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Rectal Cancer clinical trials

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NCT ID: NCT02279771 Recruiting - Rectal Cancer Clinical Trials

Transanal Reinforcement of Low Rectal Anastomosis in Rectal Cancer Surgery

LessStoReS
Start date: January 2015
Phase: N/A
Study type: Interventional

Anastomotic leak after low rectal cancer surgery occurs between 3 and 24% of the cases and is a severe complication leading to sepsis, permanent colostomy, higher risk of local cancer recurrence and eventually death. In order to prevent this complication a protecting diverting stoma is usually fashioned with consequent morbidity due to the stoma and its closure and severe impact on patients' quality of life. This prospective, multi-center, parallel-arm, randomized controlled equivalence trial is aimed to demonstrate whether a transanal reinforcement of the suture line can prevent anastomotic leakage after low rectal cancer surgery thus avoiding the need for a covering ileostomy

NCT ID: NCT02277158 Recruiting - Rectal Cancer Clinical Trials

Phase I Study of CCRT as Adjuvant Treatment for Stage II/III Operable Rectal Cancer.

Start date: November 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the maximum tolerated dose and safety of S-1 plus radiotherapy for patients with rectal cancer

NCT ID: NCT02266849 Terminated - Ulcerative Colitis Clinical Trials

Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study

Start date: October 2014
Phase: Phase 3
Study type: Interventional

Clinical experience show limited effect of the drug Loperamide used to decrease output in stoma patients. Therefore the investigators see the need for a randomized blinded clinical trial to determine the effect of Loperamide opposite Placebo. Loperamide will be evaluated in relation to the following parameters - Change in ileostomy output in g/day in relation to oral intake - Quantification of the change in intestinal transit time using a radiopaque marker - The patient´s own assessment on which period they received Loperamide or Placebo

NCT ID: NCT02243267 Completed - Rectal Cancer Clinical Trials

GI SPORE Colon Biosample Protocol

Start date: September 2014
Phase: N/A
Study type: Observational

The investigators are creating a data and specimen repository to study causes , early detection, prevention and treatment of colon and rectal cancer. The investigators are collecting data and specimens (blood, stool, urine and tissue) from people who have colon or rectal cancer, or who are risk for developing colorectal cancer or had normal colonoscopies. Data and samples are held in the repository until there are enough to be used for a large study or until there are new techniques that can be used to test them. The GI SPORE Program at the University of Michigan maintains a repository of specimens for colorectal diseases that the investigators hope will help fuel new research. The investigators hope that this work may lead to new treatments or earlier detection of colorectal cancer or improved diagnosis and treatment of other colon and rectal diseases.

NCT ID: NCT02236884 Completed - Surgery Clinical Trials

The Feasibility and Safety of No-scar Transanal Total Mesorectal Excision for Rectal Cancer

Start date: September 2014
Phase: Phase 1/Phase 2
Study type: Interventional

During the past three years, a revolutionized radical surgical approach for rectal cancer ("down to up TME " approach or "transanal TME (TaTME)"approach, which is opposite to the conventional approach) has emerged and it is a concept that combines natural orifice transluminal endoscopic surgery(NOTES) and total mesorectal excision(TME) with curative intent. The feasibility, safety and reproducibility of it were first demonstrated in swine survival experiments and subsequently in human cadaver series, and then it was successfully applied to human patients in few centers around the world, most of which were performed with assistance of laparoscopy, namely hybrid transanal TME. In addition, pure-NOTES without conventional laparoscopic assistance (no scar) has also been demonstrated, though the cases were more limited. In the initial stage, our group has successfully performed this no-scar transanal TME in a series of human cadavers with satisfactory outcome. Hence the investigators conduct this study, looking to see if this pure transanal NOTES investigational procedure is a safe and effective approach to radically remove rectal cancer of the mid and lower rectum and meanwhile, if it can reduce pain, gain faster recovery and better function and life quality when gaining the best cosmetic effect.

NCT ID: NCT02217020 Completed - Rectal Cancer Clinical Trials

Neoadjuvant FOLFOXIRI Chemotherapy Alone for Locally Advanced Rectal Cancer

FORTUNE
Start date: August 15, 2014
Phase: Phase 2
Study type: Interventional

The standard treatment for stage 2/3 rectal cancer is neoadjuvant 5-Fu based chemoradiation. However, preoperative radiation cause kinds of adverse events, some were irreversible. And the survival benefit was not obvious. Whether chemotherapy alone is effective enough in treating rectal cancer is not yet known. Here, the investigators chose all the three active cytotoxic agents (5-FU, Oxaliplatin, Irinotecan) as the neoadjuvant treatment regimen (FOLFOXIRI). The purpose of the study is to evaluate the efficacy of FOLFOXIRI as neoadjuvant regimen in treating patients with locally advanced rectal cancer.

NCT ID: NCT02205307 Terminated - Rectal Cancer Clinical Trials

A Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection

PILLAR III
Start date: January 2015
Phase: N/A
Study type: Interventional

This is a randomized, controlled, parallel, multicenter study to determine the difference in post-operative anastomotic leak rate in low anterior resection procedures where colon and rectal tissue perfusion is evaluated using PINPOINT as an adjunct to standard surgical practice compared to surgical procedures performed according to standard surgical practice alone.

NCT ID: NCT02195141 Recruiting - Rectal Cancer Clinical Trials

Trial of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer

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

Pathological complete response, (pCR) correlates with a favorable overall prognosis in locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a pCR might be beneficial. The aim of the study is to investigate safety and efficacy of preoperative SIB-IMRT(56Gy) combine with capecitabine. primary endpoint is pathological complete remission rate.

NCT ID: NCT02190656 Completed - Rectal Cancer Clinical Trials

Anterior Resection Syndrome Following Sphincter-preserving Surgery

Start date: May 2014
Phase: N/A
Study type: Observational

Bowel cancer is the third most common cancer in the UK in both males and females. The rectum is the most commonly affected part of the bowel. Improvements in surgery have meant that many patients with rectal cancer can now undergo surgery that removes the rectum and avoids a permanent stoma. The operation that most patients have is an anterior resection of the rectum. Unfortunately this surgery frequently leads to a change in bowel function, with patients suffering from incontinence, urgency and unpredictability a problem known as anterior resection syndrome. These problems are believed to be fairly common following surgery but follow up appointments have traditionally concentrated on ensuring that the cancer has not returned and have not reviewed functional outcomes in enough detail. Because of this we are unsure exactly how common the problems described are. The proposed study will allow us to determine how many patients have ongoing symptoms following their surgery for rectal cancer. It will also allow us to use a newly developed scoring system the Low Anterior Resection Syndrome (LARS) score for the first time in a UK population, to ensure that it can accurately be used in the future to measure the problem and aid development of new therapies. An appreciation of the impact of symptoms on postoperative quality of life will encourage routine assessment of functional outcomes in clinical practice, allowing identification of patients who may benefit from treatment.

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.