Obesity, MorbidTB-LSGNCT04782648
Transit Bipartition After Sleeve Gastrectomy
An observational study of Obesity, Morbid and Weight Gain, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
Retrospective analysis of 100 morbidly obese patients who underwent a transit bipartition (TB) procedure ("Single Anastomosis Sleeve Ileal bypass") for inadequate weight loss or weight recidivism after a previous sleeve gastrectomy. Data were collected prospectively in strictly pseudonymous form. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Morbid, Weight Gain, Bariatric Surgery Candidate
- What is being tested?
- transit bipartition
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2017to 20 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Morbidly obese patients (BMI > 30) who underwent transit bipartition (SASI bypass) for inadequate weight loss or weight regain after laparoscopic sleeve gastrectomy
Who may be able to join
- TB for excess weight loss (EWL) < 50% ≥ 12 months post LSG or weight recidivism of > 5 kg/qm with a body mass index (BMI) > 30 kg/qm.
Who cannot join
- endocrine disorders other than T2DM, major psychiatric disorders, ASA ≥ III, pregnancy.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum Vest GmbH
Recklinghausen, North Rhine-Westphalia, 45657
About this study
Official title: Transit Bipartition to Promote Weight Loss After Laparoscopic Sleeve Gastrectomy
Retrospective analysis of 100 morbidly obese patients who underwent a transit bipartition (TB) procedure ("Single Anastomosis Sleeve Ileal bypass") for inadequate weight loss or weight recidivism after a previous sleeve gastrectomy. Data were collected prospectively in strictly pseudonymous form. The primary endpoint of the study is weight loss at 1, 3, 6 and 12 months after TB. A subgroup analysis evaluates the effect of the length of the common channel. Secondary endpoints include impact on obesity related comorbidities (type 2 diabetes, hypertension, sleep apnea, gastroesophageal reflux) as well as safety.
Read the detailed description
Prospective data base of 100 consecutive morbidly obese patients who had undergone transit bipartition (TB, also termed "Single Anastomosis Sleeve Ileal bypass") after a previous sleeve gastrectomy (LSG). Inclusion criteria were TB for excess weight loss (EWL) < 50% ≥ 12 months post LSG or weight recidivism of > 5 kg/qm with a body mass index (BMI) > 30 kg/qm. Patients with endocrine disorders other than type 2 diabetes mellitus (T2D), major psychiatric disorders, American Society of Anesthesiologists (ASA) III and higher or pregnant patients were excluded from the study. Data were prospectively collected in strictly pseudonymous form. Follow up time points were at 1, 3, 6 and 12 months following TB. The primary endpoint of the study is weight loss at 1, 3, 6 and 12 months after TB. A subgroup analysis evaluates the effect of the length of the common channel. Secondary endpoints include impact on obesity related comorbidities such as T2D, hypertension, sleep apnea, gastroesophageal reflux as well as safety.
- Conditions
- Obesity, Morbid, Weight Gain, Bariatric Surgery Candidate
- Being tested
- transit bipartition
- Keywords
- obesity, weight regain, sleeve gastrectomy, SASI bypass
- Medical subject headings
- Obesity, Morbid, Weight Gain, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transit bipartitionProcedure or surgery
Also called SASI bypass
transit bipartition as revisional bariatric surgery for weight regain after sleeve gastrectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
percent excess weight loss (EWL)
preoperative weight-current weight / preoperative weight-ideal weight x 100 (ideal weight defined as BMI 25 kg/qm
Measured: 12 months
Secondary outcomes (4)
number of patients with improvement of type 2 diabetes
number of patients with HbA1c <6 %, fasting blood glucose <100 mg/dL in the absence of antidiabetic medications
Measured: 12 months
number of patients with improvement of gastro-esophageal reflux (GERD)
number of patients with no GERD symptoms, reflux symptom score (RSI) < 13 in the absence of medication
Measured: 12 months
number of patients with improvement of hypertension
number of patients with normotensive blood pressure (<120/80 mmHg) in the absence of antihypertensive medication
Measured: 12 months
number of patients with improvement of sleep apnoea
number of patients with discontinued use of sleep apnea treatment (continuous positive airway pressure - CPAP) based on improved symptoms and Obstructive Sleep Apnoea (OSA) screening.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 Nov 2017
- Primary completion30 Nov 2019
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Markus Reiser, M.D., Ruhr University of Bochum
- Investigators
- Markus Reiser, M.D., Principal investigator, Dept. Gastroenterology, Klinikum-Vest GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782648
- Sponsor's protocol ID
- TB-LSG-01
- Acronym
- TB-LSG
- Status last verified
- Mar 2021
- First submitted
- 27 Feb 2021
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transit Bipartition to Promote Weight Loss After Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT04782648
- Acronym / sponsor ID
- TB-LSG / TB-LSG-01
- Conditions
- Obesity, Morbid, Weight Gain, Bariatric Surgery Candidate
- Keywords
- obesity, weight regain, sleeve gastrectomy, SASI bypass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 4 Mar 2021 (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.
Retrospective analysis of 100 morbidly obese patients who underwent a transit bipartition (TB) procedure ("Single Anastomosis Sleeve Ileal bypass") for inadequate weight loss or weight recidivism after a previous sleeve gastrectomy. Data were collected prospectively in strictly pseudonymous form. The primary endpoint of the study is weight loss at 1, 3, 6 and 12 months after TB. A subgroup analysis evaluates the effect of the length of the common channel. Secondary endpoints include impact on obesity related comorbidities (type 2 diabetes, hypertension, sleep apnea, gastroesophageal reflux) as well as safety.
Detailed description
Prospective data base of 100 consecutive morbidly obese patients who had undergone transit bipartition (TB, also termed "Single Anastomosis Sleeve Ileal bypass") after a previous sleeve gastrectomy (LSG). Inclusion criteria were TB for excess weight loss (EWL) < 50% ≥ 12 months post LSG or weight recidivism of > 5 kg/qm with a body mass index (BMI) > 30 kg/qm. Patients with endocrine disorders other than type 2 diabetes mellitus (T2D), major psychiatric disorders, American Society of Anesthesiologists (ASA) III and higher or pregnant patients were excluded from the study. Data were prospectively collected in strictly pseudonymous form. Follow up time points were at 1, 3, 6 and 12 months following TB. The primary endpoint of the study is weight loss at 1, 3, 6 and 12 months after TB. A subgroup analysis evaluates the effect of the length of the common channel. Secondary endpoints include impact on obesity related comorbidities such as T2D, hypertension, sleep apnea, gastroesophageal reflux as well as safety.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Morbidly obese patients (BMI > 30) who underwent transit bipartition (SASI bypass) for inadequate weight loss or weight regain after laparoscopic sleeve gastrectomy
Key inclusion criteria (1 listed)
- TB for excess weight loss (EWL) < 50% ≥ 12 months post LSG or weight recidivism of > 5 kg/qm with a body mass index (BMI) > 30 kg/qm.
Key exclusion criteria (1 listed)
- endocrine disorders other than T2DM, major psychiatric disorders, ASA ≥ III, pregnancy.
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 |
|---|---|---|
| transit bipartitionAlso: SASI bypasstransit bipartition as revisional bariatric surgery for weight regain after sleeve gastrectomy | Procedure or surgery | – |
Primary outcome
percent excess weight loss (EWL)
Time frame: 12 months
preoperative weight-current weight / preoperative weight-ideal weight x 100 (ideal weight defined as BMI 25 kg/qm
4 secondary outcomes
number of patients with improvement of type 2 diabetes
Time frame: 12 months
number of patients with improvement of gastro-esophageal reflux (GERD)
Time frame: 12 months
number of patients with improvement of hypertension
Time frame: 12 months
number of patients with improvement of sleep apnoea
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
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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.
Markus Reiser, M.D. principal investigator
Dept. Gastroenterology, Klinikum-Vest GmbH
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, Morbid and Weight Gain, run by Ruhr University of Bochum at 1 site in Germany.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Mar 2021. 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 Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
percent excess weight loss (EWL) (time frame: 12 months). 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 4 Mar 2021; AzTrials last refreshed its copy on 26 Oct 2026.