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Rectal Neoplasms clinical trials

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NCT ID: NCT03257332 Withdrawn - Quality of Life Clinical Trials

Determining Early Development of Faecal Incontinence and Anorectal Muscle Function After Surgery for Rectal Cancer.

EDFI-Cohort
Start date: November 12, 2019
Phase:
Study type: Observational [Patient Registry]

Background: Patients treated for rectal cancer are in high risk of developing poor quality of life and faecal incontinence. Faecal incontinence has a negative impact on quality of life. However, there is limited knowledge on how to prevent it. Known exposures are ; age at surgery, gender, tumor height, pre-operative radiotherapy, surgical technique and temporary stoma. In order to evaluate the underlying mechanisms of faecal incontinence, it is central to evaluate the anorectal muscle function for sensory and motor impairment. Exposures representing different constructs in the biopsychosocial model are likewise likely to be associated with quality of life and faecal incontinence. These exposures include sexual dysfunction, urinary incontinence, fatique, physical inactivity and finding meaning in life. There are to our knowledge, no records on these relationships from prior to surgery to 2 years after. These biopsychosocial exposures are central to include when developing strategies that can prevent poor quality of life and faecal incontinence for patients treated for rectal cancer. Purpose: The primary purpose of the EDFI-Cohort study is to determine how several variables (surgical technique, anorectal muscle function, faecal incontinence, urinary incontinence, sexual dysfunction, fatigue, physical activity and finding meaning in life) develop over time and predicts quality of life. Secondary how it predicts LARS-score in patients with rectal cancer from prior to surgery to 2 years after primary treatment. Methods: We will include subjects diagnosed with rectal cancer and have received curative surgery (low anterior resection) with/without adjuvant (radiation/chemo) therapy. The cohort aim to recruit all eligible patients in a one year period. We estimate to recruit 70 patients. Self-reported outcomes will be collected with a series of validated questionnaires that subjects will be asked to complete 6 times during the two year study at 3, 6, 12, 26 78 and 104 weeks. Outcomes include: Quality of life using (EORTC QLQ-C30) (primary outcome), (CR29) and (FA12), bowel related quality of life (LARS-score) (secondary outcome), faecal incontinence (Vaizey score), urinary incontinence (ICIQ-UI), (MLUTS/FLUTS) and (MLUTSsex/FLUTSsex), physical activity level from Danish National Health Profile and finding meaning in life (SOME). Objective measures will be collected at 6 weeks, 6 months, 12 months and 24 months and include: Anorectal manometry that measures anorectal muscle function and rectal perception, a digital examination of anorectal muscle function using the Digital Rectal Examination Scoring System (DRESS) and the six-minute walk test a measure of submaximal exercise capacity. We plan to analyze the EDFI-Cohort study as repeated measures with both simple and multiple linear regression models for the continuous data. We plan to adjust for known confounders and variables related to treatment.

NCT ID: NCT03254498 Completed - Colonic Neoplasms Clinical Trials

Detection in Tandem Endocuff Cap Trial

DETECT
Start date: April 2016
Phase: N/A
Study type: Interventional

A randomised back to back study comparing cap and Endocuff to detect adenomas during colonoscopy

NCT ID: NCT03253302 Enrolling by invitation - Rectal Cancer Clinical Trials

Laparoscopic Assisted Transanal Total Mesorectal Excision for Rectal Cancer in Low Site

LATERAL-01
Start date: October 1, 2017
Phase:
Study type: Observational [Patient Registry]

At present, surgical resection is still the main treatment for the potential cure of rectal cancer. Total mesorectal excision (TME) is the gold standard. The traditional laparoscopic or open surgery for some special patients is really difficult, especially for male, prostate hypertrophy, obesity, low tumor and pelvic stenosis patients to expose the gap around the mesorectum and separate to the pelvic floor. While transanal total mesorectal excision (TaTME) approach could be more directly separate the low mesorectum and relatively simple to complete distal rectal transection, which would bring some considerable advantages. Although active learning from abroad, laparoscopic assisted TaTME surgery is now in its infancy in China. It is urgent for clinical studies to obtain the results in China. This multicenter, observational study will help to encourage research in this field and to obtain data on the safety and efficacy of this procedure in Chinese patients with rectal cancer.

NCT ID: NCT03252821 Completed - Prostate Cancer Clinical Trials

Effects of High-intensity Training Compared to Resistance Training in Cancer Patients Undergoing Radiotherapy

Start date: August 15, 2017
Phase: N/A
Study type: Interventional

The aim of this study is to assess the impact of a high-intensity aerobic training and resistance training on fatigue in prostate, head and neck and rectum cancer patients undergoing radiotherapy. A three-arm randomized controlled trial will be conducted. Patients will be randomised into either a high-intensity aerobic training group or a resistance training group or a control group. Participants in the training groups will exercised for five to eight weeks. Exercise sessions will be take place 3 days per week under the supervision of an experienced therapist. Subjects will be assessed at baseline and post-intervention. The primary outcome will be fatigue measured using the FACIT-fatigue questionnaire. The secondary outcomes will be: functional capacity, quality of life, executive functions, sleep disturbances, somnolence syndrome, insomnia, depression symptoms.

NCT ID: NCT03248661 Completed - Colo-rectal Cancer Clinical Trials

Assessing Repeat Fit Testing for CRC

ARFT
Start date: August 1, 2015
Phase: Phase 3
Study type: Interventional

This study will randomly assign 220 men and women to either a social media intervention or a standard reminder system to have a repeat screening test for colo-rectal cancer.

NCT ID: NCT03245203 Not yet recruiting - Rectal Cancer Clinical Trials

A Pilot Study of Neoadjuvant Chemotherapy Combined With Bevacizumab for Locally Advanced Rectal Cancer

Start date: August 2017
Phase: N/A
Study type: Interventional

Background: Neoadjuvant chemoradiotherapy (CRT) and total mesorectum excision (TME) has become the standard therapy for the treatment of locally advanced rectal cancer (LARC) to reduce the local recurrence rate, however, no improvement of distant metastasis rate was observed, and the incidence of postoperative local recurrence and distant metastasis can reach more than 25%. It is still a challenge for us to improve the RO resection rate of locally advanced rectal cancer and reduce the incidence of local recurrence and distant metastasis.

NCT ID: NCT03242187 Recruiting - Rectal Cancer Clinical Trials

Trans-anal Versus Laparoscopic TME for Mid and Low Rectal Cancer

MansTaTME
Start date: May 25, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

This study is designed to assess the surgical, oncological and functional outcome of either the laparoscopic or trans-anal TME in management of mid and low rectal cancer.

NCT ID: NCT03238885 Completed - Clinical trials for Locally Advanced Rectal Cancer

Predicting Pathological Complete Response of Rectal Cancer With Magnetic Resonance(MR) Radiomics

Start date: March 1, 2013
Phase:
Study type: Observational

This study plans to construct a MR radiomics model for predicting pathological complete response(pCR) to neoadjuvant chemoradiotherapy(CRT) in locally advanced rectal cancer(LARC) patients.

NCT ID: NCT03222557 Recruiting - Rectal Cancer Clinical Trials

Electroacupuncture for Postoperative Ileus After Laparoscopic Surgery for Mid and Low Rectal Cancer

Start date: November 2017
Phase: N/A
Study type: Interventional

This is a prospective, randomized, sham-controlled, superiority trial that aimed to investigate the efficacy of electroacupuncture (EA) in reducing the duration of postoperative ileus and hospital stay after laparoscopic total mesorectal excision or abdominoperineal resection for rectal cancer.

NCT ID: NCT03217773 Recruiting - Rectal Neoplasms Clinical Trials

ESD Versus TAMIS for Early Rectal Neoplasms

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

This is a prospective randomized controlled trial that aimed to compare the short-term clinical outcomes, functional outcomes, costs, and recurrence rates between endoscopic submucosal dissection (ESD) and transanal minimally invasive surgery (TAMIS) for early rectal neoplasms.