HemorrhoidsNCT04981600
LaseRF Trial: Radiofrequency Ablation vs. Laser Hemorrhoidoplasty for Hemorrhoidal Disease
A study testing Radiofrequency ablation and Laser in people with Hemorrhoids, run by Umraniye Education and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Hemorrhoids, which can be defined as "vascular cushions" located at the anorectal junction, constitute an important part of the physiological continence mechanism. However, under various pathological conditions, they can expand below the dentate line and consequently are defined as hemorrhoidal disease, which is… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Radiofrequency ablation and Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 23 Aug 2021to 1 Apr 2023
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Symptomatic patients who applied to the general surgery outpatient clinic due to stage 2 or 3 hemorrhoidal disease, unresponsive to medical treatment
- Patients who have not undergone any previous surgery due to hemorrhoidal disease
- Patients with written informed voluntary consent forms
Who cannot join
- Concomitant anorectal disease
- History of anticoagulant use
- Fecal incontinence complaint
- History of active steroid/immunosuppressive use for any reason
- Pregnancy
- Inflammatory Bowel Disease
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Pendik Medipol University Hospital
Istanbul, Pendik, 34893
University of Health Sciences Umraniye Education and Research Hospital
Istanbul, 34764
About this study
Official title: LaseRF Trial: Radiofrequency Ablation vs. Laser Hemorrhoidoplasty Procedure for Grade II-III Hemorrhoidal Disease: Prospective Randomised Controlled Trial
Hemorrhoids, which can be defined as "vascular cushions" located at the anorectal junction, constitute an important part of the physiological continence mechanism. However, under various pathological conditions, they can expand below the dentate line and consequently are defined as hemorrhoidal disease, which is characterized by various symptoms such as bleeding, pain and itching. An ideal treatment should be effective in the long term, require less intervention to the surrounding structures, have low morbidity rates and cause minimal postoperative pain, which significantly affects the quality of life of a patient following surgery. he aim of this study is to compare the two contemporary minimally invasive methods.
Read the detailed description
Hemorrhoids, which can be defined as "vascular cushions" located at the anorectal junction, constitute an important part of the physiological continence mechanism. However, under various pathological conditions, they can expand below the dentate line and consequently are defined as hemorrhoidal disease, which is characterized by various symptoms such as bleeding, pain and itching. The indication of treatment depends primarily on the individual burden of the disease rather than its stage. An ideal treatment should be effective in the long term, require less intervention to the surrounding structures, have low morbidity rates and cause minimal postoperative pain, which significantly affects the quality of life of a patient following surgery. Although conventional resection based techniques have less recurrence rates, they tend to have a greater chance of leading to various postoperative complications such as significant postoperative pain, urinary retention, bleeding, abscess formation, anal stenosis, anal fissure and fecal incontinence, deeming non-resection based less invasive techniques more favorable in terms of postoperative morbidity. The main mechanism of non-resection based techniques is creating an inflammatory stimulus inside the prolapsed hemorrhoidal tissue which ultimately causes fibrosis and relocation of the tissue above the dentate line. There are several randomized controlled trials which compared the laser procedure especially with resection based methods in this regard. However, to our knowledge, which is based on a thorough search in the Pubmed and Google Scholar, no randomized clinical trial has been made comparing the radiofrequency ablation method with the laser ablation technique .
The aim of this study is to compare the two contemporary minimally invasive methods in terms of postoperative complications, recovery process and postoperative pain.
- Conditions
- Hemorrhoids
- Being tested
- Radiofrequency ablation, Laser
- Keywords
- Radiofrequency ablation, Laser hemorrhoidoplasty, Pain, Recurrence
- Medical subject headings
- Hemorrhoids, Pain, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablationDevice
Patients in the RF group will be first examined under anesthesia at the beginning of the procedure in lithotomy position. Approximately 3-6 ml of 20 mg/ml Lidocaine (Jetokaine, Adeka İlaç Sanayi, Samsun) solution will be injected between the cushion and the internal anal sphincter to minimize heat conduction to the surrounding tissues during the procedure. The HPR45i probe (F Care Systems, Antwerpen, Belgium) connected to the Rafaelo ® EVRF machine (F Care Systems, Antwerpen, Belgium) will be placed inside the cushion and 25 watts of RF energy will be transmitted. Care will be taken by not exceeding the dentate line caudally. The recommended Joule value for each operation is 1200-3000 J. Then cold is applied on the cushion, reducing the temperature of the tissue and preventing damage to the surrounding tissues. The same procedure will be performed for other pathologic cushions as well.
LaserDevice
The same preoperative preparations will be done for the laser group as well. The NeoV 1470 (neoLaser, Israel) device will be used in this group. Following routine placement of the patient in lithotomy position and determining the cushion to be treated, a 12 W laser beam with a wavelength of 1470nm will be inserted into the cushion above the dentate line and advanced to the apex and approximately 3 laser shots are delivered throughout the course caudally, the number of which can be altered according to the size targeted cushion. Finally the procedure will be completed after gentle cold application.
An enema will be given to the patients in both study groups in the morning of the operation and patients will be discharged with analgesics on the same day.
| Study group | Role | What they receive |
|---|---|---|
| Laser Group | Active comparator | Grade II-III hemorrhoids present a special challenge to surgeons since aggressive surgery exposes the patient to several per- and postoperative complications. Therefore new techniques have been developed and one of the most popular contemporary technique is laser hemorrhoidectomy. By this technique a laser probe is inserted above the dentate line and advanced to the apex of the cushion and several shots are delivered while pulling out the probe gradually. The idea is to compromise the vascular flow of corpus cavernosum recti, hence shrinking the hemorrhoidal cushion. Receives: Device: Laser |
| RF (Radiofrequency) Group | Active comparator | Another recent and similar method is radiofrequency coagulation which depends on transmitting radiofrequency waves to tissue. This transmission results in conversion of radiofrequency waves into heat and causes coagulation necrosis in corpus cavernosum recti. The necrosis leads to fibrosis of the surrounding vessels and consequently cushion shrinkage is achieved. Receives: Device: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Healing
Hemorrhoid downgrading of at least 1 grade
Measured: 4 month
Change in Visual analog score (VAS) at 4 weeks
Patients are simply asked to score their pain from 1 to 10, which is typically called visual analog scale in the literature, with higher scores representing more severe pain.
Measured: 1st week and 4th week
Secondary outcomes (5)
Quality of Life for HSS (Hemorrhoid Severity Score)
Hemorrhoid Severity Score (HSS) is the total score obtained by the sum of the numerical grades of pruritis, pain, prolapse, bleeding and soiling. All the five components in this classification system are graded into four grades ranging from 0 to 3.
Measured: 1st week and 4th week
Operation Time
Specified in hours
Measured: Operation 1 Day
Hospitalization Time
Specified in days
Measured: Discharge day after the surgery up to 3 days
Number of admissions
Outpatient follow up per routine or due to several complications such as pain, mucosal discharge, itching etc.
Measured: 4 months after the procedure
Rate of complications
Such as bleeding, infection and hematoma
Measured: 1st week, 4th week and 4th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start23 Aug 2021
- Primary completion1 Jan 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidsStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Istanbul Medipol University Hospital, Gama Medical Ltd.
- Responsible party
- Principal investigator, Hanife Seyda Ulgur, Umraniye Education and Research Hospital
- Investigators
- Hanife Ş Ülgür, MD, Principal investigator, University of Health Sciences, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981600
- Sponsor's protocol ID
- B.10.1.TKH.4.34.H.GP.0.01/183
- Status last verified
- Jan 2025
- First submitted
- 4 Jul 2021
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Riss S, Weiser FA, Schwameis K, Riss T, Mittlbock M, Steiner G, Stift A. The prevalence of hemorrhoids in adults. Int J Colorectal Dis. 2012 Feb;27(2):215-20. doi: 10.1007/s00384-011-1316-3. Epub 2011 Sep 20.
PubMed 21932016Maloku H, Gashi Z, Lazovic R, Islami H, Juniku-Shkololli A. Laser Hemorrhoidoplasty Procedure vs Open Surgical Hemorrhoidectomy: a Trial Comparing 2 Treatments for Hemorrhoids of Third and Fourth Degree. Acta Inform Med. 2014 Dec;22(6):365-7. doi: 10.5455/aim.2014.22.365-367. Epub 2014 Dec 19.
PubMed 25684841Pucher PH, Qurashi M, Howell AM, Faiz O, Ziprin P, Darzi A, Sodergren MH. Development and validation of a symptom-based severity score for haemorrhoidal disease: the Sodergren score. Colorectal Dis. 2015 Jul;17(7):612-8. doi: 10.1111/codi.12903.
PubMed 25603811Eddama MMR, Everson M, Renshaw S, Taj T, Boulton R, Crosbie J, Cohen CR. Radiofrequency ablation for the treatment of haemorrhoidal disease: a minimally invasive and effective treatment modality. Tech Coloproctol. 2019 Aug;23(8):769-774. doi: 10.1007/s10151-019-02054-2. Epub 2019 Aug 9.
PubMed 31399891Giamundo P, Salfi R, Geraci M, Tibaldi L, Murru L, Valente M. The hemorrhoid laser procedure technique vs rubber band ligation: a randomized trial comparing 2 mini-invasive treatments for second- and third-degree hemorrhoids. Dis Colon Rectum. 2011 Jun;54(6):693-8. doi: 10.1007/DCR.0b013e3182112d58.
PubMed 21552053
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LaseRF Trial: Radiofrequency Ablation vs. Laser Hemorrhoidoplasty Procedure for Grade II-III Hemorrhoidal Disease: Prospective Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04981600
- Acronym / sponsor ID
- B.10.1.TKH.4.34.H.GP.0.01/183
- Conditions
- Hemorrhoids
- Keywords
- Radiofrequency ablation, Laser hemorrhoidoplasty, Pain, Recurrence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Collaborators
- Istanbul Medipol University Hospital, Gama Medical Ltd.
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 29 Jul 2021 (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.
Hemorrhoids, which can be defined as "vascular cushions" located at the anorectal junction, constitute an important part of the physiological continence mechanism. However, under various pathological conditions, they can expand below the dentate line and consequently are defined as hemorrhoidal disease, which is characterized by various symptoms such as bleeding, pain and itching. An ideal treatment should be effective in the long term, require less intervention to the surrounding structures, have low morbidity rates and cause minimal postoperative pain, which significantly affects the quality of life of a patient following surgery. he aim of this study is to compare the two contemporary minimally invasive methods.
Detailed description
Hemorrhoids, which can be defined as "vascular cushions" located at the anorectal junction, constitute an important part of the physiological continence mechanism. However, under various pathological conditions, they can expand below the dentate line and consequently are defined as hemorrhoidal disease, which is characterized by various symptoms such as bleeding, pain and itching. The indication of treatment depends primarily on the individual burden of the disease rather than its stage. An ideal treatment should be effective in the long term, require less intervention to the surrounding structures, have low morbidity rates and cause minimal postoperative pain, which significantly affects the quality of life of a patient following surgery. Although conventional resection based techniques have less recurrence rates, they tend to have a greater chance of leading to various postoperative complications such as significant postoperative pain, urinary retention, bleeding, abscess formation, anal stenosis, anal fissure and fecal incontinence, deeming non-resection based less invasive techniques more favorable in terms of postoperative morbidity. The main mechanism of non-resection based techniques is creating an inflammatory stimulus inside the prolapsed hemorrhoidal tissue which ultimately causes fibrosis and relocation of the tissue above the dentate line. There are several randomized controlled trials which compared the laser procedure especially with resection based methods in this regard. However, to our knowledge, which is based on a thorough search in the Pubmed and Google Scholar, no randomized clinical trial has been made comparing the radiofrequency ablation method with the laser ablation technique .
The aim of this study is to compare the two contemporary minimally invasive methods in terms of postoperative complications, recovery process and postoperative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Group | Active comparator | Device: LaserGrade II-III hemorrhoids present a special challenge to surgeons since aggressive surgery exposes the patient to several per- and postoperative complications. Therefore new techniques have been developed and one of the most popular contemporary technique is laser hemorrhoidectomy. By this technique a laser probe is inserted above the dentate line and advanced to the apex of the cushion and several shots are delivered while pulling out the probe gradually. The idea is to compromise the vascular flow of corpus cavernosum recti, hence shrinking the hemorrhoidal cushion. |
| RF (Radiofrequency) Group | Active comparator | Device: Radiofrequency ablationAnother recent and similar method is radiofrequency coagulation which depends on transmitting radiofrequency waves to tissue. This transmission results in conversion of radiofrequency waves into heat and causes coagulation necrosis in corpus cavernosum recti. The necrosis leads to fibrosis of the surrounding vessels and consequently cushion shrinkage is achieved. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Symptomatic patients who applied to the general surgery outpatient clinic due to stage 2 or 3 hemorrhoidal disease, unresponsive to medical treatment
- Patients who have not undergone any previous surgery due to hemorrhoidal disease
- Patients with written informed voluntary consent forms
Key exclusion criteria (6 listed)
- Concomitant anorectal disease
- History of anticoagulant use
- Fecal incontinence complaint
- History of active steroid/immunosuppressive use for any reason
- Pregnancy
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 |
|---|---|---|
| Radiofrequency ablationPatients in the RF group will be first examined under anesthesia at the beginning of the procedure in lithotomy position. Approximately 3-6 ml of 20 mg/ml Lidocaine (Jetokaine, Adeka İlaç Sanayi, Samsun) solution will be injected between the cushion and the internal anal sphincter to minimize heat conduction to the surrounding tissues during the procedure. The HPR45i probe (F Care Systems, Antwerpen, Belgium) connected to the Rafaelo ® EVRF machine (F Care Systems, Antwerpen, Belgium) will be placed inside the cushion and 25 watts of RF energy will be transmitted. Care will be taken by not exceeding the dentate line caudally. The recommended Joule value for each operation is 1200-3000 J. Then cold is applied on the cushion, reducing the temperature of the tissue and preventing damage to the surrounding tissues. The same procedure will be performed for other pathologic cushions as well. | Device | RF (Radiofrequency) Group |
| LaserThe same preoperative preparations will be done for the laser group as well. The NeoV 1470 (neoLaser, Israel) device will be used in this group. Following routine placement of the patient in lithotomy position and determining the cushion to be treated, a 12 W laser beam with a wavelength of 1470nm will be inserted into the cushion above the dentate line and advanced to the apex and approximately 3 laser shots are delivered throughout the course caudally, the number of which can be altered according to the size targeted cushion. Finally the procedure will be completed after gentle cold application. An enema will be given to the patients in both study groups in the morning of the operation and patients will be discharged with analgesics on the same day. | Device | Laser Group |
Primary outcome
Rate of Healing
Time frame: 4 month
Hemorrhoid downgrading of at least 1 grade
Change in Visual analog score (VAS) at 4 weeks
Time frame: 1st week and 4th week
Patients are simply asked to score their pain from 1 to 10, which is typically called visual analog scale in the literature, with higher scores representing more severe pain.
5 secondary outcomes
Quality of Life for HSS (Hemorrhoid Severity Score)
Time frame: 1st week and 4th week
Operation Time
Time frame: Operation 1 Day
Hospitalization Time
Time frame: Discharge day after the surgery up to 3 days
Number of admissions
Time frame: 4 months after the procedure
Rate of complications
Time frame: 1st week, 4th week and 4th month
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 28 Jan 2025.
- Background: PubMed 21932016Riss S, Weiser FA, Schwameis K, Riss T, Mittlbock M, Steiner G, Stift A. The prevalence of hemorrhoids in adults. Int J Colorectal Dis. 2012 Feb;27(2):215-20. doi: 10.1007/s00384-011-1316-3. Epub 2011 Sep 20.
- Background: PubMed 25684841Maloku H, Gashi Z, Lazovic R, Islami H, Juniku-Shkololli A. Laser Hemorrhoidoplasty Procedure vs Open Surgical Hemorrhoidectomy: a Trial Comparing 2 Treatments for Hemorrhoids of Third and Fourth Degree. Acta Inform Med. 2014 Dec;22(6):365-7. doi: 10.5455/aim.2014.22.365-367. Epub 2014 Dec 19.
- Background: PubMed 25603811Pucher PH, Qurashi M, Howell AM, Faiz O, Ziprin P, Darzi A, Sodergren MH. Development and validation of a symptom-based severity score for haemorrhoidal disease: the Sodergren score. Colorectal Dis. 2015 Jul;17(7):612-8. doi: 10.1111/codi.12903.
- Background: PubMed 31399891Eddama MMR, Everson M, Renshaw S, Taj T, Boulton R, Crosbie J, Cohen CR. Radiofrequency ablation for the treatment of haemorrhoidal disease: a minimally invasive and effective treatment modality. Tech Coloproctol. 2019 Aug;23(8):769-774. doi: 10.1007/s10151-019-02054-2. Epub 2019 Aug 9.
- Background: PubMed 21552053Giamundo P, Salfi R, Geraci M, Tibaldi L, Murru L, Valente M. The hemorrhoid laser procedure technique vs rubber band ligation: a randomized trial comparing 2 mini-invasive treatments for second- and third-degree hemorrhoids. Dis Colon Rectum. 2011 Jun;54(6):693-8. doi: 10.1007/DCR.0b013e3182112d58.
- Individual participant dataSharing planned: No
Related trials for Hemorrhoids
Not yet recruiting
Auricular Indwelling Needles Added to Diosmin/Hesperidin for Grade I-II Internal Hemorrhoids With Heat-Toxin Syndrome
Internal Haemorrhoids
Enrolling by invitation
Ultrasound-Guided Versus Landmark-Guided Pudendal Block for Post-Hemorrhoidectomy Pain
Hemorrhoids, Postoperative Pain
Not yet recruitingObservational study
Bleeding Reduction in Grade II-III Haemorrhoids Through Embolization Treatment
Hemorrhoid, Hemorrhoid Bleeding
Recruiting
Ligasure Versus Conventional Diathermy in Hemorrhoidectomy
Hemorrhoids
Enrolling by invitationObservational study
Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
Arteriovenous Malformation, Gastrointestinal Bleed
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.
Hanife Ş Ülgür, MD principal investigator
University of Health Sciences, Umraniye Education and Research Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation and Laser in people with Hemorrhoids, run by Umraniye Education and Research Hospital at 2 sites in Turkey (Türkiye).
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 3 inclusion and 6 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 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Rate of Healing (time frame: 4 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04981600, which also lists 5 linked publications.
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 28 Jan 2025.