NCT05504512

Brief Summary

Background of the project: The surgical treatment of parapelvic cysts is currently less researched and there is no gold standard for surgery. Previously, in percutaneous nephrolithotomy, we found that fenestration and fenestration drainage in the simultaneous treatment of pararenal pelvis cysts under nephroscopic nephroscopic surgery has clear curative effect, less trauma, and quicker recovery. Objective: To clarify the safety, efficacy and long-term efficacy of percutaneous nephroscopy in the treatment of parapelvic cysts. Nature: Retrospective case cohort study. Basic research process: Retrospective collection of cases in our hospital who underwent percutaneous nephroscopy for the treatment of parapelvic cysts, and comparison of preoperative and postoperative cyst size changes and long-term efficacy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

November 30, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 24, 2022

Status Verified

August 1, 2022

Enrollment Period

1 year

First QC Date

August 14, 2022

Last Update Submit

October 20, 2022

Conditions

Keywords

Parapelvic CystRecurrenceKidney Diseases

Outcome Measures

Primary Outcomes (1)

  • cyst size

    Cyst maximum plane diameter

    At least 1 year after percutaneous nephroscopy for parapelvic cysts

Study Arms (1)

Parapelvic cyst

Other: No intervention

Interventions

No intervention

Parapelvic cyst

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have undergone percutaneous nephroscopic surgery for parapelvic cysts

You may qualify if:

  • Age 18 or older
  • Has undergone percutaneous nephroscopic surgery for parapelvic cysts
  • Ability to receive study follow-up

You may not qualify if:

  • Patient refuses or is unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya hospital of central south university

Changsha, Hunan, China

Location

MeSH Terms

Conditions

Kidney CalculiKidney DiseasesRecurrence

Condition Hierarchy (Ancestors)

NephrolithiasisUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Yu Cui, M.D.

    Xiangya Hospital of Central South University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hequn Chen, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2022

First Posted

August 17, 2022

Study Start

November 30, 2022

Primary Completion

November 30, 2023

Study Completion

December 31, 2023

Last Updated

October 24, 2022

Record last verified: 2022-08

Locations