| CTRI Number |
CTRI/2024/05/067957 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
19/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective and prospective record based study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Optimal duration of drains in breast cancer patients post breast surgery. |
|
Scientific Title of Study
|
Development and Validation of a Nomogram to Predict the Drainage
Duration in Breast Cancer Patients Treated with Modified Radical
Mastectomy – A Record based Study |
| 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. Jibetosh Biswas |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
2nd Floor, Department of General Surgery, Old block
Jawaharlal institute of postgraduate medical education and research, Pondicherry- 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8967993229 |
| Fax |
|
| Email |
biswas.jibu1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ankit Jain |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
2nd Floor, Department of General Surgery, Old block
Jawaharlal institute of postgraduate medical education and research, Pondicherry- 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7838964296 |
| Fax |
|
| Email |
pikachooa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Jibetosh Biswas |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
2nd Floor, Department of General Surgery, Old block
Jawaharlal institute of postgraduate medical education and research, Pondicherry- 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8967993229 |
| Fax |
|
| Email |
biswas.jibu1995@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
Jipmer campus road
Jipmer campus
Puducherry-605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Jibetosh Biswas |
Jawaharlal institute of postgraduate medical education and research |
2nd Floor, Department of General Surgery, Old block
Pondicherry- 605006
Pondicherry
PONDICHERRY |
8967993229
biswas.jibu1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for observational studies, Jawaharlal institute of postgraduate medical education and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
Records of all the patient who has undergone or willing to undergo MRM in General Surgery department,JIPMER |
|
| ExclusionCriteria |
| Details |
1. Patients with seroma formation, post drain removal requiring aspiration
2. Less than 10 lymph nodes dissected in axillary dissection
3. Incomplete documentation of drain duration
4. Flap necrosis or SSI requiring suture removal in postoperative period |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Plot the dependent and independent factors of the selected
population to predict the duration of drain removal
â— To study the factors associated with drainage duration
in breast cancer patients treated with modified radical
mastectomy
â— To develop a predictive nomogram using the explored
factors and this nomogram can be used to assess the
drainage duration of the individual patients
|
Baseline (during hospital admission) |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="1100"
Sample Size from India="1100"
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)
|
30/05/2024 |
| 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="8"
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
|
As breast carcinoma is most common carcinoma in female and second most common cause of death. Main modality of treatment is surgery that is modified radical mastectomy. Post operatively patients are monitored for duration of drain and any complications of seroma formation, increased hospital stay, flap necrosis and suture dehiscence. Optimum drain removal plays an important role in reducing all complications in these patients. This study deals mainly with the evaluating the factors responsible for increased drain duration and plotting these factors on a diagnostic tool- Nomogram and thus provides an optimal duration of removal of drains. |