. Epub 2007 Nov 27.
- Background: PubMed 20798995Sanchez-Pernaute A, Herrera MA, Perez-Aguirre ME, Talavera P, Cabrerizo L, Matia P, Diez-Valladares L, Barabash A, Martin-Antona E, Garcia-Botella A, Garcia-Almenta EM, Torres A. Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S). One to three-year follow-up. Obes Surg. 2010 Dec;20(12):1720-6. doi: 10.1007/s11695-010-0247-3.
- Background: PubMed 22963820Sanchez-Pernaute A, Rubio MA, Perez Aguirre E, Barabash A, Cabrerizo L, Torres A. Single-anastomosis duodenoileal bypass with sleeve gastrectomy: metabolic improvement and weight loss in first 100 patients. Surg Obes Relat Dis. 2013 Sep-Oct;9(5):731-5. doi: 10.1016/j.soard.2012.07.018. Epub 2012 Aug 7.
- Background: PubMed 26694182Cottam A, Cottam D, Medlin W, Richards C, Cottam S, Zaveri H, Surve A. A matched cohort analysis of single anastomosis loop duodenal switch versus Roux-en-Y gastric bypass with 18-month follow-up. Surg Endosc. 2016 Sep;30(9):3958-64. doi: 10.1007/s00464-015-4707-7. Epub 2015 Dec 22.
- Individual participant dataSharing planned: No
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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.
Tammy Kindel, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Type-2 Diabetes Mellitus, run by Medical College of Wisconsin 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 4 inclusion and 12 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: stopped early, as of the sponsor's last update on 7 Jul 2016. 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?
The study was stopped early (reason given: Principal investigator terminated study due to low enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excess weight loss (EWL) (time frame: 12 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02671331, which also lists 4 linked publications.
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 7 Jul 2016; AzTrials last refreshed its copy on 1 Nov 2026.