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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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