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
We compare the rate of recovery and postoperative complications in patients with grade 3 and 4 hemorrhoids in two mucopexy surgical methods with and without Doppler Guided Hemorrhoidal Artery Ligation(DG-HAL).
Design
This is a Randomized Clinical Trial study. The intervention group includes patients undergoing mucopexy with DG-HAL and the control group are patients undergoing mucopexy without DG-HAL. Sample size includes 36 patients, 18 in each parallel group. Patients are divided into two groups of intervention and control by randomization of allocating 5-digit special code to each individual. The study is single-blinded and only patients (participants) are not aware of the mucopexy surgical methods. The trial phase is 2-3.
Settings and conduct
Study Setting: General Surgery, Colorectal Surgery, Study Location: Firoozgar Hospital, Tehran, Study Method: Interventional (clinical trial), Single-Blinded: only the patients (participants) are blinded.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients with diagnosis of Grade 3 and 4 hemorrhoids.
Exclusion Criteria: 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.
Intervention groups
Intervention group includes patients undergoing mucopoxy operation with DG-HAL,The control group includes patients undergoing mucopexy operation without DG-HAL.
Main outcome variables
Recovery rate; postoperative complications.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190927044897N1
Registration date:2019-10-29, 1398/08/07
Registration timing:registered_while_recruiting
Last update:2019-10-29, 1398/08/07
Update count:0
Registration date
2019-10-29, 1398/08/07
Registrant information
Name
Sara Sohrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1000
Email address
sohrabi.s@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2021-04-19, 1400/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The effect of mucopexy surgical method on the incidence of postoperative complications.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients referred to Surgery Clinic of Firoozgar Hospital for diagnosis of grade 3 and 4 hemorrhoids.
Exclusion criteria:
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
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Shahid Hemmat Highway, Tehran, Tehran Province
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-07-23, 1398/05/01
Ethics committee reference number
IR.IUMS.FMD.REC.1398.167
Health conditions studied
1
Description of health condition studied
Grade 3 and 4 Hemorrhoids, Doppler Guided Hemorrhoidal Artery Ligation, Mucopexy with DG-HAL, Mucopexy without DG-HAL, General Surgery, Colorectal Surgery, Anorectal Diseases
ICD-10 code
K64
ICD-10 code description
Hemorrhoids and perianal venous thrombosis
2
Description of health condition studied
Grade 3 and 4 Hemorrhoids, Mucopexy with DG-HAL, Mucopexy without DG-HAL, General Surgery, Colorectal Surgery, Anorectal Diseases
ICD-10 code
K64.3
ICD-10 code description
Fourth degree hemorrhoids
Primary outcomes
1
Description
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
Secondary outcomes
1
Description
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
Intervention groups
1
Description
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.
Category
Treatment - Surgery
2
Description
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.
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Firoozgar Clinical Research Development Center(FCRDC), Firoozgar Hospital
Proportion provided by this source
50
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
Iran University of Medical Sciences
Full name of responsible person
Sara Sohrabi
Position
Doctor of Medicine (Intern)
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Faculty of Medicine, Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 1021
Email
sohrabi.s@tak.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sara Sohrabi
Position
Doctor of Medicine Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Faculty of Medicine, Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 1021
Email
sohrabi.s@tak.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sara Sohrabi
Position
Doctor of Medicine Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Faculty of Medicine, Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 1021
Email
sohrabi.s@tak.iums.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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
All data can potentially be shared after making people unrecognizable.
When the data will become available and for how long
starting of accessibility will be 6 months after publication
To whom data/document is available
only available for people working in academic institutions
Under which criteria data/document could be used
- researchers - people working in academic institutions - data could not be used in other studies. - data is available for elucidating the results of this study.
From where data/document is obtainable
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
What processes are involved for a request to access data/document
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