HemorrhoidectomyNCT03938714
Hemorrhoidectomy in Patients With Grade III and IV Disease:Harmonic Scalpel Compared With Conventional Technique
A study testing Hemorrhoidectomy in people with Hemorrhoidectomy and Third Degree Hemorrhoids, run by Services Hospital, Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemorrhoidectomy, Third Degree Hemorrhoids, Fourth Degree Hemorrhoids
- What is being tested?
- Hemorrhoidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Aug 2015to 28 Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients between age 20-60 years, both male and female with III and IV degree hemorrhoids diagnosed during last 1 year.
Who cannot join
- • 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hemorrhoidectomy, Third Degree Hemorrhoids, Fourth Degree Hemorrhoids, Operative Time, Postoperative,Pain, Length of Stay
- Being tested
- Hemorrhoidectomy
- Keywords
- VAS pain score, Harmonic Scalpel Hemorrhoidectomy, Conventional Hemorrhoidectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemorrhoidectomyProcedure or surgery
Also called Ferguson Closed Hemorrhoidectomy
Excision of third and fourth degree hemorrhoids
| Study group | Role | What they receive |
|---|---|---|
| CH( Conventional Hemorrhoidectomy) | Active comparator | Closed Conventional Hemorrhoidectomy Receives: Procedure: Hemorrhoidectomy |
| HS( Harmonic Scalpel) | Experimental | Harmonic Scalpel Hemorrhoidectomy Receives: Procedure: Hemorrhoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Time
from start of incision to the dressing in minutes
Measured: The time was monitored from incision to the dressing approximately in 15 minutes to 50 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
Measured: Each Patient was measured in 24 hours
Hospital Stay
was measured in days from postoperative day till resolution of preoperative complaint of bleeding per rectum and VAS (<3)
Measured: the Duration was measured from the day surgery performed till the day of Discharge i.e 1 to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start27 Aug 2015
- Primary completion26 Feb 2016
- Study completion28 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Coagulating Shears ® model
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Hospital, Lahore
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Safia Zahir Ahmed, Services Hospital, Lahore
- Investigators
- Safia Z Ahmed, FCPS, Principal investigator, Services Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938714
- Sponsor's protocol ID
- IRB/503/SIMS
- Status last verified
- May 2019
- First submitted
- 3 May 2019
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I want to share the abstract to other researches
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemorrhoidectomy in Patients With Grade III and IV Disease:Harmonic Scalpel Compared With Conventional Technique
- ClinicalTrials.gov ID
- NCT03938714
- Acronym / sponsor ID
- IRB/503/SIMS
- Conditions
- Hemorrhoidectomy, Third Degree Hemorrhoids, Fourth Degree Hemorrhoids, Operative Time, Postoperative,Pain, Length of Stay
- Keywords
- VAS pain score, Harmonic Scalpel Hemorrhoidectomy, Conventional Hemorrhoidectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Services Hospital, LahoreOther government
- Study start
- 27 Aug 2015 (actual)
- Primary completion
- 26 Feb 2016 (actual)
- Study completion
- 28 Feb 2016 (actual)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Coagulating Shears ® model
| Arm | Type | Receives |
|---|---|---|
| CH( Conventional Hemorrhoidectomy) | Active comparator | Procedure: HemorrhoidectomyClosed Conventional Hemorrhoidectomy |
| HS( Harmonic Scalpel) | Experimental | Procedure: HemorrhoidectomyHarmonic Scalpel Hemorrhoidectomy |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients between age 20-60 years, both male and female with III and IV degree hemorrhoids diagnosed during last 1 year.
Key exclusion criteria (5 listed)
- • Patients with permenantly prolapsed hemorrhoids limited to one quadrant only and had been assessed on per rectal examination and proctoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemorrhoidectomyAlso: Ferguson Closed HemorrhoidectomyExcision of third and fourth degree hemorrhoids | Procedure or surgery | CH( Conventional Hemorrhoidectomy), HS( Harmonic Scalpel) |
Primary outcome
Operative Time
Time frame: The time was monitored from incision to the dressing approximately in 15 minutes to 50 minutes
from start of incision to the dressing in minutes
post operative pain
Time frame: Each Patient was measured in 24 hours
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
Time frame: the Duration was measured from the day surgery performed till the day of Discharge i.e 1 to 5 days
was measured in days from postoperative day till resolution of preoperative complaint of bleeding per rectum and VAS (<3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Individual participant dataSharing planned: Yes. I want to share the abstract to other researches
Related trials for Hemorrhoidectomy
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Ultrasound-Guided Versus Landmark-Guided Pudendal Block for Post-Hemorrhoidectomy Pain
Hemorrhoids, Postoperative Pain
Recruiting
Ligasure Versus Conventional Diathermy in Hemorrhoidectomy
Hemorrhoids
Recruiting
The Use of Electronic Bidets Compared to Water Rinsing After Surgery for Anal Fistula or Haemorrhoidal Disease: a Pilot Study
Anal Fistula Surgery, Anal Fistula
Not yet recruiting
Laser Hemorrhoidoplasty Versus Open Hemorrhoidectomy for Postoperative Pain
Hemorrhoid
Not yet recruitingPhase 2
Comparing Rectal Artery Embolization and Surgery for Treatment of Bleeding Grade 2 and 3 Internal Hemorrhoids
Hemorrhoids Internal, Hemorrhoids Second Degree
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Safia Z Ahmed, FCPS principal investigator
Services Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemorrhoidectomy in people with Hemorrhoidectomy and Third Degree Hemorrhoids, run by Services Hospital, Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative Time (time frame: The time was monitored from incision to the dressing approximately in 15 minutes to 50 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.