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Anorectal Disorder clinical trials

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NCT ID: NCT06363513 Not yet recruiting - Anorectal Disorder Clinical Trials

The Efficacy of Aescin in Combination With MPFF in the Early Control of Bleeding From Acute Internal Hemorrhoids, A Randomized Controlled Trial

Start date: April 2024
Phase: N/A
Study type: Interventional

Hemorrhoidal disease, characterized by symptomatic enlargement and distal displacement of anal cushions, has been a subject of recognition and management for centuries. The etymology of "hemorrhoid" is traced back to the Greek words haima (blood) and rhoos (flow). Prevalent in over 20% of the population across various life stages, this anorectal condition impacts both genders. The multifaceted development of the disease incorporates theories encompassing abnormal dilation of hemorrhoidal plexuses, distension of arteriovenous anastomoses, prolapse of anal pads, and a myriad of genetic, anatomical, dietary, and lifestyle factors. Manifestations range from venous distension to bleeding and thrombosis, with classification based on location (internal/external/combined) and degree of prolapse (grade 1-4). Upon comprehensive history-taking and examinations, including digital rectal and proctoscope assessments, a definitive diagnosis is established, leading to the treatment phase. Although outpatient procedures demonstrate efficacy, patients may persist with pain and discomfort. Medical intervention assumes significance for stages 1 and 2, incorporating approaches such as rubber-band ligation, injection sclerotherapy, and dietary modifications. Micronized Purified Flavonoid Fraction (MPFF), integral to hemorrhoid treatment, has been scrutinized for its ability to mitigate pathogenic processes culminating in acute bleeding. The stagnation of blood in vascular plexuses prompts an inflammatory response, activating white cells and increasing vessel wall permeability. MPFF's flavonoid compounds are posited to alleviate bleeding by augmenting venous tone, reducing stasis, inhibiting inflammatory mediators, and enhancing lymphatic drainage[8]. Multiple trials substantiate MPFF's efficacy in ceasing bleeding, alleviating symptoms, and preventing hemorrhoid relapse. Aescin, a saponin mixture found in Aesculus hippocastanum (horse chestnut). The primary active component, β-aescin, contributes to the plant's medicinal attributes. Experimental investigations in animal models underscore its anti-edematous, anti-inflammatory, and venotonic properties, attributed to molecular mechanisms facilitating ion entry into channels and elevating venous tension. While the therapeutic benefits of aescin for hemorrhoids are acknowledged, the absence of randomized control trials impedes the conclusive validation of its efficacy. In the realm of diverse treatment options, this proposed randomized controlled trial aims to assess the comparative effectiveness of combining aescin with MPFF versus MPFF alone in managing hemorrhoid-related symptoms. The study aspires to furnish valuable insights for refining therapeutic strategies in the management of hemorrhoids and enhancing patient outcomes.

NCT ID: NCT06315179 Not yet recruiting - Ulcerative Colitis Clinical Trials

Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation (STRIDE)

STRIDE
Start date: April 2024
Phase:
Study type: Observational [Patient Registry]

This is a prospective observational study collecting long-term clinical data and samples for research in pediatric inflammatory bowel disease (IBD) patients with gut inflammation and a control cohort of pediatric patients with disorders of the brain-gut interactions (DBGI) with no detectable gut inflammation.

NCT ID: NCT06128031 Not yet recruiting - Clinical trials for Psychiatric Disorder

Psychiatric Disorder in Anorectal Dyssynergia

Start date: November 1, 2023
Phase:
Study type: Observational

1. evaluate psychiatric disorders among patients with anorectal dyssynergia 2. evaluate the effect of delayed diagnosis of anorectal dyssynergia on the quality of the life

NCT ID: NCT05579223 Completed - Analgesia Clinical Trials

Intrathecal Hydromorphone for Postoperative Pain of Anorectal Surgery

IMPAS
Start date: October 17, 2022
Phase: Phase 2
Study type: Interventional

Anorectal problems, such as hemorrhoids, fistula, fissures, Etc., often require surgical treatment. Patients often have postoperative pain after these surgeries, which increases discomfort and hospital length of stay. The efficacy of oral non-opioids in the treatment of such pain is poor. Hydromorphone is an opioid analgesic commonly used orally or intravenously for postoperative pain management. We designed this trial to investigate the efficacy and safety of intrathecal (delivery directly to the spinal cord during spinal anesthesia) single dose hydromorphone versus intrathecal placebo in treating postoperative pain among human subjects after anorectal surgery, but also the recovery of postoperative motor capacity in these human subjects.

NCT ID: NCT05571202 Completed - Anorectal Disorder Clinical Trials

Urine Retention Rate Between Spinal and General Anesthesia for Anorectal Surgery

Start date: January 1, 2017
Phase:
Study type: Observational

Anorectal surgery includes pilonidal sinus, hemorrhoidectomy, anal fissure, and anal fistula operations. General and spinal anesthesia were common anesthetic methods in anorectal surgery. We designed this study to test the hypothesis that general anesthesia was superior than spinal anesthesia with respect to urine retention rate, pain score, recovery time, and side effects.

NCT ID: NCT04409054 Completed - Anorectal Disorder Clinical Trials

The Guarding Reflex Anal, Study of the Modulation Function of Rectal Distension

Start date: February 17, 2020
Phase:
Study type: Observational

The term Guarding Reflex refers to a progressive, involuntary increase in the external urethral sphincter activity during bladder filling.This is a mechanism of continence, preventing from unwanted urine leakage in situation of stress. Anal continence is essential, and any impairment of this function can have a severe impact on quality of life. Anal continence at rest is mainly insured by the tone of the internal anal sphincter. The external anal sphincter activity during gradually rectal filling is continuous and varies according to the volume of rectal distension. During an effort, or a cough, the increasing intra-abdominal pressure is transmitted to the rectum. Increased intra-abdominal pressure during an expiratory against resistance effort proportionally increases the response of the external anal sphincter. The reflex contraction of the EAS is an active mechanism under spinal control, and result in a stronger contraction than a voluntary one. This reflex contraction is the equivalent of "Guarding Reflex" and provides part of the continence in situation of stress. The main purpose of this study is to research a correlation between the ano rectal distension volume and the external anal sphincter response to a stress. Patient over eighteen years old, consulting for anorectal manometry examination in order to explore anorectal disorders are included. Age, sex, ano rectal symptoms, treatments, past history, manometrics data, area under the curve for electromyography activity of the EAS and intercostal muscles during cough with a Valsalva effort are recorded. Slope curve representing the EAS response to stress according to the intercostal activity reflecting cough (intensity response curve) effort are calculated. The protocol consists in distending the rectum at four different volumes. For each volume, the patient is asked to cough three times gradually, and perform a Valsalva effort three times gradually. Primary outcome is the difference in curve slope (intensity response curves) between empty rectum and maximal tolerable volume at cough Secondary outcomes are the differences in curve slope between each volume of distension at cough, and Valsalva type effort.

NCT ID: NCT04245774 Completed - Anesthesia Clinical Trials

Comparing the Effects of Levobupivacaine and Bupivacaine in Saddle Spinal Anesthesia

Start date: November 21, 2007
Phase: Phase 4
Study type: Interventional

İn this study; it was aimed to investigate the effects of equipotent doses of hyperbaric bupivacaine and hyperbaric levobupivacaine in outpatient anorectal surgery under saddle block. Sixty patients between the age of 18- 50 and in the risk group of ASA I-II included in the study. 7,5 mg of 0,5% hyperbaric bupivacaine or 7,5 mg of 0,5% hyperbaric levobupivacaine injected into the intrathecal space in sitting position through L4-L5 or L5-S1 intervertebral space in 30 seconds. All patients kept in sitting position for 5 minutes with aid after intrathecal injection and than layed in supine position, finally they positioned in prone jack-knife. Hemodynamic parameters like NIBP, HR, SpO2, sensory and motor block characteristics, duration of analgesia, time of first voiding, mobilization time, patient and surgeon satisfaction, adverse effects and discharge time were recorded during and after surgery.

NCT ID: NCT03992079 Terminated - Pain, Postoperative Clinical Trials

A Multimodal Enhanced Recovery Program in Anorectal Surgery

ARSE
Start date: June 20, 2019
Phase: N/A
Study type: Interventional

The goal of this study is to establish whether an opioid-sparing Enhanced Recovery After Surgery (ERAS) program in ambulatory anorectal surgery can be safely introduced at a single tertiary referral center without an increase in postoperative pain or negative impact on the patient experience. A single-center, single-blinded randomized control trial is proposed, where patients will be assigned in a 1:1 ratio to either usual care, which includes extended opioids (control group) or the enhanced recovery group (experimental), which includes preemptive pain control, targeted education, and multimodal opioid-sparing pain management during the intraoperative and postoperative periods. The expected outcome is that the enhanced recovery program will significantly reduce opioid utilization with comparable pain scores and patient satisfaction after anorectal surgery.

NCT ID: NCT03738904 Completed - Anorectal Disorder Clinical Trials

Prospective Randomized Controlled Trial of an Enhanced Recovery Protocol for Anorectal Surgery

Start date: October 26, 2018
Phase: Phase 4
Study type: Interventional

The purpose of the study is to evaluate whether being randomized to an aggressive postoperative non-narcotic pain regimen that treats pain from multiple different pathways may decrease postoperative pain levels, decrease constipation, and decrease the dependency on opioid medications after anorectal surgery versus the standard of care for managing pain. This use of a more aggressive pain regimen is considered an enhanced recovery after surgery (ERAS) protocol because it is theorized to improve or "enhance" postoperative recovery by both decreasing the use of narcotics and their detrimental effects as well as increasing the benefit of using additional non-narcotic pain medication.

NCT ID: NCT03591393 Recruiting - Pregnancy Related Clinical Trials

Pelvic Floor Dysfunction and Its Influence on Body Image and Sexual Function

PFD-BI
Start date: August 1, 2018
Phase: N/A
Study type: Interventional

The first objective to determinate the prevalence of pelvic floor dysfunction in pregnant women and in the first year postpartum. The second objective is to assess the anatomical (both clinical and ultrasound), demographic and obstetric variables in symptomatic women and their association with pelvic floor dysfunction, sexual function and Body Image. This is a single center prospective cohort study. Women will be asked to fill out a questionnaire at the time of their 1st and 3rd trimester scan, at the postpartum checkup and 12 months postpartum. Furthermore, they will undergo a pelvic floor ultrasound at the time of their first and third trimester scan. The presence of pelvic floor dysfunctions will be recorded through validated self-administered questionnaires with five domains: Wexner questionnaire for anal incontinence, PAC-SYM for constipation, International Consultation on Incontinence Questionnaire Short Form for urinary incontinence, the Pelvic Organ Prolapse Distress Inventory for pelvic organ prolapse, POP/UI Sexual Questionnaire - IUGA revised for sexual function. The body image perception will be assessed using the Dutch-validated version of the self-administered Body Image Disturbance Questionnaire. The anatomy of the pelvic floor will be objectively assessed off line on 3D/4D transperineal ultrasound volumes and POP-Q examination. The demographic variables and information about the pregnancy and the delivery will be obtained from the medical records.