The purpose of the study is to compare efficacy and complication of "intrahemorrhoidal coagulation with 980 nanometer diode LASER" with "hemorrhoid resection using Milligan Morgan method". In this randomized controlled trial, 60 patients would be enrolled after taking informed consent. The patients are those with symptomatic hemorrhoids who have not responded to medical treatment. Those with extensive grade 4 lesions, drug-addicted patients and those with other simultaneous anorectal lesions (e.g. fissure) would be excluded. Patients would be randomly divided into two groups. One group undergo usual milligan Morgan hemorrhoidectomy and the other group are treated by intrahemorrhoidal coagulation with 980 nanometer diode LASER. Postoperative pain, narcotic use, complications and symtoms recovery (3 month later) would be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104272982N2
Registration date:2011-10-14, 1390/07/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-10-14, 1390/07/22
Registrant information
Name
Zhamak Khorgami
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2450
Email address
khorgami@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
As a thesis in Tehran University of Medical Sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intrahemorrhoidal coagulation using 980 nanometer diode LASER with Milligan Morgan hemorrhoidectomy in Shariati hospital in 2010-2012
Public title
Comparison of intrahemorrhoidal coagulation using 980 nanometer diode LASER with Milligan Morgan hemorrhoidectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: those with symptomatic hemorrhoids (mainly grade II and III) refractory to medical treatments
Exclusion Criteria: extensive circumferencial grade 4 hemorrhoids, drug-addicted patients, other simultaneous anorectal problems (e.g. fissure)
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Central building, Qhods avenue
City
Tehran
Postal code
Approval date
2011-01-12, 1389/10/22
Ethics committee reference number
1275 / 130 / د / 89
Health conditions studied
1
Description of health condition studied
haemorrhoids
ICD-10 code
I84.9
ICD-10 code description
Unspecified haemorrhoids without complication
Primary outcomes
1
Description
postoperative narcotic usage
Timepoint
continuous till time of discharge
Method of measurement
Patient controlled analgesia device
Secondary outcomes
1
Description
postoperative urinary retention
Timepoint
At the time of discharge
Method of measurement
History taking
2
Description
postoperative bleeding
Timepoint
At the time of discharge
Method of measurement
History taking and clinical records
3
Description
operation time
Timepoint
At the end of surgery
Method of measurement
from start (after prep and drep) till end (before dressing)
4
Description
Bleeding during surgery
Timepoint
At the end of surgery
Method of measurement
based on the number of wet gauzes
5
Description
Postoperative pain
Timepoint
6 hour interval
Method of measurement
Visual analogue scale
6
Description
Hospital stay
Timepoint
At the time of discharge
Method of measurement
based on medical reocords
7
Description
Recovery of treated hemorrhoids
Timepoint
3 months after surgery
Method of measurement
Physical examination
8
Description
Surgical site infection
Timepoint
At the time of discharge and one week later
Method of measurement
Physical examination
9
Description
Recovery of symptoms
Timepoint
3 months after surgery
Method of measurement
History taking
Intervention groups
1
Description
control group: patients undergo general anesthesia with defined protocol and would be placed in lithotomy position. After anoscopy and determining abnormal hemorrhoidal pads,
they are removed by eliptical incision from anal verge to anorectal ring. Then the base is suture ligated and wound is left open. Patient controlled analgesia device (PCAD)- contains 30 mg morphine sulfate in 30 cc normal saline - is connected in recovery unit and a loading dose is injected. Bolus volume and lock out time would be 1 cc (1 mg morphine) and 8 minutes respectively. Patient are educated before the procedure on how to work with PCAD. One dose of intravenous ceftriaxone and metronidazole given before and continues till 24 hours after surgery.
Category
Treatment - Surgery
2
Description
intervention group: patients undergo general anesthesia with defined protocol and would be placed in lithotomy position. After anoscopy and determining abnormal hemorrhoidal pads, each one would be coagulated using 980 nanometer diode LASER with 15 watts energy and 3 seconds pulses fired in parallel lines, 5 mm apart. No resection is done. Patient controlled analgesia device (PCAD)- contains 30 mg morphine sulfate in 30 cc normal saline - is connected in recovery unit and a loading dose is injected. Bolus volume and lock out time would be 1 cc (1 mg morphine) and 8 minutes respectively. Patient are educated before the procedure on how to work with PCAD. One dose of intravenous ceftriaxone and metronidazole given before and continues till 24 hours after surgery.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Zhamak Khorgami
Street address
Shariati Hospital, North Kargar Avenue,
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhonzade
Street address
Research deputy, Medicine faculty, Poursina avenue, Keshavarz Blvd
City
Tehran
Grant name
در قالب بودجه پایان نامه دستیار تخصصی
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences - Shariati Hospital
Full name of responsible person
Zhamak Khorgami
Position
General Surgeon / faculty of surgery department
Other areas of specialty/work
Street address
Shariati Hospital, North Kargar Avenue
City
Tehran
Postal code
Phone
+98 21 8490 2450
Fax
+98 21 8863 3039
Email
khorgami@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences - Shariati hospital
Full name of responsible person
Zhamak Khorgami
Position
General Surgeon / faculty of surgery department
Other areas of specialty/work
Street address
Shariati Hospital, North Kargar Avenue
City
Tehran
Postal code
Phone
+98 21884902450
Fax
+98 21 8863 3039
Email
khorgami@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)