| CTRI Number |
CTRI/2024/04/066564 [Registered on: 30/04/2024] Trial Registered Prospectively |
| Last Modified On: |
23/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Scalpel versus Electrocautery Skin Incision for Elective Inguinal Hernioplasty |
|
Scientific Title of Study
|
Scalpel versus Electrocautery Skin Incision for Elective Inguinal Hernioplasty - A Randomised Control Trail |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MANIKYAM SREEVANI |
| Designation |
Post Graduate in MS General Surgery |
| Affiliation |
Aarupadai Veedu Medical College, Pondicherry |
| Address |
Department of General Surgery,
C Block, Aarupadai Veedu Medical College, Kirumampakkam, Pondicherry, India.
Pondicherry
PONDICHERRY
607402
India |
| Phone |
7093321292 |
| Fax |
|
| Email |
msvdvcb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.T Ramachandrudu |
| Designation |
Professor in General Surgery |
| Affiliation |
Aarupadai Veedu Medical College, Pondicherry |
| Address |
Department of General Surgery, C Block, Aarupadai Veedu Medical College, Kirumampakkam, Pondicherry, India.
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8608702876 |
| Fax |
|
| Email |
general.surgery@avmc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. T Ramachandrudu |
| Designation |
Professor in General Surgery |
| Affiliation |
Aarupadai Veedu Medical College, Pondicherry |
| Address |
Department of General Surgery,
C Block, Aarupadai Veedu Medical College, Kirumampakkam, Pondicherry, India.
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8608702876 |
| Fax |
|
| Email |
general.surgery@avmc.edu.in |
|
|
Source of Monetary or Material Support
|
| Aarupadai Veedu Medical College, Kirumampakkam, Pondicherry, India. |
|
|
Primary Sponsor
|
| Name |
Aarupadai Veedu Medical College |
| Address |
Aarupadai Veedu Medical College, Kirumampakkam, Pondicherry, 607402. |
| Type of Sponsor |
Private 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 Manikyam Sreevani |
Aarupadai Veedu Medical College |
Department of General Surgery, C Block
Pondicherry
PONDICHERRY |
7093321292
msvdvcb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AVMC INSTITUTIONAL HUMAN ETHICAL COMMITEE |
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 |
Using Electrocautery for Skin Incision in Patients undergoing Elective Inguinal Hernioplasty |
1. Using Electrocautery for Skin Incision in Patients undergoing Elective Inguinal Hernioplasty
2. Compare post operative wound healing and complications at Post operative day 1 to day 7
3. Compare post operative pain at 6 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours and on 7th day
4. Follow up on 2 weeks, 1 month, 2 months and 3 months |
| Intervention |
Using Scalpel for Skin Incision in Patients undergoing Elective Inguinal Hernioplasty |
1. Using Scalpel for Skin Incision in Patients undergoing Elective Inguinal Hernioplasty
2. Compare post operative wound healing and complications at Post operative day 1 to day 7
3. Compare post operative pain at 6 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours and on 7th day
4. Follow up on 2 weeks, 1 month, 2 months and 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing Elective Inguinal Hernioplasty of age group 18-80 years.
Patients willing for consent, study and follow up |
|
| ExclusionCriteria |
| Details |
1. Coagulopathies or bleeding disorders.
2. Immunocompromised status.
3. Severe Cardiovascular, Renal Dysfunction.
4. Malignancy.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome to assess
1. Post operative wound healing and
2. Post operative complications |
1. Day of Suture Removal
2. Post Operative Days 1-7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcome to assess
1. Time taken for incision,
2.Amount of blood loss during incision, 3. Post operative pain score using VAS score.
4. Number of Days of hospital stay post surgery |
1. Time - At the start of surgery during incision
2.Blood loss - At the start of surgery during incision till aponeurosis
3. Pain score - At 6 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours and on 7th day.
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
04/05/2024 |
| 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="6"
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
|
Historically, surgical skin incisions are made with scalpel. Use of scalpel causes bleeding resulting in clouded operative field. Alternatively,electrocautery can be used to decrease incision time and ensure a bloodless operative field.Using electrocautery instead of scalpel for skin incision in elective inguinal hernia repair, results in decreased post operative pain and post operative wound complications like seroma, hematoma, wound dehiscence resulting in short duration of hospital stay.Several studies comparing the advantages and disadvantages of scalpel and electrocautery incision are needed to improve patient care. Studying them in clean cases like elective inguinal hernioplasty will help us to form a basic theory upon which further studies can be done on various other surgeries. So this study attempts to compare safety and efficacy of the use of electrocautery skin incision has better outcome than traditional use of scalpel in elective inguinal hernioplasty in patients admitted in department of Surgery.Application of the results of the study will result in improvement of patient care.
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