To compare outcomes in open hemorrhoidectomy versus ligasure hemorrhoidectomy.
Design
Randomized Controlled Trial
Settings and conduct
Department of Surgery, Allama Iqbal Teaching Hospital DG Khan.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients aged 25 – 65 years of either gender, planned to undergo surgery for grade III or IV hemorrhoids.
Exclusion Criteria: Patients with recurrent hemorrhoids, rectal carcinoma (medical record) and patients with thrombosis of hemorrhoids (on clinical examination) will be excluded.
Intervention groups
This study has been planned to compare open versus ligasure hemorrhoidectomy (in terms of pain, bleeding, operative time, hospital stay, and urinary retention) in our local setting. Ligasure is considered safe procedure which does not need any special skill. However, Ligasure is an expensive device. Our study results will provide local evidence for surgeons to opt most beneficial surgical approach, keeping in view cost as well while dealing with patients having 3rd or 4th degree hemorrhoids. So, patients will get benefit of resuming their routine activities earlier and with ease.
Main outcome variables
Operative time: Time in minutes from induction of anesthesia to extubation of endotracheal tube. Time will be recorded by nursing staff using a stopwatch.
Intra-operative blood loss: Amount of blood (in ml) collected in graduated bottles and pre- weighted surgical sponge (1-gram increase = 1 ml).
Pain will be graded 24-hours postoperatively using visual analogue scale 0 – 10, where 0 is no pain and 10 is worst bearable pain.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250117064410N1
Registration date:2025-01-29, 1403/11/10
Registration timing:prospective
Last update:2025-01-29, 1403/11/10
Update count:0
Registration date
2025-01-29, 1403/11/10
Registrant information
Name
waqas bhati
Name of organization / entity
Quetta Institute of Medical Sciences
Country
Pakistan
Phone
+92 81 2864601
Email address
tifal_bydagh@ymail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-02-01, 1403/11/13
Expected recruitment end date
2025-07-31, 1404/05/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of outcomes in open hemorrhoidectomy versus Ligasure hemorrhoidectomy
Public title
Comparison of open hemorrhoidectomy versus Ligasure hemorrhoidectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 25 – 65 years of either gender, planned to undergo surgery for grade III or IV hemorrhoids.
Exclusion criteria:
Patients with recurrent hemorrhoids, rectal carcinoma (medical record) and patients with thrombosis of hemorrhoids (on clinical examination) will be excluded.
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to group A and group B through lottery method using sealed opaque envelopes.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients will not know whether they are undergoing open or Ligasure hemorrhoidectomy.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Review Committee, DG Khan Medical College Dera Ghazi Khan
Street address
Jampur Road Dera Ghazi Khan
City
Dera Ghazi Khan
Postal code
32200
Approval date
2024-12-31, 1403/10/11
Ethics committee reference number
0011/198/MED/DGKMC
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
Operative time
Timepoint
From induction of anesthesia to extubation of endotracheal tube
Method of measurement
Time will be recorded by nursing staff using a stopwatch
2
Description
Intra-operative blood loss
Timepoint
Amount of blood (in ml) collected in graduated bottles and pre- weighted surgical sponge
Method of measurement
Amount of blood (in ml) collected in graduated bottles and pre- weighted surgical sponge (1-gram increase = 1 ml).
3
Description
Pain
Timepoint
It will be graded 24-hours postoperatively
Method of measurement
Using visual analogue scale 0 – 10, where 0 is no pain and 10 is worst bearable pain.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A -open hemorrhoidectomy
Category
Treatment - Surgery
2
Description
Intervention group: B- Ligasure hemorrhoidectomy
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Allama Iqbal Teaching Hospital-DG khan medical college, Dera Ghazi Khan
Full name of responsible person
Dr Fatima Asad
Street address
Jampur Road Dera Ghazi Khan
City
Dera Ghazi Khan
Postal code
32200
Phone
+92 64 9260631
Email
info@dgkmc.edu.pk
Web page address
https://dgkmc.edu.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
DG khan Medical College Dera ghazi khan
Full name of responsible person
Dr Fatima Asad
Street address
Jampur Road Dera Ghazi Khan
City
Dera Ghazi Khan
Postal code
32200
Phone
+92 64 9260631
Email
info@dgkmc.edu.pk
Web page address
https://dgkmc.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
DG khan Medical College Dera ghazi khan
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
DG Khan Medical College
Full name of responsible person
Dr Fatima Asad
Position
Resident Surgeon
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Derpartment of Surgery Allama Iqbal Teaching Hospital DG Khan
City
Dera Ghazi Khan
Province
Punjab
Postal code
32200
Phone
N/A
Email
fatimaasad973@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
DG Khan Medical College
Full name of responsible person
Dr Fatima Asad
Position
Resident Surgeon
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Derpartment of Surgery Allama Iqbal Teaching Hospital DG Khan
City
Dera Ghazi Khan
Province
Punjab
Postal code
32200
Phone
N/A
Email
fatimaasad973@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
DG Khan Medical College
Full name of responsible person
Dr Fatima Asad
Position
Resident Surgeon
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Derpartment of Surgery Allama Iqbal Teaching Hospital DG Khan
City
Dera Ghazi Khan
Province
Punjab
Postal code
32200
Phone
N/A
Email
fatimaasad973@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected deidentified IPD
When the data will become available and for how long
after 31 july 2025, 6 moths after publication
To whom data/document is available
For researches in the field of General Surgery
Under which criteria data/document could be used
After taking consent on email indicate clear purpose of the required information.
From where data/document is obtainable
From the Contact person (Dr Fatima Asad) through email
What processes are involved for a request to access data/document
Email to contact person indicating clear purpose for using the required information.