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

NCT05551442 | Completed DMC FDA Device

• 1 other identifier: Xu Pu
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nurse-Patient Relations

Keywords

ureteropelvic junction obstruction

Outcome Measures

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

  From December 2021 to January 2022

Study Arms (3)

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

To explore the comparative study of different positioning methods in robot assisted laparoscopic pyeloplasty. PROCEDURE

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

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 platform DEVICE

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

In control group A,; control group B; observation group C

Eligibility Criteria

• Age: 2 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may not qualify if:

• Patients who can use balloon dilation to achieve the therapeutic purpose
• Open surgery is required

Sponsors & Collaborators

• Guiyang Maternal and Child Health Care Hospital: lead

Study Sites (1)

GuiyangMaternalChildHCH

Guiyang, China

Location

MeSH Terms

Conditions

Multicystic renal dysplasia, bilateral

Study Officials

• Jing P Liu, doctorat

  Guizhou Provincial People's Hospital

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 22, 2022
• Study Start: December 12, 2021
• Primary Completion: January 9, 2022
• Study Completion: September 7, 2022
• Last Updated: September 22, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN (1)