UMIN-CTR Clinical Trial
| Recruitment status | Main results already published |
| Unique ID issued by UMIN | UMIN000016781 |
| Receipt No. | R000019100 |
| Scientific Title | The analysis of risk facotors of post colon ESD pain |
| Date of disclosure of the study information | 2015/03/11 |
| Last modified on | 2019/12/06 (Ver. 7) |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
| Basic information | ||
| Public title | The analysis of risk facotors of post colon ESD pain | |
| Acronym | The analysis of risk facotors of post colon ESD pain | |
| Scientific Title | The analysis of risk facotors of post colon ESD pain | |
| Scientific Title:Acronym | The analysis of risk facotors of post colon ESD pain | |
| Region |
|
|
| Condition | ||
| Condition | The adapted lesion of colon ESD | |
| Classification by specialty |
|
|
| Classification by malignancy | Malignancy | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | The aim of this study is to clarify the risk factor of post colon ESD |
| Basic objectives2 | Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | Exploratory |
| Trial characteristics_2 | Pragmatic |
| Developmental phase | Not applicable |
| Assessment | |
| Primary outcomes | Pain scale (Visula analog scale) (POD1, POD2, POD3 and POD4) |
| 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 |
|
|||
| Age-upper limit |
|
|||
| 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
Histroy of regular use of analgesic 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 |
|
||||||
| Organization | Yokohama City University | ||||||
| Division name | Department of endoscopy | ||||||
| Zip code | 236-0004 | ||||||
| Address | 3-9 Fukuura Kanazawa Yokohama Japan | ||||||
| TEL | 045-787-2640 | ||||||
| takuma_h@yokohama-cu.ac.jp | |||||||
| Public contact | |||||||
| Name of contact person |
|
||||||
| Organization | Yokohama City University | ||||||
| Division name | Department of endoscopy | ||||||
| Zip code | 236-0004 | ||||||
| Address | 3-9 Fukuura Kanazawa Yokohama Japan | ||||||
| TEL | 045-787-2640 | ||||||
| Homepage URL | |||||||
| 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 | |
| Other related organizations | |
| Co-sponsor | Omori Red Cross Hospital
NTT Medical Center Tokyo 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 | 045-787-2640 |
| irb@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 | 横浜市立大学 大森赤十字病院 NTT関東病院 平塚市民病院 |
| Other administrative information | |||||||
| Date of disclosure of the study information |
|
||||||
| Related information | |
| URL releasing protocol | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5842075/ |
| Publication of results | Published |
| Result | |||||||
| URL related to results and publications | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5842075/ | ||||||
| Number of participants that the trial has enrolled | 106 | ||||||
| Results | Female gender, location of lesion in the cecum, and ESD operation time >？90 minutes were significant risk factors independent of PECS. These findings are important to management of PECS.？ |
||||||
| Results date posted |
|
||||||
| Results Delayed | |||||||
| Results Delay Reason | |||||||
| Date of the first journal publication of results |
|
||||||
| Baseline Characteristics | This was a prospective multicenter observational trial (UMIN000016781) conducted in 106 of 223 patients who underwent ESD between March 2015 and April 2016. We investigated age, sex, tumor location, ESD operation time, lesion size, duration of hospitalization, and frequency of PECS.？We defined PECS as local abdominal pain (evaluated on a visual analogue scale) in the region corresponding to the site of the ESD that occurred within 4 days of the procedure. |
||||||
| Participant flow | This was a prospective multicenter observational trial (UMIN000016781) conducted in 106 of 223 patients who underwent ESD between March 2015 and April 2016. We investigated age, sex, tumor location, ESD operation time, lesion size, duration of hospitalization, and frequency of PECS.？We defined PECS as local abdominal pain (evaluated on a visual analogue scale) in the region corresponding to the site of the ESD that occurred within 4 days of the procedure. |
||||||
| Adverse events | PECS occurred in 15/106 (14.2？%), and 10 were women ( P ？=？0.01, OR: 7.74 [1.6？-？36.4]), 7 had lesions in the cecum ( P ？<？0.001, OR: 20.6 [3.7？-？115.2]), and 9 in whom ESD operation time was >？90？min ( P ？=？0.002, OR: 10.3 [2.4？-？44.6]). Frequency of deviation from the prescribed clinical path was significantly higher (47？% [7/15] vs. 2？% [2/91], P ？<？0.001, OR: 38.9 [6.9？-？219.6]), and hospital stay was significantly longer in the PECS group. |
||||||
| Outcome measures | PECS occurred in 15/106 (14.2？%), and 10 were women ( P ？=？0.01, OR: 7.74 [1.6？-？36.4]), 7 had lesions in the cecum ( P ？<？0.001, OR: 20.6 [3.7？-？115.2]), and 9 in whom ESD operation time was >？90？min ( P ？=？0.002, OR: 10.3 [2.4？-？44.6]). Frequency of deviation from the prescribed clinical path was significantly higher (47？% [7/15] vs. 2？% [2/91], P ？<？0.001, OR: 38.9 [6.9？-？219.6]), and hospital stay was significantly longer in the PECS group. |
||||||
| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Main results already published | ||||||
| Date of protocol fixation |
|
||||||
| Date of IRB |
|
||||||
| Anticipated trial start date |
|
||||||
| Last follow-up date |
|
||||||
| Date of closure to data entry |
|
||||||
| Date trial data considered complete |
|
||||||
| Date analysis concluded |
|
||||||
| Other | |
| Other related information | Prospective observational Study |
| Management information | |||||||
| Registered date |
|
||||||
| Last modified on |
|
||||||
| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019100 |
