A Controlled Study of Improved Javelin Side Recumbent Position and Conventional Postural Placement
September 20, 2022 updated by: Guiyang Maternal and Child Health Care Hospital
Xu Pu, Director, Clinical Researcher
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Guiyang, China
- GuiyangMaternalChildHCH
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
Selection Criteria:
- Clinical diagnosis of obstruction at the renal pelvis ureteral junction.
- Must be able to fit the treatment done under the robot platform
Exclusion Criteria:
- Patients who can use balloon dilation to achieve the therapeutic purpose
- Open surgery is required
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
In control group A,
In control group A, we adopted the conventional lateral position
|
The incidence of surgical positioning time and secondary berths, surgical time, intraoperative blood loss and intraoperative complications were compared among the three groups.
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
|
The incidence of surgical positioning time and secondary berths, surgical time, intraoperative blood loss and intraoperative complications were compared among the three groups.
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
|
The incidence of surgical positioning time and secondary berths, surgical time, intraoperative blood loss and intraoperative complications were compared among the three groups.
To discuss the comparative study of different position placement methods of renal pelvis ureteroplasty on the Da Vinci robotic Xi platform
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The da Vinci surgical robot Xi system assists laparoscopic pyeloneuroplasty with an absolute advantage in the modified javelin lateral recumbent position
Time Frame: From December 2021 to January 2022
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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
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From December 2021 to January 2022
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Jing P Liu, doctorat, Guizhou Provincial People's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 12, 2021
Primary Completion (Actual)
January 9, 2022
Study Completion (Actual)
September 7, 2022
Study Registration Dates
First Submitted
September 19, 2022
First Submitted That Met QC Criteria
September 20, 2022
First Posted (Actual)
September 22, 2022
Study Record Updates
Last Update Posted (Actual)
September 22, 2022
Last Update Submitted That Met QC Criteria
September 20, 2022
Last Verified
December 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Xu Pu
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
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
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
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