UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Retrospective study of postoperative management of robot-assisted rectal resection performed at our hospital
Title of the study (Brief title)	postoperative management of robot-assisted rectal resection
Region	Japan

Condition
Condition	Rectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Clarify postoperative condition and recovery of robot-assisted rectal resection in a retrospective manner
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	postoperative pain (postoperative day 0-2) pain scale dose of analgesics
Key secondary outcomes	Recovery of bowel function (postoperative day 0-2) peristaltic sound postoperative nausea and vomiting Peripheral neuropathy postoperative delirium

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	18 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	patients underwent robot-assisted rectal resection under general anesthesia at our hospital from March 1, 2014 to September 30, 2018
Key exclusion criteria	none
Target sample size	40

Research contact person
Name of lead principal investigator	Yukitoshi Niiyama
Organization	Sapporo medical university school of medicine
Division name	Department of anesthesiolgy
Address	S1 W16, Chuo-ku, Sapporo, 060-8556, Japan
TEL	011-611-2111(35680)
Email	niiyama@sapmed.ac.jp

Public contact
Name of contact person	Yukitoshi Niiyama
Organization	Sapporo medical university school of medicine
Division name	Department of anesthesiolgy
Address	S1 W16, Chuo-ku, Sapporo, 060-8556, Japan
TEL	011-611-2111(35680)
Homepage URL
Email	niiyama@sapmed.ac.jp

Sponsor
Institute	Department of anesthesiolgy, Sapporo medical university school of medicine
Institute
Department

Funding Source
Organization	Department of anesthesiolgy, Sapporo medical university school of medicine
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	2018 Year 11 Month 28 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 11 Month 05 Day
Anticipated trial start date	2018 Year 11 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We clarify the postoperative state and recovery of bowel function after robot-assisted rectal resection at our hospital in a retrospective manner and feed back for better perioperative management.

Management information
Registered date	2018 Year 11 Month 27 Day
Last modified on	2018 Year 11 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039928