UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025821 |
|---|---|
| Receipt number | R000029694 |
| Scientific Title | Postoperative analgesia after laparoscopic colectomy |
| Date of disclosure of the study information | 2017/01/24 |
| Last modified on | 2017/01/24 13:41:05 |
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Basic information
Public title
Postoperative analgesia after laparoscopic colectomy
Acronym
Postoperative analgesia after laparoscopic colectomy
Scientific Title
Postoperative analgesia after laparoscopic colectomy
Scientific Title:Acronym
Postoperative analgesia after laparoscopic colectomy
Region
| Japan |
Condition
Condition
Colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effective analgesic therapy after laparoscopic colectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative pain score and the need for rescue analgesic drugs
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All consecutive patients who underwent elective LCR for primary colon cancers between June 2008 and August 2015 at Hokkaido University Hospital.
Key exclusion criteria
Patients with colon cancers in pathologic stage IV, those with reduced port surgery, and those who required conversion to open surgery or underwent multiple organ resection.
Target sample size
196
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akinobu Taketomi |
Organization
Hokkaido University Graduate School of Medicine
Division name
Gastroenterological Surgery I
Zip code
Address
Kita-15, Nishi-7, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5927
taketomi@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigenori Homma |
Organization
Hokkaido University Hospital
Division name
Gastroenterological Surgery I
Zip code
Address
Kita-14, Nishi-5, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5927
Homepage URL
homma.s@nifty.com
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients: all consecutive patients who underwent elective laparoscopic colon resection for primary colon cancers between June 2008 and August 2015 at Hokkaido University. Excluded from this retrospective analysis were patients with colon cancers in pathologic stage IV, those with reduced port surgery, and those who required conversion to open surgery or underwent multiple organ resection.
Study design: a reterospective comparative study
Methods: The patients in group E received epidural analgesia before the induction of general anesthesia. Soon after surgery, the patients were given 0.2 % ropivacaine continuously at a rate of 4 mL/h via an epidural catheter. The catheter was removed after 72 h.
The operations in the group FC patients were performed under general anesthesia alone, without epidural anesthesia. Soon after surgery, intravenous fentanyl citrate (20 ug/h)(Fentanyl Injection; Janssen Pharmaceutical K.K., Tokyo, Japan) was started and continued for 24 h. Subsequently,on the morning of postoperative day 1, the patients were also given 200 mg celecoxib (Celecox; Astellas Pharma, Tokyo, Japan) twice a day orally, for 7 days.
To evaluate the degree of postoperative pain, we used the Wong-Baker FACES Pain Scale. The rescue analgesic requirements were evaluated according to the number of times these rescue analgesic drugs were used
during the first 7 days after surgery.
Management information
Registered date
| 2017 | Year | 01 | Month | 24 | Day |
Last modified on
| 2017 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029694
