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Hemorrhoids clinical trials

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NCT ID: NCT04251884 Completed - Postoperative Pain Clinical Trials

Pudendal Nerve Block for Hemorrhoidectomy

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Patients undergoing Milligan-Morgan hemorrhoidectomy will be randomized to receive or not the pudendal nerve block after the spinal anesthesia.

NCT ID: NCT04248205 Recruiting - Hemorrhoids Clinical Trials

Ketamine for Post-operative Analgesia in Hemorrhoidectomy

Start date: June 15, 2020
Phase: Phase 4
Study type: Interventional

This is a prospective, randomized study of ketamine versus no ketamine in approximately 100 patients undergoing hemorrhoidectomy for Grade III or IV hemorrhoids. The participants will be blinded to which treatment arm they are assigned, because participants will be under anesthesia when the ketamine is administered. The investigators will know whether the participant receives ketamine or not.

NCT ID: NCT04229784 Recruiting - Clinical trials for Surgical Procedure, Unspecified

Multicentrique Prospective Evaluation of Radiofrequency Surgical Treatment of Homorrhoidal Disease

RF-GREP
Start date: July 1, 2019
Phase: N/A
Study type: Interventional

Hemorrhoids consist of a tissue rich in blood vessels and are present in all individuals inside the anus. Hemorrhoidal disease (HD) is when hemorrhoids become troublesome and cause symptoms such as pain, bleeding, prolapse or seepage. The first steps in the treatment of HD involve either drugs or instrumental gestures (sclerosis, ligation). In the event of failure or of a disease that is significant from the outset, it is possible to envisage a surgical treatment. The use of a radiofrequency is a new technique, already used frequently by vascular surgeons in the treatment of varicose veins of the lower limbs. This technique has been developed for radiofrequency destruction of hemorrhoidal vascular tissue. In France, no studies have been carried out to evaluate this new technique.

NCT ID: NCT04188171 Active, not recruiting - Hemorrhoids Clinical Trials

Sclerotherapy With Polidocanol Foam In The Treatment Of Hemorrhoidal Disease In Patients With Bleeding Disorders

Start date: August 1, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Treatment of hemorrhoidal disease includes a conservative approach (dietary and behavioral measures, venotropic and topical medication), office-based treatments and surgery. Rubber banding is currently considered the instrumental method of choice in the treatment of hemorrhoidal disease grades I to III (Goligher's classification). However, its use in patients with bleeding disorders is not recommended. Sclerotherapy can be performed in these patients since the hemorrhagic risk is very low. The most commonly used agent for sclerotherapy is liquid polidocanol. Polidocanol foam seems to be more effective than the liquid formulation and is safe in the treatment of hemorrhoidal disease even in patients with coagulation disorders. This study is aimed to evaluate the efficacy and safety of polidocanol foam sclerotherapy in the treatment of hemorrhoidal disease grades I to III in patients with bleeding disorders.

NCT ID: NCT04169152 Recruiting - Rectal Prolapse Clinical Trials

CAES for Internal Hemorrhoids and Rectal Prolapse

Start date: December 30, 2019
Phase:
Study type: Observational

Cap-assisted endoscopic sclerotherapy (CAES) is a new interventional therapy for internal hemorrhoids and rectal prolapse under colonoscopy. However, the long-term efficacy and safety of CAES in the treatment of internal hemorrhoids and rectal prolapse are still not clear due to the lack of large sample studies. Therefore, a nationwide multi-center, large sample, prospective and cohort study was designed to evaluate the efficacy and safety of CAES in the treatment of internal hemorrhoids and rectal prolapse, to provide reliable evidence for popularization of this minimally invasive technology.

NCT ID: NCT04139876 Recruiting - Hemorrhoids Clinical Trials

Ligasure Hemorrhoidectomy Versus Open Hemorrhoidectomy

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

This is a single center randomized clinical trial comparing Ligasure Hemorrhoidectomy and Open Hemorrhoidectomy for the treatment of prolapsing haemorrhoids. The primary aim of the study is to evaluate symptoms related to hemorrhoids one year postoperatively, according to a hemorrhoidal disease symptom score (HDSS). Secondary endpoints are patient satisfaction with the operation, Health related Quality of Life and effect on anal continence.

NCT ID: NCT04119401 Recruiting - Hemorrhoids Clinical Trials

Hemorrhoid Artery LigatioN Without Doppler Trial

HAND
Start date: January 8, 2019
Phase: N/A
Study type: Interventional

Hemorrhoidal artery ligation with Doppler guidance (HAL) and suture fixation of hemorrhoidal nodes (RAR) is a popular minimally invasive technique for hemorrhoidal disease (HD) treatment which uses an ultrasound probe to detect hemorrhoidal arteries for further ligation. We hypothesized that ultrasound guidance has no advantages over manual hemorrhoidal arteries detection for HD treatment. The aim is to compare the results of HAL-RAR procedure in patients with stage II-III HD with Doppler and manual HA detection. In this ongoing randomized, controlled, single center clinical study 200 patients randomly divided into group A (HAL-RAR with Doppler US navigation) and group B (HAL with manual HA detection and mucopexy) are planned to be included. The primary endpoint was recurrence of any symptoms of HD; secondary endpoints were pain syndrome severity (VAS), treatment satisfaction (1 to 5 points) and need for the drug therapy in 30 days and 8 weeks after surgery. Ultrasound guidance technology of HAL with mucopexy could have the same efficacy the manual HA detection regarding the HD treatment effectiveness and patient satisfaction.

NCT ID: NCT04101773 Not yet recruiting - Hemorrhoids Clinical Trials

Napoleon Trial: Optimal Treatment for Recurrent Haemorrhoidal Disease

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

Rationale: There is level I evidence in literature that the first management step of HD is basic treatment, including laxatives and high fibre dieti, ii. The next treatment modality after basic treatment in case of persistent symptoms is rubber band ligation (RBL), which can be repeated if necessary. There is currently no consensus and a lack of evidence regarding the best treatment option for these patients having recurrent HD: continuing RBL or a surgical intervention. Furthermore, there is no estimate of costs and cost-effectiveness in this patient group. Objective: The primary objective of this RCT is to compare the effectiveness of RBL, sutured mucopexy and haemorrhoidectomy regarding recurrence and patient-reported symptoms for recurrent grade 2 and 3 HD after at least 2 previous RBL treatments. Secondary objectives are to compare RBL, sutured mucopexy and haemorrhoidectomy for recurrent grade 2 and 3 HD after previous RBL treatments in terms of early and late complications, impact of symptoms on daily activities, patient satisfaction with treatment, health-related quality of life, costs and cost-effectiveness, and budget impact. Study design: Dutch prospective multicentre randomized controlled trial. Study population: Patients ≥18 who have recurrent grade 2 or 3 haemorrhoidal disease and who had at least 2 rubber band ligation treatments. In total, 558 patients will be included. Intervention: Rubber band ligation versus sutured mucopexy versus haemorrhoidectomy. All three interventions are part of Dutch usual care, and serve as each other's control. Main study parameters/endpoints: Primary outcomes are (1) recurrence and (2) patient-reported symptoms assessed after 12 months. Secondary outcome variables are early and late complications, impact of symptoms on daily activities, patient satisfaction with treatment, health-related quality of life, costs, cost-effectiveness and budget-impact.

NCT ID: NCT04091763 Completed - Clinical trials for Hemorrhoids, Internal

Polidocanol Foam Versus Rubber Band Ligation in the Treatment of Hemorrhoidal Disease

Start date: August 1, 2018
Phase: Phase 2
Study type: Interventional

Background: Hemorrhoidal disease is a common benign condition seen frequently in clinical settings. Rubber band ligation and sclerotherapy have proven to be the office-based procedures of choice in hemorrhoidal disease, with various studies reporting rubber band ligation as being more effective but also more painful and bleeding prone than sclerotherapy with liquid polidocanol. However, there are no studies comparing rubber band ligation and sclerotherapy with polidocanol foam, a new type of sclerosant agent that has already proved to be more effective and safer than liquid polidocanol in grade I hemorrhoidal disease. The present study was designed to establish the clinical effectiveness and safety of sclerotherapy with polidocanol foam compared with rubber band ligation. Methods: This randomized controlled trial includes patients with symptomatic hemorrhoidal disease grades I to III. The participants were randomly assigned (in a 1:1 ratio) to either rubber band ligation or sclerotherapy with polidocanol foam, stratified by grade of hemorrhoidal disease. During the intervention period the patients are submitted to one of the office-based procedures and, afterwards, in the follow-up period, evaluated every three months for a total period of one year. The efficacy outcomes include symptom resolution, number of treatment sessions needed to achieve therapeutic success and evolution of hemorrhoidal disease grade in the intervention period and, during follow-up, recurrence incidence. Primary safety outcomes include the occurrence of any complication related to the office-based procedures.

NCT ID: NCT04031131 Completed - Hemorrhoids Clinical Trials

The Use of Topical Anaesthetic in the Banding of Internal Haemorrhoids

TAB
Start date: October 17, 2019
Phase: Phase 2
Study type: Interventional

The investigators' aim is to assess if they can complete a study measuring the effect of local anaesthetic gel (Instillagel) on reducing pain experienced by patients undergoing a common treatment for haemorrhoids (piles). This treatment is called rubber band ligation and is commonly performed in the investigators'clinics.