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Concurrent Chemoradiation Versus Wide Pelvic Lymphadenectomy for Advanced Rectal Cancer

ABSTRACT: Based on the neurophysiology, it is well known that sympathetic nerves control the ejaculatory function and bladder neck closure. In contrast, the parasympathetic nerves control penile erection and bladder wall contraction. Because of the difference in cultural background of the patients and training background of the physicians between Western and Oriental Countries, the Western people did not believe in the efficacy of wide pelvic lymphadenectomy. In the Oriental countries, due to the shortage of standardized facilities, treatment protocol, and manpower, the concurrent preoperative chemoradiation therapy (CCRT) of American style is currently not widely accepted. Therefore, the advantage and disadvantage of these two treatment modalities for advanced rectal cancers need be further clarified. In this project, we plan to randomly assign the patients into two groups: (1) concurrent preoperative chemoradiation therapy (CCRT) + conventional surgery group; (2) wide pelvic lymphadenectomy group. Thereafter, we plan to evaluate: (1) the anorectal function by anorectal manometry and colonic transit time using radioopaque markers; (2) the micturition function using urodynamic study; (3) the penile erection by RigiScan; and (4) the ejaculatory function by clinical interview of the patients. Moreover, the various clinicopathologic factors, including the depth of tumor invasion and the status of lymph node invasion, were recorded in detail according to the guidelines recommended by the Japanese Society of Coloproctology. Furthermore, we will evaluate the oncological results for these patients.

DISEASE(S): Rectal Neoplasms,Colorectal Cancer

PROVIDER: 2016113 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: Name: Pelvic floor rehabilitation program Rationale: Patients after anterior resection +/- radiochemotherapy for colorectal cancer can suffer from bowel dysfunction that includes faecal incontinence and defaecatory problems. A structured pelvic floor rehabilitation program on pelvic floor muscle strengthening, anorectal sensory and coordination training can improve bowel function after surgery. This study will also examine the feasibility of the intervention in an outpatient setting. Intervention: A 15 minutes of education session will be provided at the commencement of the program at first week. Participants will be provided education on normal bowel function and the bowel issues associated with colorectal cancer surgery. They will also receive information on good bladder and bowel habits, dietary advice, and pelvic floor exercises.The educational information and home exercise pamphlet is specifically designed for this study. Each participant will be assessed on their anorectal physiology by a colorectal surgeon and pelvic floor physiotherapist. Patient reported outcomes on bladder, bowel, sexual function and quality of life will be examined with questionnaires before and after the intervention. The intervention is a 10 week face to face program of weekly attendance to the outpatient clinic for 1 hour under supervision (ie 1 hour session, once per week for 10 weeks in an outpatient clinic). The program includes: pelvic floor muscle strengthening with use of transperineal ultrasound for visual biofeedback, anorectal sensory and coordination retraining using rectal balloon catheter biofeedback. Visual feedback will be provided via the application of a transperineal ultrasound. The patient will be able to visualise the pelvic floor muscle activity on the screen du Primary outcome(s): Adherence to pelvic floor rehabilitation program.Proportion with >80% attendance of supervised sessions. >80% of completion for weekly home exercises. This will be assessed by an attendance log and home exercise diary completion. [Post intervention program (12 weeks)] Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy

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Concurrent Chemoradiation Versus Wide Pelvic Lymphadenectomy for Advanced Rectal Cancer

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