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Hemorrhoids clinical trials

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NCT ID: NCT04621695 Recruiting - Hemorrhoids Clinical Trials

Comparison of Rubber Band Ligation and Haemorrhoidectomy in Patients With Symptomatic Haemorrhoids Grade III

HollAND
Start date: November 25, 2019
Phase: N/A
Study type: Interventional

Rationale: Haemorrhoidal disease is one of the most common anorectal disorders which affects nearly half of the general population1. Given the current numerous modalities the obvious question which needs to be answered is which treatment is the best. An interesting conclusion from a recent systematic review regarding operative procedures for haemorrhoidal disease is that all procedures have their own advantages and disadvantages. There is a need for evaluating treatment from the patient's point of view and transparency in surgical and non-surgical treatment outcome. So far there is no sufficiently large trial that meets that demand. Objective: To establish the best treatment of patients with symptomatic haemorrhoids grade III: haemorrhoidectomy versus rubber band ligation (RBL). Patient bound effectiveness, clinical effectiveness and cost-utility of both treatments is compared; primary outcome is quality of life at 24 months measured with the EQ-5D-5L with Dutch rating and recurrence at one year post procedure. The assumption is that treatment with rubber band ligation is equally effective in comparison with haemorrhoidectomy in terms of quality of life. Study design:Multicentre randomized controlled non-inferiority trial with cost-utility analysis. Two treatment protocols are compared: haemorrhoidectomy and rubber band ligation. Study population: Patients aged ≥ 18 years with symptomatic haemorrhoids gr III. Patients are recruited in multiple clinics during 18-24 months. Intervention: Participants are allocated to either rubber band ligation or haemorrhoidectomy. Main study parameters/endpoints: Primary outcome measure is quality of life at 24 months measured with the EQ-5D-5L with Dutch rating and recurrence at one year post procedure. Secondary outcomes are: complaint reduction with proctology specific patient-related outcome measure (HSS, PROM, PROMHISS), vaizey score, resumption of work, pain (VAS), complications and recurrence at two years.

NCT ID: NCT04588467 Completed - Pregnancy Related Clinical Trials

Treatment of Thrombosed Haemorrhoids in Pregnancy

Start date: January 2, 2019
Phase: N/A
Study type: Interventional

Thrombosis of the external hemorrhoids (TEH) is one of the most frequent complain during pregnancy, particularly during the third trimester. The paucity of the medical literature on this topic has recently been underlined in the European guidelines for hemorrhoid treatment . The aim of this prospective study is to compare the efficacy and safety of conservative versus surgical treatment of TEH in pregnant women

NCT ID: NCT04578730 Completed - Hemorrhoids Clinical Trials

aCute HemORrhoidal Disease evALuation International Study

CHORALIS
Start date: April 16, 2021
Phase:
Study type: Observational

The primary objective of this study is to assess in real-life setting the effectiveness of conservative treatments on signs, symptoms and quality of life in patients consulting for hemorrhoids in acute phase of the disease

NCT ID: NCT04567485 Completed - Surgery Clinical Trials

Impact of Moderate to Severe Pain in the Post-intervention Monitoring Room After Hemorrhoidectomy on the Length of Stay in the Outpatient Surgery Unit

HEM_DOULEUR
Start date: October 1, 2020
Phase:
Study type: Observational

The target rate for outpatient surgery has been set by the Ministry of Health at 70% for 2020. To achieve this objective, this requires increasing the panel of eligible outpatient procedures to more mutilating surgeries and usually performed in conventional hospitalization. This switch from conventional hospitalization to an outpatient stay increases the risk of converting stays into unscheduled hospitalization. Postoperative pain is one of the main factors in converting outpatient stays. Poor control is associated with increased length of stay, and unscheduled consultations and readmissions. In addition, the increased time spent with severe pain during the first 24 hours postoperatively is a risk factor for chronicization. Proctology, and, in particular, hemorrhoidal surgery is the perfect example. Outpatient management of open pedicle hemorrhoidectomy is increasing year by year, but the rate of conversion to unscheduled hospitalizations remains high. Urine retention, postoperative hemorrhage and poor pain control are the main causes. Within the Paris Saint Joseph Hospital Group, hemorrhoidal surgery has the highest rate of conversions from hospitalization to proctology (8% in 2019), despite the implementation since 2015 of a dedicated, developed according to the current recommendations of the SNFCP. The pain after hemorrhoidal surgery is always severe in the absence of analgesics and appears upon arrival in the post-interventional monitoring room (SSPI). Despite the administration of analgesics or the implementation of locoregional analgesia techniques (pudendal block), moderate to severe pain is frequently observed in the post-intervention monitoring room. In the medical literature, there is little data evaluating the means of management of postoperative pain in this surgery, and even less the effect of the different associations. Retrospectively and, from the data collected in our information systems, we wish to assess the impact on the length of stay of the presence of moderate to severe pain in the IPSS after a two-way or tri-pedicle hemorrhoidal surgery open on our cohort of patients operated in outpatient surgery. Our hypothesis is that the presence of moderate to severe pain in PPSS increases the total length of stay, placing the patient at an increased risk of conversion. The purpose of our study is also to identify predictive factors (aggravating or protective) of the onset of moderate to severe pain immediately after surgery, in order to establish a strategy to limit its frequency.

NCT ID: NCT04535765 Completed - Hemorrhoids Clinical Trials

Effect of Early Warm Water Sitz Bath on Urinary Retention After Hemorrhoidectomy

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

Background: Hemorrhoid is one of the most common chronic anorectal diseases. The prevalence rate is about 44%. It occurs in adults aged 45-65 years. Hemorrhoidetomy resection is still the standard treatment for grade III and IV hemorrhoid. Urinary retention is one of the most common complications after hemorrhoid surgery, and the complications occur within 24 hours after surgery. The warm water sitz bath is a routine nursing care after hemorrhoid surgery in the clinic. The purpose is to provide moist heat of the perineum and anus to clean, promote healing and drainage, relieve pain, stimulate urination and promote relaxation. In contrast, all current studies, warm water sitz bath intervention time is the first day after surgery, the complications within 24 hours after surgery are not alleviated. Objective: The main purpose was to use experimental research methods to verify the effect of early warm water sitz bath on urinary retention after hemorrhoidectomy. The secondary objective was the effect of early warm water sitz bath on wound pain after hemorrhoidectomy. Methods: This study was a single-blind randomized trial in which subjects were randomly assigned to an experimental or control group with symptomatic stage III or IV end hemorrhoid who were admitted to the hospital for hemorrhoidectomy. The experimental group started the warm water bath 6 hours after the end of the operation, while the control group started the warm water sitz bath on the first day after the operation. The investigator assessed the amount of residual urine and wound pain index before and after each operation of the warm water sitz bath after surgery, and each subject was evaluated 8 times until 24 hours after surgery.

NCT ID: NCT04398823 Recruiting - Clinical trials for Prolapsed Grade II Internal Haemorrhoid

A Multicenter Prospective Clinical Study of Endoscopic Foam Sclerotherapy for Internal Hemorrhoids

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

"Internal hemorrhoid" affects the quality of life due to hemorrhage and prolapse as a common and frequently-occurring disease. Endoscopic sclerosing agent injection has replaced traditional surgery and become the most commonly used treatment method in developed countries. At present, how to reduce the side effects of sclerosing agent and accurately determine the injection site and depth has become a difficult clinical problem. The research group creatively put forward the theory of foam sclerosing agent to treat internal hemorrhoids in the early stage. With the aid of transparent cap, the visibility of surgical field of vision can be improved. The mini probe ultrasound (MPS) is proposed to effectively evaluate the submucosal in

NCT ID: NCT04362384 Not yet recruiting - Pain Clinical Trials

Topical Vitamin E Ovules for the Treatment of Hemorrhoids

Start date: May 1, 2020
Phase: Phase 3
Study type: Interventional

Patients with hemorrohoids grade II and III were included. Patients were randomized into 2 groups: - Experimental group: Patients will receive a treatment with vitamin E ovules, which must be placed inside the annus - Control group: Patients will receive a treatment with corticoid ointment, with endoanal application Bleeding, pain and stinging will be evaluated 14 days after beginning the treatment.

NCT ID: NCT04329364 Recruiting - Hemorrhoids Clinical Trials

RCT Comparing Conventional Haemorrhoidectomy With Laser Haemorrhoidoplasty

COHLAH
Start date: October 1, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Haemorrhoids or piles are the most common colorectal condition in the local population. Patients often present with bleeding with bowel movement or anal discomfort, both of which causes significant anxiety and stress. For symptomatic sizeable piles, the treatment of choice still remains the conventional open excision (COH). However, this technique carries with it a significant risk of bleeding and pain immediately after the operation, leading to some period of discomfort for the patients. The laser haemorrhoidoplasty procedure (LAH) has been shown in preliminary studies to have less pain, and less complications compared to COH. This study aims to directly compare these two techniques in a local Asian population. The investigators would be conducting a single-centre RCT simultaneously comparing the conventional open Milligan-Morgan haemorrhoidectomy (COH) and the laser haemorrhoidoplasty procedure (LAH) for the treatment of symptomatic grade ll-lV haemorrhoids. Primary outcomes will be post-operative pain while secondary outcomes include post-operative bleeding, readmission and/or reoperations, haemorrhoid-related quality of life (QoL) results and recurrence of symptoms up to a year post procedure

NCT ID: NCT04290351 Completed - Clinical trials for Hemorrhoids, Internal

The Effect of Rubber Band Ligation in Bleeding Internal Hemorrhoids.

Start date: November 1, 2020
Phase:
Study type: Observational

In this study, the researchers planned to compare the treatment results of patients undergoing rubber band ligation in addition to drug therapy in hemorrhagic internal hemorrhoids patients and those treated only with anti-hemorrhoidal drugs.

NCT ID: NCT04276298 Completed - Hemorrhoids Clinical Trials

Topical Analgesia Post-Haemorrhoidectomy

Start date: September 1, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Symptomatic haemorrhoids, or piles, have significant effects on quality of life. The treatment for advanced disease is surgical excision (haemorrhoidectomy) which is extremely effective. However, pain following haemorrhoidectomy is known by all to be a miserable experience and current treatment is not very effective. We have formulated a new cream treatment which targets three theorised mechanisms of pain after haemorrhoidectomy. We will test the effectiveness of the treatments with a multi-centred randomised controlled factorial trial with four parallel double-blinded arms containing different combinations of the active agents. The outcomes include pain scores, amount of analgesia required and time to return to work. The results of our study could provide evidence of an effective treatment for post haemorrhoidectomy pain. The treatment may provide considerable benefit to patients undergoing this surgical procedure.