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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура Laparoscopic Roux-en Y Gastric bypass (RYGB)- Conventional approach
  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
• Процедура Laparoscopic Roux-en Y Gastric bypass (RYGB)- Tailored approach
  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

Первичные конечные точки

• Percentage of total weight loss (%TWL) [Срок оценки: 3, 6 and 12 months]
• Improvement in BMI [Срок оценки: 3, 6 and 12 months]

Вторичные конечные точки (6)

• Improvement in Type 2 diabetes [Срок оценки: 3, 6 and 12 months]
• Improvement in Hypertension [Срок оценки: 3, 6, 12 months]
• Improvement in dyslipidemia [Срок оценки: 3, 6, 12 months]
• Nutritional status [Срок оценки: 3, 6 and 12 months]
• Quality of life of patient [Срок оценки: 3, 6 and 12 months]
• Surgical complications [Срок оценки: 3, 6 and 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Индия · 1 центр

• GEM Hospital and Research Center — Coimbatore

Идентификаторы

NCT: NCT06756789 · GemBariatricRYGB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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