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Hemorrhoids clinical trials

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NCT ID: NCT05807425 Recruiting - Liver Cirrhosis Clinical Trials

Polidocanol Foam in Hemorrhoidal Disease in Patients With Liver Cirrhosis

Start date: March 31, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Hemorrhoidal disease (HD) is a common health problem, affecting up to 38,9% of adult population. HD is also a common finding in up to 36% of cirrhotic patients, as hemorrhoidal plexus is a possible site of portosystemic venous anastomosis. Cirrhotic patients represent a group often neglected in clinical trials so, little is known about the optimal treatment for HD these patients. The objective of this study is to prospectively evaluate the efficacy and safety of treatment of grade I, II and III internal HD with polidocanol foam in cirrhotic patients.

NCT ID: NCT05788497 Terminated - Clinical trials for Haemorrhoids Without Complication

Efficacy and Safety of Hemorrane Plus Versus Hemorrane and Versus Placebo in Patients With Uncomplicated Haemorrhoids

Start date: March 30, 2023
Phase: Phase 3
Study type: Interventional

This is a Multicentre, double-blind, randomised clinical trial to evaluate and compare the efficacy and safety of Hemorrane Plus (Hemorrane® + benzocaine) with Hemorrane® and with placebo in patients with uncomplicated haemorrhoids.

NCT ID: NCT05782010 Recruiting - Clinical trials for Gastrointestinal Diseases

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

SCI-Pex
Start date: June 15, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05772351 Completed - Hemorrhoids Clinical Trials

Preoperative Micronized Flavonoid Fraction (MFF) Use in Multimodal Anesthesia in Anorectal Surgery

Start date: November 25, 2021
Phase: N/A
Study type: Interventional

Aim: To assess the efficiency of the micro-flavonoid fraction (MMF) administration prior to anorectal surgery with spinal anesthesia on postoperative pain severity reduction. Methods: Patients who meet the following criteria are included: participants must be diagnosed with surgical treatment of anorectal diseases. All participants are randomly divided into 2 groups: the first one gets a tablet with 1000 mg MFF (Detralex®), the second one gets a tablet containing starch per os 14 days before surgery (72 participants per arm). Then patients of each group will continue MFF administration for 30 days after surgery. Patients of both arms receive spinal anesthesia and undergo surgery. Following the procedure the primary and secondary outcomes are evaluated: frequency of the opioid drugs intake, the severity of the postoperative pain syndrome, duration and frequency of other drugs intake, readmission rate, overall quality of life, time from the procedure to returning to work and the complications rate, C-reactive protein level. Discussion: the MFF intake allows reducing the severity of the hemorrhoidal disease symptoms during conservative treatment. In addition, the Detralex® efficacy has been proven in postoperative pain reduction for patients diagnosed with varicose veins of the lower extremities. The investigators intend to evaluate the feasibility of the preoperative MFF administration for the postoperative pain reduction and the decrease of the postoperative complications in patients with hemorrhoidal disease.

NCT ID: NCT05770141 Not yet recruiting - Hemorrhoids Clinical Trials

Laser Hemorrhoidoplasty Versus Open Surgical Hemorrhoidectomy in Second and Third Degree Piles

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

The study aims to compare the pain , duration of intervention and long term outcomes of laser hemorrhoidoplasty versus open surgical hemorrhoidectomy

NCT ID: NCT05750563 Not yet recruiting - Haemorrhoids Clinical Trials

Randomised, Double-blind, Placebo-controlled to Assess the Efficacy and Safety of the Food Supplement Microsmin® Plus

Start date: February 28, 2023
Phase: N/A
Study type: Interventional

Haemorrhoids are variceal dilatations of the anal and perianal venous plexus and often develop secondary to the persistently elevated venous pressure within the haemorrhoidal plexus . The classical position of haemorrhoids corresponds to three positions which are the right anterior, right posterior and the left lateral areas of the anal canal. Haemorrhoids may be external or internal. External haemorrhoids are covered with skin and internal haemorrhoids are covered with anal mucous membranes. The grading system used by Banov to classify internal haemorrhoids is one of the most common grading systems used by clinicians and is used to guide therapeutic practice. Internal haemorrhoids can be divided into four categories depending on the degree of prolapse (the protrusion of the haemorrhoid through the anus). The most widely accepted classification is the Goligher classification: - Bleeding but no prolapse (grade I). - Hemorrhoidal piles prolapse through the anus during straining, but they reduce spontaneously (grade II). - Hemorrhoidal piles prolapse through the anus during straining and require manual reduction (grade III). - The prolapse is irreducible (grade IV). Most symptoms and signs which patients present with arise from internal haemorrhoids, derive from structural changes of the normal anatomic padding (enlarged internal haemorrhoids) and are generally associated with chronic straining either due to constipation, diarrhoea or prolonged periods trying to defecate. They are also common during pregnancy and childbirth.

NCT ID: NCT05697562 Recruiting - Hemorrhoids Clinical Trials

Evaluation of Superior Rectal Arterial Embolization in Hemorrhoidal Disease

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

SRAE is a promising treatment of bleeding HD as a minimally invasive approach without sphincter damage nor direct mucosal anorectal trauma. Feasibility, efficacy and safety were studied in several trials. A randomized controlled study should confirm the benefits of this technique and will define its therapeutic role in HD. Embolization and DG-HAL are based on the same concept of vascular occlusion of hemorrhoidal branches of the rectal artery. Furthermore, DG-HAL and RBL are equally effective procedures. The assumption is that treatment with SRAE is not inferior in comparison to RBL or DG HAL in respectively patients without or with antiplatelet/anticoagulation therapy in terms of symptom control and bleeding (non-inferiority study).

NCT ID: NCT05605080 Completed - Hemorrhoids Clinical Trials

Hemostatic and Analgesic Effect of Gel Foam and Gauze With Bosmin After Anal Surgery

Start date: November 7, 2022
Phase: N/A
Study type: Interventional

To evaluate the hemostatic and analgesic effect of using gauze with Bosmin or Gelfoam after anal surgery.

NCT ID: NCT05602987 Completed - Hemorrhoids Clinical Trials

Comparison Study of the Effect of Enema in Anal Surgery

Start date: November 14, 2022
Phase: N/A
Study type: Interventional

To evaluate whether receiving enema before anal surgery or not affects the postoperative recovery and complications.

NCT ID: NCT05519189 Recruiting - Hemorrhoids Clinical Trials

Evaluation of the Value of Perianal Infiltration During Thermodestruction of Haemorrhoidal Disease by Radiofrequency

RAFAELOCAL
Start date: January 10, 2023
Phase: Phase 4
Study type: Interventional

Haemorrhoidal disease is a common and benign condition (1). Anatomically, there is an external and internal component. Only internal haemorrhoidal disease is managed by radiofrequency. Different levels of severity of internal haemorrhoidal disease have been defined by the Goligher classification (1). According to the recommendations for clinical practice established by the French National Society of ColoProctology (SNFCP), grade I and II haemorrhoidal disease should be managed instrumentally after failure of medical treatment. Grade III and IV haemorrhoidal disease is an indication for surgical management in the first instance or after failure of instrumental treatments. The standard technique is the Milligan and Morgan procedure (pedicle haemorrhoidectomy) described in 1937 (2). This technique consists of the removal of the 3 internal haemorrhoidal bundles. It remains the most effective but is responsible for postoperative complications, in particular pain, haemorrhage, anal strictures and anal incontinence (3), (4). Less aggressive techniques have been developed (Longo technique, HAL-RAR technique). The Longo technique is a circular stapling haemorrhoidopexy. The haemorrhoidal packets are brought up into the anal canal with the help of a circular aggravating forceps removing a collar of rectal mucosa. This removal of the mucosa also allows the vascularisation of the haemorrhoidal venous network to be interrupted. The HAL- RAR technique is a non-resection technique consisting of arterial ligation of the haemorrhoidal packets in order to interrupt the vascularisation supplying the haemorrhoidal packets. This technique can be performed with or without Doppler guidance. Recently, Renshaw et al. described a technique for coagulation of haemorrhoidal bundles using a radiofrequency probe (5). This technique has shown satisfactory results and is an interesting option in the management of haemorrhoidal disease (6) with low postoperative pain (7). In order to limit patients' postoperative pain and reduce their apprehension during defecation episodes, a perianal block has been shown to reduce postoperative pain in patients with a haemorrhoidectomy technique (8,9). In 2019, a prospective randomised trial (10) confirmed the value of this perianal block without a neurostimulator during a haemorrhoidal pack resection procedure. A perianal infiltration of 40 ml of 0.5% Ropivacaine was performed. These 40ml were divided into 4 injections of 10ml each in the left and right antero-lateral position and in the left and right postero-lateral position in relation to the anal margin. The hemorrhoidal pack resection technique is known to induce postoperative pain. Haemorrhoidal radiofrequency (RAFAELO® procedure) is a new minimally invasive technique that reduces postoperative pain and is usually performed on an outpatient basis (6). Currently, peri-anal infiltration is routinely performed for all haemorrhoidal surgery whether or not there is a haemorrhoidal resection. No studies have evaluated the relevance of maintaining peri-anal infiltration in non-resected haemorrhoidal surgery and in particular during radiofrequency haemorrhoidal packets. In addition, ropivacaine infiltration is not without risks. Local anaesthesia has potential risks for the patient: - Adverse reaction or hypersensitivity to local anaesthetics and components - Infection at the injection site or infiltration - Haematoma at the injection or infiltration site The aim of our study is to demonstrate the non-inferiority of discontinuing perianal infiltration in patients with thermodestructive haemorrhoidal surgery.