| CTRI Number |
CTRI/2024/12/077931 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
|
Comparing post operative pain in invagination versus ligation of hernial sac in patients with indirect inguinal hernia |
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Scientific Title of Study
|
Comparison of the post operative pain in hernial sac invagination versus ligation in Lichtenstein’s tension free mesh hernioplasty for indirect inguinal hernia: A Randomised control trial |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kritie Saluja |
| Designation |
PG Student |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of General Surgery, Jawaharlal Nehru Medical College, KLE, Belgavi
Belgaum
KARNATAKA
590010
India |
| Phone |
09611224247 |
| Fax |
|
| Email |
krities@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Kenawadekar |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of General Surgery, Jawaharlal Nehru Medical College, KLE, Belgavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8073753341 |
| Fax |
|
| Email |
dr.rahuldk@gmail.com |
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Details of Contact Person
Public Query
|
| Name |
Dr Rahul Kenawadekar |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of General Surgery, Jawaharlal Nehru Medical College, KLE, Belgavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8073753341 |
| Fax |
|
| Email |
dr.rahuldk@gmail.com |
|
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Source of Monetary or Material Support
|
| KLEs Dr. Prabhakar Kore Hospital and Medical Centre, Nehru Nagar, Belagavi, Karnataka- 590010, India |
|
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Primary Sponsor
|
| Name |
Dr Kritie Saluja |
| Address |
Department of General Surgery, Jawaharlal Nehru Medical College, KLE, Belgavi |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kritie Saluja |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Centre- Belagavi |
OPD 4, Department of General Surgery, KLEs Dr. Prabhakar Kore Hospital and Medical Research Centre, NH Service Road, Nehru Nagar, Belagavi- 590010
Belgaum
KARNATAKA |
9611224247
krities@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Invagination of Hernial sac |
In the Intervention group, the patients with Indirect Uncomplicated Inguinal Hernia will be taken up for Lichtenstein tension free mesh hernioplasty. The intervention will be made one time intraoperatively i.e after dissection of the sac, the sac with the prolapsing viscera will be invaginated and returned to the abdomen without the sac being opened. Following that, a plain polypropylene mesh will be used which will be positioned at the posterior wall of the inguinal canal and secured using polypropylene sutures and abdomen will be closed in layers.
Following surgery patient will be assessed for post operative pain at 6,12,24 hours and day 3 using visual analogue scale
seroma formation will be defined as fluid collection or swelling at the surgical site or in scrotum and will be assessed at 7 days and 1 month post operatively.
length of hospital stay will be assessed by the number of nights spent in the hospital. |
| Comparator Agent |
Ligation and Excision of the Hernial sac |
In the Control group, the patients with Indirect Uncomplicated Inguinal Hernia will be taken up for Lichtenstein tension free mesh hernioplasty. After dissection of the sac, the hernial sac is opened, the bowel loops or omentum will be pushed back into the abdomen after which high ligation will be carried out with an absorbable suture, and the extra sac will be excised. Following that, a plain polypropylene mesh will be used which will be positioned at the posterior wall of the inguinal canal and secured using polypropylene sutures and abdomen will be closed in layers.
Following surgery patient will be assessed for post operative pain at 6,12,24 hours and day 3 using visual analogue scale
seroma formation will be defined as fluid collection or swelling at the surgical site or in scrotum and will be assessed at 7 days and 1 month post operatively.
length of hospital stay will be assessed by the number of nights spent in the hospital. |
|
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with uncomplicated incomplete indirect inguinal hernias
Patients willing to give consent to participate in the surgery |
|
| ExclusionCriteria |
| Details |
Patients under 18 years or more than 75 years
Patients with direct inguinal hernia
Patients with complete inguinal hernia
Patients with irreducible, recurrent or incarcerated indirect inguinal hernias
Patients not willing to give consent
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare Post operative pain intensity in patients undergoing invagination vs ligation of the hernial sac |
6, 12, 24 hours and post operative day 3 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To compare incidence of seroma formation in patients undergoing invagination vs ligation of the hernial sac |
post operative day 1 and 1 month |
| To compare operative time in patients undergoing invagination vs ligation of the hernial sac |
Intraoperative |
| To compare length of hospital stay in patients undergoing invagination vs ligation of the hernial sac |
total number of nights spent in the hospital after the operation |
|
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Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/12/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
The gold standard technique employed by surgeons to treat inguinal hernias is considered to be Lichtenstein’s tension free mesh hernioplasty. High ligation and excision of the hernial sac is being used as the method of managing the indirect inguinal hernia sac. However, studies indicate that this could lead to an increase in the post operative pain due to peritoneal injury. Thus, the need for ligation of the sac is being questioned. Thus our study aims to compare the post operative pain between invagination of the hernia sac and ligation and excision of the sac in Lichtenstein tension free mesh hernioplasty for indirect inguinal hernia. Study protocol Study will be conducted among patients undergoing indirect inguinal hernia repair in Department of General Surgery of KLES Dr. Prabhakar Kore Hospital and MRC, Belagavi. A random number table created by computer software will be used for the randomization process. An assignment to a random treatment will be made using opaque, sealed, serially numbered envelopes. These envelopes will be opened right before the procedure and patients will subsequently be split into two research groups: Group A, i.e. invagination of the hernial sac, and Group B, i.e. ligation and excision of the sac In group A, the prolapsing viscera and the sac will be returned to the abdomen without the sac being opened. In group B, after the sac is opened, the bowel loops or omentum will placed back into the abdomen after which high ligation will be carried out with an absorbable suture, and the extra sac will cut out. Following that, a Lichtenstein tension-free mesh hernioplasty will carried out on each patient. Plain polypropylene mesh will be used which will be positioned at the posterior wall of the inguinal canal and secured using polypropylene sutures Following the surgery, the patient will be assessed at 6, 12, 24 hours and post operative day 3 for post operative pain using visual analogue scale (VAS) of 1–10
Seroma formation would be defined as fluid collection or swelling at the surgical site or in the scroÂtum. It will be assessed by physical examination of the patient on post operative day 7 and 1 month as a palpable budge at the site operative site. Length of hospital stay is defined as the total number of nights spent in the hospital after the operation.
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