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Comparison of the results of ghost ileostomy versus protective ileostomy in low anterior resection surgery, in rectal cancer undergoing neoadjuvant chemo-radiotherapy.

Protocol summary

Study aim
To compare anastomotic leakage in two groups of patients with and without ileostmy
Design
Randomized clinical trial, no blindness, with control group in 2 groups of 40 rectal cancer patients (total of 80) with and without ghost ileostomy. Randomized with EXCEl software.
Settings and conduct
Randomized clinical double blind trial 80 rectal cancer patients Admitted In Emam khomeini hospital in Tehran, treated with surgery and doubled blinded with Excel software into two groups of 1- with ghost ileostomy 2- without ghost ileostomy
Participants/Inclusion and exclusion criteria
inclusion criteria: Patients undergone conventional chemoradiotherapy- anastomosis locations is 5 cm above the anal verge. exclusion criteria: adhesion; positive leak test; incomplete doughnut; obstruction or peritonitis-diabetes; age>75; immune suppressed.
Intervention groups
Intervention group: a loop of ileum is elevated under the fascia with a silk thread and the ghost ileostomy is made. Control group: ileostomy is matured in a classic method of surgery.
Main outcome variables
Anastomosis leakage; re exploration of abdomen; readmission; mortality; days of hospitalization.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120129008861N3
Registration date: 2021-01-10, 1399/10/21
Registration timing: retrospective

Last update: 2021-01-10, 1399/10/21
Update count: 0
Registration date
2021-01-10, 1399/10/21
Registrant information
Name
Mohammad Reza Keramati
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1657
Email address
mr-keramati@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-21, 1398/03/31
Expected recruitment end date
2020-07-21, 1399/04/31
Actual recruitment start date
2019-08-22, 1398/05/31
Actual recruitment end date
2020-09-21, 1399/06/31
Trial completion date
2020-11-20, 1399/08/30
Scientific title
Comparison of the results of ghost ileostomy versus protective ileostomy in low anterior resection surgery, in rectal cancer undergoing neoadjuvant chemo-radiotherapy.
Public title
Comparison of the results of ghost ileostomy versus protective ileostomy in rectal cancer.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Rectal cancer patients History of previous neoadjuvant chemoradiotherapy tumor located more than 5 cm from anal verge candidate for low anterior resection surgery
Exclusion criteria:
difficult surgery or excessive bleeding immune suppression , steroid use , malnutrition obstruction or peritonitis ASA score >3 BMI>30 Diabetes Age >75 years incomplete doughnut at the end of surgery positive air leak test of anastomosis
Age
To 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 80
Actual sample size reached: 63
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple Randomization; Random unit: Individual; Randomization tool: Excel; Randomization Output: 1=With Ghost Ileostomy 2=Without Ghost Ileostomy
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran university of medical sciences ethics committee
Street address
Tehran University of Medical Sciences, Poursina Avenue, Qods Street, Enqelab Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2018-04-22, 1397/02/02
Ethics committee reference number
IR.TUMS.IKHC.REC.1398.020

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
anastomosis leakage
Timepoint
anastomosis leakage 1week,1,3,6 months
Method of measurement
colonoscopy

2

Description
Abdomen re-explorization
Timepoint
Anytime the abdomen is re-explored for surgery
Method of measurement
Observation

3

Description
Mortality
Timepoint
Time of death one year from surgery
Method of measurement
Observation

4

Description
Re-admission
Timepoint
Date of re-admission 3 months after surgery
Method of measurement
Observation

Secondary outcomes

empty

Intervention groups

1

Description
Control group: protective ileostomy group
Category
Treatment - Surgery

2

Description
Intervention group: ghost ileostomy group
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mohamad Reza Keramati
Street address
End of Keshavarz Blvd,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119
Email
mr-keramati@razi.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamad Reza Keramati
Street address
Poursina street,Qods street, Enqelab square,Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6111 3411
Email
razi@tums.ac.ir
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

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Marzieh Ghanbari
Position
MD / Resident of Surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
end of Keshavarz avnue, Gharib st, Imam khomeini hospital
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119
Email
ghanbari.mrz@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Keramati
Position
Associate Professor of Surgery
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini hospital, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1657
Email
mr-keramati@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamad Reza Keramati
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini hospital, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1657
Email
mr-keramati@tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data will be shared after blinding of datasheet.
When the data will become available and for how long
Data will be shared within 6 months after publication.
To whom data/document is available
Data will be accessible for researchers affiliated to universities.
Under which criteria data/document could be used
Data can be used for further meta-analysis after permission of the person responsible for this project.
From where data/document is obtainable
Data request should be sent through email for the person responsible for this project. Dr. Mohammad Reza Keramati mr-keramati@tums.ac.ir
What processes are involved for a request to access data/document
Following the primary request, all the researchers will be informed by the responsible person and after permission the data will be shared.
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