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Comparison of open hemorrhoidectomy versus hemorrhoidectomy with electrocautery on inter-postoperative signs in patients with hemorrhoid grade 3 and 4

Protocol summary

Summary
Objective: comparison of two methods of open hemorrhoidectomy using electrocautery; Study design: randomized single-blind, placebo-uncontrolled, single-center, phase II trials; Study population: all patients with hemorrhoid referring to the surgery clinic; Inclusion criteria: hemorrhoids grade 3 or 4 which is proven by clinical examination, aged between 15 and 50 years, surgical indication; Exclusion criteria: history of previous anal surgery, diseases such as anal fissure or fistula, some degree of incontinency, thrombosed hemorrhoids, history of anticoagulant intake, coagulation disorders, patients with anesthesia prohibiton, addiction, the same disease that causes pain; Sample size: 60; Interventions: The first group included 30 patients will be treated by open hemorrhoidectomy, the second group of 30 patients will be treated with electrocautery hemorrhoidectomy procedures; Outcomes: the mean of pain in the first day after surgery, need for analgesic injection on the first day, hospitalization period, time to return to daily activities, pain in the first week and first month after surgery, bleeding after surgery, postoperative urinary retention, subcutaneous abscess, surgical site infection, anal fissure after surgery, gas or stool incontinancy after surgery, fistula after surgery, recurrence after surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016072028993N2
Registration date: 2016-08-21, 1395/05/31
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-08-21, 1395/05/31
Registrant information
Name
Ehsan Rahimi
Name of organization / entity
Zahedan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5580
Email address
dr.ehsanrahimi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zahedan University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-08-05, 1395/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of open hemorrhoidectomy versus hemorrhoidectomy with electrocautery on inter-postoperative signs in patients with hemorrhoid grade 3 and 4
Public title
Comparison of open hemorrhoidectomy versus hemorrhoidectomy with electrocautery in patients with hemorrhoid
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: hemorrhoids grade 3 or 4 which is proven by clinical examination; aged between 15 and 50 years; surgical indication; Exclusion criteria: history of previous anal surgery; diseases such as anal fissure or fistula; some degree of incontinency; thrombosed hemorrhoids; history of anticoagulant intake; coagulation disorders; patients with anesthesia prohibiton; addiction; similar disease presents as hemorrhoid pain.
Age
From 15 years old to 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Block randomized in blocks of six and a total of 10 blocks

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Zahedan Medical University of Science
Street address
Ethics Committee of Zahedan Medical University of Science, Zahedan Medical University of Science, Dr.Hesabi Square, Zahedan
City
Zahedan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.zaums.rec.1394.177

Health conditions studied

1

Description of health condition studied
Haemorrhoid
ICD-10 code
I84, I84.4
ICD-10 code description
Haemorrhoids

Primary outcomes

1

Description
Operation duration
Timepoint
Since the start of the operation until its end
Method of measurement
Minute

2

Description
Interoperation bleeding
Timepoint
Based on the number of impregnated gauze
Method of measurement
Number

3

Description
Postoperation bleeding
Timepoint
One week, one month, three months, six months after surgery
Method of measurement
Based on physical examination and patients statement

4

Description
Need for intravenous analgesic
Timepoint
First day after surgery
Method of measurement
Number

5

Description
Hospitalization period
Timepoint
From admission to discharge
Method of measurement
Day

6

Description
Postoperation pain
Timepoint
Up to 24 hours after surgery in intervals of every 4 hours
Method of measurement
VAS Criteria

7

Description
Postoperation urinary retention
Timepoint
One week, one month, three months, six months after surgery
Method of measurement
Based on physical examination and patients statement

8

Description
Subcutaneous abscess
Timepoint
One week, one month, three months, six months after surgery
Method of measurement
Based on physical examination and patients statement

9

Description
Surgery site infection
Timepoint
One week, one month, three months, six months after surgery
Method of measurement
Based on physical examination and patients statement

10

Description
Anal fissure
Timepoint
One week, one month, three months, six months after surgery
Method of measurement
Based on physical examination and patients statement

11

Description
Anal stricture
Timepoint
One week, one month, three months, six months after surgery
Method of measurement
Based on physical examination and patients statement

12

Description
Fistula
Timepoint
One week, one month, three months, six months after surgery
Method of measurement
Based on physical examination and patients statement

13

Description
Recurrance
Timepoint
One week, one month, three months, six months after surgery
Method of measurement
Based on physical examination and patients statement

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: open surgical hemorrhoidectomy
Category
Treatment - Surgery

2

Description
Control group: hemorrhoidectomy using electrocautery
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali-ebn Abi Taleb Hospital, Zahedan
Full name of responsible person
Ehsan Rahimi
Street address
Surgery Department, Ali-ebn Abi Taleb Hospital, Salamat Boulevard, Dr.Hesabi Square, Daneshgah Avenue, Zahedan
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Zahedan University of Medical Sciences
Full name of responsible person
Mohsen Taheri
Street address
Vice chancellor for research, Zahedan University of Medical Sciences, Zahedan
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Zahedan 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
Zahedan Medical University
Full name of responsible person
Ehsan Rahimi
Position
Surgery Residence
Other areas of specialty/work
Street address
Surgery Department, Ali-ebn Abi Taleb Hospital, Salamat Boulevard, Dr.Hesabi Square, Daneshgah Avenue, Zahedan
City
Zahedan
Postal code
Phone
+98 54 3329 5583
Fax
Email
dr.ehsanrahimi@zaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan Medical University
Full name of responsible person
Dr. Alireza Khazaee
Position
Associate Professor of Surgery
Other areas of specialty/work
Street address
Surgery Department, Ali-ebn Abi Taleb Hospital, Salamat Boulevard, Dr.Hesabi Square, Daneshgah Avenue, Zahedan
City
Zahedan
Postal code
Phone
+98 54 3329 5583
Fax
Email
dr.alirezakhazaie@zaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ehsan Rahimi
Position
Infectious Diseases Residence
Other areas of specialty/work
Street address
Surgery Department, Ali-ebn Abi Taleb Hospital, Salamat Boulevard, Dr.Hesabi Square, Daneshgah Avenue, Zahedan
City
Zahedan
Postal code
Phone
+98 54 3329 5794
Fax
Email
dr.ehsanrahimi@zaums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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