Conventional Vs Tailored Limb Lengths in Laparoscopic Roux-en Y Gastric Bypass Surgery (TAILO-R-YGB)

GEM Hospital & Research Center

Status: Enrolling

Conditions: RYGB; Metabolic Surgery; Bariatric Surgery Candidate; Obesity; Metabolic Disease

Treatments: Procedure: Laparoscopic Roux-en Y Gastric bypass (RYGB)- Tailored approach; Procedure: Laparoscopic Roux-en Y Gastric bypass (RYGB)- Conventional approach

Study type: Interventional

Funder types: Other

Identifiers

NCT06756789

GemBariatricRYGB

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age: 18-65 years

2. 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).

3. ASA - less than or equal to 3

4. Informed Consent: Ability and willingness to provide written informed consent and comply with procedures.

5. Previous Weight Loss Attempts: Documentation of previous attempts at weight loss through diet, exercise, or medical management.

Exclusion criteria

1. Previous Bariatric Surgery: Prior bariatric or major gastrointestinal surgery that might affect the outcome of RYGB.
2. 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).
3. Uncontrolled Psychiatric Disorders: Severe psychiatric illness or substance abuse issues that are not well-controlled, including eating disorders.
4. Pregnancy: Current pregnancy or plans to become pregnant within 12 months post-surgery.
5. Malignancy: Active malignancy or history of malignancy requiring treatment in the past 5 years (excluding non-melanoma skin cancer).
6. Severe Liver Disease: Cirrhosis or significant liver dysfunction (e.g., Child-Pugh B or C).
7. Inability to Comply: Patients who are unable or unwilling to comply with the postoperative follow-up schedule and dietary requirements.
8. Chronic Use of Medications: Chronic use of medications known to affect weight or metabolism significantly, such as corticosteroids or antipsychotics.
9. 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Conventional group

Placebo Comparator group

Description:

In this arm, standard limb lengths of 75cms BP limb and 125cms Alimentary limb were measured and performed, irrespective of the total bowel length

Treatment:

Procedure: Laparoscopic Roux-en Y Gastric bypass (RYGB)- Conventional approach

Tailored group

Active Comparator group

Description:

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.

Treatment:

Procedure: Laparoscopic Roux-en Y Gastric bypass (RYGB)- Tailored approach