UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042056 |
|---|---|
| Receipt number | R000047997 |
| Scientific Title | A randomized controlled trial of the effect of intraperitoneal prophylactic drain placement on postoperative quality of life after elective laparoscopic colon surgery |
| Date of disclosure of the study information | 2020/10/15 |
| Last modified on | 2020/10/08 21:32:52 |
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Basic information
Public title
Effect of intraperitoneal drainage on postoperative quality of life after laparoscopic colon surgery
Acronym
A study of the effect of drains on postoperative quality of life after colon surgery
Scientific Title
A randomized controlled trial of the effect of intraperitoneal prophylactic drain placement on postoperative quality of life after elective laparoscopic colon surgery
Scientific Title:Acronym
A randomized controlled trial of the effect of intraperitoneal prophylactic drain placement on postoperative quality of life after elective laparoscopic colon surgery
Region
| Japan |
Condition
Condition
colon surgery
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The effect of intraperitoneal prophylactic drains on postoperative quality of life after laparoscopic colon surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
SF-8 mental health score on postoperative day 3
Key secondary outcomes
Preoperative SF-8 Physical Health Score
Preoperative SF-8 mental health score
SF-8 physical health score on postoperative day 3
SF-8 physical health score on postoperative day 5
SF-8 mental health score on postoperative day 5
SF-8 physical health score at 1 month postoperatively
SF-8 mental health score at 1 month postoperatively
Incidence of infectious complications
period of hospitalization
post-operative pain
NRS on postoperative day 1
NRS on postoperative day 3
NRS on post-operative day 5
The eight subscales of the preoperative SF-8
(Physical functioning, daily role functioning, body pain, overall sense of health, vitality, Social life functioning, daily role functioning (mental) and mental health)
Eight subscales of the SF-8 on postoperative day 3
(physical functioning, daily role functioning, body pain, overall sense of well-being, vitality, social functioning, daily role functioning (mental), and mental health)
Eight subscales of the SF-8 on postoperative day 5
(physical functioning, daily role functioning, body pain, overall sense of well-being, vitality, social functioning, daily role functioning (mental), and mental health)
Eight subscales of the SF-8 at 1 month postoperatively
(physical functioning, daily role functioning, body pain, overall sense of well-being, vitality, social functioning, daily role functioning (mental), and mental health)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Place an intraperitoneal drain.
Interventions/Control_2
No intraperitoneal drains in place.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing laparoscopic colon surgery
Key exclusion criteria
Patients with peritonitis
Patients with serious lung disease with a rate of less than 50% per second
Patients with serious cardiac conditions of NYHA III or higher
Patients with HbA1c 8.0 or higher at the time of enrollment and with diabetes
Patients with cirrhosis of the liver with a Child classification of B or greater
Patients with impaired renal function with a serum Cr of 2 mg/dl at enrollment
Patients on dialysis
Patients with undecompressed preoperative bowel obstruction
Patients who received systemic steroids within 28 days prior to enrollment
Patients unable to obtain informed consent
Patients unable to complete the survey
Emergency surgery patients.
Patients who are considered inappropriate by their physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Miyake |
Organization
Shiga University of Medical Science
Division name
Department of Surgery
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga
TEL
077-548-2238
hqsurge1@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Miyake |
Organization
Shiga University of Medical Science
Division name
Department of Surgery
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga
TEL
077-548-2238
Homepage URL
hqsurge1@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
None
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
Shiga University of Medical Science Research Ethics Committee.
Address
Seta Tsukinowa-cho, Otsu, Shiga
Tel
077-548-3576
hqrec@belle.shiga-med.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
滋賀医科大学医学部附属病院
(Shiga University of Medical Science Hospital)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 15 | 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
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
Preinitiation
Date of protocol fixation
| 2020 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 08 | Day |
Last modified on
| 2020 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047997
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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