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TO COMPARE THE WEIGHT LOSS BETWEEN BANDED GASTRIC BYPASS PATIENTS AND NON BANDED GASTRIC BYPASS PATIENTS. BANDED GASTRIC BYPASS IS MEANT TO BE AN APPLICATION OF SILICONE BAND/RING AROUND THE STOMACH POUCH THAT IS CREATED INTRAOPERATIVELY FROM A PROPORTION OF PART OF STOMACH

To compare the outcomes of banded versus non banded gastric bypass procedures(Roux-en-Y gastric bypass & One anastomosis gastric bypass) for patients of morbid obesity-A Prospective Randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042634
Enrollment
28
Registered
2022-05-18
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Banded Gastric bypass procedures (RYGB & OAGB).: Application of Band/ring to gastric pouch following gastric bypass procedures. As it is surgical intervention unlike medical interventi

Sponsors

Dept of surgical Disciplines AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patients with morbid obesity, defined as Body Mass Index (BMI) > 37.5kg/m2. 2)Patients with BMI > 32.5 kg/m2 with obesity related co-morbidities. 3)Patients who have failed to maintain weight loss after trying appropriate non-surgical measures. 4)Patients who have comprehension and commitment to long term follow up. 5)Patients who gave consent for the study. 6)Age >18, &

Exclusion criteria

Exclusion criteria: 1)Any contraindication for bariatric surgery There are no absolute contraindications for bariatric surgery. Relative contraindications are: -severe heart failure -unstable coronary artery disease -end-stage lung disease -active cancer treatment -portal hypertension -drug/alcohol dependency -impaired intellectual capacity 2)Patients requiring revision gastric bypass. 3)Refusal to participate in the study. 4)Ageless than18 & more than 65 years.

Design outcomes

Primary

MeasureTime frame
To compare the mean percentage of excess weight loss (% EWL) at the end of 6 months & 1 year follow up period between patients who underwent banded Gastric bypass with non-banded gastric bypass procedures.Timepoint: At the end of 6 months & 1 year follow-up period.

Secondary

MeasureTime frame
i.To compare the following for: 1.Mean OT time. 2.Mean length of hospital stay. 3.Incidence of complications, between the two procedures. 4.The impact of comorbidities (Diabetes Mellitus, Hypertension, Obstructive Sleep Apnea, Gastro-esophageal reflux disease, Dyslipidemia, Hypothyroidism) between the two types of procedures. 5.The quality of life (BAROS) score, GI quality of life score (GIQLI). Timepoint: At the end of 6 months & 1 year follow-up period.

Countries

India

Contacts

Public ContactSandeep Aggarwal

All India Institute of Medical sciences

sandeep_aiims@yahoo.co.in9810235580

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026