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.
Adult
Hemorrhoidal disease grade II and III
American Society of Anesthesiologists (ASA) classification I-III.
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.
Single group
PexyEazy
DevicePexyEazy 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.
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.
Validation of device
The handling and performance of the device is validated through a questionnaire that the surgeon fills out after the procedure.
Registered duration of surgery
Duration of surgery (minutes)
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.
Use of pain relief drugs after surgery
The use of pain relief drugs (name of drug, dosage, number/day)
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.
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).
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.
Cost
Calculate the total cost of the procedure including the cost for treatment of any complications, use of pain relief drugs and sick leave during the 3 month follow up period.
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