Health Condition 1: K810- Acute cholecystitis
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Intuitive Surgical India Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients (18 years or more) undergoing cholecystectomy for cholecystitis/gallstone disease. 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 |
|---|---|
| To compare the change in Health-Related Quality of Life (HRQoL), as measured by the EQ-5D-3L index score, from pre-operative baseline to postoperative day 30 between patients undergoing laparoscopic or robotic-assisted cholecystectomy.Timepoint: At baseline, and at Day 3 (+1) day, day 7 (+1) day, Day 14 (+3) days, and Day 30 (+5) days post surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare perioperative outcomes: operative time, estimated blood loss, conversion to open surgery, intraoperative complications, postoperative complications, post-anesthesia care unit (PACU) time, Intensive Care Unit (ICU) stay, & length of hospital stay (LOS).Timepoint: At discharge;To compare patient-reported pain intensity as assessed by the Numeric Rating Scale (NRS) at predefined time pointsTimepoint: At baseline, & at 6, 12, 24 hours, day 3, & day 7 post surgery;To compare cumulative analgesic consumption during the first 7 postoperative days.Timepoint: At Day 7 post surgery;To compare time to return to activities of daily living & return to work.Timepoint: At day 3, 7 & 14 post surgery.;To collect optional cost data to evaluate direct treatment costs, costs of adverse event (AE) management, readmissions & reoperations & perform exploratory cost-effectiveness analyses (e.g., cost per QALY gained using EQ-5D utility values).Timepoint: At baseline & at 30 days post surgery.;To document survival status, EQ-5D-3L, bile duct injury, port side hernia, and any costs related to readmission and reoperation.Timepoint: 3, 6, and 12 months post surgery | — |
Countries
India
Contacts
Public ContactDr Akhil Dahiya
Intuitive Surgical India Pvt. Ltd.
Outcome results
None listed