| CTRI Number |
CTRI/2023/03/051106 [Registered on: 28/03/2023] Trial Registered Prospectively |
| Last Modified On: |
27/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Laparoscopic cholecystectomy |
|
Scientific Title of Study
|
Retrieval of Gallbladder through Umbilical Versus Epigastric Port during Laparoscopic Cholecystectomy: A Randomized Controlled Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divish Saxena |
| Designation |
Assistant Professor |
| Affiliation |
All India Institue Of Medical Sciences, Nagpur |
| Address |
Room No 202, OPD Building, Department of General Surgery, AIIMS, Nagpur.
Nagpur
MAHARASHTRA
441108
India |
| Phone |
7066501626 |
| Fax |
|
| Email |
drdivishsaxena@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Divish Saxena |
| Designation |
Assistant Professor |
| Affiliation |
All India Institue Of Medical Sciences, Nagpur |
| Address |
Room No 202, OPD Building, Department of General Surgery, AIIMS, Nagpur.
Nagpur
MAHARASHTRA
441108
India |
| Phone |
7066501626 |
| Fax |
|
| Email |
drdivishsaxena@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Divish Saxena |
| Designation |
Assistant Professor |
| Affiliation |
All India Institue Of Medical Sciences, Nagpur |
| Address |
Room No 202, OPD Building, Department of General Surgery, AIIMS, Nagpur.
Nagpur
MAHARASHTRA
441108
India |
| Phone |
7066501626 |
| Fax |
|
| Email |
drdivishsaxena@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences, Nagpur |
|
|
Primary Sponsor
|
| Name |
Dr.Ateet Fulmali |
| Address |
Room No 202, OPD Building, AIIMS, Nagpur. |
| Type of Sponsor |
Other [Co-Investigator] |
|
|
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 |
| ATEET FULMALI |
All India Institute Of Medical Sciences, Nagpur |
Department of General Surgery, room no 202, 2nd floor, AOPD building, AIIMS Nagpur Sez MIHAN Maharashtra 441108.
Nagpur
MAHARASHTRA |
8793270610
ateetf@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, AIIMS, Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (3) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Retrieval of gall bladder from epigastric port for 1.5 years |
Retrieval of gall bladder from epigastric port in laparoscopic cholecystectomy |
| Intervention |
Retrieval of gall bladder from umbilical port for 1.5 years |
Retrieval of gall bladder from umbilical port in laparoscopic cholecystectomy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients coming for elective laparoscopic cholecystectomy shall be included in the trial |
|
| ExclusionCriteria |
| Details |
Patient with comorbidities like uncontrolled Diabetes Mellitus, Immuno-suppresive conditions.
Patients with intra-operative spillage of bile |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post-operative pain using Visual Analogue Scale post-operatively at 12 hours, 24 hours and 48 hours for both the groups. |
At 12 hours, 24 hours, 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Port-site infection will be evaluated using Southampton grading. |
Day 5,7, 14 |
| Any incidence of port site hernia |
To be noted in 6 month follow up period |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
30/03/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Laparoscopic cholecystectomy (LC) is the gold standard procedure for managing patients with symptomatic gall bladder diseases GB is usually extracted after LC either from the epigastric or umbilical port According to review of literature epigastric port for GB retrieval is preferred due to the surgeon’s ease and also as there was no need to change the position of the telescope, however, retrieval through umbilical port has less post-operative pain as mentioned in few studies. Therefore, till date, there is no level 1 evidence or meta- analysis to support the superiority of one port over another for GB extraction in terms of postoperative port- site pain This study is undertaken to compare gall bladder (GB) retrieval from umbilical port with epigastric port in terms of post-operative pain, port site infection, retrieval time and port site herniation in adult patients undergoing elective laparoscopic cholecystectomy E |