The purpose of this clinical trial is to assess the effectiveness of endoscopic resection in alleviating the symptoms of patients suffering from polypoid solitary rectal ulcer syndrome and compare it with Delorme's procedure.
Design
Clinical trial with control group, with parallel groups, without blinding, and randomized. A sealed envelope was used for randomization.
Settings and conduct
Patients with polypoid type of solitary rectal ulcer syndrome, referring to Taleghani Hospital in Tehran, will receive one of the interventions randomly in two groups of 25 people.
Participants/Inclusion and exclusion criteria
Inclusion criteria were: symptoms such as rectorrhagia, mucosal discharge, dyschezia, rectal tenesmus, or the need for anal digitation; Confirmation of polypoid solitary rectal ulcer syndrome in colonoscopy and pathology prepared from biopsy
Exclusion criteria were:
High-risk patients for anesthesia; Patients taking warfarin; Patients who should not have their polyps removed; Patients with cardiovascular disorders; Patients with coagulation problems; People with systemic diseases; Patients who cannot diet; Patient's non-cooperation; Failure to attend for biofeedback; Patients for whom biofeedback treatment is not effective
Intervention groups
One group of patients underwent endoscopic resection and the other group, as a control group, underwent surgical intervention with the Delorme procedure.
Main outcome variables
Clinical manifestations
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211101052935N2
Registration date:2023-01-22, 1401/11/02
Registration timing:retrospective
Last update:2023-01-22, 1401/11/02
Update count:0
Registration date
2023-01-22, 1401/11/02
Registrant information
Name
Mohsen Rajabnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2303 1799
Email address
dr.rajabnia@outlook.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-16, 1395/12/26
Expected recruitment end date
2021-12-30, 1400/10/09
Actual recruitment start date
2017-06-18, 1396/03/28
Actual recruitment end date
2021-10-16, 1400/07/24
Trial completion date
2022-09-17, 1401/06/26
Scientific title
The efficiency of endoscopic resection of polypoid solitary rectal ulcer syndrome (SRUS) compared to Delorme's procedure: A clinical trial.
Public title
Solitary rectal ulcer endoscopic trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
symptoms such as rectorrhagia, mucosal discharge, dyschezia, rectal tenesmus, and the need for anal digitation
Confirmation of polypoid solitary rectal ulcer syndrome in colonoscopy and pathology prepared from biopsy
Exclusion criteria:
High-risk patients for anesthesia
Patients taking warfarin
Patients who should not have their polyps removed
Patients with cardiovascular disorders
Patients with coagulation problems
People with systemic diseases
Patients who cannot diet
Patient's non-cooperation
Failure to attend for biofeedback
Patients for whom biofeedback treatment is not effective
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
35
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with a sealed previously prepared envelope
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 Shahid Behrshti University of Medical Sciences
Polypoid variant of rectal solitary ulcer syndrome
ICD-10 code
K62.6
ICD-10 code description
Ulcer of anus and rectum
Primary outcomes
1
Description
The patient's clinical symptoms including rectorrhagia, obstruction, rectal tenesmus, anal digitation, painful defecation, and mucus defecation.
Timepoint
At the beginning of the study (before the start of the intervention), 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years after the procedure
Method of measurement
Questions about the patient's symptoms and checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Endoscopic polypoid resection as a novel low-risk and low-complication surgical method
Category
Treatment - Surgery
2
Description
Control group: Delorme procedure as one of the standard methods of treatment of solitary rectal ulcer syndrome
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital-Tehran
Full name of responsible person
Mohsen Rajabnia
Street address
Gastroenterology and Liver Diseases Research Institute, No 1, Ayatollah Taleghani Hospital, Shahid Arabi Ave., Yaman St., Shahid Chamran Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
dr.rajabnia@outlook.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mojgan Forootan
Street address
Gastroenterology and Liver Diseases Research Institute, No 1, Ayatollah Taleghani Hospital, Shahid Arabi Ave., Yaman St., Shahid Chamran Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 912 326 5382
Email
mojganforootan@sbmu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Doctor Mojgan Forootan
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohsen Rajabnia
Position
Adult gastroenterology and hepatology subspecialist assistant
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Gastroenterology and Liver Diseases Research Institute, No 1, Ayatollah Taleghani Hospital, Shahid Arabi Ave., Yaman St., Shahid Chamran Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
dr.rajabnia@outlook.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohsen Rajabnia
Position
Gastroenterology and hepatology subspecialist assistant
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Gastroenterology and Liver Diseases Research Institute, No 1, Ayatollah Taleghani Hospital, Shahid Arabi Ave., Yaman St., Shahid Chamran Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
dr.rajabnia@outlook.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Erfan Ghadirzadeh
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Sari, Amir Mazandarani Street, Imam Khomeini Hospital, Gastroenterology and Liver Diseases Research Institute
City
Sari
Province
Mazandaran
Postal code
4816117949
Phone
+1133033406
Email
e.ghadirzadeh@mazums.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
Yes - There is 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
Only a portion of the potential data related to the primary outcome can be shared after de-identifying individuals.
When the data will become available and for how long
After publishing the article
To whom data/document is available
The data will be available to researchers
Under which criteria data/document could be used
It can be used in secondary studies or studies with Bayesian analysis
From where data/document is obtainable
After publication of the article resulted from this data, they can make contact with the corresponding author to receive the documents:
Dr. Mojgan Forootan
mfrootan2003@yahoo.com
+989123265382
What processes are involved for a request to access data/document
After receiving the email, the requested information will be sent in less than a week.