UMIN-CTR Clinical Trial

Basic information
Public title	The analysis of the impact of colon ESD on gastrointestinal symptoms
Acronym	The analysis of the impact of colon ESD on gastrointestinal symptoms
Scientific Title	The analysis of the impact of colon ESD on gastrointestinal symptoms
Scientific Title:Acronym	The analysis of the impact of colon ESD on gastrointestinal symptoms
Region	Japan

Condition
Condition	The adapted lesion of colon ESD
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to clarify the impact of colon ESD on gastrointestinal symptoms
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	GSRS(Gastrointesitinal Symptom Rating Scale) before and after(2week to 4week after) procedure
Key secondary outcomes	Size of the lesion Location of the lesion Time of procedure Use of analgetic agent Use of antiboitics

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	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with ESD adapted colonic lesions
Key exclusion criteria	History of heart failure, renal failure, liver cirrhosis or chronic hepatic failure Pregnancy or possibility of pregnancy Patients judged as being inappropriate candidates for the trial by the investigators
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Takuma Middle name Last name Higurashi
Organization	Yokohama City University
Division name	Department of endoscopy
Zip code	236-0004
Address	3-9 Fukuura Kanazawa Yokohama Japan
TEL	0457872800
Email	takuma_h@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Takuma Middle name Last name Higurashi
Organization	Yokohama City University
Division name	Department of endoscopy
Zip code	236-0004
Address	3-9 Fukuura Kanazawa Yokohama Japan
TEL	0457872800
Homepage URL
Email	takuma_h@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Yokohama City University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Hiratsuka City Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama City University Hospital IRB
Address	3-9 Fukuura Kanazawa-ku Yokohama City
Tel	81-45-787-2640
Email	takuma_h@yokohama-cu.ac.jp

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	2015 Year 03 Month 25 Day

Related information
URL releasing protocol	DOI:10.1007/s00464-020-08278-w
Publication of results	Published

Result
URL related to results and publications	DOI:10.1007/s00464-020-08278-w
Number of participants that the trial has enrolled	171
Results	Comparing the GSRS before and after ESD, overall scores changed from 1.58 +- 0.58 to 1.48 +- 0.48, and the five subscales (reflux syndrome, abdominal pain, indigestion syndrome, diarrhea syndrome, and constipation syndrome) were slightly improved. Overall scores, indigestion syndrome, and constipation syndrome were statistically significantly different before and after ESD (P < 0.05).
Results date posted	2021 Year 11 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 01 Month 27 Day
Baseline Characteristics	patients who underwent colorectal ESD and answered the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire from March 2015 to August 2019.
Participant flow	patients who underwent colorectal ESD and answered the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire from March 2015 to August 2019.
Adverse events	none
Outcome measures	We evaluated abdominal symptoms in the patients using the GSRS questionnaire before ESD and a few weeks after ESD.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 01 Day
Date of IRB	2015 Year 03 Month 20 Day
Anticipated trial start date	2015 Year 03 Month 25 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 04 Month 30 Day
Date analysis concluded	2020 Year 05 Month 31 Day

Other
Other related information	Prospective observational Study

Management information
Registered date	2015 Year 03 Month 25 Day
Last modified on	2021 Year 11 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019476