Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202402831197428 Date of Registration: 19/02/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Value of Using Ultrasonic Shears in Reducing Seroma Formation after Axillary Lymph Node Dissection in Breast Cancer Patients
Official scientific title Value of Using Ultrasonic Shears in Reducing Seroma Formation after Axillary Lymph Node Dissection in Breast Cancer Patients
Brief summary describing the background and objectives of the trial Background: Axillary Lymph Node Dissection (ALND) is an essential step in the management of breast cancer. ALND is conventionally performed using radio-frequency electrosurgery. The postoperative complications of utilizing such energy (such as prolonged drainage time, seroma, or infection) lead to prolonged recovery. Hence, it may delay the initiation of adjuvant chemo/radiotherapy for this critical category of patients. Using ultrasound shears provides a wide spectrum of tissue effects via mechanical oscillation. The absence of an electric circuit in ultrasound shears reduces thermal injury and accordingly cellular damage. Objective: Comparing utilization of ultrasound shears in axillary lymph node dissection to conventional radio frequency electrosurgery in terms of operative time, post-operative drainage amount and days, post-operative pain, the incidence of seroma or infection, and lymph node yield.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/01/2021
Actual trial start date 01/01/2021
Anticipated date of last follow up 01/05/2021
Actual Last follow-up date 01/05/2021
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 56
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ultrasound Shears In the surgery all through the surgery using Ultrasound shears to dissect level 1 an 2 of the axilla 28
Control Group Electrocautery Diathermy all through the surgery all through the surgery using electrocautery diathermy device to dissect level 1 and 2 axillary lymph nodes 28 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with Breast cancer and pathological axillary lymph nodes are operated upon for ALND; either up-front or post Neo – Adjuvant Chemo Therapy (NACT); as a part of Breast Conservation Surgery (BCS) or Modified Radical Mastectomy (MRM). Metastatic breast cancer cases. 80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 62 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/02/2022 cairo university research ethics committee
Ethics Committee Address
Street address City Postal code Country
Al Saraya street, Al Manial Cairo 11956 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Significant difference was found regarding the total drain volume, where group A had a mean of 319.6 ml in contrast to 407.5 ml for group B. This volume difference did not appear on the first 48 hrs. of drainage, but appeared on further days, summing up to total drainage days mean of 8 days for group A versus 12.5 days for group B as described in table 3. Higher rates of seroma were recorded in group B, with a total of 9 (31%) cases versus 6 (20%) for group A, where the higher rates were accounted for the higher incidence of infection in group B. when the drain was getting removed
Secondary Outcome Post operative pain records had a mean score of 5.7 (moderate) for group A and 5.9 (moderate) for group B with no statistical significance. Mean Lymph Node yield was not affected between groups A or B. A mean operative time of 29.4 minutes was recorded for group A versus 31.6 minutes for group B which wasn’t statistically significant at the drain removal
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kasr Alainy School of Medicine Al Saraya street, Al Manial Cairo 11956 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
non N/A Cairo 11956 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Non N.A Cairo 11956 Egypt N.A no sponsors
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yousra Elshoura Yosra.M.alshoury@students.kasralainy.edu.eg 07708132532 100, disrtrict 4, northen loutes, 5th settelment
City Postal code Country Position/Affiliation
cairo 11835 Egypt PhD Student
Role Name Email Phone Street address
Public Enquiries Yousra Elshoura Yosra.M.alshoury@students.kasralainy.edu.eg 07708132532 100, 4th district, northen lotus, 5th settelement
City Postal code Country Position/Affiliation
Cairo 11835 Egypt PhD student
Role Name Email Phone Street address
Scientific Enquiries Yousra Elshoura Yosra.M.alshoury@students.kasralainy.edu.eg 07708132532 100, 4th district, Northen Lotus, 5th settelment
City Postal code Country Position/Affiliation
Cairo 11835 Egypt PhD Student
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Information about the study, participant characters, intervention details, outcome measures, adverse events, data analysis and statistical analysis plan is open and allowed to all viewers and will be made available when published. the individual participant data will be restricted. Clinical Study Report Conditional Sharing: IPD sharing is subject to certain conditions or restrictions, such as requiring data requestors to meet specific criteria, obtaining approval from the institutional board, and signing data-sharing agreements outlining the terms of use and data protection measures. Medical professionals with research and scientific intentions are allowed access and can obtain details about the study after approval of the institutional board.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
no URL available as the study is not published yet. Yes 16/02/2024 16/02/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 16/02/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks not available as study was not published yet
Changes to trial information