Comparison of the Safety and Aesthetic Outcomes of a Novel Endoscopic-Assisted Breast-Conserving Surgery (SRRSHzb-EABCS) With Those of Conventional Breast-Conserving Surgery
NCT07920094, Not applicable, Recruiting, Sir Run Run Shaw Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Comparison of the Safety and Aesthetic Outcomes of a Novel Endoscopic-Assisted Breast-Conserving Surgery (SRRSHzb-EABCS) With Those of Conventional Breast-Conserving Surgery | ClinicalTrials.gov |
| NCT number | NCT07920094 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 422 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Sir Run Run Shaw Hospital | ClinicalTrials.gov |
| Conditions | Breast Cancer | ClinicalTrials.gov |
| Interventions | Endoscopy-assisted breast-conserving surgery (SRRSHzb-EABCS), Conventional open breast-conserving surgery (CBCS) | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Intraoperative and Postoperative Positive Margin Rate | Intraoperatively and up to 1 month after surgery (final pathology report) | Proportion of participants with positive resection margins of the breast-conserving specimen, including the first and any subsequent positive margins on intraoperative frozen section assessment and the positive margin rate on postoperative routine paraffin pathology. | ClinicalTrials.gov |
| Secondary | Incidence of Intraoperative and Postoperative Complications | Intraoperatively and up to 1 month (±2 weeks) after surgery | Incidence of intraoperative and postoperative complications, including wound infection, postoperative bleeding, subcutaneous seroma, and flap necrosis, with their management and outcomes recorded. Complications are counted per participant (one participant with complications counts as one event). | ClinicalTrials.gov |
| Secondary | Aesthetic Outcome and Quality of Life Assessed by BREAST-Q | 1 month (±2 weeks) and 18 months (±3 months) after surgery | Patient-reported aesthetic outcome (satisfaction with breast appearance) and quality of life, measured by the BREAST-Q questionnaire (Breast-Conserving Therapy module). BREAST-Q domain scores are transformed to a scale ranging from 0 to 100, where higher scores indicate a better outcome (greater satisfaction and better quality of life). | ClinicalTrials.gov |
| Secondary | Local Recurrence Rate | From the date of surgery up to 5 years (5-year assessment window: ±6 months) | Proportion of participants with ipsilateral breast tumor recurrence (local recurrence) during follow-up. | ClinicalTrials.gov |
| Secondary | Disease-Free Survival (DFS) | From the date of surgery up to 5 years (5-year assessment window: ±6 months) | Time from surgery to the first occurrence of local recurrence, distant metastasis, or death from any cause, whichever occurs first. | ClinicalTrials.gov |
| Secondary | Overall Survival (OS) | From the date of surgery up to 5 years (5-year assessment window: ±6 months) | Time from surgery to death from any cause. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 3
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)