Conventional Vs Tailored Limb Lengths in Laparoscopic Roux-en Y Gastric Bypass Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGEM Hospital & Research Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 18-65 years
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Laparoscopic Roux-en Y Gastric bypass (RYGB)- Conventional approach
Procedure/SurgeryThe 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/SurgeryThe 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Conventional groupPlacebo comparator 1 intervention
Group B: Tailored groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of total weight loss (%TWL)
Time frame
3, 6 and 12 months2
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.
Time frame
3, 6 and 12 monthsSecondary outcomes
1
Improvement in Type 2 diabetes
HbA1c for Type 2 diabetes
Time frame
3, 6 and 12 months2
Improvement in Hypertension
Blood pressure measurement for Hypertension
Time frame
3, 6, 12 months3
Improvement in dyslipidemia
Lipid profiles for dyslipidemia
Time frame
3, 6, 12 months4
Nutritional status
Assessed with the skeletal muscle mass
Time frame
3, 6 and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov