UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021003 |
|---|---|
| Receipt number | R000024242 |
| Scientific Title | Prospective observational study of intraoperative positioning and post-operative shoulder pain in patients undergoing esophagectomy by prone position. |
| Date of disclosure of the study information | 2016/02/20 |
| Last modified on | 2017/08/19 00:42:53 |
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Basic information
Public title
Prospective observational study of intraoperative positioning and post-operative shoulder pain in patients undergoing esophagectomy by prone position.
Acronym
Prospective observational study of intraoperative positioning and post-operative shoulder pain in patients undergoing esophagectomy by prone position.
Scientific Title
Prospective observational study of intraoperative positioning and post-operative shoulder pain in patients undergoing esophagectomy by prone position.
Scientific Title:Acronym
Prospective observational study of intraoperative positioning and post-operative shoulder pain in patients undergoing esophagectomy by prone position.
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Recently, surgical techniques for esophagectomy has been improved significantly and getting less invasive continuously. In our institution, prone position for thoracoscopy assisted esophagectomy has been introduced, but substantial numbers of patients suffered from postoperative shoulder pain. One of the potential reasons of this shoulder pain would be intraoperative prone positioning. To reduce this pain, we introduced new intraoperative right arm positioning. In this prospective observational study, we studied the details of postoperative shoulder pain and range of motion in patients after esophagectomy with prone position to check our new right arm positioning.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative day 1, 3, 7 of the right shoulder joint around pain
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
New intraoperative positions in prone position thoracoscopic esophageal cancer resection to perform the settings. For the new intraoperative positions, and leadership to the surgical unit nurse preconfigure the adequate intraoperative positions by physiotherapist. By setting a new intraoperative positions on top of that, physical therapist for confirmation as a final confirmation. Physiotherapist entering the operating room is the same person, We do check and modify new intraoperative positions. Start of surgery limb position is prone position with the retention of the right upper extremity fist significant because it becomes approach from the right chest. In order to obtain reproducibility in performing the position setting, sagittal plane using a goniometer, horizontal surface, measured from three directions of the frontal and sets.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
After having received a sufficient explanation, on a sufficient understanding, the document agreed by the free will of the patient himself was obtained patient.
Key exclusion criteria
Surgery cases of surgical procedure is thoracoscopy due to a prone position and laparoscopic or laparotomy.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Morimatsu |
Organization
okayama university graduate school of medicine,dentistry and pharmaceutical siences
Division name
Anesthesiology & Critical Care Medicine
Zip code
Address
2-5-1 shikatacho kitaku okayama 700 8558 japan
TEL
+81-86-235-7778
morima-h@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Iwai |
Organization
Okayama University Hospital
Division name
Division Of Physical Medicine and Rehabilitation
Zip code
Address
2-5-1 shikatacho kitaku okayama 700 8558 japan
TEL
+81-86-235-7752
Homepage URL
kenjiiwai7013@yahoo.co.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama University Hospital Perioperative management center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 05 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 13 | Day |
Last modified on
| 2017 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024242
