UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010658 |
|---|---|
| Receipt number | R000012465 |
| Scientific Title | A Randomized, Prospective, Double-blind, Placebo-controlled Trial of the Effect of Diltiazem Gel on Pain after Hemorrhoidectomy |
| Date of disclosure of the study information | 2014/01/01 |
| Last modified on | 2013/05/07 19:59:53 |
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Basic information
Public title
A Randomized, Prospective, Double-blind, Placebo-controlled Trial of the Effect of Diltiazem Gel on Pain after Hemorrhoidectomy
Acronym
The Effect of Diltiazem Gel on Pain after Hemorrhoidectomy
Scientific Title
A Randomized, Prospective, Double-blind, Placebo-controlled Trial of the Effect of Diltiazem Gel on Pain after Hemorrhoidectomy
Scientific Title:Acronym
The Effect of Diltiazem Gel on Pain after Hemorrhoidectomy
Region
| Japan |
Condition
Condition
Goligher 3rd or 4th degree hemorrhoids
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We have evaluated the effects of topical diltiazem on the postoperative pain after hemorrhoidectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The postoperative pain scores,oral analgesic tablets consumed, wound healing, and patient satisfaction score.
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients receive diltiazem gel.
Interventions/Control_2
Patients receive Placebo gel.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who had Goligher 3rd or 4th degree hemorrhoids
Key exclusion criteria
patients with a history of current calcium channel blocker use, ischemic heart disease, pregnancy, severe hypertension, orthostatic hypotension, previous anal operation, incarcerated hemorrhoid, or American Society of Anesthesiologists physical status (ASA-PS) classification 3 and 4
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Tsunoda |
Organization
Kameda Medical Center
Division name
Surgery
Zip code
Address
929 Higashi-cho, Kamogawa-city
TEL
04-7092-2211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kameda Medical Center
Division name
Surgery
Zip code
Address
929 Higashi-cho, Kamogawa-city
TEL
04-7092-2211
Homepage URL
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
Funding Source
Organization
Kameda Medical Center
Organization
Division
Category of Funding Organization
Self funding
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
亀田総合病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 01 | 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
The postoperative pain scores tended lower in the diltiazem group during defecation. Oral analgesic tablets consumed was higher in the placebo group when considered on a daily basis, but the difference did not reach a statistical significance. Total incidence of complications was significantly higher in the diltiazem group than in the placebo group, although each incidence of complication was not significantly different between the groups. There was no significant difference in the incidence of edema on 1 week, wound healing on week 3, or anal stenosis on week 6. Patient satisfaction score was not different between the groups.
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
| 2010 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2012 | Year | 05 | Month | 04 | Day |
Date of closure to data entry
| 2012 | Year | 05 | Month | 04 | Day |
Date trial data considered complete
| 2012 | Year | 05 | Month | 04 | Day |
Date analysis concluded
| 2012 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 07 | Day |
Last modified on
| 2013 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012465
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
