| CTRI Number |
CTRI/2024/09/073604 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [SCROTAL SUPPORT] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of scrotal support in reducing post operative pain, edema, hematoma following laparoscopic inguinal hernia Surgery: A Randomized control trial |
|
Scientific Title of Study
|
Role of scrotal support in reducing post operative pain, edema, hematoma following laparoscopic inguinal hernia surgery: A randomized control trial |
| Trial Acronym |
NO |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deeksha kumbhawat |
| Designation |
Junior resident |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Room no. 310, 3rd floor Surgery Block AIIMS New Delhi
South
DELHI
110049
India |
| Phone |
8393033100 |
| Fax |
|
| Email |
deekshakumbhawat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohit Joshi |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS NEW DELHI |
| Address |
4th floor, surgery block aiims new delhi
South
DELHI
110049
India |
| Phone |
09891539794 |
| Fax |
|
| Email |
drmohitjoshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Joshi |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS NEW DELHI |
| Address |
4th floor, surgery block aiims new delhi
South
DELHI
110049
India |
| Phone |
09891539794 |
| Fax |
|
| Email |
drmohitjoshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Surgery Block AIIMS NEW DELHI 110049, INDIA |
|
|
Primary Sponsor
|
| Name |
Deeksha kumbhawat |
| Address |
Room no. 310 Surgery Block AIIMS New Delhi 110049 INDIA |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Deeksha kumbhawat |
Hospital |
AIIMS Delhi, Ansari Nagar
South
DELHI |
08393033100
deekshakumbhawat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for PG research AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Role of scrotal support |
Comparison to evaluate post op pain, edema and hematoma in without scrotal support group |
| Intervention |
Role of scrotal support |
To evaluate postoperative pain, edema, hematoma after 24Hr, 72Hr and 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
1.ASA grade 1
2.Small and medium sized hernia
3.Uncomplicated inguinal hernia |
|
| ExclusionCriteria |
| Details |
1.Patient not willing
2.Bilateral hernia
3.Patient on anticoagulant medications
4.Patient with coexisting scrotal or testicular pathology |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the incidence of post-operative scrotal complications viz., scrotal pain, hematoma and seroma formation at 24 hours, 72 hours and 7 days after laparoscopic groin hernia surgery in patients with uncomplicated, incomplete inguinal hernia with or without the use of scrotal support. |
24Hr, 72Hr, 7 days after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of scrotal complications with duration of surgery, type of inguinal hernia (direct or indirect), type of inguinal hernia surgery (TAPP or TEP) & between small & medium sized inguinal hernias. |
24Hr, 72Hr, 7 days after surgery |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
23/09/2024 |
| 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 |
|
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
|
The practice of supporting the scrotum following
inguinal hernia surgery is a universal practice. The groin hernia surgery has
evolved from open repair to minimally invasive one over time with consequent
decrease in incidence of post-operative local complications. The utility of scrotal
support in reducing local complications following laparoscopic repair of
inguinal hernia has seldom been investigated despite the advantages of
minimally invasive surgery. Through this RCT, we attempt to investigate the
utility of scrotal support in preventing post-operative pain, edema and
hematoma in patients undergoing laparoscopic repair for small and medium sized inguinal
hernia |