| CTRI Number |
CTRI/2024/12/077640 [Registered on: 04/12/2024] Trial Registered Prospectively |
| Last Modified On: |
02/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the differences between scalpel vs electrocautery in terms of blood loss and post operative pain in elective midline abdominal incisions. |
|
Scientific Title of Study
|
TO COMPARE BLOOD LOSS AND POST OPERATIVE PAIN IN SCALPEL VS DIATHERMY IN ELECTIVE MIDLINE ABDOMINAL INCISION, A ONE YEAR RANDOMIZED CONTROL TRIAL, AT KAHERS JAWAHARLAL NEHRU MEDICAL COLLGE, BELGAVI. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Arjun Ravi |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College Belgaum KARNATAKA |
| Address |
Junior resident in Department of General Surgery - Unit A Jawaharlal Nehru Medical College Belgaum
KARNATAKA
590010
india
Belgaum
KARNATAKA
590010
India |
| Phone |
8310469439 |
| Fax |
|
| Email |
skyhigh.ar16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shrishail C. Metgud |
| Designation |
Professor and Head Of The Department Of General Surgery |
| Affiliation |
Jawaharlal Nehru Medical College Belgaum KARNATAKA |
| Address |
Junior resident in Department of General Surgery - Unit A Jawaharlal Nehru Medical College Belgaum
KARNATAKA
590010
india
Belgaum
KARNATAKA
590010
India |
| Phone |
8310469439 |
| Fax |
|
| Email |
drshrishailmetgud@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Arjun Ravi |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College Belgaum KARNATAKA |
| Address |
Junior resident in Department of General Surgery - Unit A Jawaharlal Nehru Medical College Belgaum
KARNATAKA
590010
india
Belgaum
KARNATAKA
590010
India |
| Phone |
8310469439 |
| Fax |
|
| Email |
skyhigh.ar16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical college , University Campus , Nehru Nagar Belagavi Karnataka india 590010 |
|
|
Primary Sponsor
|
| Name |
KLE Dr Prabhakar Kore Hospital and Medical Research Centre |
| Address |
KLEs Dr Prabhakar Kore Hospital and Medical Research Centre , NH Service road , Nehru nagar Belagavi ,karnataka india 590010 |
| 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 Arjun ravi |
KLES Dr Prabhakar Kore Hospital And Medical Research Centre |
OPD No 4 Department of General Surgery KLEs Dr Prabhakar kore hospital and medical research centre , front enterance NH service road karnataka india 590010
Belgaum
KARNATAKA |
08310469439
skyhigh.ar16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTE |
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 |
Electrocautery incision |
Using electrocautery to make incision for elective abdominal cases a 1 year study. |
| Comparator Agent |
Scalpel Incision. |
Using scalpel blade to make incision for elective abdominal cases a 1 year study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Willing to participate in study
2.Patients of both sexes needing a elective open hernia repair.
|
|
| ExclusionCriteria |
| Details |
1.Age above 60 years and age less than 18 years
2.Patients with serious co-morbidities like
coagulopathies or ASA-3 and above.
3.Patients with diabetes with glycosylated
hemoglobin,(HbA1c) above 7.5.
4.Patients with complaints of pre-existing pain at
the incision site or any neuropathy.
5.Patients on psychotropic drugs or history of
drug abuse.
6.Patients with grossly distorted liver or renal
function parameters.
7.Patients with pre-existing gross infections at
surgical site.
8.Patients on corticosteroids, chemotherapy, immunosuppressants, or anti-coagulation therapy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare blood loss when using scalpel and electrocautery for abdominal incisions. |
Intra-operative at the time of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare post Operative pain when using scalpel vs electrocautery in midline abdominal incisions. |
on post operative day 1,2 & 7. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
As most surgeons prefer to give incisions using scalpel, with the advent of electrocautery there is a gradual shift in surgeons from the olden scalpel to modern electrocautery, to give incisions. This study is a randomized control trial, done to compare blood loss and post operative pain on day 1,3,7, when using a scalpel blade and electrocautery in elective midline abdominal incisions.
|