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Rectal Cancer clinical trials

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NCT ID: NCT02830633 Not yet recruiting - Rectal Cancer Clinical Trials

Trial to Evaluate Laparoscopy-assisted Nerve-preserved Total Mesorectal Excision (LNTME) Versus Open TME for Rectal Cancer

Start date: July 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine: (1) whether laparoscopy-assisted nerve-preserved total mesorectal excision (LNTME) is as safe as open TME for rectal cancer, and (2) whether LNTME is more effective for protection of pelvic autonomic nerve function from surgical impairing when comparing to open TME.

NCT ID: NCT02702089 Not yet recruiting - Rectal Cancer Clinical Trials

Hartmann's Versus Intersphincetric APE: A Prospective, Multicentre Study

HiP
Start date: March 2016
Phase: N/A
Study type: Observational

14,000 new cases of rectal cancer are diagnosed each year, frail and elderly patients represent a rising proportion of these patients. Whilst the gold standard is often to remove the tumour and restore bowel continuity, surgeons will often avoid this procedure in this group of patients as they unfortunately tolerate surgical complications very poorly. Such surgical complications may present with life threatening sepsis, can prolong hospital stay, delay further cancer therapy and in the elderly or frail patient often leads to loss of independence and quality of life. In this setting, there are two alternative procedures (Hartmann's procedure OR intersphincteric APE) that may be used and these are employed in roughly equal measure in the UK (nationwide survey, Dec 2013, unpublished data). It is anecdotally felt that Hartmann's procedure (HP) has a greater risk of surgical complications (30%) and a few small retrospective studies have shown this (1-3), however there are no prospective data to support this view. Whilst some surgeons do choose intersphincteric APE (IAPE) on the basis of a lower surgical complication rate, many do not due to perceived limitations in the technique (longer operating time, risk of tumour perforation), which are unproven. We feel that a larger, prospective dataset is required to demonstrate the superiority of IAPE over HP and convince the remaining surgeons to change procedure. We have explored the possibility of a full randomised trial to answer this question, however this is not feasible due to the difficulty of randomisation of patients. Very little data are available regarding the use of IAPE in the setting of rectal cancer, however many surgeons who do employ the technique, specifically adapt their technique in this setting to reduce the chances of tumour perforation (two stage, stapling off rectum before removing anal canal separately). It is possible that those surgeons who prefer HP have not considered this, and combined with the lack of prospective data are reluctant to change technique. We are confident that if we can demonstrate a significant difference in surgical complication rate and promote a modification to the IAPE surgical technique then we can significantly reduce surgical harm to these frail patients.

NCT ID: NCT02498353 Not yet recruiting - Rectal Cancer Clinical Trials

Comparing Preoperative Short-course Radiotherapy With or Without Local Boost for Rectal Cancer

Start date: July 2015
Phase: N/A
Study type: Interventional

A randomized trial comparing weather preoperative short-course radiotherapy with local boost is better than conventional preoperative short-course radiotherapy for local advanced rectal cancer.

NCT ID: NCT02188927 Not yet recruiting - Colorectal Cancer Clinical Trials

Effect of an Advanced Notification Letter on Screening Colonoscopy Participation

Start date: August 2014
Phase: N/A
Study type: Interventional

Participation in a primary screening colonoscopy programs remains low. Advanced notification letter has been shown to increase participation in colorectal cancer screening with fecal occult blood testing and to be cost effective compared to standard invitation. It is unknown whether advanced notification letter increases participation rate in primary colonoscopy screening program. We hypothesize that an Advance Notification Letter will have significant influence on participation in screening colonoscopy, comparing to standard invitation procedure and will thus result in higher efficiency of the program. This randomized controlled study aims to compare the participation rate in screening colonoscopy in response to advanced notification plus standard invitation letter and standard invitation letter alone. Material and methods: 6800 individuals aged 55-64 years will be drawn from the Population Registry and randomly assigned in a 1:1 ratio to the group invited for screening colonoscopy with advanced notification letter (send two weeks before standard invitation) plus standard invitation (send six weeks before planned screening colonoscopy) or to standard invitation only (send six weeks before planned screening colonoscopy). The sample size was calculated to detect 3% difference in participation rate between the groups (25% vs 28%) with 80% power.

NCT ID: NCT02177084 Not yet recruiting - Rectal Cancer Clinical Trials

Percutaneous Tibial Nerve Stimulation in the Treatment of Anterior Resection Syndrome After Rectal Cancer Surgery

Start date: July 2014
Phase: Phase 2
Study type: Interventional

The study aims to evaluate the efficacy of percutaneous tibial nerve stimulation (PTNS) associated with conservative therapy (arm A) for the treatment of low anterior resection syndrome (LARS) compared with only conservative therapy (arm B). The secondary aims are the evaluation of the following parameters: - Effect of PTNS on manometric parameters - Effect of PTNS on quality of life - Effect of PTNS on the severity of fecal incontinence and / or obstructed defecation - Safety of PTNS

NCT ID: NCT01142713 Not yet recruiting - Rectal Cancer Clinical Trials

The Impact of Patient Positioning and Use of Belly Board on Small Bowel and Urinary Bladder Volume Irradiated in Patients Receiving Radiotherapy for Rectal Cancer: A Prospective Phase II Study

Start date: August 2010
Phase: Phase 2
Study type: Interventional

Radiotherapy has a significant impact on local control, disease free survival and overall survival in patients with rectal cancer T2, N1, M0 and T3-4, any N, M0. Treatment is accompanied by side effects, mainly due to the inclusion of the small bowel and urinary bladder in the treatment fields. Two major modalities have been pursued to reduce the volume of small intestine and urinary bladder in treatment volume. One is a surgical procedure, such as absorbable mesh. These procedures have failed implementation in daily clinical practice. The second modality aims to save the small intestine and urinary bladder from the toxicity of radiotherapy by modulating the radiotherapy planning procedure. Using the belly board and changing the standard position from supine to prone could achieve this aim; in part due to gravitational displacement of the bowel. Several studies have evaluated the impact of positioning and use of belly board in patients receiving pelvis irradiation for rectal cancer. The results are inconclusive, but the prone position with belly board appears promising. This study carefully evaluates the impact of patient's positioning and belly board on dose volume histogram of small bowel and urinary bladder

NCT ID: NCT01006577 Not yet recruiting - Rectal Cancer Clinical Trials

Side-to-end Anastomosis Versus Colon J Pouch for Reconstruction After Low Anterior Resection for Rectal Cancer (SAVE)

SAVE
Start date: June 2010
Phase: N/A
Study type: Interventional

Primary hypothesis: Side-to-end anastomosis is non-inferior to colon J pouch for reconstruction after low anterior resection for rectal cancer in fecal incontinence (Wexner score). Research questions: Are there differences between side-to-end anastomosis and colon J pouch in - bowel function (fecal incontinence, frequency of bowel movements, rectal urgency, incomplete evacuation) - quality of life - sexual function - urinary function - postoperative complications - operation time/ institutional costs