SCI-Pex Study - Safety and Performance of PexyEazy®, a Device for Treatment of Hemorrhoids

Study Overview
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Brief Summary
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The SCI-Pex study is a multicenter, prospective, non-controlled investigation on PexyEazy®, a new device for treatment of hemorrhoids based on the mucopexy method. Mucopexy is a well established method where sutures are applied above the hemorrhoids. When knots are tied, the hemorrhoids are lifted inwards to their normal position, which makes them swell down and symptoms disappears. PexyEazy® perform a mukopexy in a semiautomatic, faster and easier way on awake patient in less than 10 minutes. The SCI-Pex study will evaluate the safety and performance of PexyEazy on 35 patients with hemorrhoids grade II and III with a follow-up after 1 week, 3 months and 5 years. Adverse events, pain and other complications will be recorded, quality of life and hemorrhoid symptom questionnaires and clinical examination after 3 months will be monitored to evaluate the result after a PexyEazy® procedure.

Detailed Description
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Background: The generally accepted theory of why hemorrhoidal disease (HD) occurs is that the hemorrhoidal cushions slid down in the anal canal (muco-anal prolapse), which allows them to swell up. This creates problems with bleeding, leakage (soiling), itching and pain. Traditionally, severe HD is treated by surgical removal of the hemorrhoids, but the procedure is associated with long recovery time, pain and complications like stenosis and incontinence. Minimal invasive and hemorrhoid preserving surgery has gained popularity during the last two decades with new methods like Procedure for Prolapse and Hemorrhoids (PPH)/Stapled Anopexy and Transanal Hemorrhoidal Dearterialisation (THD)/Hemorrhoidal Artery Ligation and Recto Anal Repair (HAL/RAR). Several studies have shown, thought that mucopexy alone result in equally good result as THD/HAL-RAR. There are several ways to perform a mucopexy with different ways in how the sutures are applied and how many rows of sutures that are done. Other available methods focus on tissue destruction, for example sclerosing injections, laser, radio ablation, or methods with applied electricity that induce heat. These methods make the hemorrhoids to swell down but does not treat the muco-anal prolapse that are present in grade II and III hemorrhoids. PexyEazy® perform a mucopexy in a new, semi-automatic way with the benefit of reducing the cost and time of surgery and is estimated to be able to be conducted without the need of general anesthesia. Method: PexyEazy® is a single-use device for surgical treatment of internal HD grade II and III (according to the Goligher classification). It is based on the mucopexy method, but instead of applying the sutures by hand, the mucosa is folded by the device and then a loop of suture is introduced into the folded mucosa. When knots are applied, the hemorrhoids are lifted inwards, as the folded mucosa above the hemorrhoids is pulled together. Due to that the most proximal suture is longer and deeper and acts as an anchoring stich, the lifting motion is inwards, towards the deeper stitch. When the position of the hemorrhoids is normalized, the venous drainage is improved, and the hemorrhoids swell down, and symptoms disappears. PexyEazy® consists of five major parts: PexyEazy® examination proctoscope, handle with depth setting piston, light shuttle with a led lamp, PexyEazy® Mucopexy Device (MD) and the battery-pack. All parts are sterile, except the re-usable battery-pack. With the examination proctoscope, a correct position of the operation area is set by pushing a depth setting piston, that is part of the handle, towards the skin when the proctoscope is aligned with the dentate line. The handle is then transferred to the MD, which is inserted into the rectum until the depth- setting piston touches the skin, ensuring a correct position of the operation area. The MD have three operation areas that are positioned alongside the device at 3, 7, and 11 o'clock, which corresponds with the position of the three major internal hemorrhoids. Each operation area consists of 5 indentations, 4 smaller and one larger furthest in. The floor of the indentations has small holes, so when vacuum suction is applied within the device, the mucosa is sucked down into the indentations and thereby folding the mucosa above the hemorrhoids. A double needle is then pushed through the folded mucosa and docks with the ends of a loop of a suture that is stored in the suture cassette at the tip the tip of the device. When the needles are retracted, a loop of suture is introduced through the folded mucosa. The position of the sutures starts 10mm above the dentate line thanks to the settings done through the examination proctoscope and the depth setting piston. The sensation of pain is not present 10mm above the dentate line, which enables surgery without anesthesia. The stitches are 4mm wide, 3mm deep and 10mm long in the first four stitches and 6mm deep and 12mm long in the final stitch furthest in. The unit forming the walls of the indentations is divided into three longitudinal parts. When a supportive tray is removed the unit falls apart into three pieces and is removed, leaving the suture in the mucosa. Knots are then applied with a knot pusher, which pulls the folded mucosa together and the hemorrhoids are lifted inwards. The compressed mucosa is estimated to create multiple adhesion points/scar tissues that fixate the hemorrhoid in the new elevated position, ensuring a long-lasting result after the suture is absorbed (60-90 days). A special mucosa spatula is used to push out any protruding mucosa to make extraction of the device easier without damaging the tissue. Number of subjects: 31-35 patients The SCI-Pex study will evaluate the safety and performance of PexyEazy on patients with hemorrhoids grade II and III. For safety reasons will the first 6-10 patients undergo the procedure under general anesthesia and then the procedure will be done on awake patients (25) with 1 week, 3 months and 5 years follow up with questionnaires and a clinical examination after 3 months to document result.

Official Title
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SCI-Pex, a Multi-center, Prospective, Non-controlled Investigation to Evaluate the Safety and Performance of PexyEazy®, a Device for Treatment of Hemorrhoids

Conditions
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Hemorrhoids, Hemorrhoids, Internal, Suture; Complications, Infection or Inflammation, Rectal Diseases, Gastrointestinal Diseases

Intervention / Treatment
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* Device: PexyEazy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult Hemorrhoidal disease grade II and III American Society of Anesthesiologists (ASA) classification I-III. Exclusion Criteria: Previous surgical treatment for hemorrhoids by all methods except rubber band ligation or sclerosing injection therapy within the last 3 years. Previous surgical treatment with rubber band ligation or injection therapy within the last 2 months. More than three surgical treatments with rubber band ligation or sclerosing injection therapy within the last 3 years. Under medication with immunosuppressive drugs and/or anticoagulant drugs (not including 75mg acetylsalicylic acid) and not able to interrupt the anticoagulant drug medication or replace it with low molecular weight heparin for 5 days. Have ulcerative colitis, Crohn's disease or other intestinal inflammatory disease or presence of inflamed or thickened mucosa of the rectum. Presence of anal fissure, anal stenosis, stricture, fistulas or ulcers in the rectal area. The rectum has not been prepared prior to the investigation with rectal enema and is contaminated with feces that cannot easily be removed. Have schizophrenia, untreated depression or other mental illness or conditions that may affect judgment, sensation of pain or inability to complete the follow-up. Under medication of morphine or other strong painkillers, not including paracetamol. Fecal incontinence (not including soiling due to hemorrhoidal disease), or conditions with impaired sensation in the rectal area or impaired function of the anal sphincter. Previous rectal radiation. Rectal cancer or previous surgery due to rectal cancer. Pregnancy Hypercoagulability disorders or diseases that result in increased risk of bleeding. Impaired immune system or condition that increases the risk of infection.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PexyEazy procedure<br>PexyEazy procedure on patients with hemorrhoidal disease grade II and III. The study is descriptive and non-comparable to evaluate the safety and performance of PexyEazy. | Device: PexyEazy<br>* PexyEazy procedure on patients with hemorrhoidal disease grade II and III. The study is descriptive and non-comparable to evaluate the safety and performance of PexyEazy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical result | Clinical evaluation that a proper mucopexy has been achieved above all three locations (3, 7 and 11 o'clock) and any signs of bleeding or other damage to the mucosa, which is documented by the surgeon and by photography. | Directly after the surgical procedure | 
| Validation of device | The handling and performance of the device is validated through a questionnaire that the surgeon fills out after the procedure. | Directly after the surgical procedure. | 
| Registered duration of surgery | Duration of surgery (minutes) | Directly after the surgical procedure. | 
| Presence of pain | The patient fill in a questionnaire with a scale between 1 and 10, where 1 is no pain and 10 is the worst possible pain. | Directly after the surgical procedure. | 
| Need of anesthesia, pain relief or local anesthesia | The need for per-operative anesthesia and/or sedation and/or pain relied (morphine) and/or local anesthesia will be registered. | Directly after the surgical procedure. | 
| Per-operative complications | Adverse events (both complication and device malfunction) during or directly after the procedure, which will be registered by a questionnaires filled in by patient and surgeon. | Directly after the surgical procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of pain relief drugs after surgery | The use of pain relief drugs (name of drug, dosage, number/day) | 1 week, 3 months and 5 years after surgery | 
| Pain after surgery | The patient fill in a questionnaire with a scale between 1 and 10, where 1 is no pain and 10 is the worst possible pain. | 1 week, 3 months and 5 years after surgery | 
| Post operative complications | Registration of any post-operative complications (fecal incontinence, anal stenosis, bleeding, perianal hematoma, urinary retention or incontinence, presence of infection/abscess and assessment by Clavien-Dindo classification). | 1 week, 3 months and 5 years after surgery | 
| Clinical outcome | Evaluation of the rectum and anal canal 3 months after the procedure to register presence of complications and recurrence of the hemorrhoidal disease. The result is documented by the surgeon and by a photography of the mucosa. | 3 months after surgery | 
| Change of symptoms | Change of hemorrhoid symptoms through a questionnaire called Hemorrhoidal Disease Symptom Score and Hemorrhoidal Disease Symptom Score (HDSS and HSS). The score can vary between 4-28.The higher the value, the more severe/worse symptoms. | Before the procedure, 1 week, 3 months and 5 years after the procedure. | 
| Change in quality of life | Change in quality of life through a questionnaire called 36-Item Short Form Health Survey (SF-36). The score can vary between 0-100.The higher the value, the better quality of life. | Before the procedure, 3 months and 5 years after the procedure. | 
| Duration of sick-leave/unable to perform normal activities. | The patient fills in a questionnaire about how long and to what degree the patient needed sick-leave or were not able to perform normal activities (in case the patient does not work). | 1 week, 3 months and 5 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PexyEazy