UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039902 |
|---|---|
| Receipt number | R000045510 |
| Scientific Title | Prospective cohort study on postoperative complications of functional end-to-end anastomosis in colectomy |
| Date of disclosure of the study information | 2020/03/23 |
| Last modified on | 2024/09/25 12:00:01 |
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Basic information
Public title
Prospective cohort study on postoperative complications of functional end-to-end anastomosis in colectomy
Acronym
Prospective cohort study on postoperative complications of functional end-to-end anastomosis in colectomy
Scientific Title
Prospective cohort study on postoperative complications of functional end-to-end anastomosis in colectomy
Scientific Title:Acronym
FEEA study
Region
| Japan |
Condition
Condition
colorectal disease
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate postoperative complications of functional end-to-end anastomosis in colorectal resection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of early postoperative complications
Key secondary outcomes
Anastomosis-related complications
incidence of suture failure
operation time
Number of days required to discharge hospital 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.A colectomy with functional end-to-end anastomosis is planned for colorectal disease.
2.Over 20 years old
3.ECOG Performance Status (PS) 0-2
4.Organ function is sufficient and surgery can be performed safely.
5.Written informed consent from patient.
Key exclusion criteria
1.Scheduled resection of other organs
2.Scheduled anastomoses at multiple locations
3.Severe complications
Target sample size
300
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 Prefecture
TEL
0455202222
shiozawam@kcch.jp
Public contact
Name of contact person
| 1st name | Sumito |
| Middle name | |
| Last name | Sato |
Organization
Kanagawa Cancer center
Division name
Department of Gastrointestinal Surgery
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL
0455202222
Homepage URL
m.sato@kcch.jp
Sponsor or person
Institute
Kanagawa Cancer center
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 Caner Center
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
Tel
0455202222
m.sato@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）
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）
平塚共済病院（神奈川県）
秦野赤十字病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 23 | Day |
Related information
URL releasing protocol
none
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10151-024-02958-8
Number of participants that the trial has enrolled
302
Results
The incidence of anastomotic leakage was 1.7%.
The FEEA could be performed safely regardless of the anastomosis procedure.
The one-step technique with simultaneous excisional anastomosis required fewer staplers.
Results date posted
| 2024 | Year | 09 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 07 | Month | 09 | Day |
Baseline Characteristics
Among the 302 patients who underwent colonic resection at the seven hospitals during the study period, nine were excluded because of intraoperative findings that led to a change in procedure: three patients required more than one anastomosis, two required a hand-sewn anastomosis, one required an end-to-end anastomosis, one had a colostomy without anastomosis, one had an ileal tumour intraoperatively, and one was unassessable. The remaining 293 eligible patients were included in the final analysis. The demographic and clinicopathological data are summarised in Table 1. FEEA was created using the OS method in 194 patients (66.2%) and the TS method in 99 patients (33.8%). The baseline characteristics, including patient age, sex, body mass index, and ECOG-PS score, were similar between the groups. The proportion of patients receiving antithrombotic agents was higher in the TS group (10.8% vs. 22.2%; p = 0.01).
Participant flow
All participants provided written informed consent before enrolment in the study.
Adverse events
Complication rates were similar between the OS and TS groups.
Outcome measures
The primary endpoint of the study was the postoperative abdominal complication rate in the OS and TS groups. In this study, anastomotic leakage, anastomotic bleeding, intra-abdominal abscess, enteritis, ileus, surgical site infection, and other abdominal complications were defined as surgery-related abdominal complications. Complication grade was determined according to the Clavien Dindo classification system, and grade II or higher complications were evaluated in this study. The secondary endpoints were the number of staplers used for anastomosis, operative time, and bleeding. In addition, we used multivariate analysis to determine whether differences in the anastomosis procedures (OS or TS) contributed to postoperative surgery-related abdominal complications.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, We investigate the method for functional end-to-end anastomosis in colectomy in each hospital, and we assess perioperative complications and short-term outcomes.
Management information
Registered date
| 2020 | Year | 03 | Month | 23 | Day |
Last modified on
| 2024 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045510
