Nurse-Patient RelationsNCT05551442
A Controlled Study of Improved Javelin Side Recumbent Position and Conventional Postural Placement
An observational study of Nurse-Patient Relations, run by Guiyang Maternal and Child Health Care Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Nurse-Patient Relations
- What is being tested?
- To explore the comparative study of different positioning methods in robot assisted laparoscopic pyeloplasty. and To discuss the comparative study of different position placement methods of renal pelvis ureteroplasty on the Da Vinci robotic Xi platform
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2021to 7 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
None listed.
Who cannot join
- Patients who can use balloon dilation to achieve the therapeutic purpose
- Open surgery is required
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Nurse-Patient Relations
- Being tested
- To explore the comparative study of different positioning methods in robot assisted laparoscopic pyeloplasty., To discuss the comparative study of different position placement methods of renal pelvis ureteroplasty on the Da Vinci robotic Xi platform
- Keywords
- ureteropelvic junction obstruction
- Medical subject headings
- Multicystic renal dysplasia, bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To explore the comparative study of different positioning methods in robot assisted laparoscopic pyeloplasty.Procedure or surgery
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 platformDevice
To discuss the comparative study of different position placement methods of renal pelvis ureteroplasty on the Da Vinci robotic Xi platform
| Study group | Role | What they receive |
|---|---|---|
| In control group A, | In control group A, we adopted the conventional lateral position Receives: 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From December 2021 to January 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start12 Dec 2021
- Primary completion9 Jan 2022
- Study completion7 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse-Patient RelationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guiyang Maternal and Child Health Care Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing P Liu, doctorat, Study director, Guizhou Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551442
- Sponsor's protocol ID
- Xu Pu
- Status last verified
- Dec 2021
- First submitted
- 19 Sep 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xu Pu, Director, Clinical Researcher
- ClinicalTrials.gov ID
- NCT05551442
- Acronym / sponsor ID
- Xu Pu
- Conditions
- Nurse-Patient Relations
- Keywords
- ureteropelvic junction obstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Guiyang Maternal and Child Health Care HospitalUniversity, hospital or other
- Study start
- 12 Dec 2021 (actual)
- Primary completion
- 9 Jan 2022 (actual)
- Study completion
- 7 Sep 2022 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| In control group A, | – | 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 platformIn control group A, we adopted the conventional lateral position |
| control group B | – | 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 platformcontrol group B adopted the lumbar bridge cushion lateral position |
| observation group C | – | 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 platformobservation group C adopted the modified javelin lateral position |
Who may qualify
- Ages
- 2 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Patients who can use balloon dilation to achieve the therapeutic purpose
- Open surgery is required
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| To 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. | Procedure or surgery | In control group A,, control group B, observation group C |
| To discuss the comparative study of different position placement methods of renal pelvis ureteroplasty on the Da Vinci robotic Xi platformTo discuss the comparative study of different position placement methods of renal pelvis ureteroplasty on the Da Vinci robotic Xi platform | Device | In control group A,, control group B, observation group C |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Individual participant dataSharing planned: 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
Related trials for Nurse-Patient Relations
Not yet recruitingObservational study
Surgical Nurses' Pain Management Self-Efficacy and Patients' Postoperative Pain Outcomes
Postoperative Pain
Active, not recruitingObservational study
Meaning-Centered Psychotherapy at Home
Nurse-Patient Relations, Psychology, Social
Not yet recruiting
Reducing Physical Workload Among Assistant Nurses Through Ergonomic Work Technique Training With or Without Biofeedback
Work-Related Musculoskeletal Disorders
Not yet recruiting
Impact of an Emergency Advanced Practice Nurse on Complications After Home Discharge of Oxygen-Dependent Patients Managed in the Emergency Department: A Quantitative and Qualitative Study
Acute Respiratory Conditions Requiring Oxygen Therapy, Advanced Practice Nursing
Recruiting
Nurse-Led Dialysis Self-Management Program for Hemodialysis Distress
Hemodialysis, Dialysis-Related Distress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing P Liu, doctorat study director
Guizhou Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nurse-Patient Relations, run by Guiyang Maternal and Child Health Care Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.