Clinical trial NCT04981600: LaseRF Trial: Radiofrequency Ablation vs. Laser Hemorrhoidoplasty for Hemorrhoidal Disease
Official title: LaseRF Trial: Radiofrequency Ablation vs. Laser Hemorrhoidoplasty Procedure for Grade II-III Hemorrhoidal Disease: Prospective Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhoids
Keywords: Radiofrequency ablation
Laser hemorrhoidoplasty
Pain
Recurrence
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Istanbul Medipol University Hospital
name: Gama Medical Ltd.
First posted: 2021-07-29
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Concomitant anorectal disease
* History of anticoagulant use
* Fecal incontinence complaint
* History of active steroid/immunosuppressive use for any reason
* Pregnancy
* Inflammatory Bowel Disease

Primary outcomes:
measure: Rate of Healing
timeFrame: 4 month
measure: Change in Visual analog score (VAS) at 4 weeks
timeFrame: 1st week and 4th week
Secondary outcomes:
measure: Quality of Life for HSS (Hemorrhoid Severity Score)
timeFrame: 1st week and 4th week
measure: Operation Time
timeFrame: Operation 1 Day
measure: Hospitalization Time
timeFrame: Discharge day after the surgery up to 3 days
measure: Number of admissions
timeFrame: 4 months after the procedure
measure: Rate of complications
timeFrame: 1st week, 4th week and 4th month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Pendik Medipol University Hospital
state: Pendik
city: İstanbul
country: Turkey
facility: University of Health Sciences Umraniye Education and Research Hospital
Study officials:
affiliation: University of Health Sciences, Umraniye Education and Research Hospital
name: Hanife Ş Ülgür, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Maloku 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.
citation: Pucher 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.
citation: Eddama 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.
citation: Giamundo 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.