| CTRI Number |
CTRI/2023/08/056577 [Registered on: 17/08/2023] Trial Registered Prospectively |
| Last Modified On: |
16/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To compare intensity of pain in patients undergoing two types of laparoscopic surgeries for inguinal hernias |
|
Scientific Title of Study
|
To compare post operative pain and rescue analgesic requirement in patients undergoing laparoscopic transabdominal pre peritoneal (tapp) and laparoscopic totally extra peritoneal (tep) approach for inguinal hernias |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Shanuj Tyagi |
| Designation |
Dnb resident anesthesia |
| Affiliation |
Max super speciality hospital, Mohali |
| Address |
Max super speciality hospital, phase-6, sector-56, Mohali, Punjab
Chandigarh
CHANDIGARH
160055
India |
| Phone |
9289426611 |
| Fax |
|
| Email |
shanujtyagi27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Y. K. Batra |
| Designation |
Head of department, Anesthesiology and pain management |
| Affiliation |
Max super speciality hospital, Mohali |
| Address |
Department Of anesthesiology and pain management, Max super speciality hospital, sector 56, phase 6, Mohali, Punjab
Chandigarh
CHANDIGARH
160055
India |
| Phone |
9646624870 |
| Fax |
|
| Email |
ykbatrapgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Y. K. Batra |
| Designation |
Head of department, Anesthesiology and pain management |
| Affiliation |
Max super speciality hospital, Mohali |
| Address |
Department of anesthesiology and pain management, Max super speciality hospital, sector 56, phase 6, Mohali, Punjab
Chandigarh
CHANDIGARH
160055
India |
| Phone |
9646624870 |
| Fax |
|
| Email |
ykbatrapgi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Max super speciality hospital, Mohali, Punjab |
|
|
Primary Sponsor
|
| Name |
Max super speciality hospital |
| Address |
Max super speciality hospital, sector 56, phase 6, Mohali, Punjab |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Shanuj Tyagi |
Max super speciality hospital |
Anesthesia office, first floor OT complex, department of anesthesiology and pain management
Chandigarh
CHANDIGARH |
9289426611
shanujtyagi27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Max Super Speciality Hospital, Mohali |
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 |
| Comparator Agent |
TAP repair |
It is an observational study inn which we are observing difference between pain scores in two types of Inguinal hernia surgery. so there are two groups. |
| Intervention |
TEPP repair |
It is an observational study inn which we are observing difference between pain scores in two types of Inguinal hernia surgery. so there are two groups. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged more than or equal to 18 years
2. Patients with ASA status I, II, III
3. Patients capable of providing a written, informed consent |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Patients having a history of chronic pain and analgesic requirement
3. Any surgery converted to open surgery
4. Patients with recurrent inguinal hernias
5. Patients with a previous history of abdominal surgery
6. Patients with complicated hernias |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare post operative pain of group A (tep repair) and group B (tapp repair) |
At 1 hour, 6 hours, 12 hours, 24 hours postoperatively and on OPD follow up visit post discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare -
1. The need for additional analgesic requirement
2. Incidence of post operative nausea & vomiting
3. Sites of pain
4. Duration of hospital stay & patient satisfaction |
At 1 hour, 6 hours, 12 hours, 24 hours postoperatively & on OPD follow up visit post discharge |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/08/2023 |
| 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="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
|
This study is a prospective, consecutive, non randomised, non blinded, observational study that will be organised and carried out in the department of anesthesiology and pain management, Max super speciality hospital, Mohali, Punjab with due authorisation from the Institutional Ethics Committee and Review Board and in compliace to informed, written consents taken from the patients. This study will assess and compare the postoperative pain, need for additional analgesics postoperatively, incidence of postoperative nausea and vomiting, sites of pain, duration of hospital stay, and patient satisfaction among patients undergoing laparoscopic totally extra peritoneal (tep - group A) repair and laparoscopic transabdominal pre peritoneal (tapp - group B) repair for inguinal hernias. |