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IRCT20211101052935N2 IRCT 2023-01-22 Shahid Beheshti University of Medical Sciences Solitary rectal ulcer endoscopic trial The efficiency of endoscopic resection of polypoid solitary rectal ulcer syndrome (SRUS) compared to Delorme's procedure: A clinical trial. 2017-03-16 anticipated 50 Complete https://irct.ir/trial/67889 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization with a sealed previously prepared envelope. N/A Polypoid variant of rectal solitary ulcer syndrome. Intervention 1: Intervention group: Endoscopic polypoid resection as a novel low-risk and low-complication surgical method. Intervention 2: Control group: Delorme procedure as one of the standard methods of treatment of solitary rectal ulcer syndrome. Yes - There is a plan to make this available What will be shared: Only a portion of the potential data related to the primary outcome can be shared after de-identifying individuals. When: After publishing the article To whom: The data will be available to researchers Conditions: It can be used in secondary studies or studies with Bayesian analysis Where to obtain: 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 How to obtain: After receiving the email, the requested information will be sent in less than a week. Comments:
public Mohsen Rajabnia
Gastroenterology and Liver Diseases Research Institute, No 1, Ayatollah Taleghani Hospital, Shahid Arabi Ave., Yaman St., Shahid Chamran Highway, Tehran.
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2243 2560 dr.rajabnia@outlook.com Shahid Beheshti University of Medical Sciences scientific Mohsen Rajabnia
Gastroenterology and Liver Diseases Research Institute, No 1, Ayatollah Taleghani Hospital, Shahid Arabi Ave., Yaman St., Shahid Chamran Highway, Tehran.
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2243 2560 dr.rajabnia@outlook.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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 no limit no limit Both 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 K62.6 Ulcer of anus and rectum Treatment - Surgery Treatment - Surgery Intervention group: Endoscopic polypoid resection as a novel low-risk and low-complication surgical method Control group: Delorme procedure as one of the standard methods of treatment of solitary rectal ulcer syndrome 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. Doctor Mojgan Forootan Approved 2021-12-15 Ethics committee of Shahid Behrshti University of Medical Sciences Ayatollah Taleghani Hospital, Shahid Arabi Ave., Yaman St., Shahid Chamran Highway, Tehran. Tehran Tehran Iran (Islamic Republic of)