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

NCT ID: NCT06756789

Last Updated: 2025-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Metabolic Disease Bariatric Surgery Candidate Metabolic Surgery RYGB

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Conventional group

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

Group Type PLACEBO_COMPARATOR

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

Intervention Type 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

Tailored group

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

Interventions

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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

Intervention Type PROCEDURE

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 as BP limb and alimentary limb respectively.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GEM Hospital & Research Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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GEM Hospital and Research Center

Coimbatore, Tamil Nadu, India

Site Status RECRUITING

Countries

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India

Facility Contacts

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Praveenraj Palanivelu

Role: primary

9842417537

Other Identifiers

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GemBariatricRYGB

Identifier Type: -

Identifier Source: org_study_id

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