A Comparative Study Between Oncoplastic Breast Surgery and Standard Conservative Surgery:Margin Status and Patient Satisfaction

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03012152
• Collaborator: (none)
• Enrollment: 70
• Arms: 2
• Duration (Months): 48

Study Details

Study Description

Brief Summary

This non randomized study is a comparative study between standard conservative breast surgery and oncoplastic surgery as regard margin status and patient satisfaction.

Condition or Disease	Intervention/Treatment	Phase
Breastcancer	Procedure: Standard conservative breast surgery; Procedure: Oncoplastic breast surgery	N/A

Detailed Description

This planned study was conducted on 70 female patients presented to our tertiary referral breast unit at Ain Shams University hospitals with breast cancer amid the period from September 2012 to May 2013 .

Every one of them signed an informed consent to partake in this study that was approved in a meeting held by the ethical committee on august 2012 at Ain Shams University. All patients sharing in the study received closed envelope before surgery in a randomized way in which the surgical technique is written either standard conservative surgery or oncoplastic surgery(Double Blind).

Our patients were partitioned into 2 equal groups: group A (35patients) who underwent standard conservative surgery, group B (35patients) who underwent oncoplastic surgery.

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Comparative Study Between Oncoplastic Breast Surgery and Standard Conservative Surgery:Margin Status and Patient Satisfaction Among Egyptian Females
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard conservative group Group A (35 patients) have standard curative conservative breast surgery without integration of plastic techniques . .	Procedure: Standard conservative breast surgery
Active Comparator: Oncoplastic group Group B(35 patients) have curative oncoplastic surgery in which plastic techniques integrated with oncological procedures	Procedure: Oncoplastic breast surgery

Outcome Measures

Primary Outcome Measures

1. Margins in all specimens measured in millimeters 2. [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Female Patients with stage 1,2 breast cancer.

Exclusion Criteria:

• Patients >60 years.

• Patients with previous breast surgery.

• patients candidate for mastectomy or palliative excision. Patients with collagen disease.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yasser Mohamed Abdel-samii, Lecturer of General surgery, Ain Shams University
• ClinicalTrials.gov Identifier: NCT03012152
• Other Study ID Numbers: 16379
• First Posted: Jan 6, 2017
• Last Update Posted: Jan 6, 2017
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Yasser Mohamed Abdel-samii, Lecturer of General surgery, Ain Shams University: Oncoplastic surgery; Standard conservative surgery; Patient satisfaction; Margin Status
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Jan 6, 2017