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IRCT20190927044897N1 IRCT 2019-10-29 Iran University of Medical Sciences The effect of mucopexy surgical method on the incidence of postoperative complications. Comparative study of the rate of recovery and postoperative complications of two mucopexy surgical methods with and without Doppler Guided Hemorrhoidal Artery Ligation (DG-HAL) in patients with grade 3 and 4 hemorrhoids 2019-09-23 anticipated 36 Complete https://irct.ir/trial/42543 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method of randomization in this study is Simple and unit of randomization is individual. No stratified randomization is used. Sealed envelopes are used as the tool in randomization. The random sequence is built by envelopes shuffling. In allocation concealment we consider a 5-digit code for each envelope and if the third number is even the patient is in case group. If the third number is odd the patient is in control group, Blinding description: All of the participants are aware of their participation in this study and have announced their consent forms. Also, this study has the permission from ethical committee of university. the study is single-blinded, and only the participants are unaware of which of the two mucopexy surgical methods with or without DG-HAL used to treat grade 3 and 4 hemorrhoids. Also, a checklist is provided for each patient, including name, age, sex, height, weight, BMI and demographic characteristics, as well as hemorrhoid grade. These checklists with surgical procedure name coded (mucopexy with DG-HAL) as even third digit in 5-digit code and (mucopexy without DG-HAL) as odd third digit in 5-digit code randomly given to the patients before their operation. 2-3 Condition 1: Grade 3 and 4 Hemorrhoids, Doppler Guided Hemorrhoidal Artery Ligation, Mucopexy with DG-HAL, Mucopexy without DG-HAL, General Surgery, Colorectal Surgery, Anorectal Diseases. Condition 2: Grade 3 and 4 Hemorrhoids, Mucopexy with DG-HAL, Mucopexy without DG-HAL, General Surgery, Colorectal Surgery, Anorectal Diseases. Intervention 1: Intervention group: includes patients undergoing mucopexy with DG-HAL. These patients have grade 3 and 4 hemorrhoids requiring surgical intervention. DG-HAL mucopexy surgery is performed by blocking hemorrhagic artery and hemorrhoid repair using Doppler device during surgery. Intervention 2: Control group: includes patients undergoing mucopexy without DG-HAL.These patients have grade 3 and 4 hemorrhoids requiring surgical intervention. mucopexy surgery without DG-HAL is performed without the use of a Doppler device during hemorrhoid repair. Yes - There is a plan to make this available What will be shared: All data can potentially be shared after making people unrecognizable. When: starting of accessibility will be 6 months after publication To whom: only available for people working in academic institutions Conditions: - researchers - people working in academic institutions - data could not be used in other studies. - data is available for elucidating the results of this study. Where to obtain: contact responsible person: dr. Sara Sohrabi, academic e-mail address: sohrabi.s@tak.iums.ac.ir , address: Firoozgar Hospital, Beh Afarin Ave., Valiasr Square, Tehran second responsible person: dr. Mahdi AlemRajabi , Assistant professor, e-mail addres: mahdialemrajabi@gmail.com How to obtain: researcher information including name, address, telephone number and e-mail address - researcher CV/resume - Sending a request letter to responsible person for accessing data - Approval letter from academic institution Comments:
public Sara Sohrabi
Faculty of Medicine, Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 1021 sohrabi.s@tak.iums.ac.ir Iran University of Medical Sciences scientific Sara Sohrabi
Faculty of Medicine, Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 1021 sohrabi.s@tak.iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patients referred to Surgery Clinic of Firoozgar Hospital for diagnosis of grade 3 and 4 hemorrhoids. no limit no limit Both Patients with diagnosis of grade 1 and 2 hemorrhoids Patients with underlying disease such as diabetes and hypertension Patients with a history of hemorrhoidal surgery Patients with a history of rectal surgery K64 K64.3 Hemorrhoids and perianal venous thrombosis Fourth degree hemorrhoids Treatment - Surgery Treatment - Surgery Intervention group: includes patients undergoing mucopexy with DG-HAL. These patients have grade 3 and 4 hemorrhoids requiring surgical intervention. DG-HAL mucopexy surgery is performed by blocking hemorrhagic artery and hemorrhoid repair using Doppler device during surgery. Control group: includes patients undergoing mucopexy without DG-HAL.These patients have grade 3 and 4 hemorrhoids requiring surgical intervention. mucopexy surgery without DG-HAL is performed without the use of a Doppler device during hemorrhoid repair. The incidence percentage of postoperative complications of mucopexy with and without DG-HAL in patients with grade 3 and 4 hemorrhoids. Timepoint: One, three and six months after operation. Method of measurement: According to checklists and evidence of patients' history and physical examination in follow-up visits for presence or absence of pain, signs of infection, bleeding, gas incontinence, stool incontinence, anal stenosis, fistula, prolapse and hemorrhoid recurrence. The rate of recovery. Timepoint: One, three and six months after operation. Method of measurement: Checklists and evidence of patients' history and physical examination in follow-up visits for presence or absence of pain, signs of infection, bleeding, gas incontinence, stool incontinence, anal stenosis, fistula, prolapse, and hemorrhoid recurrence. Iran University of Medical Sciences Iran University of Medical Sciences Firoozgar Clinical Research Development Center(FCRDC), Firoozgar Hospital Approved 2019-07-23 Ethics Committee of Iran University of Medical Sciences Shahid Hemmat Highway, Tehran, Tehran Province Tehran Tehran Iran (Islamic Republic of)