| CTRI Number |
CTRI/2019/02/017615 [Registered on: 12/02/2019] Trial Registered Prospectively |
| Last Modified On: |
21/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the results of gall bladder retrieval from two different ports in laparoscopic cholecystectomy |
|
Scientific Title of Study
|
A RCT to compare gall bladder retrieval from epigastric versus umbilical port in laparoscopic cholecystectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dronacharya Routh |
| Designation |
Assoc Prof |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Surgery
AFMC Wanoworie
Pune
MAHARASHTRA
411040
India |
| Phone |
9464667808 |
| Fax |
|
| Email |
drona_routh@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dronacharya Routh |
| Designation |
Assoc Prof |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Surgery
AFMC Wanoworie
MAHARASHTRA
411040
India |
| Phone |
9464667808 |
| Fax |
|
| Email |
drona_routh@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
ANSHUL VAISHIST |
| Designation |
Resident Surgery |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Surgery
AFMC Wanoworie
Pune
MAHARASHTRA
411040
India |
| Phone |
9581280232 |
| Fax |
|
| Email |
dranshulvashisht@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Armed Forces Medical College |
| Address |
Wanoworie, Pune 411040 |
| 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 |
| Dronacharya Routh |
Command Hosp, Southern Command |
Room No 10 Civil OPD and Room No 1 Service OPD Command Hosp Wanoworie, Pune 411040
Pune
MAHARASHTRA |
9464667808
drona_routh@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AFMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Epigastric port extraction |
Patient will undergo laparoscopic cholecystectomy and extraction of gall bladder will be done through epigastric port |
| Intervention |
Umbillical port extraction |
Patient will undergo laparoscopic cholecystectomy and extraction of gall bladder will done through umbillical port |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
16-80 years old patients undergoing elective laparoscopic cholecystectomy for benign GB diseases (symptomatic gallstones, GB polyps)
Patients in whom informed consent could be obtained. |
|
| ExclusionCriteria |
| Details |
Acute cholecystitis
Empyema GB
Mucocele of GB,
Suspected/proven malignancy of GB
Patients in whom laparoscopic cholecystectomy has to be converted in open procedure
Patients who are chronic users of analgesic medicines and steroids.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the post operative pain at the port site in both groups |
Pain score will be graded by the patient with VAS score (0-10) at 6 hours, 12 hours, 24 hours and 48 hours following surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the ease of retrieval of gall bladder |
The difficulty in GB retrieval will be graded by the operative surgeon by using VAS score (0- easy retrieval, 10- very difficult retrieval) |
| To assess the time taken for retrieval of gall bladder following dissection from liver bed |
The time taken for removal of the gall bladder following dissection to retrieval in minutes |
| To assess the incidence of port site infection |
Port site infection to be graded by South Hampton wound scoring system on day 7, 14 and 06 weeks following surgery |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/03/2019 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
1. Kaya C, Bozkurt E, Yazici P. The impact of gallbladder retrieval from an epigastric vs. umbilical port on trocar-site complications A prospective randomized study. Ann Ital Chir. 2017; 88:326-29.
2. 13. Nadeem Ahmed Siddiqui, Rizwan Azami, Ghulam Murtaza, Sana Nasim. Postoperative port-site pain after gall bladder retrieval from epigastric vs. umbilical port in laparoscopic cholecystectomy: A randomized controlled trial. International Journal of Surgery 2012; 10:213-16 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Laparoscopic Cholecystectomy is one of the most common procedures performed by general surgeons. However, there have been no studies in our setting to evaluate the umbilical vs epigastric port site gall bladder extraction and its relation to post-operative pain as well as other complications related to port site. Despite a lot of literature available on laparoscopic cholecystectomy, still it is not clear which port site is best to extract gall bladder. This current study aims to explore a better port for gallbladder retrieval in laparoscopic cholecystectomy in terms of pain outcome, time taken for delivery of gall bladder out of abdomen and ease of extraction by randomized controlled trial study to be conducted at our tertiary care teaching hospital. |