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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025821
Receipt No. R000029694
Scientific Title Postoperative analgesia after laparoscopic colectomy
Date of disclosure of the study information 2017/01/24
Last modified on 2017/01/24

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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
Email 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
Email homma.s@nifty.com

Sponsor
Institute Hokkaido University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029694

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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