Condition or disease | Intervention/treatment | Phase |
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Hemorrhoidectomy Third Degree Hemorrhoids Fourth Degree Hemorrhoids Operative Time Postoperative,Pain Length of Stay | Procedure: Hemorrhoidectomy | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Coagulating Shears ® model |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Hemorrhoidectomy in Patients With Grade III and IV Disease:Harmonic Scalpel Compared With Conventional Technique |
Actual Study Start Date : | August 27, 2015 |
Actual Primary Completion Date : | February 26, 2016 |
Actual Study Completion Date : | February 28, 2016 |
Arm | Intervention/treatment |
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Active Comparator: CH( Conventional Hemorrhoidectomy)
Closed Conventional Hemorrhoidectomy
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Procedure: Hemorrhoidectomy
Excision of third and fourth degree hemorrhoids
Other Name: Ferguson Closed Hemorrhoidectomy
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Experimental: HS( Harmonic Scalpel)
Harmonic Scalpel Hemorrhoidectomy
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Procedure: Hemorrhoidectomy
Excision of third and fourth degree hemorrhoids
Other Name: Ferguson Closed Hemorrhoidectomy
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Ages Eligible for Study: | 20 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
• Patients with permenantly prolapsed hemorrhoids limited to one quadrant only and had been assessed on per rectal examination and proctoscopy
Pakistan | |
services Hospital | |
Lahore, Punjab, Pakistan, 54000 |
Principal Investigator: | Safia Z Ahmed, FCPS | Services Hospital |
Tracking Information | |||||||||||||||||||
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First Submitted Date ICMJE | May 3, 2019 | ||||||||||||||||||
First Posted Date ICMJE | May 6, 2019 | ||||||||||||||||||
Last Update Posted Date | May 6, 2019 | ||||||||||||||||||
Actual Study Start Date ICMJE | August 27, 2015 | ||||||||||||||||||
Actual Primary Completion Date | February 26, 2016 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||
Change History | No Changes Posted | ||||||||||||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Descriptive Information | |||||||||||||||||||
Brief Title ICMJE | Hemorrhoidectomy in Patients With Grade III and IV Disease:Harmonic Scalpel Compared With Conventional Technique | ||||||||||||||||||
Official Title ICMJE | Hemorrhoidectomy in Patients With Grade III and IV Disease:Harmonic Scalpel Compared With Conventional Technique | ||||||||||||||||||
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. |
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Study Type ICMJE | Interventional | ||||||||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Coagulating Shears ® model Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Procedure: Hemorrhoidectomy
Excision of third and fourth degree hemorrhoids
Other Name: Ferguson Closed Hemorrhoidectomy
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||||||
Actual Enrollment ICMJE |
100 | ||||||||||||||||||
Original Actual Enrollment ICMJE | Same as current | ||||||||||||||||||
Actual Study Completion Date ICMJE | February 28, 2016 | ||||||||||||||||||
Actual Primary Completion Date | February 26, 2016 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years to 60 Years (Adult) | ||||||||||||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||
Listed Location Countries ICMJE | Pakistan | ||||||||||||||||||
Removed Location Countries | |||||||||||||||||||
Administrative Information | |||||||||||||||||||
NCT Number ICMJE | NCT03938714 | ||||||||||||||||||
Other Study ID Numbers ICMJE | IRB/503/SIMS | ||||||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Safia Zahir Ahmed, Services Hospital, Lahore | ||||||||||||||||||
Study Sponsor ICMJE | Services Hospital, Lahore | ||||||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||||||
Investigators ICMJE |
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PRS Account | Services Hospital, Lahore | ||||||||||||||||||
Verification Date | May 2019 | ||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |