CTRI Number |
CTRI/2023/02/049897 [Registered on: 20/02/2023] Trial Registered Prospectively |
Last Modified On: |
18/02/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Medical Device |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
A RANDOMISED CONTROL STUDY COMPARING THE PLACEMENT OF 2 DRAINS, THAT IS, IN AXILLA AND PECTORAL SKIN FLAP VERSUS SINGLE DRAIN IN AXILLA POST MODIFIED RADICAL MASTECTOMY IN PREVENTING POST OPERATIVE SEROMA AND LOCAL COMPLOCATIONS |
Scientific Title of Study
|
A prospective randomized controlled study to compare the efficacy of combined Axillary and Pectoral drainage versus Sole Axillary drainage in Modified Radical Mastectomy |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DR SIDDHARTH P DUBHASHI |
Designation |
HEAD OF DEPARTMENT |
Affiliation |
AIIMS NAGPUR |
Address |
DEPARTMENT OF GENERAL SURGERY
AIIMS NAGPUR
PLOT NO 2, SECTOR 20
SUMTHANA
Nagpur MAHARASHTRA 441108 India |
Phone |
9881624422 |
Fax |
|
Email |
spdubhashi@aiimsnagpur.edu.in |
|
Details of Contact Person Scientific Query
|
Name |
DR DEEPALI SHETTY |
Designation |
JUNIOR RESIDENT |
Affiliation |
AIIMS, NAGPUR |
Address |
ROOM 202, 2ND FLOOR
DEPARTMENT OF GENERAL SURGREY
AIIMS NAGPUR
PLOT NO2, SECTOR 20
MIHAN, NAGPUR
Nagpur MAHARASHTRA 441108 India |
Phone |
9008811623 |
Fax |
|
Email |
djshetty97@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DR DEEPALI SHETTY |
Designation |
JUNIOR RESIDENT |
Affiliation |
AIIMS, NAGPUR |
Address |
ROOM 202, 2ND FLOOR
DEPARTMENT OF GENERAL SURGERY
AIIMS NAGPUR
PLOT NO2, SECTOR 20
MIHAN, NAGPUR
Nagpur MAHARASHTRA 441108 India |
Phone |
9008811623 |
Fax |
|
Email |
djshetty97@gmail.com |
|
Source of Monetary or Material Support
|
AIIMS, NAGPUR
PLOT NO2, SECTOR 20
MIHAN, SUMTHANA
441108, NAGPUR |
|
Primary Sponsor
|
Name |
DR DEEPALI SHETTY |
Address |
AIIMS NAGPUR
MIHAN, SUMTHANA |
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 DEEPALI J SHETTY |
AIIMS NAGPUR |
DEPARTMENT OF GENERAL SURGERY, ROOM 202
AIIMS NAGPUR
PLOT NO 2, SECTOR 20
SUMTHANA
Nagpur MAHARASHTRA |
9008811623
djshetty97@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, Department of Pharmacology, AIIMS Nagpur |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
COMBINED AXILLARY AND PECTORAL DRAIN |
ROMOVAC NO 14 DRAIN PLACED IN AXILLA AND PECTORAL FLAP
FREQUENCY NOT APPLICABLE
DURATION- PATIENT DEPENDANT |
Intervention |
SINGLE AXILLARY DRAIN |
SINGLE ROMOVAC SUCTION DRAIN NO 14 PLACED IN AXILLA
FREQUENCY NOT APPLICABLE
DURATION- PATIENT DEPENDANT |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
90.00 Year(s) |
Gender |
Female |
Details |
Histologically proven Breast cancer patients of Stage 1 and II undergoing Modified Radical Mastectomy
Stage III breast cancer not receiving neo-adjuvant treatment undergoing Modified Radical Mastectomy
|
|
ExclusionCriteria |
Details |
Recurrent breast cancer
Patients receiving Neoadjuvant chemotherapy or Radiotherapy
Metastatic breast cancer
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To assess occurrence of post-operative seroma with use of single versus double drainage in modified radical mastectomy, in patients with histologically proven breast cancer not undergoing neoadjuvant therapy |
1ST, 3RD, 5TH, 7TH, 9TH DAY POST OPERATIVELY |
|
Secondary Outcome
|
Outcome |
TimePoints |
Post-operative pain
Occurrence of Flap necrosis
Duration of drain in-situ
Drain output
Length of hospital stay
|
3RD, 6TH, 9TH DAY POST OPERATIVELY |
|
Target Sample Size
|
Total Sample Size="156" Sample Size from India="156"
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)
|
25/02/2023 |
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)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NONE YET |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Breast cancer has seen a rapid rise in
incidence, becoming the leading cause of global cancer incidence in 2020.
Choice of treatment is Modified Radical Mastectomy (MRM). Most commonly
encountered complication of MRM is formation of seroma, which can be prevented
by the use of closed suction drainage system, preferable active suction
drainage.
This
Prospective Randomised controlled study attempts to compare the efficacy and
the morbidities associated with use of combined axillary and pectoral drain
versus single axillary drainage post modified radical mastectomy.
Objectives:
Assessing the incidence of seroma formation, post op wound infection, duration
of drain insitu, drain output and length of hospital stay
Women
with histologically proven breast cancer, stage 1,2 3 not undergoing
neoadjuvant therapy undergoing MRM, will be included in the study and will be
randomized into 2 groups using envelope method, Group A (single axillary drain)
and Group B (combined axillary and pectoral drainage), with 78 patients in each
group (total sample size 156)
Standardized
operative procedure and post-operative course will be followed in all patients
in both groups in drain emptying and dressing
Patient will be followed up postoperatively
to evaluate drain output, incidence of surgical site infection, flap necrosis,
seroma formation (clinically and quantified with ultrasonography), timing of
drain removal and total duration of hospital stay.
Data will
collected and analyzed with SPSS version 28.
The quantitative data will be reported as mean
and standard deviation. Differences between means will be tested with Student’s
t-test and the incidence of seroma, flap necrosis and wound infection will be
reported as number and percentages and Fisher’s exact test/ Chi square test
will be employed.
|