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NCT Number: NCT06565598

Single-layer Robot-assisted Transperitoneal Retroperitoneal Tubeless Radical Nephrectomy

To investigate the effect of single-layer robot-assisted retroperitoneal approach for radical nephrectomy without tubularization

Recruiting

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Key information

Conditions

Nonfunctional Kidney Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Renal Cancer Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

In this study, a multi-center retrospective study was conducted to evaluate the clinical efficacy of single-layer robot-assisted peritoneal retroperitoneal radical nephrectomy in patients with nephrectomy, and to compare the safety and effectiveness of traditional robot-assisted peritoneal radical nephrectomy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with various causes requiring radical nephrectomy

Exclusion criteria

  • patients who could not tolerate laparoscopic surgery for various reasons
  • patients whose preoperative blood pressure and blood glucose were not controlled to normal
  • patients with contralateral nonfunctioning kidney or solitary kidney
  • Multiple organ surgery at the same time

Treatment and study plan

Single-layer robot-assisted transperitoneal retroperitoneal tubeless radical nephrectomy

Procedure

Free through the single layer of the posterior abdominal cavity

Other names: Single layer approach

Primary outcomes

  1. intraoperative blood loss

    Time frame: 24 months

    Blood loss during operation

  2. postoperative time of getting out of bed

    Time frame: 24 months

    Time to get out of bed after surgery

  3. postoperative hospital stay

    Time frame: 2-5 Days

    Length of hospital stay after surgery

  4. Whether to convert to laparotomy or not

    Time frame: 24 months

    According to the surgical records in the medical records, whether the operation was converted to laparotomy was checked, and the data were recorded when collecting the data.

  5. Operation time

    Time frame: 1-3 Hours

    Complete operative time

  6. whether the tumor was completely removed

    Time frame: 24 months

    Observe whether the tumor is complete according to the naked eye after surgery，Record and record to the surgical record, record when collecting the receipt.

Secondary outcomes

  1. Clavien-Dindo grading

    Time frame: 24 months

    Grade I : long-term pain, fever, continuous bleeding and exudate, transient intestinal obstruction ; grade II : need blood transfusion, pneumonia ; grade III : hematuria requiring cystoscopy ; level IV : renal insufficiency requiring hemodialysis, respiratory insufficiency requiring ICU treatment, and cardiac insufficiency requiring ICU care.

Study contacts

Contact information is provided by the study sponsor or research team.

Baisheng Xu, Ph.D

CONTACT

[email protected]

+86-18779248191

Sponsors and collaborators

Lead sponsor

The First People's Hospital of Xiushui

Other

Registry information

Official study title

Observation on the Efficacy of Single-layer Robot-assisted Transperitoneal Retroperitoneal Tubeless Radical Nephrectomy

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2024
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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