| CTRI Number |
CTRI/2024/06/068569 [Registered on: 07/06/2024] Trial Registered Prospectively |
| Last Modified On: |
01/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Assessing consent for laparotomy] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Practice of informed consent in patients undergoing abdominal operations electively |
|
Scientific Title of Study
|
Practice of informed consent in patients undergoing elective laparotomy |
| 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 Aathif Jalal |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College and Kasturba Hospital, Manipal |
| Address |
Department of General Surgery, 3rd floor, Smt. Sharadha Madhav Pai OPD building, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9611433050 |
| Fax |
|
| Email |
aathif.kmcmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Stanley Mathew |
| Designation |
Professor of General Surgery |
| Affiliation |
Kasturba Medical College and Hospital, Manipal |
| Address |
Department of General Surgery, 3rd floor, Smt. Sharadha Madhav Pai OPD building, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844409900 |
| Fax |
|
| Email |
stanley.mathew@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Badareesh L |
| Designation |
Professor of General Surgery |
| Affiliation |
Kasturba Medical College and Kasturba Hospital, Manipal |
| Address |
Department of General surgery, 3rd floor, Smt Sharada Madhav Pai OPD building, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8861038876 |
| Fax |
|
| Email |
badareesh.l@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery, 3rd Floor, Smt.Sharadha Madhav Pai OPD Building, Kasturba Hospital, Kasturba Medical College, Manipal - 576104, Udupi District, Karnataka State, India |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Dr.Padmaraj Hegde, Dean, First Floor, Administrative Building, Kasturba Medical College, Madhav Nagar, Manipal 576104, Udupi District, Karnataka State, India
|
| 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 Stanley Mathew |
Kasturba Hospital, Manipal |
Department of General Surgery, 3rd floor, Smt. Sharadha Madhav Pai OPD building
Kasturba Hospital, Manipal - 576104
Udupi
KARNATAKA |
9844409900
stanley.mathew@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z718||Other specified counseling, (2) ICD-10 Condition: K918||Other intraoperative and postprocedural complications and disorders of digestive system, (3) ICD-10 Condition: K638||Other specified diseases of intestine, (4) ICD-10 Condition: Z712||Person consulting for explanationof examination or test findings, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NA |
| Intervention |
Validated questionnaire to assess the practice of consent for patients undergoing laparotomy |
Patients and care givers are administered validated questionnaires to determine their level of understanding of consenting practices. The answers are then analyzed to determine how appropriate has the consenting process been. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective laparotomy and their caregiver |
|
| ExclusionCriteria |
| Details |
1) Patients undergoing laparoscopic procedures
2) Patients undergoing emergency laparotomy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The adequacy of informed consent will be assessed by descriptive statistics |
1 day (prior to surgery) |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="139"
Sample Size from India="139"
Final Enrollment numbers achieved (Total)= "139"
Final Enrollment numbers achieved (India)="139" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/06/2024 |
| Date of Study Completion (India) |
12/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response (Others) - Any regulatory agency or editor / reviewer of a scientific publication
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - Data will be provided on written request
- For how long will this data be available start date provided 31-08-2027 and end date provided 31-08-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
After admission, the participant (patients undergoing laparotomy and their care giver) will be approached by the researcher for participation in this study. After written informed consent is obtained, the participant will be asked about the informed consent process related to the elective laparotomy procedure that is going to be carried out during the admission. The participants demographic details will be recorded and then the participants knowledge about their condition and procedure will be assessed with the help of a proforma, checklist and questionnaire. |