UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Postoperative analgesia after laparoscopic colectomy
Title of the study (Brief title)	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	Akinobu Taketomi
Organization	Hokkaido University Graduate School of Medicine
Division name	Gastroenterological Surgery I
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	Shigenori Homma
Organization	Hokkaido University Hospital
Division name	Gastroenterological Surgery I
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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