The aim of this study is to investigate the complications of conventional and LigaSure hemorroidectomy techniques. The method is analytical study (clinical trial) and will be done on about 100 patients 19–80 years old both gender with III, IV-degree hemorrhoids in Shahid Sadoughi hospital. About one half of patients will be treated by conventional diathermy and the others by LigaSure. Patients will receive analgesic administration (IV) for about 24 hours after operations and, after hospital discharge with oral Nsaid, analgesia will be administered until 5 days.(three times a day). All patients require to record pain from the first postoperative day until the 28th postoperative day on a self-administered NAS scale. Patients will be assessed with questioner, face to face one week, one month, six, and twelve months after the operation. The patients will be evaluated on the basis of the following main outcomes: mean operative time, postoperative pain (score and duration), bleeding loss in operation, early (within the first month after surgery) and late (after the first month) complications in conventional and LigaSure hemorroidectomy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014022816773N1
Registration date:2014-04-19, 1393/01/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-19, 1393/01/30
Registrant information
Name
Naeimeh Heiranizadeh
Name of organization / entity
Shahid Sadoughi university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1823 2170
Email address
naeimeh_heiranizadeh@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Residents Grant of Yazd Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2011-04-04, 1390/01/15
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the evaluation of early and late hemorrhoidectomy complications in conventional and ligasure technique
Public title
compare of hemorrhoidectomy complications in conventional and ligasure technique
Purpose
Treatment
Inclusion/Exclusion criteria
patiens in our literature have grade III,IV symptomatic internal hemorrhoid that need to surgery in shahid sadoughi hospital in 1390_91. patients whome had anorectal disease ago , have others anorectal diseases,recurrence hemorrhoid and dont want to attand delete from this study.
Age
From 19 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
101
Randomization (investigator's opinion)
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
shahid sadoughi university of medical sciences
Street address
Shahid Bahonar Square, Shahid sadoughi street, central building
City
Yazd
Postal code
Approval date
2011-11-28, 1390/09/07
Ethics committee reference number
107720
Health conditions studied
1
Description of health condition studied
Haemorrhoid
ICD-10 code
I84
ICD-10 code description
Haemorrhoids
Primary outcomes
1
Description
The post operation pain
Timepoint
Every day until 28nd day, after a week, after a month, after six month and after one year
Method of measurement
In terms of Numeral Pain Score
2
Description
Bleeding during operation
Timepoint
Only during the operation
Method of measurement
The number of blood Gauze
3
Description
The time of operation
Timepoint
During operation
Method of measurement
In minutes
Secondary outcomes
1
Description
The time of returne to work
Timepoint
a week, a month, six month and 12 month
Method of measurement
Questioner and face to face in days
2
Description
Pain score
Timepoint
a week, a month, six month and one year
Method of measurement
numeral pain score with questionare and face to face
3
Description
Anal stenisis
Timepoint
numeral pain score
Method of measurement
PH/E, HX (DRE)
Intervention groups
1
Description
LigaSure hemorrhoidectomy: The patients are anesthetized general or spinal. Position is lithotomy. We use disposable thyroid LigaSure from Covidien Company with the size of 17 cm and its grade of temperature is 2. By using great retractor during surgery LigaSure forceps lay on vascular pedicle level and scissor tissue cut coagulated line. We do not transfixation and it left open. Finally we insert hemostasis sponge in to anal canal.
Category
Treatment - Surgery
2
Description
The patients are anesthetized general or spinal. Position is lithotomy. By using great retractor during surgery we incise hemorrhoidal pile above the dentate line with scissor tissue. With blunt dissection internal sphincter muscle separated from hemorrhoidal pile. With absorbable cotton, pile transfixes and cut and also Hemostasis is achieved. It left open in open technique and repairs with absorbable cotton in close technique. Finally we insert hemostasis sponge in to anal canal.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Naeimeh Heiranizadeh
Street address
Shahid Sadoughi University of Medical Sciences
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Mrs Ayazi
Street address
Central building, Shahid Sadoughi Blvd, Bahonar Sqr.
City
Yazd
Grant name
بودجه پژوهانه
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd Shahid Sadoughi University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences