| CTRI Number |
CTRI/2025/08/092774 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of pain after gall bladder removal surgery using standard keyhole method versus robotic method |
|
Scientific Title of Study
|
Comparison of Postoperative Pain Between Standard 4-Port Laparoscopic and Robotic Cholecystectomy: An Open-Label Randomised Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankadala Anirudh Babu |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room 311, 3rd floor, Unit 1, Department of Surgical Disciplines,Surgery Block
All India Institute of Medical sciences, New Delhi 110029
India
New Delhi
DELHI
110029
India |
| Phone |
7978744671 |
| Fax |
|
| Email |
anirudhbabu853@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yashwant Rathore |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Delhi |
| Address |
Room no 429, 4th Floor,
Surgery Block
Department of Surgical Disciplines,
All India Institute of Medical sciences, New Delhi 110029
India
New Delhi
DELHI
110029
India |
| Phone |
9911337726 |
| Fax |
|
| Email |
dryashvant.r@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yashwant Rathore |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Delhi |
| Address |
Room no 429, 4th Floor,
Surgery Block
Department of Surgical Disciplines,
All India Institute of Medical sciences, New Delhi 110029
India
New Delhi
DELHI
110029
India |
| Phone |
9911337726 |
| Fax |
|
| Email |
dryashvant.r@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi, India
PIN: 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
All India Institute of Medical Sciences
New Delhi, 110029 |
| Type of Sponsor |
Government medical college |
|
|
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 Ankadala Anirudh Babu |
All India Institute of Medical Sciences |
Department of Surgical Disciplines
Surgery Block
All India Institute of Medical sciences, New Delhi 110029
India
New Delhi
DELHI |
7978744671
anirudhbabu853@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for PG Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
laparoscopic cholecystectomy |
Standard 4 port cholecystectomy will be performed which
includes placement of a 12 mm camera port in the umbilicus, a 12 mm port in the epigastric
region and two 5 mm ports on the right side of the abdomen. Specimen will be extracted via
the epigastric port.
The total duration of this procedure takes approximately 45mins to 90 mins depending on the intra operative findings. |
| Comparator Agent |
Robotic cholecystectomy |
Robotic cholecystectomy- Standard 4 ports will be used. Three 8 mm robotic ports will be
placed in the horizontal line at the level of the umbilicus approximately 8 cm away from each
other. A 12 mm port will be placed at the right flank which will be utilised for specimen
retrieval.
The total duration of this procedure is approximately 60mins to 120 mins depending on the intra operative findings. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA Grade 1,2 and 3
2. BMI below 35 kg/m2
3. Symptomatic Cholelithiasis planned for routine OT |
|
| ExclusionCriteria |
| Details |
1. Acute cholycestitis and associated complications like Pyocelele, emphysematous or gangrenous cholecystitis
2. Emergency cholecystectomy
3. History of choledocholithiasis
4. Presence of umbilical hernia
5. History of upper abdominal surgery
6. Pregnant women
7. History of chronic analgesic medication intake
8. Known case of chronic kidney disease
9. Patients at high risk of bleeding
10. Unfit for general anesthesia
11. Refusal of consent for participation in study |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare postoperative pain between standard 4 port laparoscopic cholecystectomy
and robotic cholecystectomy. |
On admission (baseline), 6 hours after
surgery, 24 hours after surgery, 7 days after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the operative time between standard 4 port laparoscopic cholecystectomy
and robotic cholecystectomy. |
Start of surgery to end of the surgery |
To compare the conversion rate from laparoscopic to open procedure in standard 4 port
laparoscopic cholecystectomy & robotic to laparoscopic/open procedure in robotic
cholecystectomy. |
At the end of the surgery |
To compare the overall complication rate in terms of bile duct injury, surgical site
infections(SSI), port site pain,port site hernia, port site sinus & re-admission rates
between standard 4 port laparoscopic cholecystectomy & robotic cholecystectomy. |
After 1 week |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
21/08/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
An open label randomised controlled trial comparing the post operative pain between the patients of symptomatic gall stone disease following standard 4 port laparoscopic cholecystectomy and robotic cholecystectomy. |