Health Condition 1: K00-K95- Diseases of the digestive system
Conditions
Interventions
Intervention1: Group B: Surgical management
: Patients will be undergoing Frey Procedure
Control Intervention1: Group A: Medical management: Patients will be taking standard medical therapy
Sponsors
IPGMER SSKMH
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults more than equal to 18 years diagnosed with CP as per the above definition having a severity of COPPS 2. Willing to give informed consent.
Exclusion criteria
Exclusion criteria: 1. Acute pancreatitis (defined by Revised Atlanta Classifation) or acute-on-chronic pancreatitis at the time of inclusion 2. CP patients with COPPS-A and COPPS-C severity at enrollment 3. Previous pancreatic surgery and/or pancreatic endotherapy 4. Confirmed pancreatic malignancy (on Endoscopic Ultrasound guided FNA of any solid mass lesion seen on Imaging) 5. Patients with significant co-morbidities (as defined by Charlson s co-morbidity index more than equal to 2) making them high-risk for surgery-related complications 6. Pregnant Women 7. Human Immunodeficiency Virus Infection 8. Patients not giving Informed consent for inclusion in an RCT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients needing at least one hospitalization for pain ( acute exacerbation) during a follow-up period of 12 monthsTimepoint: Proportion of patients needing at least one hospitalization for pain ( acute exacerbation) during a follow-up period of 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients needing at least one hospitalization for any cause during a follow-up period of 12 months 2. Total number of hospitalizations (all reasons) during the 12 months follow-up 3. Total number of days spent in hospital during the 12 months follow-up 4. Total number of days in which oral analgesics was consumed during the 12 months follow-up Timepoint: At 12 months | — |
Countries
India
Contacts
Public ContactAkash Karmakar
IPGMER SSKMH
Outcome results
None listed