| CTRI Number |
CTRI/2025/07/091474 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study among breast cancer patients undergoing surgery (modified radical mastectomy) to compare recovery and complications after placing one drain versus two drains. |
|
Scientific Title of Study
|
To compare Post operative outcomes of Single drain versus Double drain placement in Modified Radical Mastectomy,a Randomized Controlled Trail |
| 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 Vikas Prasad |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences Gorakhpur |
| Address |
Department of General Surgery
All India Institute of Medical Sciences Gorakhpur
Gorakhpur UTTAR PRADESH 273008 India |
| Phone |
7209833082 |
| Fax |
|
| Email |
Sikkyprasad@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Gaurav Gupta |
| Designation |
Additional Professor of surgery |
| Affiliation |
All India Institute of Medical Sciences Gorakhpur |
| Address |
Department of General Surgery
All India Institute of Medical Sciences Gorakhpur
Gorakhpur UTTAR PRADESH 273008 India |
| Phone |
7988631360 |
| Fax |
|
| Email |
drgaurav1975@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Gaurav Gupta |
| Designation |
Additional Professor of surgery |
| Affiliation |
All India Institute of Medical Sciences Gorakhpur |
| Address |
Department of General Surgery
All India Institute of Medical Sciences Gorakhpur
Gorakhpur UTTAR PRADESH 273008 India |
| Phone |
7988631360 |
| Fax |
|
| Email |
drgaurav1975@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery
All India Institute of Medical Science Gorakhpur Uttar Pradesh India pincode 273008 |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF GENERAL SURGERY AIIMS GORAKHPUR |
| Address |
DEPARTMENT OF GENERAL SURGERY, All India Institute of Medical Sciences Gorakhpur Uttar Pradesh India 273008 |
| 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 Vikas Prasad |
All India Institute of Medical Sciences Gorakhpur Uttar Pradesh India |
Department of General Surgery
All India Institute of Medical Sciences Gorakhpur Gorakhpur UTTAR PRADESH |
7209833082
Sikkyprasad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee All India Institute of Medical Sciences Gorakhpur |
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, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Patients who underwent Double Drain placement in Modified Radical Mastectomy. |
Two 16 French Negative suction Drains will be placed intra operatively for the patients of this group. Drains one in the axilla and the another one beneath the mastectomy flap. Drain output will be measured and recorded on daily basis for both the Drains post operatively. All patients will receive the same postoperative care to minimize treatment variability. Drains will be removed once the daily output falls below 10 ml. Pain, Flap necrosis, Wound Gaping and Lymphedema will be accessed in post operative period on Day 1, Day 3, Day 7, Day 10, day 15 and Day 30. |
| Intervention |
Patients who underwent Single Drain placement in Modified Radical Mastectomy |
A Negative suction drain of size 16 French will be placed beneath the mastectomy flap and coming out through axilla intra operatively for the Patients of this group. Drain output will be measured and recorded on daily basis post operatively. All patients will receive the same postoperative care to minimize treatment variability. Drain will be removed once the daily output falls below 10 ml. Pain, Flap necrosis, Wound Gaping and Lymphedema will be accessed in post operative period on Day 1, Day 3, Day 7, Day 10, day 15 and Day 30. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All operable cases of Carcinoma Breast who will undergo Modified Radical Mastectomy |
|
| ExclusionCriteria |
| Details |
Patient who Refused To give Consent for The Study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of postoperative Seroma formation in Single drain placement vs Double drain placement in Modified Radical Mastectomy patients. |
Primary outcomes will be assessed post operatively after completion of surgery on Day 1, Day 3, Day 7, Day 10, day 15 and Day 30. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare postoperative
1. Pain
2. Flap Necrosis
3. Wound Gaping
4. Lymphedema
In single-drain placement and double-drain placement in MRM patients.
|
All patients will be followed in post operative period on Day 1, Day 3, Day 7, Day 10, day 15 and Day 30. |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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 4 |
|
Date of First Enrollment (India)
|
08/08/2025 |
| 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="2" 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
|
Breast cancer is the most common malignancy worldwide and a leading cause of cancer related death among women. Modified Radical Mastectomy remains a cornerstone of surgical management, but postoperative complications such as seroma formation remain a significant concern. Seroma, the most frequent complication following mastectomy, occurs in 3 to 85 percent of cases and can result in flap necrosis, infection, and wound dehiscence. The use of closed suction drains is a common strategy to reduce seroma formation, but there is ongoing debate regarding the optimal number of drains. The study will be conducted at the Department of General Surgery, All India Institute of Medical Sciences, Gorakhpur Uttar Pradesh India. This tertiary care centre is equipped with advanced medical facilities and a high volume of surgical cases, providing a suitable environment for conducting a randomized controlled trial. The setting ensures access to a diverse patient population undergoing Modified Radical Mastectomy, allowing for robust data collection and analysis. This study is a prospective, randomized, controlled, single blinded, parallel assignment, single centre trial designed to compare post operative outcomes of single drain versus double drain placement in patients undergoing Modified Radical Mastectomy. A patient who will fulfil the inclusion criteria and does not satisfy any of the exclusion criteria will be randomized into two groups. Group A (Single Drain Group) single drain will be placed beneath the mastectomy flap and coming out through axilla. Group B (Double Drain Group) Two drains will be placed one in the axilla and the other beneath the mastectomy flap. All patients will have a 16 French negative suction drain placed intraoperatively. The drain output will be measured and recorded daily. Drains will be removed once the daily output falls below 10 ml. All patients will receive the same postoperative care, including antibiotics and other medications, to minimize treatment variability. Statistical analysis will be performed to assess differences in outcomes between the two groups. The study evaluates outcomes including incidence of seroma, Pain, Flap necrosis, Wound Gaping and Lymphedema will be accessed in post operative period on Day 1, Day 3, Day 7, Day 10, day 15 and Day 30. The results of this study will provide evidence to Rationalize the use of Single Drain or Double drain and guide best practices, improve patient outcomes, and optimize healthcare resource utilization in Modified Radical Mastectomy. |