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Understanding Healing and Complications After Back-Muscle Flap Breast Reconstruction for Breast Cancer

Morbidity Of Latissimus Dorsi Flap Reconstruction in Breast Cancer Surgery(MILD Study) - MILD Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/12/099131
Enrollment
290
Registered
2025-12-15
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Nil: Nil

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
To assess shoulder morbidity at 6 Months( 1 Months) Measured by: Range of Motion(ROM) Constant Murley Score(CMS)Timepoint: To assess shoulder morbidity at 6 Months( 1 Months) Comparison between: LD flap reconstruction group and Non-LD flap (control) group

Secondary

MeasureTime frame
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 outcomesTimepoint: 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

Countries

India

Contacts

Public ContactDr Kallol Kumar Das Poddar

Tata Memorial Centre

kallolkumardaspoddar@gmail.com02224177198

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026