Single Port Endoscopic Breast Conserving Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-70
SponsorRen,Yu
About this trial
The center plans to carry out a prospective clinical study of single hole total endoscopic breast conserving surgery for early breast cancer compared with open breast conserving surgery, to provide high-level evidence-based medical evidence for the development of endoscopic breast conserving surgery for early breast cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Breast cancer confirmed by pathology；
Tumor <5 cm, TNM stage 0-II；
Single Port Endoscopic or traditional open surgery; (4)20 to 70 years old female patients.
Disqualifiers
Bilateral breast cancer;
Reconstruction after breast conserving surgery ;
Basic information is not complete；
Breast conserving surgery was converted to modified radical resection or subcutaneous adenoidectomy.
Trial population
Female patients aged 20-70 years who are eligible for breast-conserving surgery and are willing to undergo breast-conserving surgery.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
endoscopic breast conserving surgery
Procedure/SurgeryBreast endoscopy technology completes complex surgical operations through small incisions, achieving aesthetically pleasing results while ensuring tumor safety.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: single port endoscopic breast conserving surgery1 intervention
Group B: open breast conserving surgery1 intervention
Trial outcomes
Primary outcomes
1
Six months after operation SURVIVAL EFFECTS
To compare the overall survival (OS) within 6 months after single-port endoscopic breast-conserving surgery and open breast-conserving surgery.
Time frame
From enrollment to the end of 6 months after surgerySecondary outcomes
1
Intraoperative blood loss
To compare the total blood loss between single-port endoscopic breast-conserving surgery and open breast-conserving surgery.
Time frame
From the beginning to the end of the operation2
Postoperative drainage volume in the first three days after breast conserving surgery
The total drainage volume in the first three days after breast conserving surgery was compared between single-port endoscopic breast conserving surgery and open breast conserving surgery.
Time frame
3 days after surgery3
Length of surgical incision
The total incision length was compared between single-port endoscopic breast-conserving surgery and open breast-conserving surgery.
Time frame
1 week after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Ren,Yu
Lead sponsor
First Affiliated Hospital Xi'an Jiaotong University
Sponsor institution
Source ClinicalTrials.gov