CClinicalTrials.gg
CompletedNCT05551442Updated Sep 22, 2022

A Controlled Study of Improved Javelin Side Recumbent Position and Conventional Postural Placement

An observational study in Nurse-Patient Relations, sponsored by Guiyang Maternal and Child Health Care Hospital. Completed at 1 site in China. Open to participants aged 2 Months to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-22.

Sponsored by Guiyang Maternal and Child Health Care Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
60
Ages
2 Months to 5 Years
Sex
All
01

Study summary

The Da Vinci surgical robot Xi system assisted laparoscopic pyeloureteroplasty uses the improved javelin side lying position, which can alleviate the unsafe factors of falling from the bed caused by the conventional posture, shorten the time of placing the posture5, prevent the possible pressure injuries and intraoperative complications caused by the conventional posture surgery, and the operation is more simple and convenient. The mechanical arm of the Da Vinci robot will not have the potential risk factors of crushing the head, face and trunk of the patient during the entire operation process, It is safe and reliable, making the whole process of positioning convenient and time-saving. It can not only improve the connection efficiency of each operation, but also ease the work intensity of nurses and reduce the incidence of robot secondary berths. Operator satisfaction. It is safe and reliable to achieve good results, improve the operation safety, effectively avoid intraoperative and postoperative complications, and ensure the operation safety of patients, which is worth promoting.

Read the detailed description

To discuss the comparative study of different localization methods in robot-assisted laparoscopic epirenoplasty.

From December 2021 to January 2022, the researchers selected 60 participants to undergo laparoscopic pyroplasty assisted by the Da Vinci Robotic Xi system. Depending on the order of the surgeries, the researchers randomly assigned them, the subjects into three groups: control group A, control group B and observation group C, each with 20 cases. In control group A, we adopted the conventional lateral position, control group B adopted the lumbar bridge cushion lateral position, and observation group C adopted the modified javelin lateral position, The operation time, secondary berth incidence, operation time, intraoperative blood loss and the incidence of intraoperative complications were compared among the three groups.

02

Conditions studied

  • Nurse-Patient Relations

Keywords

  • ureteropelvic junction obstruction
03

In context

Lead sponsor

This is the only study on the registry with Guiyang Maternal and Child Health Care Hospital as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Months to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

From December 2021 to January 2022, 60 patients with da Vinci robotic Xi system assisted laparoscopic pyelonegal ureteroplasty surgery were selected in our hospital, and according to the order of surgery, we randomly divided the study objects into three groups, namely control group A, control group B and observation group C 20 cases each, control group A We took the conventional lateral lying position, control group B adopted the lumbar bridge pad high lateral recumbent position, observation group C adopted the design to improve the javelin side lying position, compared the three groups of surgical positioning time, secondary berth incidence, and surgical time 3. Intraoperative blood loss and incidence of intraoperative complications.

Eligibility criteria

Selection Criteria:

  1. Clinical diagnosis of obstruction at the renal pelvis ureteral junction.
  2. Must be able to fit the treatment done under the robot platform

Exclusion Criteria:

  1. Patients who can use balloon dilation to achieve the therapeutic purpose
  2. Open surgery is required
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • In control group A,

    In control group A, we adopted the conventional lateral position

    Procedure: To explore the comparative study of different positioning methods in robot assisted laparoscopic pyeloplasty. · Device: To discuss the comparative study of different position placement methods of renal pelvis ureteroplasty on the Da Vinci robotic Xi platform

  • control group B

    control group B adopted the lumbar bridge cushion lateral position

    Procedure: To explore the comparative study of different positioning methods in robot assisted laparoscopic pyeloplasty. · Device: To discuss the comparative study of different position placement methods of renal pelvis ureteroplasty on the Da Vinci robotic Xi platform

  • observation group C

    observation group C adopted the modified javelin lateral position

    Procedure: To explore the comparative study of different positioning methods in robot assisted laparoscopic pyeloplasty. · Device: To discuss the comparative study of different position placement methods of renal pelvis ureteroplasty on the Da Vinci robotic Xi platform

Interventions

  • ProcedureTo explore the comparative study of different positioning methods in robot assisted laparoscopic pyeloplasty.

    The incidence of surgical positioning time and secondary berths, surgical time, intraoperative blood loss and intraoperative complications were compared among the three groups.

  • DeviceTo discuss the comparative study of different position placement methods of renal pelvis ureteroplasty on the Da Vinci robotic Xi platform

    To discuss the comparative study of different position placement methods of renal pelvis ureteroplasty on the Da Vinci robotic Xi platform

06

What researchers measure

Primary outcomes

  1. The da Vinci surgical robot Xi system assists laparoscopic pyeloneuroplasty with an absolute advantage in the modified javelin lateral recumbent position

    The use of modified javelin side recumbent position during surgery can alleviate the unsafe factors of falling from the bed caused by conventional positioning, which is safe and reliable, and achieves good results

    Time frame: From December 2021 to January 2022

07

Study locations

1 site
  • GuiyangMaternalChildHCH
    Guiyang, China
08

References and documents

Individual participant data

Plan to share: Yes — A study design of the modified lateral position of javelin and the conventional position of body in the operation of pediatric ureteropelvic junction obstruction with Da Vinci Xi platform

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05551442
Lead sponsor
Guiyang Maternal and Child Health Care Hospital
Responsible party
Sponsor
First posted
Sep 22, 2022
Start date
Dec 12, 2021
Primary completion
Jan 9, 2022
Completion
Sep 7, 2022
Last update
Sep 22, 2022

Study contacts

Jing P Liu, doctorat
study director · Guizhou Provincial People's Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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