A prospective randomized study to compare laser hemorrhoplasty(LHP) and Milligan and Morgan hemorrhoidectomy In patients with hemorrhoids
Design
Phase 3, two arm parallel group, open label trial. 80 patients, enrolled between March 2011 and March 2013 followed for 6 months.
Settings and conduct
This study is carried on Ghaem and Sina Hospital in Mashhad, Iran.
This study is an open label trial..
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients are selected with two and three hemorrhoids
Exclusion criteria: Patients who refused to collaborate and follow-up are excluded.
Intervention groups
In Intervention group surgery is done using laser and by LHP technique and in control group, surgery is done using Milligan and Morgan method.
Main outcome variables
Delayed bleeding; the presence of urinary retention; painful defecation; fistula; acute infection fissure; anal stenosis; fecal incontinence and postoperative thrombosis
General information
Reason for update
Acronym
LHP
IRCT registration information
IRCT registration number:IRCT20180204038605N1
Registration date:2018-04-01, 1397/01/12
Registration timing:retrospective
Last update:2018-04-01, 1397/01/12
Update count:0
Registration date
2018-04-01, 1397/01/12
Registrant information
Name
Hosein Shabahang
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2840
Email address
shabahangh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2012-07-21, 1391/04/31
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A prospective randomized study of laser hemorrhoplasty (LHP) versus milligan and morgan hemorrhoidectomy In patients with hemorrhoids
Public title
Study of Laser in the Treatment of Hemorrhoid Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with hemorrhoid grade 2 or 3
Exclusion criteria:
Patients who refused to collaborate in follow-up
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Mashhad University of Medical Sciences
Street address
Ghaem Haspital, َAhmad abad street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2012-07-21, 1391/04/31
Ethics committee reference number
IR.MUMS.REC.1391.93
Health conditions studied
1
Description of health condition studied
Digestive diseases
ICD-10 code
K90-K93
ICD-10 code description
K90-K93:Other diseases of the digestive system
Primary outcomes
1
Description
Pain
Timepoint
Twenty-first day
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Quality of life Score
Timepoint
7 days
Method of measurement
SF-12 short questionnaire (12 questions)
Intervention groups
1
Description
In Intervention group , surgery is done using laser and by LHP technique. Diod Lesar 1470 (Biolitec company) (CERALAS model) is used.The patients put under general anesthesia. After Prep and Drep, special optical fiber enter the hemorrhoidal packe. Then, the hemorrhoidal packe is measured from the proximal part to the distal part using LHP technique. In the next step, with a cotton 3.0 string, mucosopexy is performed from the proximal part to the distal part of the packe. At the end of the procedure, two or three packes are treated at a time.
Category
Treatment - Surgery
2
Description
In control group, surgery is done using Milligan and Morgan method. After Prep and Drep, the patients are under either general or spinal anesthesia. Afterwards, they are placed in the Lithotomy position. By this method, three hemorrhoid packes with at an angle of about 60° are selected. Then, the packe have to be eliminated below the tooth line of the anus while the skin and the mucous bridges between packes stayed preserved.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Haspital, Mashhad University of Medical Sciences
Full name of responsible person
Hossein Shabahang
Street address
Ghaem Haspitalو Ahmad Abad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3801 2806
Fax
+98 51 3843 6199
Email
shabahangh@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
University Research Deputy
Street address
َAhmad Abad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3801 2806
Email
shabahangh@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Shabahang
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
َAhmad Abad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3801 2806
Email
shabahangh@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Shabahang
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Ahmad Abad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3801 2806
Email
Shabahangh@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Shabahang
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Ahmad Abad street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3801 2806
Email
Shabahangh@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available