| CTRI Number |
CTRI/2024/05/068146 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
27/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of two techniques for primary inguinal hernia repair( Lichenstein versus Desarda technique) in adolescents and young adults. |
|
Scientific Title of Study
|
A Randomised Control Trial to compare Lichenstein versus Desarda technique for primary inguinal hernia repair in adolescents and young adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IM012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohit Kapoor |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Raebareli |
| Address |
Room No. 608, Sixth Floor, Hospital Building All India Institute of Medical Sciences, Dalmau Road, munshiganj, Raebareli Rae Bareli UTTAR PRADESH 229405 India |
| Phone |
9453193753 |
| Fax |
|
| Email |
rohit.kapoor13081988@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Rohit Kapoor |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Raebareli |
| Address |
Room No. 608, Sixth Floor, Hospital Building All India Institute of Medical Sciences, Dalmau Road, munshiganj, Raebareli
UTTAR PRADESH 229405 India |
| Phone |
9453193753 |
| Fax |
|
| Email |
rohit.kapoor13081988@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Rohit Kapoor |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Raebareli |
| Address |
Room No. 608, Sixth Floor, Hospital Building All India Institute of Medical Sciences, Dalmau Road, munshiganj, Raebareli
UTTAR PRADESH 229405 India |
| Phone |
9453193753 |
| Fax |
|
| Email |
rohit.kapoor13081988@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Raebareli, Dalmau Road, Munshiganj, Raebareli, U.P. India-229405 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Raebareli |
| Address |
All India Institute of Medical Sciences, Dalmau Road, Munshiganj, Raebareli, U.P, India- 229405 |
| 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 Rohit Kapoor |
All India Institute of Medical Sciences, Raebareli |
All India Institute of Medical Sciences, Raebareli, Almau road, Munshiganj, Raebareli, U.P. India-229405 Rae Bareli UTTAR PRADESH |
9453193753
rohit.kapoor13081988@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BIOETHICS CELL, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAEBARELI |
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 |
Desarda procedure |
Desarda mesh free tissue repair that was described by Dr Mohan P Desarda in 2001. Involves use of External oblique Aponeurosis to strengthen posterior wall of inguinal canal without use of mesh |
| Comparator Agent |
Licheinstein repair |
Involves use of Prolene mesh to strengthen posterior wall/ floor of the inguinal canal. |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
All adolescents and young adults aged between 13 years to 25 years diagnosed as case of inguinal hernia in department of paediatric surgery and department of general surgery and fit for regional/general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patients below 13 years and above 25 years of age.
Patients with an aponeurosis that was divided, tiny, and/or weak.
Patients with recurrent or strangulated hernias.
American Society of Anesthesiologists(ASA) scale at more than 3 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Hernia recurrence in one year of follow-up.
Occurrence of any chronic pain- defined as moderate (VAS 30 to 54) or strong (VASgreater than 54) pain lasting more than 6 months after surgery.
|
1 year.
6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| General and local complications(graded as per clavein dindo classification) |
1 year |
|  Length of time to return to various levels of everyday activity{Return to normal activity will be defined as the patient’s ability to perform elementary activities [i.e., dressing, walking, bathing (basic activity)]; usual activities at home [i.e., preparing food, cleaning house (home activity)]; and returning to all previously performed activities (work activity)} |
1 year |
| ï‚§ Presence or absence of foreign body sensation, and abdominal wall stiffness in the groin area. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
15/06/2024 |
| 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)
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- 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 - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - A cloud link will be shared as soon as final data is compiled for analysis
- For how long will this data be available start date provided 27-05-2026 and end date provided 27-05-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Inguinal hernia is generally
defined as protrusion of the contents of the abdominal cavity or preperitoneal
fat through a defect in the inguinal area. Although incidence and prevalence
reported in literature vary and is not precisely known, the lifetime chance of
a person being operated for inguinal hernia is quiet high, 27% in men and 3% in
women. As per European hernia
society(EHS) guidelines published in 2009 for management of adult hernias state
that Lichenstein technique or endoscopic methods should be used for repair of
inguinal hernias in adults. This is in contrast to practice
in paediatric population where high ligation of hernia sac is recommended.
However, adolescent patients represent a “gray zone†between children and
adults, and there is no consensus on the most appropriate surgery for inguinal
hernias in these patients. Type of operation in these
patients largely depends on the surgeon. Adult surgeons prefer to repair
adolescent hernias with a mesh repair and pediatric surgeons tend to repair
them with a high ligation of the sac. Although, mesh has been shown to
be quite beneficial in terms of decreasing recurrence rates in inguinal hernias
in adults, there are potential morbidities related to mesh use, such as chronic
pain, seromas, infections, and infertility. Because of this, the avoidance of
mesh may be preferable in inguinal hernia repairs in adolescents and young
adults, if not at the sacrifice of increased hernia recurrence. Due to this, various mesh free
tissue repair techniques have been described in literature. The most popular is
the Shouldice repair technique, which is considered best among the non-mesh
repair techniques with strength of recommendation level 1A. However, although the Shouldice
method has recurrence rates of less than 1%, its technically demanding nature
can potentially increase the incidence of recurrence of up to 15% with the less
experienced and less trained hands. Therefore, other mesh free tissue
repair techniques have been described throughout the literature one of which is
Desarda mesh free tissue repair that was described by Dr Mohan P Desarda in
2001. The technique requires no
complicated dissection or suturing, and is easy to learn as its developer
claimed. Moreover, It does not require any foreign material and does not use
weakened muscles or transversalis fascia for repair. Some authors have therefore
concluded that the Desarda repair has the potential to become the new gold
standard particularly in low-income and middle-income countries. Also, as results of Desarda
technique appears promising in various studies in literature, a randomised
control trial can be planned to compare this comparatively newer technique with
the standard Lichtenstein technique of inguinal hernia repair, especially in
adolescent and young adult population. |