Determine the efficacy of Appendicostomy in reducing the psychological complications of patients undergoing APR (Abdominoperineal resection) surgery
Determine the efficacy of Appendicostomy in gas incontinence of patients undergoing APR surgery
Determine the efficacy of Appendicostomy in satisfaction of patients undergoing APR surgery
Design
Two arm parallel group randomized controlled concurrent clinical trial
Settings and conduct
Patients with rectal cancer are admitted to the surgery department of Imam Khomeini Hospital in Sari. Patients will be divided into two groups using random numbers. A group undergoing abdominoprenal resection without appendicostomy, and in second group abdominoprenal resection is performed with appendicostomy.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all patients with a diagnosis of rectal cancer by a pathologist faculty member based on World Health Organization criteria. Includes operable low and very low rectal cancer, or those with a high stage rectal cancer who after neoadjuant therapy are down stage and operable. Exclusion criteria: heart failure, mental retardation, diabetes, high dose corticosteroid therapy and other deseases that have effect on wound healing.
Intervention groups
Patients undergoing abdominoperineal resection with or without appendicostomy
Main outcome variables
Improvement of functional results, control of gas incontinence and quality of life in patients with rectal cancer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180514039651N1
Registration date:2018-06-13, 1397/03/23
Registration timing:registered_while_recruiting
Last update:2018-06-13, 1397/03/23
Update count:0
Registration date
2018-06-13, 1397/03/23
Registrant information
Name
Amin Salimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3339 1126
Email address
dr.aminsalimi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-31, 1396/10/10
Expected recruitment end date
2018-12-31, 1397/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of appendicostomy on functional outcomes and quality of life in patients undergoing surgery abdominoperineal resection due to rectal cancer
Public title
Appendicostomy in rectal cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Rectal adenocarcinoma confirmed by pathology
Patients with operable low or very low Rectal cancer or patients with operable high stage Rectal cancer after neoadjuvant therapy
Exclusion criteria:
Heart failure
Mental retardation
Diabetes
High dose Corticosteroid therapy
Immunodeficiency
Cases that have delay in wound healing
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
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
Ethics committee of Sari University of Medical Sciences
Street address
Tohid Alley, Shahband Ave.,
City
Sari
Province
Mazandaran
Postal code
4815696869
Approval date
2018-04-22, 1397/02/02
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1397.1150
Health conditions studied
1
Description of health condition studied
Rectal cancer
ICD-10 code
C21.8
ICD-10 code description
Malignant neoplasm of overlapping sites of rectum, anus and anal canal
Primary outcomes
1
Description
Quality of life score of EORTC-QLQ-C30 (The European organization for research and treatment of cancer quality of life questionnaire)
Timepoint
3, 6, 12 months after surgery
Method of measurement
EORTC-QLQ-C30(The European organization for research and treatment of cancer quality of life questionnaire)
2
Description
Evaluation of continence in Wexner questinnaire
Timepoint
3, 6, 12 months after surgery
Method of measurement
Wexner questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Appendicostomy: Surgery is done in two steps. First, after the release of the disending colon, the inferior mesenteric artery and vein are high ligated. The sigmoid colon is removed from the middle portion. Then the perineal phase is done and The complex of anal sphincter and the rectum and distal sigmoid are resected and left side colostomy are inserted and perineal incision are closed. At the same time, an appendicectomy is inserted for patient.To do this, the appendix is dissected and the longitudinal insision of the distal appendices is done,then in right lower quadrant skin U shape insision is performed and anti mesenteric edges are sutured to the skin with 4-0 absorbable. A small catheter is placed in the appendicectomy for a week and the first antegrade enema with one liter of water is done. The necessary care and method of using appendicectomy is given to patients before discharge.
Category
Treatment - Surgery
2
Description
Control group: without appendicostomy: First, after the release of the disending colon, the inferior mesenteric artery and vein are high ligated. The sigmoid colon is removed from the middle portion. Then the perineal phase is done and The complex of anal sphincter and the rectum and distal sigmoid are resected and left side colostomy are inserted and perineal incision are closed.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mina Alvandipour
Street address
Amir Mazandarani Ave.
City
Sari
Province
Mazandaran
Postal code
4416633131
Phone
+98 11 3335 0670
Email
dr.aminsalimi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Mazandaran University of Medical Sciences, Joybar three ways
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3324 9815
Email
dr.aminsalimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Amin Salimi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Shahband Ave., Tohid all.
City
Sari
Province
Mazandaran
Postal code
4815696869
Phone
+98 935 856 6806
Email
dr.aminsalimi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Amin Salimi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Shahband Ave., Tohid all.
City
Sari
Province
Mazandaran
Postal code
4815696869
Phone
+98 935 856 6806
Email
dr.aminsalimi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Amin Salimi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Shahband Ave., Tohid all.
City
Sari
Province
Mazandaran
Postal code
4815696869
Phone
+98 935 856 6806
Email
dr.aminsalimi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
The questionnaie of patients
When the data will become available and for how long
At the same as the results
To whom data/document is available
University researchers
Under which criteria data/document could be used
...
From where data/document is obtainable
Sari Imam Khomeini Hospital
What processes are involved for a request to access data/document