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Hemorrhoids clinical trials

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NCT ID: NCT06170736 Recruiting - Haemorrhoids Clinical Trials

Radiofrequency Ablation vs Doppler-guided Haemorrhoidal Artery Ligation in the Treatment of Haemorrhoidal Disease

RADIOLIGA
Start date: February 21, 2024
Phase: N/A
Study type: Interventional

Surgical treatment of grade II/III internal haemorrhoidal disease is indicated in the case of medical and/or instrumental treatment failure. Minimal invasive alternatives to haemorrhoidectomy have been introduced in the last decades to treat grade II/III haemorrhoids. Doppler-Guided haemorrhoidal artery ligation (DGHAL) represents a good therapeutic option in this condition with good short and mid-term outcomes but postoperative recurrence rates up to 35% at 5 years. Recently, a technique of radiofrequency ablation (RFA) has been introduced with promising outcomes. A recent systematic review reported a significant improvement of preoperative symptoms and a recurrence rate < 5%. To date, there is no study comparing DGHAL to RFA in the treatment of grade II/III haemorrhoids. The aim of this study is to demonstrate the non-inferiority in terms of failure rate of haemorrhoidal radiofrequency ablation compared to Doppler-guided haemorrhoidal artery ligation, associated with mucopexy, in the treatment of grade II and III haemorrhoidal disease

NCT ID: NCT06106269 Recruiting - Internal Hemorrhoid Clinical Trials

Outcomes and Quality of Life Following Rectal Artery Embolization for Bleeding Internal Hemorrhoids

HEMBO-1
Start date: June 7, 2024
Phase:
Study type: Observational

This study will assess how effective and safe rectal artery embolization works to treat symptomatic bleeding predominant internal hemorrhoids.

NCT ID: NCT06079892 Recruiting - Hemorrhoid Prolapse Clinical Trials

Hemorrhoid Radiofrequency

RFH
Start date: March 1, 2017
Phase:
Study type: Observational

Triapedicular haemorroidectomy is currently the gold standard in haemorrhoidal pathology. Minimally invasive surgical techniques now play an important role in the haemorrhoidal management algorithm, particularly for less advanced stages of the disease. Among these techniques, radiofrequency is one of the most recent and is gradually gaining ground. It involves applying a radiofrequency current to the internal haemorrhoidal tissue in order to induce its involution. The literature has shown that this technique leads to symptomatic improvement in over 60% of cases and a high satisfaction rate, even though some patients still seem to have haemorrhoidal symptoms postoperatively. The aim of this study is to evaluate the efficacy of this technique in patients with haemorrhoidal pathology operated on at our centre, using "hard" criteria which are thought to be more rigorous ("cure" rather than "improvement").

NCT ID: NCT06005727 Recruiting - Postoperative Pain Clinical Trials

Cryotherapy Post-haemorrhoidectomy (CYPHER) Randomized Controlled Trial

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

Haemorrhoids is a common problem with an estimated prevalence of 5 to 36%. Surgery is indicated in patients with grade 3 to 4 piles and in patients whom conservative measures have failed. There have been several surgical techniques described such as the Milligan- Morgan, Ferguson haemorrhoidectomy, stapled and laser haemorrhoidectomy. However, most patients experience different degrees of postoperative pain which may cause anxiety and dissatisfaction. A relatively non-invasive and cost-effective technique targeting inflammation is cryotherapy which has been shown to decrease pain secondary to trauma, injury or disease. Cryotherapy has few deleterious side effects due to its non-pharmacologic nature and has become widespread in sports medicine to treat soft tissue damage. Therefore, we aim to evaluate the role of cryotherapy in improving postoperative pain and outcomes among patients who undergo haemorrhoidectomy.

NCT ID: NCT05990569 Recruiting - Hemorrhoids Clinical Trials

Pudendal Nerve Block With Bupivacaine Alone and Bupivacaine With Methylene Blue for Postoperative Analgesia

Start date: August 12, 2023
Phase: N/A
Study type: Interventional

Study Description: The goal of this clinical trial is to compare the duration of postoperative pain relief achieved with two different approaches to pudendal nerve block in patients undergoing elective perianal surgery. The main question this study aims to answer is whether adding Methylene Blue to Bupivacaine pudendal nerve block can prolong postoperative analgesia compared to using Bupivacaine alone. Participants in this study will be individuals with ASA I and II physical status undergoing elective perianal surgery under spinal anesthesia. They will be randomly assigned to one of two groups: 1. Group A (Case Group): Participants will receive a pudendal nerve block with Bupivacaine combined with Methylene Blue. 2. Group B (Control Group): Participants will receive a pudendal nerve block with Bupivacaine alone. The pudendal nerve block will be performed using ultrasound guidance at the level of the ischial spine. The needle tip will be positioned between the Sacro tuberous and sacrospinous ligaments to inject the local anesthetic or the local anesthetic combined with Methylene Blue. Throughout the study, the researchers will monitor the time to the first rescue analgesic, assess pain levels using the Numeric Rating Scale at various time intervals (2, 6, 24, 48 hours, and 7 days), and observe for any side effects or complications related to the intervention. Participants will be closely observed after surgery to assess their pain levels and analgesic requirements. The researchers will also evaluate patient satisfaction using the Likert scale. By comparing the outcomes between the two groups, the study aims to determine if the addition of Methylene Blue to Bupivacaine pudendal nerve block provides superior postoperative analgesia in perianal surgery patients. This information will contribute to the understanding of effective pain management strategies for individuals undergoing perianal surgical procedures and potentially reduce the need for opioids and improve patient outcomes.

NCT ID: NCT05959577 Recruiting - Haemorrhoid Clinical Trials

Traditional Ferguson Hemorrhoidectomy vs Stapled Hemorrhoidopexy

Start date: August 17, 2022
Phase: N/A
Study type: Interventional

This study aimed to compare the short- and long-term outcomes of stapled hemorrhoidopexy (the procedure for prolapsed hemorrhoids, PPH) with anoplasty versus traditional Ferguson method for the treatment of patients with grade III /IV hemorrhoids.

NCT ID: NCT05889962 Recruiting - Postoperative Pain Clinical Trials

Ultrasound-guided Pudendal Nerve Block for Pain After Hemorrhoidectomy

Start date: October 26, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to investigate the effects of ultrasound-guided pudendal nerve block on postoperative pain, opioid consumption, and quality of recovery in patients receiving Ferguson hemorrhoidectomy.

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: 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: 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).