| CTRI Number |
CTRI/2026/01/101580 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
18/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Complications after surgery in breast cancer patients |
|
Scientific Title of Study
|
To evaluate the post-operative complications in carcinoma breast 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 Naval |
| Designation |
Junior Resident |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of surgery
Surgery unit one
2nd floor in ward
Sri Guru Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar 143501, Punjab, India.
Bathinda
PUNJAB
143501
India |
| Phone |
6283834391 |
| Fax |
|
| Email |
navalgarggna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjit singh uppal |
| Designation |
Professor |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of surgery
Surgery unit one
2nd floor in ward
Sri Guru Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar 143501, Punjab, India.
Amritsar
PUNJAB
143501
India |
| Phone |
9815088007 |
| Fax |
|
| Email |
vicechancellor@sgrduhs.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naval |
| Designation |
Junior Resident |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of surgery
Surgery unit one
2nd floor in ward
Sri Guru Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar 143501, Punjab, India.
Bathinda
PUNJAB
143501
India |
| Phone |
6283834391 |
| Fax |
|
| Email |
navalgarggna@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Guru Ram Das Institute of Medical Sciences and Research, Mehta Road,Vallah,
Amritsar,143501,Punjab,India. |
|
|
Primary Sponsor
|
| Name |
Department of surgery in Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Sri Guru Ram Das Institute of Medical Sciences and Research,
Mehta Road,Vallah,Amritsar,
143501,
Punjab,India.
|
| 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 NAVAL |
Sri Guru Ram Das Institute of Medical Sciences and Research, Vallah, Amritsar |
Department of surgery
Surgery unit one
2nd floor in ward
Amritsar
PUNJAB |
6283834391
navalgarggna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE |
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 |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
1. Female patients diagnosed with carcinoma breast undergoing modified radical mastectomy.
2. Patients aged 18 years and above.
|
|
| ExclusionCriteria |
| Details |
1. Patients not planned for modified radical mastectomy (MRM) or inoperable patients.
2. Patients undergoing salvage mastectomy.
3. Patients who have received neoadjuvant chemotherapy or neoadjuvant radiotherapy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the incidence of post-operative complications in patients undergoing modified radical mastectomy, in terms of seroma, wound infection, flap necrosis, hematoma, and shoulder stiffness on the 5th post-operative day, at the 2nd week, and at the 4th week follow-up. |
5th post-operative day
2nd week
4th week |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
29/01/2026 |
| 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) |
Open to Recruitment |
|
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
|
This prospective observational study aims to evaluate the pattern and incidence of postoperative complications among carcinoma breast patients undergoing modified radical mastectomy . All eligible female patients aged more than 18 years will undergo standard MRM with axillary clearance and postoperative follow-up on the 5th day, 2nd week, and 4th week. Incidence of seroma, wound infection, flap necrosis, hematoma, and shoulder stiffness will be documented along with drain output, timing of drain removal, and hospital stay. The study aims to improve understanding of morbidity and guide strategies to reduce postoperative complications in breast cancer surgery. |