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IRCT20111211008375N17 IRCT 2018-09-23 Birjand University of Medical Sciences Evaluation of the efficacy of topical sucralfate on hemorrhoidectomy wound healing process and pain severity Evaluation of the efficacy of topical sucralfate on hemorrhoidectomy wound healing process and pain severity 2017-05-10 anticipated 40 Complete https://irct.ir/trial/30412 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Balanced block randomization, Blinding description: This study is conducted as a single blinded investigation for participants. The main reason for single blinding is the absence of another surgeon for the study. 2-3 The effect of topical sucralfate on hemorrhoidectomy wound healing process .. Intervention 1: Investigation group: In the investigation group, after open hemorrhoidectomy (by Milligan-Morgan method) and complete homeostasis and ensuring of the absence of bleeding, a gauze with 10%sucralfate ointment will be applied on the operation site and the patient will be transferred to recovery. The gauze will be placed inside the anal canal for 24 hours. After that the sucralfate ointment will be applied by the patient after each defecation. Intervention 2: Control group: In this group, after open hemorrhoidectomy (by Milligan-Morgan method) and complete homeostasis and ensuring of the absence of bleeding, a gauze with placebo(vaseline) will be applied on the operation site and patient will be transferred to recovery.The gauze will be placed inside the canal for 24 hours. After that the placebo (vaseline) will be applied by the patient after each defecation. Yes - There is a plan to make this available What will be shared: The shared data will include a patient-specific file for both control and intervention groups, including age and gender, and the patients responses in each step of the study to any intervention. This includes only parts of the entire data. When: Data access starts in 1398 (2020) and ends in 1400 (2022). To whom: The data can be sent to all students and researchers affiliated to medical universities of Iran. Conditions: The applicants must provide the general information about their place of employment or university, the student number and the reason for requesting this information in their request e-mail. Obviously, if they have the data, they can perform tests in order to verify the accuracy of the statistical analysis. but any other use Without the permission of the researcher of this study is not allowed. Where to obtain: Applicants can send their requests to Doctor Vejdan by this e-mail address : vejdan_sa@bums.ac.ir How to obtain: Any eligible applicant must send an e-mail to: vejdan_sa@bums.ac.ir including a notice containing their academic and university information and the purpose of the data request, and then after a maximum of 4 weeks,the data file will be received the from the above e-mail address. Comments:
public Dr Amir kazem vejdan
Imam Reza hospital
Birjand Iran (Islamic Republic of) 9714811151 +98 56 3222 2300 vejdan_sa@bums.ac.ir Birjand University of Medical Sciences scientific Dr Amir Kazem Vejdan
Taleghani St
Birjand Iran (Islamic Republic of) 9714811151 +98 56 3222 2300 vejdan_sa@bums.ac.ir Birjand University of Medical Sciences Iran (Islamic Republic of) Patients who had hemorrhoidectomy surgery. no limit no limit Both Diabetes Drug abuse Other specific diseases K64.1 Second degree hemorrhoids Treatment - Drugs Placebo Investigation group: In the investigation group, after open hemorrhoidectomy (by Milligan-Morgan method) and complete homeostasis and ensuring of the absence of bleeding, a gauze with 10%sucralfate ointment will be applied on the operation site and the patient will be transferred to recovery. The gauze will be placed inside the anal canal for 24 hours. After that the sucralfate ointment will be applied by the patient after each defecation. Control group: In this group, after open hemorrhoidectomy (by Milligan-Morgan method) and complete homeostasis and ensuring of the absence of bleeding, a gauze with placebo(vaseline) will be applied on the operation site and patient will be transferred to recovery.The gauze will be placed inside the canal for 24 hours. After that the placebo (vaseline) will be applied by the patient after each defecation. Pain. Timepoint: The first 24 hours after operation and after that in 4-day periods until the end of epithelialization. Method of measurement: VAS. Epithelialization. Timepoint: Every 3 days until complete epithelialization. Method of measurement: Rectal examination by surgeon. Birjand University of Medical Sciences Approved 2017-03-05 Ethical committee of Birjand University of Medical Sciences Ghaffari St Birjand South Khorasan Iran (Islamic Republic of)