Protocol summary
-
Study aim
-
Determination of the results of early ostomy closure in patients with stage2,3 rectal cancer who underwent LAR.
-
Design
-
A clinical trial with a control group, with parallel, randomized groups, on 100 patients
-
Settings and conduct
-
Study place: In the surgical ward of Sinai Hospital in Tehran during 2015 and 2016.
According to the calculation, patients with stage 2,3 rectal cancer who have received neoadjuvant radiotherapy after L.A.R and implantation of protective ileostomy will be studied.
-
Participants/Inclusion and exclusion criteria
-
Including criteria:
(1) Patients with locally advanced rectal cancer (stage 2,3)
(2) Receive neoadjuvant radiotherapy.
(3) L.A.R and implantation of protective ileostomy
(4) Satisfaction with premature ostomy closure.
Excluding Criteria:
1- Leak evidence of anastomosis in the study of water-soluble contrast
2- Do not start Adj chemotherapy during 2-4 weeks after the first surgery
3- Dissatisfaction with ostomy closure
4- Occurrence of systemic complications not related to postoperative underlying disease including PTE, MI, CVA
5- Concomitant diseases such as diabetes, heart and lung failure
-
Intervention groups
-
Group A includes patients who meet the inclusion criteria after receiving the second dose of adjuvant chemotherapy and a week of rest after that (6 weeks of surgery) to close the ostomy, be hospitalized and undergo surgery.
Group B will also include eligible patients. In this group, ostomy adjuvant chemotherapy will be closed after the end of 6 courses. The evaluation of these patients during hospitalization and after discharge will be similar to the previous group.
-
Main outcome variables
-
Length of second operation, ostomy complications, Stage, type of operation, time interval between second operation and first operation, CEA, anastomotic complications
General information
-
Reason for update
-
Continue the patient recruitment process and increase the sample size and complete the information
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20201113049373N1
Registration date:
2021-01-02, 1399/10/13
Registration timing:
retrospective
Last update:
2021-06-15, 1400/03/25
Update count:
1
-
Registration date
-
2021-01-02, 1399/10/13
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2016-03-20, 1395/01/01
-
Expected recruitment end date
-
2017-09-21, 1396/06/30
-
Actual recruitment start date
-
2016-03-20, 1395/01/01
-
Actual recruitment end date
-
2019-09-21, 1398/06/30
-
Trial completion date
-
2020-01-20, 1398/10/30
-
Scientific title
-
Evaluation of the results of early ileostomy closure in patients with rectal cancer (stage 2,3) who underwent LAR surgery compared to the usual method (delayed closure after the end of chemotherapy adjuvant)
-
Public title
-
Early closure ileostomy in patients with rectal cancer (stage 2,3) who have undergone LAR surgery.
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
(1) Patients with locally advanced rectal cancer (stage 2,3)(2) Receive neoadjuvant radiotherapy.(3) L.A.R and implantation of protective ileostomy(4) Satisfaction with premature ostomy closure
Exclusion criteria:
1- Leak evidence of anastomosis in the study of water-soluble contrast 2- Do not start Adj chemotherapy during 2-4 weeks after the first surgery 3- Dissatisfaction with ostomy closure 4- Occurrence of systemic complications not related to postoperative underlying disease including PTE, MI, CVA 5- Concomitant diseases such as diabetes, heart and lung failure
-
Age
-
No age limit
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
No information
-
Sample size
-
Target sample size:
70
Actual sample size reached:
104
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Based on blockchain of quadruple numbers
For randomization, the variable blocks method was used, which was due to the ease of execution and balance in the number of groups. In this way, the samples were divided into A and B and for the four blocks, six modes were created and based on the number of samples, the cards were replaced.
AABB ABAB BBAA BABA ABBA BAAB
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2016-05-21, 1395/03/01
-
Ethics committee reference number
-
IR.TUMS.MEDICINE.REC.1396.3145
Health conditions studied
1
-
Description of health condition studied
-
Rectal cancer
-
ICD-10 code
-
C20
-
ICD-10 code description
-
Malignant neoplasm of rectum
Primary outcomes
1
-
Description
-
Complications of early ileostomy closure
-
Timepoint
-
1،2،3،4،5،14،30،90،180 day
-
Method of measurement
-
questionnaire
2
-
Description
-
Survival of patients
-
Timepoint
-
3,6,12 month
-
Method of measurement
-
questionnaire
Intervention groups
1
-
Description
-
Intervention group: Group A includes patients who meet the inclusion criteria after receiving the second dose of adjuvant chemotherapy and two week of rest after about (8weeks of surgery) to close the ostomy, be hospitalized and undergo surgery.
-
Category
-
Treatment - Surgery
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Tehran University of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Undecided - It is not yet known if there will be a plan to make this available
-
Study Protocol
-
Undecided - It is not yet known if there will be a plan to make this available
-
Statistical Analysis Plan
-
Undecided - It is not yet known if there will be a plan to make this available
-
Informed Consent Form
-
Yes - There is a plan to make this available
-
Clinical Study Report
-
Yes - There is a plan to make this available
-
Analytic Code
-
Undecided - It is not yet known if there will be a plan to make this available
-
Data Dictionary
-
Undecided - It is not yet known if there will be a plan to make this available
-
Title and more details about the data/document
-
Not all data can be shared
-
When the data will become available and for how long
-
Access period 6 months after printing
-
To whom data/document is available
-
All people
-
Under which criteria data/document could be used
-
All analyzes are possible on the data.
-
From where data/document is obtainable
-
dr.rahimpour83@gmail.com
00989123705047
-
What processes are involved for a request to access data/document
-
The request will be sent within about 2 weeks.
-
Comments
-