Clinical Trial Comparing Outcomes of Breast Conserving Operations With Classic v High-frequency Electrocoagulation

NCT01216254 | Unknown Phase 4 DMC

• 1 other identifier: NKEBN/219/2010
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the outcomes of breast conserving therapy operation depending on the type of surgical tool used: classic electrocoagulation with higher operative temperatures and high frequency electrocoagulation with lower operative temperatures. The investigators would assess the pain levels, length and amount of the lymphatic secretion as well as quality of life following breast conserving surgery.

Conditions

Breast Cancer

Keywords

breast cancer; stage 2; breast conserving therapy; sentinel lymph node dissection; high frequency electrocoagulation

Outcome Measures

Primary Outcomes (1)

• Pain Control

  Pain assessment would be performed using Visual Analogue Scale (VAS) at the days 1-5, 10 (+/- 2), 20 (+/- 2), 30 (+/- 2), and 12 weeks (+/- 2 days). SF - MPQ questionnaire would be filled in on admission, 10th (+/- 2) post-operative day and 12 weeks (+/- 2 days)after surgery.

  From the day before surgery up to 12 weeks (+/-2days) after surgery

Secondary Outcomes (3)

• Quality of life (QoL)

  From the day before surgery up to 12 weeks (+/-2days) after surgery

• Length of lymphatic secretion

  From the day before surgery up to 12 weeks (+/-2days) after surgery

• Amount of lymphatic secretion

  From the day before surgery up to 12 weeks (+/-2days) after surgery

Study Arms (2)

Classic electrocoagulation

ACTIVE COMPARATOR

Arm of the study where the classic low-frequency electrocoagulation is used during the operation

Device: classic v high-frequency electrocoagulation

High Frequency electrocoagulation

EXPERIMENTAL

Arm of the study where the tested high-frequency electrocoagulation is used during the operation

Device: classic v high-frequency electrocoagulation

Interventions

classic v high-frequency electrocoagulation DEVICE

During the BCT with SLND the investigators would use two types of electrocoagulation. The steps of the operation would remain the same in both arms, nevertheless the tool used would vary.

Also known as: Ellmann

Classic electrocoagulation; High Frequency electrocoagulation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female
• age 18-100
• breast cancer
• stage IIA and II B (cT1a-3; cN0-1; cM0)
• no previous breast surgery
• no previous cancer
• obtained informed consent

You may not qualify if:

• stages I, III, IV
• localised breast infection
• previous breast surgery for any cause
• previous cancer
• no voluntary consent

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Department of Surgical Oncology

Gdansk, Pomeranian Voivodeship, 80-211, Poland

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jacek Zielinski, M.D., Ph.D.

  Medical University of Gdansk

  PRINCIPAL INVESTIGATOR

• Janusz Jaskiewicz, M.D., Ph.D.

  Medical University of Gdansk

  STUDY DIRECTOR

Central Study Contacts

Jacek Zielinski, M.D., Ph.D.

CONTACT

+48583492440; jaziel@gumed.edu.pl

Maciej Bobowicz, M.D.

CONTACT

+48608738614; mbobowicz@gumed.edu.pl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Profesor

Study Record Dates

• First Submitted: October 4, 2010
• First Posted: October 7, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: January 31, 2012

Record last verified: 2012-01

Locations

PL (1)