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OpenTrials
Completed

NCT Number: NCT05551442

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

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.

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Key information

Age range

2 month–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

GuiyangMaternalChildHCH

Guiyang, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

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.

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Guiyang Maternal and Child Health Care Hospital

Other

Registry information

Official study title

Xu Pu, Director, Clinical Researcher

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 22, 2022
Registry last updated
Sep 22, 2022

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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