View clinical trials related to Rectal Diseases.
Filter by:The study aimed at diagnose and to detect the incidence of functional anorectal disorders in patients with inactive inflammatory bowel disease and to highlight the role of anorectal manometry in evaluating IBD patients with persistent defecatory dysfunction .
Currently, the question remains whether palliative primary tumor resection could improve overall survival of minimally symptomatic patients with colorectal cancer and synchronous unresectable metastases. The aim of this study is to determine if there is an improvement in overall survival of palliative primary tumor resection followed by chemotherapy in minimally symptomatic patients with colorectal cancer and synchronous unresectable metastases compared to those of upfront chemotherapy/radiotherapy alone.
Multiple sclerosis (MS) is known to cause urinary disorders, sexual and bowel dysfunction. Urinary symptoms due to MS are well known and profit of multiple questionnaire or tool developed in MS patients. Prevalence of bowel disorders in MS is difficult to assess. Some studies up to 70% bowel disorders in MS patients. Constipation and fecal incontinence are the two main symptoms in neurogenic bowel dysfunction and frequently coexist in this population, generally in association with urinary disorders. Because of the high prevalence of bowel disorders their and the major impact on the quality of life of patients with Multiple sclerosis (PwMS) , and the cross-talk bladder-rectum (persistence of anorectal dysfunction leading to poor neurogenic bladder control) assessment of bowel disorders in MS is necessary. But this evaluation is difficult as no specific score exist. The neurogenic Bowel Dysfunction score (NBD) is often used. The NBD was developed and validated for spinal cord injury (SCI) population but not for PwMS MS. Yet NBD is often used in research for all neurologic patients despite its lack of sensibility in various neurogenic population other than spinal cord injury patient. As recommended in a Cochrane revue in 2014, there is a need of a specific evaluation for bowel symptoms in neurogenic population, especially for PwMS. The aim of the study was to create and validate a new multidimensional questionnaire to assess bowel dysfunction and impact on quality of life in patients with MS. The investigators conducted a prospective multicenter study (8 centers) between June 2019 to April 2021. This study was developed in 3 steps. First step was literature review and qualitative interview. Then the second step was the feasibility study to evaluate comprehension, acceptability of the different items. The last part of the study was the validation study of the questionnaire. This part of the study was performed between June2020 and April 2021. Validation study allowed to determine the psychometric properties of the new tool. Patients aged over 18 years with multiple sclerosis diagnosed on the 2017 revised McDonald's criteria were included. Patients not able to read or understand the objectives and procedures for conducting the protocol and patient who had a recent relapse of MS were excluded.
Anal fissure is a common anorectal diseases characterized by tear of the anoderm from the dentate line to the anal verge leading to pain and bleeding during and post defecation. It may be a benign disease, but patients suffering from disease report significantly impacted quality of life especially when it becomes chronic. Several treatment modalities have been studied for chronic anal fissure, and topical calcium channel blockers (CCB) showed promising benefit and side effect profile in treatment of chronic anal fissure. Topical Diltiazem and Nifedipine are currently widely used CCBs for chronic anal fissure after multiple studies showing their benefits compared to different agents or modalities. To the investigators' knowledge, there is no study comparing the efficacy of topical Diltiazem and Nifedipine directly. The investigators aim to design a pragmatic randomized clinical trial to compare the efficacy, and side effect profile of topical Nifedipine and Diltiazem in treatment of chronic anal fissure.
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.
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.
The PREEMPT CRC study is a prospective multi-center observational study to validate a blood-based test for the early detection of colorectal cancer by collecting blood samples from average-risk participants who will undergo a routine screening colonoscopy.
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.
IMPROVE-IT2 is a randomized multicenter trial comparing the outcomes of ctDNA guided post-operative surveillance and standard-of-care CT-scan surveillance. The hypothesis of this study is that ctDNA guided post-operative surveillance combining ctDNA and radiological assessments could result in earlier detection of recurrent disease and identify more patients eligible for curative treatment.
This is an Open, Single Arm, Exploratory and Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With CAPEOX in RAS and BRAF wild-type patients with Metastatic Colorectal Carcinoma(CRC) as 1st Therapy. After 6 cycles of combined therapy, patients will receive capecitabine and anlotinib as maintenance therapy until tumor progression.In order to observe and evaluate the efficacy and safety of Anlotinib Hydrochloride Capsules combined with CAPEOX in treatment of patients with mCRC. The patients who are pathologically confirmed as RAS and BRAF wild-type mCRC will be enrolled. Condition or disease Invention/treatment Phase Colorectal Cancer Drug: Anlotinib Hydrochloride Drug: Capecitabine Drug: Oxaliplatin Phase 2