| CTRI Number |
CTRI/2026/01/101880 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Effect of One Drain and Two Drains on Recovery After Breast Cancer Surgery |
|
Scientific Title of Study
|
A Prospective Study to compare the efficacy of Single versus Double Drains in patients undergoing Modified Radical Mastectomy |
| 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 Simran Kaur |
| Designation |
Junior Resident |
| Affiliation |
Sri Guru RamDas Institute of Medical Sciences and Research Amritsar |
| Address |
Department of General Surgery Sri Guru RamDas Institute of Medical Sciences and Research Amritsar
Sri Guru RamDas Institute of Medical Sciences and Research Vallah Amritsar
Amritsar
PUNJAB
151203
India |
| Phone |
7986361525 |
| Fax |
|
| Email |
simransukhgill@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rana Ranjit Singh |
| Designation |
Professor Head General Surgery |
| Affiliation |
Sri Guru RamDas Institute of Medical Sciences and Research |
| Address |
Sri Guru Ram Das Institute of Medical Sciences and Research Vallah Amritsar
Sri Guru Ram Das Institute of Medical Sciences and Research Vallah Amritsar
Amritsar
PUNJAB
143501
India |
| Phone |
9876151548 |
| Fax |
|
| Email |
gurveer1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rana Ranjit Singh |
| Designation |
Professor Head General Surgery |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of General Surgery Sri Guru Ram Das Institute of Medical Sciences and Research
Sri Guru Ram Das Institute of Medical Sciences and Research Amritsar
Amritsar
PUNJAB
143501
India |
| Phone |
9876151548 |
| Fax |
|
| Email |
gurveer1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Surgery Sri Guru Ram Das Institute of Medical Sciences and Research Vallah Amritsar 143501 Punjab India |
|
|
Primary Sponsor
|
| Name |
Sri Guru Ram Das Institute of Medical sciences and Research |
| Address |
Department of Surgery Sri Guru Ram Das Institute of Medical Sciences and Research Vallah Amritsar |
| 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 Rana Ranjit Singh |
Sri Guru Ram Das Institute of Medical Scienes and Research |
Department of Surgery Sri Guru Ram Das Institute of Medical Sciences and Research Amritsar
Amritsar
PUNJAB |
9876151548
gurveer1@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: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Double Suction Drains in Modified Radical Mastectomy |
Romovac drain no 16 will be placed One in axilla and one under the flap and assessed for drain output, serum formation, SSI, pain and hospital stay |
| Intervention |
Single suction drain in Modified Radical Mastectomy |
Romovac drain no 16 will be placed only in Axilla and assessed for drain output, serum formation, SSI, hospital stay and pain |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Patients diagnosed with carcinoma breast planned for modified radical mastectomy |
|
| ExclusionCriteria |
| Details |
Patients with locally advanced or inoperable breast cancer requiring extensive reconstruction
Previous axillary surgery or radiotherapy
Patients not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study provides insights into the effectiveness of diffrent drainage stratigies in reducing postoperative complications and improving patient comfort and recovery.Findings could influence clinical decisions regarding potoperative care in breast care surgery |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
05/02/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Breast cancer patients undergoing Modified Radical Mastectomy commonly develop postoperative seroma, leading to increased morbidity and prolonged hospital stay. Closed suction drains are routinely used, but the optimal number of drains remains controversial. This prospective comparative study evaluates the efficacy of single versus double drains following MRM. Outcomes assessed include seroma formation, total drain output, duration of drainage, surgical site infections, length of hospital stay, and postoperative pain. Patients will be randomly allocated into single- and double-drain groups and followed for four weeks. The study aims to identify an effective drainage strategy that improves patient comfort and postoperative outcomes. |