ObesityTAILO-R-YGBNCT06756789
Conventional Vs Tailored Limb Lengths in Laparoscopic Roux-en Y Gastric Bypass Surgery
A study testing Laparoscopic Roux-en Y Gastric bypass (RYGB)- Conventional approach and Laparoscopic Roux-en Y Gastric bypass (RYGB)- Tailored approach in people with Obesity and Metabolic Disease, run by GEM Hospital & Research Center at 1 site in India.
Trial summary
The study aims to investigate whether tailoring limb lengths based on the 1/3rd and 2/3rd concept improves clinical outcomes in Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) surgery compared to conventional limb lengths. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Metabolic Disease, Bariatric Surgery Candidate
- What is being tested?
- Laparoscopic Roux-en Y Gastric bypass (RYGB)- Conventional approach and Laparoscopic Roux-en Y Gastric bypass (RYGB)- Tailored approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 1 Apr 2024to Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-65 years
- Body Mass Index (BMI):
- BMI ≥ 40 kg/m² or BMI ≥ 35 kg/m² with at least one obesity-related comorbidity (e.g., type 2 diabetes, hypertension, obstructive sleep apnea).
- ASA - less than or equal to 3
- Informed Consent: Ability and willingness to provide written informed consent and comply with procedures.
- Previous Weight Loss Attempts: Documentation of previous attempts at weight loss through diet, exercise, or medical management.
Who cannot join
- Previous Bariatric Surgery: Prior bariatric or major gastrointestinal surgery that might affect the outcome of RYGB.
- Severe Cardiopulmonary Conditions: Significant cardiac or pulmonary conditions that pose a high surgical risk (e.g., severe congestive heart failure, severe chronic obstructive pulmonary disease).
- Uncontrolled Psychiatric Disorders: Severe psychiatric illness or substance abuse issues that are not well-controlled, including eating disorders.
- Pregnancy: Current pregnancy or plans to become pregnant within 12 months post-surgery.
- Malignancy: Active malignancy or history of malignancy requiring treatment in the past 5 years (excluding non-melanoma skin cancer).
- Severe Liver Disease: Cirrhosis or significant liver dysfunction (e.g., Child-Pugh B or C).
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- Inability to Comply: Patients who are unable or unwilling to comply with the postoperative follow-up schedule and dietary requirements.
- Chronic Use of Medications: Chronic use of medications known to affect weight or metabolism significantly, such as corticosteroids or antipsychotics.
- Other Medical Conditions: Any other medical condition or surgical finding that, in the opinion of the investigators, would make the patient unsuitable for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
GEM Hospital and Research Center
Coimbatore, Tamil Nadu, 641045
Praveenraj Palanivelu, 9842417537, pdp.joshua@gmail.com
About this study
Official title: Randomized Controlled Trial on Conventional Vs Tailored Limb Lengths in Laparoscopic Roux-en Y Gastric Bypass Surgery
The study aims to investigate whether tailoring limb lengths based on the 1/3rd and 2/3rd concept improves clinical outcomes in Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) surgery compared to conventional limb lengths. In this study, two groups were described, first group involves patients who will undergo Lap RYGB with conventional limb lengths of 75cms and 125cms, while the second group is given tailored limb lengths according to the total small bowel length. In the follow up period, Total percentage weight loss, improvement in BMI along with the remission of co-morbidities were also assessed.
- Conditions
- Obesity, Metabolic Disease, Bariatric Surgery Candidate, Metabolic Surgery, RYGB
- Being tested
- Laparoscopic Roux-en Y Gastric bypass (RYGB)- Conventional approach, Laparoscopic Roux-en Y Gastric bypass (RYGB)- Tailored approach
- Keywords
- Obesity, RYGB, Bariatric surgery, Metabolic surgery, Metabolic syndrome
- Medical subject headings
- Obesity, Metabolic Diseases, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Roux-en Y Gastric bypass (RYGB)- Conventional approachProcedure or surgery
The procedure involves creating a small gastric pouch from the upper portion of the stomach, which is then directly connected to the small bowel, in a roux- enY fashion with another jejune-jejunal anastamosis bypassing a large part of the stomach and the duodenum. This results in reduced food intake and decreased nutrient absorption. In this arm, standard limb lengths of 75cms BP limb and 125cms Alimentary limb were measured and performed, irrespective of the total bowel length
Laparoscopic Roux-en Y Gastric bypass (RYGB)- Tailored approachProcedure or surgery
The procedure involves creating a small gastric pouch from the upper portion of the stomach, which is then directly connected to the small bowel, in a roux- enY fashion with another jejune-jejunal anastamosis bypassing a large part of the stomach and the duodenum. This results in reduced food intake and decreased nutrient absorption. In this arm, limb lengths are tailored according to the total small bowel length, 1/3rd of the total bowel length is measured and in that 3/8th and 5/8th were kept as BP limb and alimentary limb respectively.
| Study group | Role | What they receive |
|---|---|---|
| Conventional group | Placebo comparator | In this arm, standard limb lengths of 75cms BP limb and 125cms Alimentary limb were measured and performed, irrespective of the total bowel length Receives: Procedure: Laparoscopic Roux-en Y Gastric bypass (RYGB)- Conventional approach |
| Tailored group | Active comparator | In this arm, limb lengths are tailored according to the total small bowel length, 1/3rd of the total bowel length is measured and in that 3/8th and 5/8th were kept as BP limb and alimentary limb respectively. Receives: Procedure: Laparoscopic Roux-en Y Gastric bypass (RYGB)- Tailored approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of total weight loss (%TWL)
Measured: 3, 6 and 12 months
Improvement in BMI
BMI is calculated by dividing Weight in kilogram by height in square meters. This is calculated at 3,6 and 12 month intervals and BMI is calculated at each point of time. Improvement in BMI when compared to the pre-operative BMI is calculated for both the groups and analysed.
Measured: 3, 6 and 12 months
Secondary outcomes (6)
Improvement in Type 2 diabetes
HbA1c for Type 2 diabetes
Measured: 3, 6 and 12 months
Improvement in Hypertension
Blood pressure measurement for Hypertension
Measured: 3, 6, 12 months
Improvement in dyslipidemia
Lipid profiles for dyslipidemia
Measured: 3, 6, 12 months
Nutritional status
Assessed with the skeletal muscle mass
Measured: 3, 6 and 12 months
Quality of life of patient
SF (Short Form) 36 questionnaire
Measured: 3, 6 and 12 months
Surgical complications
Includes postoperative bleeding, 30 day readmission, Leaks, Re-exploration
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start1 Apr 2024
- Primary completion31 May 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GEM Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756789
- Sponsor's protocol ID
- GemBariatricRYGB
- Acronym
- TAILO-R-YGB
- Status last verified
- Dec 2024
- First submitted
- 26 Jun 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on Conventional Vs Tailored Limb Lengths in Laparoscopic Roux-en Y Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT06756789
- Acronym / sponsor ID
- TAILO-R-YGB / GemBariatricRYGB
- Conditions
- Obesity, Metabolic Disease, Bariatric Surgery Candidate, Metabolic Surgery, RYGB
- Keywords
- Obesity, RYGB, Bariatric surgery, Metabolic surgery, Metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- GEM Hospital & Research CenterUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Jan 2025 (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 study aims to investigate whether tailoring limb lengths based on the 1/3rd and 2/3rd concept improves clinical outcomes in Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) surgery compared to conventional limb lengths. In this study, two groups were described, first group involves patients who will undergo Lap RYGB with conventional limb lengths of 75cms and 125cms, while the second group is given tailored limb lengths according to the total small bowel length. In the follow up period, Total percentage weight loss, improvement in BMI along with the remission of co-morbidities were also assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional group | Placebo comparator | Procedure: Laparoscopic Roux-en Y Gastric bypass (RYGB)- Conventional approachIn this arm, standard limb lengths of 75cms BP limb and 125cms Alimentary limb were measured and performed, irrespective of the total bowel length |
| Tailored group | Active comparator | Procedure: Laparoscopic Roux-en Y Gastric bypass (RYGB)- Tailored approachIn this arm, limb lengths are tailored according to the total small bowel length, 1/3rd of the total bowel length is measured and in that 3/8th and 5/8th were kept as BP limb and alimentary limb respectively. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18-65 years
- Body Mass Index (BMI):
- BMI ≥ 40 kg/m² or BMI ≥ 35 kg/m² with at least one obesity-related comorbidity (e.g., type 2 diabetes, hypertension, obstructive sleep apnea).
- ASA - less than or equal to 3
- Informed Consent: Ability and willingness to provide written informed consent and comply with procedures.
Key exclusion criteria (9 listed)
- Previous Bariatric Surgery: Prior bariatric or major gastrointestinal surgery that might affect the outcome of RYGB.
- Severe Cardiopulmonary Conditions: Significant cardiac or pulmonary conditions that pose a high surgical risk (e.g., severe congestive heart failure, severe chronic obstructive pulmonary disease).
- Uncontrolled Psychiatric Disorders: Severe psychiatric illness or substance abuse issues that are not well-controlled, including eating disorders.
- Pregnancy: Current pregnancy or plans to become pregnant within 12 months post-surgery.
- Malignancy: Active malignancy or history of malignancy requiring treatment in the past 5 years (excluding non-melanoma skin cancer).
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 |
|---|---|---|
| Laparoscopic Roux-en Y Gastric bypass (RYGB)- Conventional approachThe procedure involves creating a small gastric pouch from the upper portion of the stomach, which is then directly connected to the small bowel, in a roux- enY fashion with another jejune-jejunal anastamosis bypassing a large part of the stomach and the duodenum. This results in reduced food intake and decreased nutrient absorption. In this arm, standard limb lengths of 75cms BP limb and 125cms Alimentary limb were measured and performed, irrespective of the total bowel length | Procedure or surgery | Conventional group |
| Laparoscopic Roux-en Y Gastric bypass (RYGB)- Tailored approachThe procedure involves creating a small gastric pouch from the upper portion of the stomach, which is then directly connected to the small bowel, in a roux- enY fashion with another jejune-jejunal anastamosis bypassing a large part of the stomach and the duodenum. This results in reduced food intake and decreased nutrient absorption. In this arm, limb lengths are tailored according to the total small bowel length, 1/3rd of the total bowel length is measured and in that 3/8th and 5/8th were kept as BP limb and alimentary limb respectively. | Procedure or surgery | Tailored group |
Primary outcome
Percentage of total weight loss (%TWL)
Time frame: 3, 6 and 12 months
Improvement in BMI
Time frame: 3, 6 and 12 months
BMI is calculated by dividing Weight in kilogram by height in square meters. This is calculated at 3,6 and 12 month intervals and BMI is calculated at each point of time. Improvement in BMI when compared to the pre-operative BMI is calculated for both the groups and analysed.
6 secondary outcomes
Improvement in Type 2 diabetes
Time frame: 3, 6 and 12 months
Improvement in Hypertension
Time frame: 3, 6, 12 months
Improvement in dyslipidemia
Time frame: 3, 6, 12 months
Nutritional status
Time frame: 3, 6 and 12 months
Quality of life of patient
Time frame: 3, 6 and 12 months
Surgical complications
Time frame: 3, 6 and 12 months
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 3 Jan 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Roux-en Y Gastric bypass (RYGB)- Conventional approach and Laparoscopic Roux-en Y Gastric bypass (RYGB)- Tailored approach in people with Obesity and Metabolic Disease, run by GEM Hospital & Research Center at 1 site in India.
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 9 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: looking for participants now, as of the sponsor's last update on 3 Jan 2025. 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 India. 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. Some participants in this study may receive a placebo. 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?
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?
Percentage of total weight loss (%TWL) (time frame: 3, 6 and 12 months). The study lists 2 primary outcomes in all. 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 3 Jan 2025; AzTrials last refreshed its copy on 26 Oct 2026.