| CTRI Number |
CTRI/2025/10/096241 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
17/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare Tumescent versus Conventional Dissection in raising flaps during Radical Modified Mastectomy |
|
Scientific Title of Study
|
Comparison of Tumescent versus Conventional Dissection in raising flaps during Modified Radical Mastectomy - A Randomized Controlled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| mamc/2024/89 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr C B Singh |
| Designation |
Head Of Department |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of surgery, Maulana Azad Medical College and Lok Nayak Hospital, Bahadurshah Zafar Marg, Delhi
Central
DELHI
110002
India |
| Phone |
9717212602 |
| Fax |
|
| Email |
drchandrabhushansingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ayushi Singla |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
1/1015, Sector 5, mohan maekin society, vasundhara, ghaziabad, uttar pradesh
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
8447608543 |
| Fax |
|
| Email |
ayushi.singla.07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ayushi Singla |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
1/1015, Sector 5, mohan maekin society, vasundhara, ghaziabad, uttar pradesh
UTTAR PRADESH
201012
India |
| Phone |
8447608543 |
| Fax |
|
| Email |
ayushi.singla.07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and Lok Nayak Hospital |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and Lok Nayak Hospital |
| Address |
Bahadurshah Zafar Marg, Delhi-110002 |
| Type of Sponsor |
Government 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 Ayushi Singla |
Lok nayak hospital |
department of surgery, 2nd floor BLT, Maulana Azad Medical College.
Central
DELHI |
8447608543
ayushi.singla.07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutuional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C504||Malignant neoplasm of upper-outerquadrant of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Mastectomy |
conventional electrocautery MRM without tumescent solution in flaps- total duration- 1 year |
| Intervention |
Tumescent mastectomy |
injecting tumescent solution (mixture of saline, lignocaine, and adrenaline) before raising flaps in MRM
total duration- 1 year (11 cases) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
18-65 yrs women |
|
| ExclusionCriteria |
| Details |
prior breast surgery (except biopsy)/ recurrence
immediate breast reconstruction
previous radiotherapy
allergy to lignocaine |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Amount of blood loss (in ml) |
baseline and day-0 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| operative time (in mins) |
baseline |
| presence of any skin flap necrosis |
baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13, 14 days |
| DURATION OF HOSPITAL STAY |
NIL |
| POSTOPERATIVE PAIN |
baseline, 1,2,3,4,5,6,7 days
|
| SURGICAL SITE INFECTION INCLUDIMG INCISIONAL DEHISECENCE |
baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14 days |
| SEROMA/HEMATOMA FORMATION |
baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13, 14 days |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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 2 |
|
Date of First Enrollment (India)
|
28/10/2025 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - TO BE DECIDED
- For how long will this data be available start date provided 01-01-2027 and end date provided 01-01-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
patients requiring mastectomy will be worked up and sorted in 2 groups- controls and cases and study will be performed. This is to see if the tumescent solutions has any added benefits with regards to blood loss and flap health to the conventional mastectomy |