| CTRI Number |
CTRI/2025/08/092566 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
2 Group observational study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing quality of recovery between patients undergoing laparoscopic cholecystectomy and robotic cholecystectomy |
|
Scientific Title of Study
|
Comparison of postoperative quality of recovery between laparoscopic cholecystectomy and robotic cholecystectomy done under general anaesthesia in adults - an observational study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naidile R |
| Designation |
Post Graduate resident |
| Affiliation |
St.Johns Medical College Hospital |
| Address |
Department of Anaesthesiology and Critical Care
St. Johns Medical College Hospital
Sarjapur Marathalli Road beside Bank Of Baroda John Nagar Koramangala Bengaluru
Bangalore
KARNATAKA
560034
India |
| Phone |
9591321011 |
| Fax |
|
| Email |
naidile1011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Rani |
| Designation |
Associate Professor |
| Affiliation |
St.Johns Medical College Hospital |
| Address |
Department of Anaesthesiology and Critical Care
St. Johns Medical College Hospital
Sarjapur Marathalli Road beside Bank Of Baroda John Nagar Koramangala Bengaluru
Bangalore
KARNATAKA
560034
India |
| Phone |
9482903401 |
| Fax |
|
| Email |
rashmi172007@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Rani |
| Designation |
Associate Professor |
| Affiliation |
St.Johns Medical College Hospital |
| Address |
Department of Anaesthesiology and Critical Care
St. Johns Medical College Hospital
Sarjapur Marathalli Road beside Bank Of Baroda John Nagar Koramangala Bengaluru
Bangalore
KARNATAKA
560034
India |
| Phone |
9482903401 |
| Fax |
|
| Email |
rashmi172007@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| ST johns Medical College Hospital |
|
|
Primary Sponsor
|
| Name |
Naidile R |
| Address |
Department of Anaesthesiology and Critical Care
Sarjapur Marathalli Road beside Bank Of Baroda John Nagar Koramangala Bengaluru Karnataka 560034 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Naidile R |
St Johns Medical college Hospital |
Room No 3 2nd floor operation theater complexSt.johns Medical college
Sarjapur Marathalli Rd beside Bank of Baroda John Nagar Koramangalabengaluru Karnataka 560034
Bangalore
KARNATAKA |
9591321011
naidile1011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe St Johns Medical College Hospitale |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and ASA grade 2 patients |
|
| ExclusionCriteria |
| Details |
Patient Refusal
Hemodynamically unstable patients
Patients with low GCS
Emergency procedures
Patients unable to understand the components of questionnaire |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the quality of recovery in patients undergoing laparoscopic cholecystectomy and robotic cholecystectomy under general anesthesia in a single tertiary-level centre |
A questionnaire will be given to patients before to the surgery part A, consisting of 10 questions on a likert scale based on patients positive symptoms and part B has 5 questions consisting patients negative symptoms each symptom can be scored 1-10 the score prior to surgery is the base line score patient is asked to answer the same questionnaire within 1 hour post surgery and 24 hours post surgery, to compare quality of recovery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the correlation between age gender duration of surgery and anaesthesia with QOR-15 score |
Scores will be recorded preoperatively and within 1 hour postoperatively and 24 hours postoperatively and quality of recovery will be comapred |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an observational study comparing the quality of recovery between patients undergoing laparoscopic cholecystectomy or robotic cholecystectomy under general anaesthesia and to assess the correlation between age gender duration of surgery and anaesthesia with QOR 15. Baseline score is calculated from the QOR 15 scale consisting of positive and negative symptoms pre-operatively. The same scale is given to the patients postoperatively on day 0 and Day 1 and the scores are calculated. Scores above 135 out of 150 indicate a good quality of recovery.The health status or quality of life of patients after surgery and anaesthesia has become an important endpoint in clinical studies as it influences the outcome of care. The quality of recovery of patients post-surgery is indicative of a successful perioperative experience. The quality of post operative recovery is an essential end point for evaluating anaesthesia and surgical measure. Patient reported outcomes and satisfaction in addition to psychological indicators of recovery help us assess the effects of anaesthesia and surgery.
|