| CTRI Number |
CTRI/2022/05/042793 [Registered on: 24/05/2022] Trial Registered Prospectively |
| Last Modified On: |
16/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
COMPARATIVE STUDY OF DIFFERENT PROCEDURES FOR ELECTIVE LOWER ABDOMEN INCISIONS |
|
Scientific Title of Study
|
COMPARISON OF ELECTRO-CAUTERY WITH SCALPEL FOR ELECTIVE LOWER ABDOMEN INCISIONS– A RANDOMISED CONTROL TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR REHANA BEGUM |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
BGS GLOBAL INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF GENERAL SURGERY
No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
9052752646 |
| Fax |
|
| Email |
rehanarayan07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MANOJ KARTHIK S |
| Designation |
PROFESSOR |
| Affiliation |
BGS GLOBAL INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF GENERAL SURGERY
BGS GLOBAL INSTITUTE OF MEDICAL SCIENCES KENGERI
Bangalore
KARNATAKA
560060
India |
| Phone |
9108666698 |
| Fax |
|
| Email |
dr.manojkarthik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MANOJ KARTHIK S |
| Designation |
PROFESSOR |
| Affiliation |
BGS GLOBAL INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF GENERAL SURGERY
BGS GLOBAL INSTITUTE OF MEDICAL SCIENCES KENGERI
Bangalore
KARNATAKA
560060
India |
| Phone |
9108666698 |
| Fax |
|
| Email |
dr.manojkarthik@gmail.com |
|
|
Source of Monetary or Material Support
|
| BGS GLOBAL INSTITUTE OF MEDICAL SCIENCES NO.67, BGS HEALTH AND EDUCATION CITY UTTARAHALLI ROAD KENGERI BANGALORE 560060 KARNATAKA |
|
|
Primary Sponsor
|
| Name |
DR REHANA BEGUM |
| Address |
BGS GLOBAL INSTITUTE OF MEDICAL SCIENCES
NO.67, BGS HEALTH AND EDUCATION CITY UTTARAHALLI ROAD KENGERI BANGALORE 560060 KARNATAKA |
| 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 |
| Dr Rehana Begum |
BGS Global Institute of Medical Sciences |
Room No.02, Ground Floor, Department of General Surgery,
No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA |
9052752646
rehanarayan07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
Electro-cautery incision |
Incision will be taken using cutting current from an electrocautery device, set to pulse sine wave of 70 watts. Haemostasis will be achieved with forceps coagulation. All procedures related to the study will complete within a day |
| Comparator Agent |
Scalpel |
Skin incision will be taken with a conventional surgical blade mounted on a BP handle. All procedures related to the study will complete within a day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients admitted under general surgery undergoing elective lower abdomen surgeries
2. Subjects Willing to provide the Informed Consent. |
|
| ExclusionCriteria |
| Details |
1) Emergency procedures
2) Recurrent surgeries
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparison of Incision procedure assessment parameters (1. Incision time,2. Incisional blood loss,3. Post operative pain and use of analgesics,4. Wound infection rates,5. Cosmesis 6. Thermal injury)
|
Day 1, Day 2, Day 3, Day 10, Day 30
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall Safety |
Day 1, Day 2, Day 3, Day 10, Day 30
|
|
|
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)
|
28/05/2022 |
| 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="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
"NILL" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients fulfilling inclusion criteria who are willing to give written informed consent will be included in the study and will be randomly allocated using lottery method in one of the two groups. Patients will be counselled about the merits and demerits of both incisions and informed consent will be obtained for the study. Group 1 (Electro-cautery incision):Incision will be taken using cutting current from an electrocautery device, set to pulse sine wave of 70 watts. Haemostasis will be achieved with forceps coagulation. Group 2 (Scalpel incision): Skin incision will be taken with a conventional surgical blade mounted on a BP handle. All the patients will be operated under spinal anaesthesia. All the patients undergoing clean procedure will receive 1gram cefotaxime intravenously, clean contaminated procedure will receive 1 gram of cefotaxime and metronidazole 500mg intravenously 30 mins prior to the commencement of procedure.
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