UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective observational study of intraoperative positioning and post-operative shoulder pain in patients undergoing esophagectomy by prone position.
Title of the study (Brief title)	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	Hiroshi Morimatsu
Organization	okayama university graduate school of medicine,dentistry and pharmaceutical siences
Division name	Anesthesiology & Critical Care Medicine
Address	2-5-1 shikatacho kitaku okayama 700 8558 japan
TEL	+81-86-235-7778
Email	morima-h@md.okayama-u.ac.jp

Public contact
Name of contact person	Kenji Iwai
Organization	Okayama University Hospital
Division name	Division Of Physical Medicine and Rehabilitation
Address	2-5-1 shikatacho kitaku okayama 700 8558 japan
TEL	+81-86-235-7752
Homepage URL
Email	kenjiiwai7013@yahoo.co.jp

Sponsor
Institute	Okayama University Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024242