Conventional Vs Tailored Limb Lengths in Laparoscopic Roux-en Y Gastric Bypass Surgery

NCT06756789 | Recruiting DMC

• 1 other identifier: GemBariatricRYGB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Obesity; RYGB; Bariatric surgery; Metabolic surgery; Metabolic syndrome

Outcome Measures

Primary Outcomes (2)

• Percentage of total weight loss (%TWL)

  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.

  3, 6 and 12 months

Secondary Outcomes (6)

• Improvement in Type 2 diabetes

  3, 6 and 12 months

• Improvement in Hypertension

  3, 6, 12 months

• Improvement in dyslipidemia

  3, 6, 12 months

• Nutritional status

  3, 6 and 12 months

• Quality of life of patient

  3, 6 and 12 months

Study Arms (2)

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

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.

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

Interventions

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

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

Conventional group

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

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.

Tailored group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• GEM Hospital & Research Center: lead

Study Sites (1)

GEM Hospital and Research Center

Coimbatore, Tamil Nadu, 641045, India

RECRUITING

MeSH Terms

Conditions

Obesity; Metabolic Diseases; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: January 3, 2025
• Study Start: April 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: December 1, 2025
• Last Updated: January 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)