To compare the outcomes like operating time, postoperative pain and bleeding and postoperative urinary retention with both procedures
Design
RCT
Settings and conduct
Study was conducted at department of general surgery Pakistan railway hospital Rawalpindi from Jan 2023 to Dec 2023.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1. Patients diagnosed with 3rd degree hemorrhoids.
Exclusion Criteria:
1. Patients who are unfit for surgery.
2. Patients who have had previous ano-rectal surgeries.
3. Patients with 1st and 2nd degree hemorrhoids.
Intervention groups
Patients Undergoing Haemorrhoidopexy with haemorrhoidal artery ligation
Main outcome variables
Operating time
Length of stay
Post-operative pain at day 1 and day 7
Post-operative complications like bleeding and urinary retention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241220064108N1
Registration date:2024-12-26, 1403/10/06
Registration timing:retrospective
Last update:2024-12-26, 1403/10/06
Update count:0
Registration date
2024-12-26, 1403/10/06
Registrant information
Name
Muhammad Asad
Name of organization / entity
Riphah International University Islamabad
Country
Pakistan
Phone
+92 334 8988136
Email address
m.asad@riphah.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-01, 1401/10/11
Expected recruitment end date
2023-12-01, 1402/09/10
Actual recruitment start date
2023-01-01, 1401/10/11
Actual recruitment end date
2023-12-01, 1402/09/10
Trial completion date
2023-12-01, 1402/09/10
Scientific title
COMPARISON OF “HEMORRHOIDOPEXY” WITH OPEN HEMORRHOIDECTOMY IN TERMS OF OUTCOMES
Public title
COMPARISON OF “HEMORRHOIDOPEXY” WITH OPEN HEMORRHOIDECTOMY IN TERMS OF OUTCOMES
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with 3rd degree hemorrhoids.
Exclusion criteria:
Patients who are unfit for surgery.
Patients who have had previous ano-rectal surgeries.
Patients with 1st and 2nd degree hemorrhoids.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were randomly assigned to intervention and control groups using a computer-generated random number sequence created with Randomizer.org. The allocation sequence was developed by an independent statistician and concealed in sequentially numbered, opaque, sealed envelopes. These envelopes were opened sequentially only after participant enrollment and baseline assessments, ensuring allocation concealment
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional review committee Islamic International Medical college Rawalpindi Pakistan
Street address
274- Peshawar road Rawalpindi
City
Rawalpindi
Postal code
IIMC, 274- Peshawar
Approval date
2023-12-12, 1402/09/21
Ethics committee reference number
Appl. # Riphah /IRC/ 22/2096
Health conditions studied
1
Description of health condition studied
3rd degree hemorrhoids
ICD-10 code
K64. 9
ICD-10 code description
K64. 9
Primary outcomes
1
Description
Operating time
Timepoint
Just at completion of intervention
Method of measurement
Measure time in minutes; start time to end time
2
Description
Length of stay
Timepoint
measured at time of discharge
Method of measurement
In days
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients undergoing Haemorrhoidopexy with haemorrhoidal artery ligation
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Pakistan Railway Hospital rawalpindi
Full name of responsible person
Dr Muhammad Asad
Street address
Carriage factory road dhok hassu rawalpindi
City
Rawalpindi
Postal code
000
Phone
+92 334 8988136
Email
m.asad@riphah.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
No grant taken
Full name of responsible person
NA
Street address
NA
City
Rawalpindi
Postal code
NA
Phone
+92 334 8988136
Email
m.asad@riphah.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
NA
Proportion provided by this source
1
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic International Medical College rawalpindi
Full name of responsible person
Muhammad Asad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Cariage factory road dhok hassu rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
000
Phone
+92 334 8988136
Email
m.asad@riphah.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic International Medical College rawalpindi
Full name of responsible person
Muhammad Asad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Cariage factory road dhok hassu rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
000
Phone
+92 334 8988136
Email
m.asad@riphah.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Islamic International Medical College rawalpindi
Full name of responsible person
Muhammad Asad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Cariage factory road dhok hassu rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
000
Phone
+92 334 8988136
Email
m.asad@riphah.edu.pk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Patient data is confidential and meant only for this study
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available