| CTRI Number |
CTRI/2025/12/099131 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
12/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding Healing and Complications After Back-Muscle Flap Breast Reconstruction for Breast Cancer |
|
Scientific Title of Study
|
Morbidity Of Latissimus Dorsi Flap Reconstruction in Breast Cancer Surgery(MILD Study) |
| Trial Acronym |
MILD Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Version2.0 –01.10.2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shalaka Joshi |
| Designation |
Professor and Surgeon |
| Affiliation |
Tata Memorial Centre |
| Address |
Room no 1208 Homi Bhabha building Tata Memorial Hospital Dr Ernest Borges road Parel Mumbai Room no 103/104 First Floor Homi Bhabha Building Tata Memorial Hospital Dr Ernest Borges road Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177198 |
| Fax |
|
| Email |
drjoshishalaka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kallol Kumar Das Poddar |
| Designation |
MCh Surgical Oncology Resident |
| Affiliation |
Tata Memorial Centre |
| Address |
Room no 1208 Homi Bhabha building Tata Memorial Hospital Dr Ernest Borges road Parel Mumbai Room no 103/104 First Floor Homi Bhabha Building Tata Memorial Hospital Dr Ernest Borges road Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177198 |
| Fax |
|
| Email |
kallolkumardaspoddar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kallol Kumar Das Poddar |
| Designation |
MCh Surgical Oncology Resident |
| Affiliation |
Tata Memorial Centre |
| Address |
Room no 1208 Homi Bhabha building Tata Memorial Hospital Dr Ernest Borges road Parel Mumbai Room no 103/104 First Floor Homi Bhabha Building Tata Memorial Hospital Dr Ernest Borges road Parel Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177198 |
| Fax |
|
| Email |
kallolkumardaspoddar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural Fund Tata Memorial Hospital Dr. Ernest Borges Marg Parel, Mumbai 400012
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital Dr Ernest Borges Road Parel Mumbai 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shalaka Joshi |
Tata Memorial Centre |
Room no 103/104 Breast Private OPD Tata Memorial Hospital Dr Ernest Borges Road Parel Mumbai
Mumbai
MAHARASHTRA |
02224177198
drjoshishalaka@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Insitutional Ethics Committee II |
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Female patients aged 18-65 years who are undergoing breast conservation surgery
or total mastectomy with or without axillary lymph node dissection (ALND) with
LD flap with or without implant will be included in the study arm
2. Patients who are able and willing to provide informed consent and comply with
study protocols, including follow-up visits. |
|
| ExclusionCriteria |
| Details |
1. Patients with prior shoulder pathology (e.g., rotator cuff injuriesor traumatic shoulder deformities, frozen shoulder, shoulder arthritis, developmental abnormalities involving the shoulder girdle, e.g. Polands syndrome) or pre- existing shoulder limitations that could confound the results of shoulder morbidity
assessment.
2. Patients with previous breast surgery for cancer (other than biopsy or minor excision biopsy) on the same side that may affect the evaluation of shoulder
morbidity or reconstruction outcomes.
3. Patients with a history of chronic pain syndromes, neurological disorders (e.g.,
stroke, multiple sclerosis), or significant psychiatric illness that might affect their
ability to participate in the study or report outcomes accurately.
4. Pregnant or breastfeeding women, as these factors may alter recovery patterns and
complicate the assessment of morbidity.
5.Patients with active infections or any uncontrolled comorbidities (e.g.,uncontrolled
diabetes, cardiovascular disease, i.e. ASA III and above) that may interfere with the recovery process and skew results.
6. Patients who are unable to attend follow-up appointments or comply with study
protocols, such as participating in physical assessments postoperatively. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess shoulder morbidity at 6 Months(± 1 Months)
Measured by:
• Range of Motion(ROM)
• Constant Murley Score(CMS) |
To assess shoulder morbidity at 6 Months(± 1 Months)
Comparison between:
• LD flap reconstruction group and
• Non-LD flap (control) group |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Shoulder morbidity at 18 Months
• ROM measurement
• Constant Murley Score (CMS)
2. Radiation-related comparisons
• Effect of:
• Regional nodal
irradiation(RNI)
• Radiation technique on shoulder morbidity
3. Dosimetric correlation
• Correlation of radiation dose to shoulder musculoskeletal structures (using shoulder OAR contour)
• With shoulder morbidity outcomes |
1. Postoperative complication rates
• Clavien-Dindo classification
• Assessed up to 3 months post-surgery
2. Patient Satisfaction
• Breast-Q score at follow-ups
3. Cosmetic outcomes
• Modified Harris Cosmetic Scale at 6 & 18 months
• BCCT.core software at 6 & 18 months |
|
|
Target Sample Size
|
Total Sample Size="290"
Sample Size from India="290"
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)
|
01/01/2026 |
| 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="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
|
This prospective, longitudinal, quasi-experimental study aims to
evaluate shoulder
morbidity in breast cancer patients undergoing partial or total breast reconstruction
using a latissimus dorsi (LD) flap, compared with patients who
do not undergo LD flap reconstruction. Although LD flaps remain valuable in
selected clinical situations—such as in obese patients, smokers, or settings
where free flaps are not feasible—they have been associated with potential
long-term shoulder dysfunction. Additional treatments such as axillary lymph node dissection (ALND) and radiotherapy (RT) may
further worsen shoulder mobility and functional outcomes.
The
study will include women aged 18–65 years undergoing breast-conserving surgery
or mastectomy with immediate LD flap reconstruction. A historical control group
(without LD flap reconstruction) will be obtained from the AiSLe study.
Exclusion criteria include pre-existing shoulder pathology, prior ipsilateral
breast cancer surgery, neurological disease, uncontrolled comorbidities, and
inability to participate in follow-up.
Participants
will undergo detailed baseline, postoperative, 6-month, and 18-month assessments.
Shoulder function will be measured using the Constant–Murley Score (CMS) and
goniometric range-of-motion (ROM). Additional evaluations include BREAST-Q satisfaction,
cosmetic assessment using Modified
Harris Scale and BCCT.core software, lymphedema
assessment, sensory abnormalities, and documentation of postoperative
complications (Clavien–Dindo). For patients receiving radiotherapy, dosimetric parameters of
the shoulder-girdle structures will be analyzed to explore correlations with
morbidity.
A
total of 290
patients will be included (145 LD flap patients and 145
matched controls). Statistical analysis will involve propensity score matching,
comparisons using t-tests or non-parametric equivalents, and chi-square tests
for categorical variables, with significance at p<0.05.
The
primary aim is to determine whether LD flap reconstruction results in increased shoulder morbidity at
6 months post-treatment. Secondary aims include long-term morbidity,
complication rates, patient satisfaction, cosmetic outcomes, and the impact of
radiotherapy and shoulder-region radiation dose
|