Health Condition 1: K810- Acute cholecystitis
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Intuitive Surgical Pvt. Ltd. India
Eligibility
Inclusion criteria
Inclusion criteria: 1. The subject is 18 years of age or older and is capable of understanding, reading, and writing in English. 2. The subject is scheduled to undergo cholecystectomy for acute cholecystitis classified as grade I or II, as assessed by the physician in accordance with the Tokyo guidelines.
Exclusion criteria
Exclusion criteria: 1. The subject has a contraindication to general anesthesia or surgical procedures. 2. The subject has been taking daily pain medications for more than 6 weeks. 3. The subject is scheduled to undergo a concomitant procedure. 4. The subject has a known bleeding or coagulation disorder. 5. The subject is pregnant or suspected to be pregnant. 6. The subject has a psychological or psychiatric disorder, or a severe systemic illness that may hinder compliance with study requirements or the ability to provide informed consent. 7. The subject is currently enrolled in another interventional or investigational research study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient-reported pain scores assessed by the Numeric Rating Scale (NRS) Pain medication usage associated with the cholecystectomy procedure for up to 7 days post-procedure Timepoint: Pre-Operative Assessment (-7 days), Intra-Operative Assessment, Post-Operative Assessment up to Discharge, Post-Operative Assessment at day 3+1 day, Post-Operative Assessment at day 7+1 day | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life Assessment Timepoint: Pre-Operative Assessment, Post-Operative Assessments at days 3, 7, 14, and 30;Length of hospital stay (LOS)Timepoint: Admission to discharge;Intra-operative and post-operative adverse events (AEs) related to the cholecystectomy procedureTimepoint: Intra-operative and post-operative up to 30 days ;Cost of treatment Timepoint: Intra-operative and post-operative up to 30 days | — |
Countries
India
Contacts
Public ContactDr Akhil Dahiya
Intuitive Surgical Pvt. Ltd. India
Outcome results
None listed