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Evaluation of endoscopic management of anastomosis leakage in rectal cancer patient operated in colorectal surgery ward in Imam Khomeini hospital in 2022-2023

Protocol summary

Study aim
Evaluation of endoscopic management in anastomosis leakage after low anterior resection in rectal cancer patients.
Design
Non randomised, non blinded, clinical trial, designed for 10 patients who undergo low anterior resection for rectal cancer and had anastomosis leakage.
Settings and conduct
All rectal cancer patients who undergo low anterior resection and have anastomosis leakage after surgery, and don't have peritonitis,are involved. endoscopic management for leakage include washing with serum and brushing is done weekly or more ad demanded for patients in endoscopy unit in colorectal ward of Imam Khomeini hospital.
Participants/Inclusion and exclusion criteria
Patients who undergo low anterior resection for rectal cancer and have anastomosis leakage.
Intervention groups
Colonoscopic washing and brushing of sinus formation around anastomosis leakage site
Main outcome variables
Anastomosis leakage repair; no dischagre from anastomosis site

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120129008861N6
Registration date: 2023-05-04, 1402/02/14
Registration timing: retrospective

Last update: 2023-05-04, 1402/02/14
Update count: 0
Registration date
2023-05-04, 1402/02/14
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
2022-12-26, 1401/10/05
Expected recruitment end date
2023-02-24, 1401/12/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of endoscopic management of anastomosis leakage in rectal cancer patient operated in colorectal surgery ward in Imam Khomeini hospital in 2022-2023
Public title
Evaluation of endoscopic management of anastomosis leakage in rectal cancer patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Anastomosis leakage Low anterior resection of rectal cancer
Exclusion criteria:
Peritonitis, Acute abdomen Patient don't accept endoscopic management
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
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
2022-11-15, 1401/08/24
Ethics committee reference number
IR.TUMS.IKHC.REC.1401.241

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
Repair of anastomosis leakage
Timepoint
Weekly until anastomosis leakage is repaired
Method of measurement
By colonoscopy

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: endoscopic washing with serum and brushing of fibrotic and granulation tissue
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran University of Medical Sciences, Imam Khomeini Hospital
Full name of responsible person
Dr. Mohammad Reza Keramati
Street address
Imam Khomeini Hospital, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
123454567890
Phone
+98 21 6119 0000
Email
mr-keramati@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nima Rezayi
Street address
Keshavarz Blvd, Ghods St, Poursina Ave. Faculty of Medicine
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6641 8466
Fax
+98 21 6641 8466
Email
rezaei_nima@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran medical university
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
Aazam Rahimi
Position
colorectal surgery fellowship
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini hospital surgery ward, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 6119 2607
Fax
+98 21 6119 2606
Email
azamrahimi7878@yahoo.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
Aazam rahimi
Position
fellowship of colorectal surgery
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini hospital surgery ward, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 6119 2607
Fax
+98 21 6119 2606
Email
azamrahimi7878@yahoo.com
Web page address

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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