CTRI

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CTRI Number

CTRI/2024/02/063061 [Registered on: 22/02/2024] Trial Registered Prospectively

Last Modified On:

11/10/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Surgical/Anesthesia

Study Design

Other

Public Title of Study

Pain difference between two laparoscopic inguinal hernia repair techniques

Scientific Title of Study

Comparison of Early Postoperative Pain between Trans Abdominal Pre Peritoneal (TAPP) and Totally Extraperitoneal (TEP) techniques of Hernia Repair for Unilateral Inguinal Hernia : A Randomised Control 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	Katyayni Singh
Designation	Postgraduate Resident
Affiliation	Department of Surgery, Lady Hardinge Medical College and associated hospitals
Address	Shaheed Bhagat Singh Marg, Connaught Place, New Delhi 110001 Central DELHI 110001 India
Phone	9990211666
Fax
Email	katyayni.20@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Sudipta Saha
Designation	Professor
Affiliation	Lady Hardinge Medical College
Address	Shaheed Bhagat Singh Marg, Connaught Place, New Delhi 110001 DELHI 110001 India
Phone	9953507156
Fax
Email	sudipta2067@gmail.com

Details of Contact Person
Public Query

Name	Katyayni Singh
Designation	Postgraduate Resident
Affiliation	Lady Hardinge Medical College
Address	Shaheed Bhagat Singh Marg, Connaught Place, New Delhi 110001 DELHI 110001 India
Phone	9990211666
Fax
Email	katyayni.20@gmail.com

Source of Monetary or Material Support

Lady Hardinge Medical College and associated hospitals, Shaheed Bhagat Singh Marg, Connaught Place, New Delhi 110001

Primary Sponsor

Name	Lady Hardinge Medical College
Address	Shaheed Bhagat Singh Marg, Connaught Place, New Delhi 110001
Type of Sponsor	Government medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Katyayni Singh	Lady Hardinge Medical College and associated hospitals	Department of Surgery, New Academic block 3rd floor, Lady Hardinge Medical College and associated Hospitals, Shaheed Bhagat Singh Marg, Connaught Place, New Delhi New Delhi DELHI	9990211666 katyayni.20@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: K409\|\|Unilateral inguinal hernia, without obstruction or gangrene,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Dr. Katyayni Singh	Principal Investigator comparing early postoperative pain between TAPP and TEP hernia repair techniques at 6 hours, 12 hours and 24 hours post operatively
Intervention	Laparoscopic Inguinal Hernia repair	Transabdominal Preperitoneal (TAPP) and Totally Extraperitoneal (TEP) hernia repair techniques, each technique lasting from 90 to 240 minutes from induction of anaesthesia to fixation of mesh

Inclusion Criteria

Age From	18.00 Year(s)
Age To	90.00 Year(s)
Gender	Both
Details	All patients aged over 18 years with a reducible uncomplicated unilateral inguinal hernia undergoing elective laparoscopic hernia repair

ExclusionCriteria

Details

conversion to open, conversion from TEP to TAPP

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
Mean pain at 6, 12 and 24 hours after operation using Visual Analogue scale	Mean pain at 6, 12 and 24 hours after operation using Visual Analogue scale

Secondary Outcome

Outcome	TimePoints
Mean diclofenac consumption during first 24 hours after surgery	1 to 4
Mean operative time in each technique	30 to 300 minutes
Mean time in days to return to work	1 to 10 days
Proportion of patients having complication within one week of operation - bowel, bladder, vascular injury, serum formation, surgical site infection	yes or no

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60"

Phase of Trial

Phase 3/ Phase 4

Date of First Enrollment (India)

01/03/2024

Date of Study Completion (India)

11/10/2024

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

11/10/2024

Estimated Duration of Trial

Years="0"
Months="2"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Completed

Recruitment Status of Trial (India)

Completed

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - YES

What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiﬁcation.

What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identiﬁed for this purpose.

For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.

By what mechanism will data be made available?
Response - Proposals should be directed to [katyayni.20@gmail.com].

For how long will this data be available start date provided 01-04-2024 and end date provided 31-03-2029?
Response (Others) - for dates mentioned, a period of 5 years

Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil

Brief Summary
Modification(s)

Study will be performed at the Department of Surgery at Lady Hardinge Medical College. A written informed consent from all the patients included in study and institutional review board approval will be obtained for this study.

Patients will be interviewed and the full history of their condition will be taken. Thorough clinical examination will be done. All routine investigations LFT, KFT and USG will be done for this study. Each patient will be randomly allocated to the TAPP group or the TEP group by sequentially numbered, opaque, sealed envelope technique on the day of surgery. An independent statistician, who is not involved in patient care, will generate the randomisation sequence via a computer-generated random number. The randomisation code will be contained in opaque sealed envelopes. A non-acad junior resident, who will open the envelope, will not be actively involved in outcome measurements. Before randomisations and during consent, all patients will receive an explanation of the objectives of the study, techniques and complications associated with both the procedures. The patient will be unaware of the assigned group of treatment.

In the preoperative area, a single prophylactic dose of injection ceftriaxone 1 gm will be intravenously administered after the skin test. All procedures will be performed under GA with the patients in supine and Trendelenburg position as per the conventional three ports technique. The patients will be randomised into two groups: TAPP or TEP groups. Post-operatively, an injection of paracetamol 1 gram to be infused intravenously every 8 hours on the day of surgery in all patients of both groups. The additional analgesic requirement will be fulfilled by injection diclofenac 75 mg by the intravenous route, as needed if the visual analog scale (VAS) score will be more than three. As assessment of pain to be made using the VAS score in the postoperative period at 1 hour, 6 hours, 12 hours and 18 hours.