Evaluation of the Safety of Reoperation for Ipsilateral R... | NCT06317207

Studies
Evaluation of the Safety of Reoperation for Ipsilateral Recurrent Tumors After Nephron-sparing Partial Nephrectomy

NCT06317207

Sponsor

The First Affiliated Hospital of Anhui Medical University

Status

Completed

Last Update Posted

Mar 19, 2024Actual

Enrollment

15Actual

Phase

Not provided

Conditions

Renal Cell Carcinoma
Robotic Surgical Procedures

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2019b07030004	Other Grant/Funding Number	Anhui Provincial Central Government Guides Local Science and Technology Development Project-Anhui Clinical Research Ce

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2013Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

Mar 9, 2024

First Submission Date that Met QC Criteria

Mar 15, 2024

First Posted Date

Mar 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2024

Last Update Posted Date

Mar 19, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chaozhao Liang, Clinical Professor, The First Affiliated Hospital of Anhui Medical UniversityPrincipal Investigator

Lead Sponsor

The First Affiliated Hospital of Anhui Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate the safety of reoperation in patients with renal tumors who have ipsilateral tumor recurrence after nephron-sparing partial nephrectomy.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Label	Type	Description	Intervention Names
observation group		patients who underwent reoperation for locally rRCC after pNSS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Operation time	Operation time	1 week

Secondary Outcomes

Measure	Description	Time Frame
Estimated blood loss	Estimated blood loss	1 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. ipsilateral local rRCC (any recurrence in the ipsilateral kidney and retroperitoneum)

Exclusion Criteria:

With distant metastasis;
Lacking essential sugery information.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

We collected the patients who underwent reoperation for locally rRCC after pNSS in our institution from 2013 to 2023.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

All the information we will provide with the publication

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002292	Carcinoma, Renal Cell

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided