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NCT Number: NCT06756789

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GEM Hospital and Research Center

Coimbatore, Tamil Nadu, 641045, India

Location status: Recruiting

Location contact

Praveenraj Palanivelu

CONTACT

[email protected]

9842417537

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

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.

Primary outcomes

  1. Percentage of total weight loss (%TWL)

    Time frame: 3, 6 and 12 months

  2. 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.

Secondary outcomes

  1. Improvement in Type 2 diabetes

    Time frame: 3, 6 and 12 months

    HbA1c for Type 2 diabetes

  2. Improvement in Hypertension

    Time frame: 3, 6, 12 months

    Blood pressure measurement for Hypertension

  3. Improvement in dyslipidemia

    Time frame: 3, 6, 12 months

    Lipid profiles for dyslipidemia

  4. Nutritional status

    Time frame: 3, 6 and 12 months

    Assessed with the skeletal muscle mass

  5. Quality of life of patient

    Time frame: 3, 6 and 12 months

    SF (Short Form) 36 questionnaire

  6. Surgical complications

    Time frame: 3, 6 and 12 months

    Includes postoperative bleeding, 30 day readmission, Leaks, Re-exploration

Sponsors and collaborators

Lead sponsor

GEM Hospital & Research Center

Other

Registry information

Official study title

Randomized Controlled Trial on Conventional Vs Tailored Limb Lengths in Laparoscopic Roux-en Y Gastric Bypass Surgery

Acronym: TAILO-R-YGB

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 3, 2025
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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