UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040756 |
|---|---|
| Receipt number | R000046537 |
| Scientific Title | Prospective study of postoperative analgesia with or without epidural anesthesia in laparoscopic colectomy |
| Date of disclosure of the study information | 2020/06/14 |
| Last modified on | 2024/12/17 10:40:56 |
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Basic information
Public title
Prospective study of postoperative analgesia with or without epidural anesthesia in laparoscopic colectomy
Acronym
Prospective study of postoperative analgesia with or without epidural anesthesia in LAC
Scientific Title
Prospective study of postoperative analgesia with or without epidural anesthesia in laparoscopic colectomy
Scientific Title:Acronym
Prospective study of postoperative analgesia with or without epidural anesthesia in LAC
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine whether analgesic methods without epidural anesthesia can achieve the same analgesic effect as epidural anesthesia in postoperative analgesia of laparoscopic colectomy for colorectal cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analog Scale (VAS) pain score 7 days after surgery
Key secondary outcomes
Minimum value of VAS scale 7 days after surgery
Time from entering the operating room to the start of surgery
Incidence of postoperative complications
Time until first walking and exhaust gas after surgery
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
1)Histologically confirmed colorectal cancer
2)Laparoscopic primary tumor resection
3)No simultaneous resection, but ostomy is acceptable
4)Adequate organ function as evidenced by the following laboratory studies within 28 days prior to enrollment;
PLT >= 80,000 /mm3
PT-INR =< 1.1
APTT =<39 sec
5)Age:>=20 years old
6)Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
7) Appropriate answers to questionnaires
8) Written informed consent
Key exclusion criteria
1) Emergency surgery
2) Use of anticoagulants and antiplatelet drugs
3) Severe drug hypersensitivity
4) Women during pregnancy or possible pregnancy
5) Other conditions judged ineligible by physician
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Shiozawa |
Organization
Kanagawa Cancer Center
Division name
Department of Gastrointestinal Surgery
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa, JAPAN
TEL
045-520-2222
shiozawam@kcch.jp
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Kato |
Organization
Kanagawa Cancer Center
Division name
Department of Gastrointestinal Surgery
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa, JAPAN
TEL
045-520-2222
Homepage URL
kato_12th@yahoo.co.jp
Sponsor or person
Institute
Kanagawa Cancer Center
Department of Gastrointestinal Surgery
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Cancer 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
Kanagawa Cancer Center
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa, JAPAN
Tel
045-520-2222
chiken-jimu4@kcch.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
神奈川県立がんセンター（神奈川県）、横浜市立大学附属病院（神奈川県）、横浜南共済病院（神奈川県）、秦野赤十字病院（神奈川県）、平塚共済病院（神奈川県）、藤沢湘南台病院（神奈川県）、済生会横浜市南部病院（神奈川県）、足柄上病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 14 | Day |
Related information
URL releasing protocol
none
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1007/s00595-024-02856-4
Number of participants that the trial has enrolled
154
Results
We compared an EDA group (Group E, n=48) and a no-EDA group (Group O, n=48) after matching. The mean VAS was not significantly different between the groups.The highest VAS was not significantly different between the groups. The VAS was lower in Group E only on POD 2. There was no difference in the incidence of complications, the time to first postoperative evacuation was shorter in Group E, and postoperative hospitalization was similar. The time to surgery was shorter in Group O.
Results date posted
| 2024 | Year | 12 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 05 | Month | 04 | Day |
Baseline Characteristics
After matching, there were no differences in the background characteristics of the two groups, including age, sex, BMI, PS, and surgical procedure. The mean age of all patients was 67.8 years. There were no cases of open conversion in either group. The TRS was shorter in Group O than in Group E (51 min vs. 64 min, respectively).
Participant flow
Patients were given verbal and written information on the study before written consent was obtained.
Adverse events
The anesthetic complications included PONV (n = 3), urinary retention (n = 1), and SSI (n = 1) in Group E, and PONV (n = 4) and SSI (n = 3) in Group O. The surgical complications included anastomotic leakage (n = 1) and bowel obstruction (n = 1) in Group E, and anastomotic leakage (n = 2), intra-abdominal abscess (n = 4), and bowel obstruction (n = 4) in Group O. There were no significant differences between the two groups in the incidence of any postoperative complications. The number of days to first postoperative evacuation was shorter in Group E, but there was no significant difference in the length of postoperative hospital stay.
Outcome measures
Later Entry
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
By comparing postoperative analgesic method with or without epidural anesthesia, it is clarified whether a sufficient analgesic effect can be obtained without using epidural anesthesia, in laparoscopic colectomy for colorectal cancer.
Thereby, selection and standardization of a more appropriate postoperative analgesia in laparoscopic colectomy can be aimed at.
Management information
Registered date
| 2020 | Year | 06 | Month | 14 | Day |
Last modified on
| 2024 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046537
