Comparison of two methods of hemorrhoid surgery: stapled hemorrhoidectomy and conventional surgery on patients clinical outcomes
Design
Clinical trial with a control group and sample size of 40 people allocated randomly by random number table in two groups of intervention and control.
Settings and conduct
Study was conducted in the department of surgery in Ahvaz Razi Hospital. In the intervention group, patients underwent stapled hemorrhoidectomy and in comtrol group patients underwent conventional hemorrhoidectomy surgery. Finally, the clinical outcomes are compared with the standard instruments in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:patients aged 18 to 60 years and patients with grade 3 or 4 internal hemorrhoids. Exclusion criteria: thrombosed hemorrhoids, drug addiction, history of previous anorectal surgery and fisher or an anal fistula
Intervention groups
Intervention group: patients in this group undergo stapled hemorrhoidectomy.
Control group: Patients in this group underwent conventional hemorrhoidectomy.
Main outcome variables
Pain; Anal sphincter pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170610034428N1
Registration date:2019-06-08, 1398/03/18
Registration timing:retrospective
Last update:2019-06-08, 1398/03/18
Update count:0
Registration date
2019-06-08, 1398/03/18
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3372 2282
Email address
ghiasi.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-25, 1396/04/04
Expected recruitment end date
2017-12-02, 1396/09/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Two Methods of Hemorrhoid Surgery: Stapled Hemorrhoidectomy and Conventional Surgery on Patients Clinical Outcomes
Public title
Stapled Hemorrhoidectomy on Patients Clinical Outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 60 years
Patients with grade 3 or 4 internal hemorrhoids
Exclusion criteria:
Thrombosed hemorrhoids
Drug addiction
History of previous anorectal surgery
Fisher or an anal fistula
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Block. Block size =4. possible ways = 6. Permuted block randomization=15. Block selection numbers with random numbers table. Unit randomization: individual. A person who specifies the sequence is the executor of plan not the surgeon,the designer must hide the information from the surgeon.
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 Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2017-08-28, 1396/06/06
Ethics committee reference number
IR.AJUMS.REC.1396.205
Health conditions studied
1
Description of health condition studied
hemorrhoid
ICD-10 code
K64.1
ICD-10 code description
Second degree hemorrhoids
Primary outcomes
1
Description
pain
Timepoint
One, two and three days after surgery
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
Anal sphincter pressure
Timepoint
Before surgery and one month after surgery
Method of measurement
Anal manometer
Intervention groups
1
Description
Intervention group: patients in this group undergo stapled hemorrhoidectomy. This is done in 5 steps and in the following order: 1. Slow anal canal dilatation for inserting the device with a dilator. 2. Speculum insertion. 3. Creata a pure-String Suture. 4. Insert Stapler. 5. Bleeding control in the anastomosis line.
Category
Treatment - Surgery
2
Description
Control group: patients in this group underwent conventional hemorrhoidectomy.In this procedure, the entire pocket is removed and the mucosa is close to the cut line and the rest of the skin wounds are kept open.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Neda Najibpour
Street address
Razi hospital, Palestin Blv, Amanieh
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3333 5935
Email
razi.hospital@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi (Deputy of Research and Technology of University)
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3337 4598
Email
badavi.m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
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
Ahvaz University of Medical Sciences
Full name of responsible person
Heydar Ghiasi
Position
Resident of surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3337 4598
Email
ghiasi.h@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Heydar Ghiasi
Position
Resident of surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3337 4598
Email
ghiasi.h@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Heydar Ghiasi
Position
resident of surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3337 4598
Email
ghiasi.h@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available