Hemorrhoidectomy in Patients With Grade III and IV Disease:Harmonic Scalpel Compared With Conventional Technique
Primary Purpose
Hemorrhoidectomy, Third Degree Hemorrhoids, Fourth Degree Hemorrhoids
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Hemorrhoidectomy
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhoidectomy focused on measuring VAS pain score, Harmonic Scalpel Hemorrhoidectomy, Conventional Hemorrhoidectomy
Eligibility Criteria
Inclusion Criteria:
- Patients between age 20-60 years, both male and female with III and IV degree hemorrhoids diagnosed during last 1 year.
Exclusion Criteria:
• Patients with permenantly prolapsed hemorrhoids limited to one quadrant only and had been assessed on per rectal examination and proctoscopy
- Any other anorectal pathology such as anal fissure ,fistula or anal cancer on history and per rectal examination
- Previous anal surgery assessed by history and per rectal examination
- Inability to give informed consent
- ASA grade III/IV on detailed history, clinical examination and laboratory findings e.g. deranged hepatic(AST/ALT >40IU/L) and renal profile ( creatinine >1:2mg/dl)and evidence of ischemic heart disease(annexure attached).
Sites / Locations
- services Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CH( Conventional Hemorrhoidectomy)
HS( Harmonic Scalpel)
Arm Description
Closed Conventional Hemorrhoidectomy
Harmonic Scalpel Hemorrhoidectomy
Outcomes
Primary Outcome Measures
Operative Time
from start of incision to the dressing in minutes
post operative pain
On Visual analogue scale, a scale to measure pain and it ranges between 0-10. Scale 0-1 means no pain, 2-4 means mild pain,5-7 means moderate pain and 8-10 means severe pain. and it was measured post-operative in 24 hours
Hospital Stay
was measured in days from postoperative day till resolution of preoperative complaint of bleeding per rectum and VAS (<3)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03938714
Brief Title
Hemorrhoidectomy in Patients With Grade III and IV Disease:Harmonic Scalpel Compared With Conventional Technique
Official Title
Hemorrhoidectomy in Patients With Grade III and IV Disease:Harmonic Scalpel Compared With Conventional Technique
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 27, 2015 (Actual)
Primary Completion Date
February 26, 2016 (Actual)
Study Completion Date
February 28, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Services Hospital, Lahore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Hemorrhoidectomy is the treatment of choice for grade 3 and 4th degree hemorrhoids. Various surgical technique has been used to improve the outcome of the procedures performed in respect to operative time ,post operative pain and hospital stay. This study compares the conventional closed technique with harmonic scalpel technique which is a device regulated with ultrasonic waves to perform the procedure with minimal postoperative complication as well as decreasing the prolong stay in hospital.
Detailed Description
INTRODUCTION:
Ferguson closed hemorrhoidectomy is conventional procedure in 3rd and 4th degree hemorrhoids but recent advances in harmonic scalpel have shown to produce favorable results. Comparison of these two is studied in terms of pain outcome as patient perceives, operative time and duration of hospital stay.
OBJECTIVES:
To compare the outcome of conventional hemorrhoidectomy versus harmonic scalpel in III and IV degree hemorrhoids.
STUDY DESIGN:
Randomized controlled trial
STUDY SETTING:
The study was conducted in surgical unit 1, Services hospital, Lahore.
DURATION OF STUDY:
Study was completed in six months after the approval of synopsis i.e. from 27th August 2015 to 26th February 2016.
DATA COLLECTION PROCEDURE:
After approval from hospital ethical committee, 100 patients fulfilling the inclusion criteria had been recruited from outdoor and emergency department. A detailed history had been taken including demographic data (age, address) and all patients had been clinically examined .Patients was divided in two groups randomly using random number tables. Group A: Conventional hemorrhoidectomy. Group B: harmonic scalpel hemorrhoidectomy. Patients had been requested to sign an informed consent. They had been assured regarding confidentiality and expertise used for the procedure. All procedures had been performed by a single surgical operating team to control bias. Per operatively operative time was noted. Post operatively pain had been assessed in 24 hours , mean hospital stay was measured in days from postoperative day till day of discharge (as per operational definition). All data had been collected and recorded on the attached Performa.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoidectomy, Third Degree Hemorrhoids, Fourth Degree Hemorrhoids, Operative Time, Postoperative,Pain, Length of Stay
Keywords
VAS pain score, Harmonic Scalpel Hemorrhoidectomy, Conventional Hemorrhoidectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Coagulating Shears ® model
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CH( Conventional Hemorrhoidectomy)
Arm Type
Active Comparator
Arm Description
Closed Conventional Hemorrhoidectomy
Arm Title
HS( Harmonic Scalpel)
Arm Type
Experimental
Arm Description
Harmonic Scalpel Hemorrhoidectomy
Intervention Type
Procedure
Intervention Name(s)
Hemorrhoidectomy
Other Intervention Name(s)
Ferguson Closed Hemorrhoidectomy
Intervention Description
Excision of third and fourth degree hemorrhoids
Primary Outcome Measure Information:
Title
Operative Time
Description
from start of incision to the dressing in minutes
Time Frame
The time was monitored from incision to the dressing approximately in 15 minutes to 50 minutes
Title
post operative pain
Description
On Visual analogue scale, a scale to measure pain and it ranges between 0-10. Scale 0-1 means no pain, 2-4 means mild pain,5-7 means moderate pain and 8-10 means severe pain. and it was measured post-operative in 24 hours
Time Frame
Each Patient was measured in 24 hours
Title
Hospital Stay
Description
was measured in days from postoperative day till resolution of preoperative complaint of bleeding per rectum and VAS (<3)
Time Frame
the Duration was measured from the day surgery performed till the day of Discharge i.e 1 to 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients between age 20-60 years, both male and female with III and IV degree hemorrhoids diagnosed during last 1 year.
Exclusion Criteria:
• Patients with permenantly prolapsed hemorrhoids limited to one quadrant only and had been assessed on per rectal examination and proctoscopy
Any other anorectal pathology such as anal fissure ,fistula or anal cancer on history and per rectal examination
Previous anal surgery assessed by history and per rectal examination
Inability to give informed consent
ASA grade III/IV on detailed history, clinical examination and laboratory findings e.g. deranged hepatic(AST/ALT >40IU/L) and renal profile ( creatinine >1:2mg/dl)and evidence of ischemic heart disease(annexure attached).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Safia Z Ahmed, FCPS
Organizational Affiliation
Services Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
services Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
I want to share the abstract to other researches
IPD Sharing Time Frame
data is available as the study is complete and for 12 month period
IPD Sharing Access Criteria
will be shared upon request
Learn more about this trial
Hemorrhoidectomy in Patients With Grade III and IV Disease:Harmonic Scalpel Compared With Conventional Technique
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