NCT06676761

Brief Summary

Nipple sparing mastectomy is oncologically safe and has a good cosmetic outcome. However, nipple sparing mastectomy was conventionally performed with reconstruction. Minimal scar mastectomy (MSM) is a novel technique which could allow women, with non-ptotic breasts, who do not want reconstruction, to conserve their nipple areolar complex (NAC) and avoid the transverse scar associated with modified radical mastectomy. This is the first study on the oncologic and surgical outcomes of MSM.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
56mo left

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress66%
Mar 2017Dec 2030

Study Start

First participant enrolled

March 1, 2017

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2024

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

November 6, 2024

Status Verified

October 1, 2024

Enrollment Period

13.8 years

First QC Date

November 5, 2024

Last Update Submit

November 5, 2024

Conditions

Keywords

breast cancernipple sparing mastectomy

Outcome Measures

Primary Outcomes (1)

  • oncological outcome

    recurrence rate

    5 years from operation

Study Arms (1)

nipple sparing mastectomy without reconstruction

nipple sparing mastectomy without reconstruction

Procedure: nipple sparing mastectomy without reconstruction

Interventions

nipple sparing mastectomy was conventionally performed with reconstruction. we aim to study the outcomes in the group of patients with Minimal scar mastectomy (MSM) who have nipple sparing mastectomy without reconstruction

nipple sparing mastectomy without reconstruction

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale breast cancer patients
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

breast cancer patients with non-ptotic breasts, who do not want reconstruction, to conserve their nipple areolar complex (NAC) and avoid the transverse scar associated with modified radical mastectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

KK Women's and Children's Hospital

Singapore, 238255, Singapore

RECRUITING

KK Women's and Children's Hospital

Singapore, Singapore

RECRUITING

Related Publications (2)

  • Lim GH, Allen JC, Ng RP. Oncoplastic round block technique has comparable operative parameters as standard wide local excision: a matched case-control study. Gland Surg. 2017 Aug;6(4):343-349. doi: 10.21037/gs.2017.03.06.

    PMID: 28861374BACKGROUND
  • Lim GH. How to do minimal scar mastectomy: first-reported novel concept of nipple sparing mastectomy without reconstruction. ANZ J Surg. 2018 Dec;88(12):1345-1346. doi: 10.1111/ans.14941. Epub 2018 Nov 1. No abstract available.

    PMID: 30384398BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy, SubcutaneousPlastic Surgery Procedures

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MastectomySurgical Procedures, Operative

Central Study Contacts

Geok hoon Lim

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2024

First Posted

November 6, 2024

Study Start

March 1, 2017

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

November 6, 2024

Record last verified: 2024-10

Locations