SCI-Pex, a Multi-center, Prospective, Non-controlled Investigation to Evaluate the Safety and Performance of PexyEazy®, a Device for Treatment of Hemorrhoids
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 6
- 主要终点
- Need of anesthesia, pain relief or local anesthesia
研究概览
简要总结
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 1 years. Adverse events, pain and other complications will be recorded, quality of life and hemorrhoid symptom questionnaires and clinical examination after 3 months and 1 year will be monitored to evaluate the result after a PexyEazy® procedure.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemorrhoidal disease grade II and III
- •American Society of Anesthesiologists (ASA) classification I-III.
排除标准
- •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.
结局指标
主要结局
Need of anesthesia, pain relief or local anesthesia
时间窗: Directly after the surgical procedure.
The need for per-operative anesthesia and/or sedation and/or pain relied (morphine) and/or local anesthesia will be registered.
Validation of device
时间窗: Directly after the surgical procedure.
The handling and performance of the device is validated through a questionnaire that the surgeon fills out after the procedure.
Presence of pain
时间窗: Directly after the surgical procedure.
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.
Per-operative complications
时间窗: Directly after the surgical procedure.
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.
Surgical result
时间窗: Directly after the surgical procedure
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.
Registered duration of surgery
时间窗: Directly after the surgical procedure.
Duration of surgery (minutes)
次要结局
- Use of pain relief drugs after surgery(1 week, 3 months and 1 year after surgery)
- Pain after surgery(1 week, 3 months and 1 year after surgery)
- Post operative complications(1 week, 3 months and 1 year after surgery)
- Change of symptoms(Before the procedure, 1 week, 3 months and 1 year after the procedure.)
- Clinical outcome(3 months and 1 year after surgery)
- Change in quality of life(Before the procedure, 3 months and 1 year after the procedure.)
- Duration of sick-leave/unable to perform normal activities.(1 week, 3 months and 1 year after surgery)