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CompletedNCT02923635Updated Oct 4, 2016

A Prospective Comparative Study Between Oncoplastic Breast Surgery and Standard Wide Local Excision

An interventional study of Standard wide local excision. and oncoplastic breast surgery. in Breast Cancer, sponsored by Ain Shams University. Completed. Open to female participants aged Up to 60 Years. Per ClinicalTrials.gov, last updated 2016-10-04.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
Up to 60 Years
Sex
Female
01

Study summary

The aim of this study is to asses the oncological safety of oncoplastic breast surgery, and its impact on patient satisfaction.

Read the detailed description

This non-randomized prospective trial was conducted on70 female patients presented to tertiary breast unit-Ain Shams University hospitals with breast cancer during the period from September 2012 to February 2013. All patients sharing in the study signed an informed consent that was approved in the ethical committee held on April 2012. Patients were classified in two groups each one 35 patients: group (A) standard wide local excision and group (B) oncoplastic group. Standard wide local excision done by general breast surgeons while oncoplastic surgeries done by breast surgeon assisted by plastic surgeon. The following data were recorded: Age, family history, margin length, weight and volume of the specimen, margin status and patient satisfaction.

02

Conditions studied

  • Breast Cancer

Keywords

  • Oncoplastic breast surgery
  • Standard Wide Local Excision
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with macromastia in oncoplastic group.
  • Tumors >20% of breast volume in oncoplastic group.
  • Young patients in oncoplastic group
  • Tumors in medial or central quadrants in oncoplastic group

Exclusion criteria

Exclusion Criteria:

  • Patients >60 years.
  • Patients with co-morbidities in oncoplastic group.
  • Tumors >20% of breast volume in standard group.
  • Tumors in medial or central quadrants in standard group
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Active comparator
    Standard Wide Local Excision group

    Group A (35 patients) have standard curative conservative breast surgery without integration of plastic techniques .

    Procedure: Standard wide local excision.

  • Active comparator
    Oncoplastic group

    Group B(35 patients) have curative oncoplastic surgery in which plastic techniques integrated with oncological procedures

    Procedure: oncoplastic breast surgery.

Interventions

  • ProcedureStandard wide local excision.

    Excision of breast cancer without integration of plastic technique

  • Procedureoncoplastic breast surgery.

    Integration of plastic techniques with oncological surgery for resection of breast cancer.

06

What researchers measure

Primary outcomes

  1. Margins in all specimens measured in millimeters

    Time frame: Two years

Secondary outcomes

  1. Patient satisfaction assessed using questionnaire

    Time frame: two years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02923635
Lead sponsor
Ain Shams University
Responsible party
Yasser Mohamed Abdel-samii (Lecturer of General surgery, Ain Shams University) — Principal investigator
First posted
Oct 4, 2016
Start date
Sep 2012
Primary completion
Aug 2013
Completion
Jun 2016
Last update
Oct 4, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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