Compare the effect of lithotomy and jackknife positions on the amount of bleeding, duration of surgery, postoperative pain, the exposure
of the operative site from surgeon's point of view, and the local discomfort of the surgeon to adapt himself to the surgical field.
Design
A parallel two-group clinical trial involving 60 patients
Settings and conduct
The present research will be conducted on patients undergoing hemorrhoidectomy in Besat hospital, Hamadan, in 2023. In this study, there is no possibility of blinding and the study is conducted in an open-label manner. The researcher will visit the operating room department of Besat hospital in two shifts, morning and evening, and informed consent will be obtained from the patients. Then, after grouping the patients into two groups randomly, the desired variables will be measured.
Participants/Inclusion and exclusion criteria
The criteria for entering this study include: age between 15 and 60 years old; suffering from grade 3 or 4 hemorrhoid disease and informed consent to participate in the study. Also exclusion criteria include: presence of thrombosed hemorrhoids; drug addiction; use of anticoagulants; history of previous anorectal surgery; presence of fissure or anal fistula and lack of consent to participate in a research project.
Intervention groups
Considering that the majority of hemorrhoidectomy surgeries are performed using the lithotomy position therefore, we will consider the lithotomy group as the control group and the jackknife group as the intervention group. Hemorrhoidectomy is considered at the beginning of surgery.
Main outcome variables
Surgical time; intraoperative bleeding; postoperative pain; the exposure of the operative site from surgeon's point of view and surgeon's local discomfort
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230129057271N1
Registration date:2023-02-14, 1401/11/25
Registration timing:prospective
Last update:2023-02-14, 1401/11/25
Update count:0
Registration date
2023-02-14, 1401/11/25
Registrant information
Name
Sina Ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3320 8792
Email address
sinaghasemi19980@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-05-20, 1402/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of jackknife and lithotomy positions on the process and complications of hemorrhoidectomy surgery
Public title
A comparative study of the effect of jackknife and lithotomy positions on the process and complications of hemorrhoidectomy surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range between 15 and 60 years old
Having grade 3 or 4 hemorrhoids
Informed consent to participate in the study
Exclusion criteria:
The presence of thrombosed hemorrhoids
Drug addiction
Taking anticoagulants
History of previous anorectal surgery
The presence of fissure or anal fistula
Lack of consent to participate in the research project
Age
From 15 years old to 60 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
Allocation of patients in two groups will be done in random blocks so that; The block size is equal to 4. The randomization tool in this research will be the use of four envelopes containing two sheets j and two sheets l, each time by removing one of the sheets, the patient will be placed in the jackknife or lithotomy group. The removed sheets will not be returned to the envelope until the 4 sheets are finished. After determining the assignment of the first 4 patients, the sheets are returned to the envelope and the next 4 patients will continue in this way until the sample size is completed.
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
Research Ethics Committee of Hamadan University of Medical Sciences
Street address
4th Floor, Vice-Chancellor for Research and Technology, University Headquarters, Shahid Fahmideh Blvd.
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2023-01-28, 1401/11/08
Ethics committee reference number
IR.UMSHA.REC.1401.940
Health conditions studied
1
Description of health condition studied
hemorrhoids
ICD-10 code
K64
ICD-10 code description
Hemorrhoids and perianal venous thrombosis
Primary outcomes
1
Description
Duration of surgery
Timepoint
From the moment of positioning the patient to the moment of placing the dressing on the surgical site
Method of measurement
Using a minute counter to measure surgery time
2
Description
The amount of bleeding during the operation
Timepoint
During surgery
Method of measurement
Using a scale to measure the amount of bleeding during surgery
3
Description
The amount of pain after the operation
Timepoint
One day, three days, seven days and two weeks after surgery
Method of measurement
Using the NRS criterion
4
Description
The amount of local discomfort for the surgeon
Timepoint
After surgery
Method of measurement
Using the LPD scale
5
Description
The exposure of the operative site from surgeon's point of view
Timepoint
After surgery
Method of measurement
5-point Likert scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, the allocation of jackknife position during the start of hemorrhoidectomy surgery is considered.
Category
Treatment - Surgery
2
Description
Control group: In this study, the lithotomy position is routinely used for the control group.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital, Hamadan city
Full name of responsible person
Sina Ghasemi
Street address
Hokama Street
City
Hmadan
Province
Hamadan
Postal code
4541165148
Phone
+98 81 3265 0030
Email
besat@umsha.ac.ir
Web page address
https://besat.umsha.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokohi
Street address
Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3131 0000
Email
vc_research@umsha.ac.ir
Web page address
https://www.umsha.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Sina Ghasemi
Position
Master of science student
Latest degree
Master
Other areas of specialty/work
Surgical technologist
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh St.
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3131 0000
Fax
Email
sinaghasemi19980@gmail.com
Web page address
https://www.umsha.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sina Ghasemi
Position
Master of science student
Latest degree
Master
Other areas of specialty/work
Surgical technologist
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh St
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3131 0000
Fax
Email
sinaghasemi19980@gmail.com
Web page address
https://www.umsha.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sina Ghasemi
Position
Master of science student
Latest degree
Master
Other areas of specialty/work
Surgical technologist
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh St
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3131 0000
Fax
Email
sinaghasemi19980@gmail.com
Web page address
https://www.umsha.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available