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Rectal Diseases clinical trials

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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: NCT04996186 Completed - Multiple Sclerosis Clinical Trials

Symptoms and Treatment Assessment of Ano-Rectal Disorders in Multiple Sclerosis Patients : STAR-Q

STAR-Q
Start date: June 1, 2019
Phase:
Study type: Observational

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.

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: NCT04080843 Completed - Colorectal Cancer Clinical Trials

Anlotinib Hydrochloride Capsules Combined With CAPEOX in RAS and BRAF Wild-type mCRC Patients

ALTER-C-002
Start date: November 15, 2019
Phase: Phase 2
Study type: Interventional

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

NCT ID: NCT04057222 Completed - Multiple Sclerosis Clinical Trials

Effect of Need to Void on Rectal Sensory Function in Multiple Sclerosis

Start date: July 26, 2019
Phase:
Study type: Observational

Multiple sclerosis causes demyelinating lesions, which can induce multiple symptoms. Ano-rectal avec urinary disorders are frequent due to specific lesions in inhibitor/activator encephalic centers, or interruption on medullary conduction. It seems to be evident that anorectal and urinary disorders are link, because of similar anatomic ways and control process. To our knowledge several studies test the effect of rectal distension and bladder sensory function but only one study examined the effect of bladder filling on rectal sensitivity on healthy people. The effect of bladder filling on rectal sensory function in patient with neurological disease stay unknown, while dysfunction often occur concomitant, and therapeutic actions in one organ may influence function of the other. Anorectal manometry is the gold standard for the evaluation of rectal sensory function and the volume of constant sensation to need to defecate is reported in literature as the most reproducible measure. Primary aim is to assess the effect of need to void on volume of constant sensation to need to defecate in multiple sclerosis with anorectal symptoms. Secondary aim is to identify the effect of need to void on modulation of rectoanal inhibitory reflex (RAIR) and external anal sphincter resting pressure. Patient with multiple sclerosis over 18 years old, consulting for anorectal disorders in a tertiary center, with an indication to realize an anorectal manometry are included. History and treatment, height, weight, Expanded Disability Status Scale (EDSS), anorectal and urinary symptoms severity by Bristol, Neurogenic Bowel Dysfunction (NBD), Cleveland, Kess, Urinary Symptom Score (USP) scores, and last urodynamic data are recorded. Patient are asked to drink water until they feel a strong need to void, for which they would go to urinate at home. 3 void volume with portable sonography are done, and the higher is recorded. Anorectal manometries are realized by the same doctor, in a specific place, with calm. Before the manometric examination, thermal and vibratory sensory thresholds on the right hand are collected. The patient is then placed in a left lateral position. Then the anorectal manometry's catheter is inserted and collect of the external anal sphincter resting pressure begins. Then the investigator proceed to search for RAIR by 5 brief distensions of the intrarectal balloon with increasing volumes of 10 mL from 10 mL to 50 mL. Finally, the investigator collect the threshold volumes of perception, need and maximum tolerable by gradually distending the intra-rectal balloon to 5 mL/s from 0 mL to 300 mL. Toilets are just next to the table of examination. Next, patient can urinate. 3 post void residual volume with portable sonography are done, and the higher is recorded. The same tests are realized after urinate, in the same order. After the classical complete manometry was performed. Primary outcome is the volume of constant sensation to need to defecate Secondary outcomes are the modulation of RAIR and the external anal sphincter resting pressure. Manometric data are collected. Influence of age, EDSS, severity of symptoms, manometric data and detrusor overactivity on rectal sensory function will be study in secondary analysis.

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: NCT03559543 Completed - Clinical trials for Gastrointestinal Neoplasms

Evaluation of Ocoxin®-Viusid® in Metastatic Colorectal Adenocarcinoma

Start date: October 25, 2018
Phase: Phase 2
Study type: Interventional

The research product, registered as a nutritional supplement (Ocoxin®, oral solution), manufactured by Laboratorios Catalysis S. L., comes in the form of single-dose vials of 30 ml. It will be used at a rate of 60 ml daily (1 vial every 12 hours). Our main objective is To evaluate the effect of Ocoxin®-Viusid® on the quality of life of patients with metastatic colorectal adenocarcinoma. Our hypothesis is that the administration of the nutritional supplement Ocoxin®-Viusid® it is expected to improve the quality of life and enhance tolerance to chemotherapy in at least 70% of patients.

NCT ID: NCT03498547 Completed - Anorectal Disorder Clinical Trials

Caudal Block,Saddle Block, Anorectal Surgery

Start date: June 20, 2018
Phase: N/A
Study type: Interventional

Anorectal surgery includes pilonidal sinus, hemorrhoidectomy, anal fissure, and anal fistula operations. Various surgical and anesthetic techniques have been used to increase the level of analgesia in perioperative period and decrease the length of stay in the hospital. In this study, investigators investigate the effects of routinely applied anesthesia techniques during anorectal surgery, caudal block and saddle block, on patients' perioperative hemodynamic values, sensory and motor block levels, and postoperative pain scores.