Bariatric SurgeryNCT06598267
Evaluate the Efficacy and Safety of SASI Compared with RYGB in the Treatment of Obesity and Related Metabolic Diseases
A study testing SASI and RYGB in people with Bariatric Surgery, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
Single anastomosis sleeve ileal bypass (SASI) is an improved surgical technique for sleeve gastrectomy (SG), which combines the advantages of SG and Roux-en-Y gastric bypass (RYGB) while avoiding their disadvantages,in order to achieve better treatment outcomes.On the one hand,SASI surgery improves the effectiveness… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery
- What is being tested?
- SASI and RYGB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2024to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing weight loss surgery,aged 18-65 years old
- Simple obesity with a BMI exceeding 35 or a BMI exceeding 32 combined with at least 2 metabolic syndromes
- Preoperative gastroscopy examination showed no high-risk factors for gastric cancer
- Preoperative multidisciplinary evaluation is suitable for gastric bypass or dual channel surgery
- Patients understand and accept long-term follow-up
- The patient agrees to participate in the clinical study and signs an informed consent form
Who cannot join
- The patient has type 1 diabetes
- Gastroscopy indicates active gastroduodenal ulcers within the past 2 months without treatment
- The patient has a history of chronic inflammatory bowel disease
- The patient is pregnant or has a recent pregnancy plan
- Having psychological disorders that require monitoring
- The patient has undergone weight loss surgery in the past to undergo corrective surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective,Single-center,Randomized,Controlled Study to Evaluate the Efficacy and Safety of SASI Compared with RYGB in the Treatment of Obesity and Related Metabolic Diseases
Single anastomosis sleeve ileal bypass (SASI) is an improved surgical technique for sleeve gastrectomy (SG), which combines the advantages of SG and Roux-en-Y gastric bypass (RYGB) while avoiding their disadvantages,in order to achieve better treatment outcomes.On the one hand,SASI surgery improves the effectiveness of weight loss surgery by adding gastrointestinal anastomosis on the basis of SG,while reducing gastric pressure and improving postoperative gastroesophageal reflux symptoms.On the other hand,it also avoids the regret of RYGB surgery leaving the stomach open for gastroscopy examination and reduces the risk of postoperative nutrition related complications.Therefore,SASI surgery has demonstrated good application prospects and is expected to be promoted in clinical practice.So far,there has been no comparative study of RCTs between RYGB and SASI internationally.In order to compare the weight loss effects of SASI and RYGB surgery,this study intends to conduct a randomized controlled trial on patients who meet the criteria and require weight loss surgery,providing high-level evidence-based medicine for the further clinical development of SASI surgery in the future.
Read the detailed description
Routine preoperative examinations should be conducted on patients planning to undergo weight loss surgery,and inclusion screening should be conducted according to the inclusion and exclusion criteria.Patients who meet the inclusion criteria will receive informed consent before enrollment and be randomly assigned to either the experimental group (SASI group) or the control group (RYGB group) for weight loss surgery based on computer randomization results.
Monitor the patient\'s surgical condition and surgical complications before discharge.
Follow up will be conducted at each follow-up node after surgery (1 month/3 months/6 months/12 months).
This study aims to measure the weight of patients before and after surgery, analyze the degree of weight loss based on the percentage of excess weight loss (% EWL) one year after surgery, and compare the weight loss effects of two surgical procedures.At the same time,based on relevant laboratory results,the effectiveness of two surgical procedures for treating metabolic syndrome,the incidence of postoperative nutritional complications,the incidence of surgical related complications,the quality of life one year after surgery,and weight loss were compared.
- Conditions
- Bariatric Surgery
- Being tested
- SASI, RYGB
- Keywords
- Obesity and Related Metabolic Disease
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SASIProcedure or surgery
single anastomosis sleeve ileal bypass
RYGBProcedure or surgery
Roux-en-Y gastric bypass
| Study group | Role | What they receive |
|---|---|---|
| SASI group | Experimental | single anastomosis sleeve ileal bypass Receives: Procedure: SASI |
| RYGB group | Experimental | Roux-en-Y gastric bypass Receives: Procedure: RYGB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of excess weight loss one year after surgery (% EWL)
Percentage of excess weight loss one year after surgery
Measured: one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start3 Sep 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuehui Chu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Xuehui Chu, Doctorate, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598267
- Sponsor's protocol ID
- 2024-557
- Status last verified
- Aug 2024
- First submitted
- 11 Sep 2024
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective,Single-center,Randomized,Controlled Study to Evaluate the Efficacy and Safety of SASI Compared with RYGB in the Treatment of Obesity and Related Metabolic Diseases
- ClinicalTrials.gov ID
- NCT06598267
- Acronym / sponsor ID
- 2024-557
- Conditions
- Bariatric Surgery
- Keywords
- Obesity and Related Metabolic Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 19 Sep 2024 (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.
Single anastomosis sleeve ileal bypass (SASI) is an improved surgical technique for sleeve gastrectomy (SG), which combines the advantages of SG and Roux-en-Y gastric bypass (RYGB) while avoiding their disadvantages,in order to achieve better treatment outcomes.On the one hand,SASI surgery improves the effectiveness of weight loss surgery by adding gastrointestinal anastomosis on the basis of SG,while reducing gastric pressure and improving postoperative gastroesophageal reflux symptoms.On the other hand,it also avoids the regret of RYGB surgery leaving the stomach open for gastroscopy examination and reduces the risk of postoperative nutrition related complications.Therefore,SASI surgery has demonstrated good application prospects and is expected to be promoted in clinical practice.So far,there has been no comparative study of RCTs between RYGB and SASI internationally.In order to compare the weight loss effects of SASI and RYGB surgery,this study intends to conduct a randomized controlled trial on patients who meet the criteria and require weight loss surgery,providing high-level evidence-based medicine for the further clinical development of SASI surgery in the future.
Detailed description
Routine preoperative examinations should be conducted on patients planning to undergo weight loss surgery,and inclusion screening should be conducted according to the inclusion and exclusion criteria.Patients who meet the inclusion criteria will receive informed consent before enrollment and be randomly assigned to either the experimental group (SASI group) or the control group (RYGB group) for weight loss surgery based on computer randomization results.
Monitor the patient\'s surgical condition and surgical complications before discharge.
Follow up will be conducted at each follow-up node after surgery (1 month/3 months/6 months/12 months).
This study aims to measure the weight of patients before and after surgery, analyze the degree of weight loss based on the percentage of excess weight loss (% EWL) one year after surgery, and compare the weight loss effects of two surgical procedures.At the same time,based on relevant laboratory results,the effectiveness of two surgical procedures for treating metabolic syndrome,the incidence of postoperative nutritional complications,the incidence of surgical related complications,the quality of life one year after surgery,and weight loss were compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SASI group | Experimental | Procedure: SASIsingle anastomosis sleeve ileal bypass |
| RYGB group | Experimental | Procedure: RYGBRoux-en-Y gastric bypass |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients undergoing weight loss surgery,aged 18-65 years old
- Simple obesity with a BMI exceeding 35 or a BMI exceeding 32 combined with at least 2 metabolic syndromes
- Preoperative gastroscopy examination showed no high-risk factors for gastric cancer
- Preoperative multidisciplinary evaluation is suitable for gastric bypass or dual channel surgery
- Patients understand and accept long-term follow-up
Key exclusion criteria (6 listed)
- The patient has type 1 diabetes
- Gastroscopy indicates active gastroduodenal ulcers within the past 2 months without treatment
- The patient has a history of chronic inflammatory bowel disease
- The patient is pregnant or has a recent pregnancy plan
- Having psychological disorders that require monitoring
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 |
|---|---|---|
| SASIsingle anastomosis sleeve ileal bypass | Procedure or surgery | SASI group |
| RYGBRoux-en-Y gastric bypass | Procedure or surgery | RYGB group |
Primary outcome
Percentage of excess weight loss one year after surgery (% EWL)
Time frame: one year after surgery
Percentage of excess weight loss one year after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
Xuehui Chu, Doctorate principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SASI and RYGB in people with Bariatric Surgery, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 19 Sep 2024. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of excess weight loss one year after surgery (% EWL) (time frame: one year after 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 19 Sep 2024.