UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048220 |
|---|---|
| Receipt number | R000054950 |
| Scientific Title | Randomized Controlled Clinical Trial on Lateral Invagination of the Colorectal Anastomosis by Double Stapling |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2022/07/01 12:33:27 |
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Basic information
Public title
Randomized Controlled Clinical Trial on Lateral Invagination of the Colorectal Anastomosis by Double Stapling
Acronym
ILAC Trial
Scientific Title
Randomized Controlled Clinical Trial on Lateral Invagination of the Colorectal Anastomosis by Double Stapling
Scientific Title:Acronym
ILAC Trial
Region
| Japan | Europe |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the double staple colorectal anastomosis lateral invagination technique reduces the incidence of suture dehiscence compared to the conventional anastomotic technique.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the rate of anastomotic dehiscence diagnosed in the first 30 postoperative days.
Key secondary outcomes
1. Duration of surgery (min)
2. Perioperative morbidity (TF: 30 and 90 days postoperative, or in hospital) using the Clavien-
Dindo classification.
3. Perioperative mortality (TF: 30 and 90 days postoperative, or in hospital)
4. Hospital stay.
5. Hospital readmissions
6. Surgical reinterventions
7. Stoma-free survival 1 year after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Anastomosis with double stapling technique
Interventions/Control_2
Anastomosis with lateral invagination technique
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Age> 18 years
- Indication of resection of the left colon, sigmoid or upper rectum
- Minimally invasive approach
- Open surgery approach
- Double staple colorectal anastomosis
- Signed informed consent for inclusion in the study
Key exclusion criteria
- Patients <18 years
- Pregnancy
- ASA> III
- Absolute contraindication for anesthesia
- Patients who receive more than 1 gastrointestinal anastomosis during the same procedure
- Planned multi-organ resection during the same procedure
- Urgent / emergent surgery
- Reinforced anastomosis after positive intraoperative leak test
- Patients with simultaneous application of debulking and HIPEC
- Crohn's disease or active ulcerative colitis
Target sample size
786
Research contact person
Name of lead principal investigator
| 1st name | Antonio |
| Middle name | M |
| Last name | Lacy |
Organization
HOSPITAL CLINIC DE BARCELONA
Division name
GASTROINTESTINAL SURGERY DEPARTMENT
Zip code
08036
Address
Carrer de Villarroel, 170 08036 Barcelona, Spain
TEL
34932275402
alacy@clinic.cat
Public contact
Name of contact person
| 1st name | Carolina |
| Middle name | |
| Last name | Gonzalez |
Organization
HOSPITAL CLINIC DE BARCELONA
Division name
GASTROINTESTINAL SURGERY DEPARTMENT
Zip code
08036
Address
Carrer de Villarroel, 170 08036 Barcelona, Spain
TEL
34932275402
Homepage URL
carol.gonzaleza@gmail.com
Sponsor or person
Institute
HOSPITAL CLINIC DE BARCELONA
Institute
Department
Personal name
Funding Source
Organization
HOSPITAL CLINIC DE BARCELONA
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Comite de Etica de la Investigacion con medicamentos del Hospital Clinic de Barcelona
Address
Villarroel, 170-08036 Barcelona (Espana)
Tel
93 227 54 00
dvargas@clinic.cat
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 01 | Day |
Last modified on
| 2022 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054950
