Impact of Long-Course Neoadjuvant Radiation on Postoperative Low Anterior Resection Syndrome and Quality of Life in Rectal Cancer: Post Hoc Analysis of a Randomized Controlled Trial.

BACKGROUND: Neoadjuvant radiation is recommended for locally advanced rectal cancer, with proven benefit in local control but not in disease-free survival. However, the impact of long-course radiation on postoperative bowel function and quality of life (QOL) remains controversial. This study aimed to investigate the impact of long-course neoadjuvant radiation on bowel function and QOL, and to identify risk factors for severe bowel dysfunction. METHODS: Patients who underwent long-course neoadjuvant chemoradiotherapy (nCRT) or chemotherapy (nCT) followed by radical low anterior resection for locally advanced rectal cancer were recruited from the FOWARC randomized controlled trial. Low anterior resection syndrome (LARS) score and European Organisation for Research and Treatment of Cancer (EORTC) C30/CR29 questionnaires were used to assess bowel function and QOL, respectively. RESULTS: Overall, 220 patients responded after a median follow-up of 40.2 months, of whom 119 (54.1%) reported major LARS, 74 (33.6%) reported minor LARS, and 27 (12.3%) reported no LARS. Compared with the nCT group, the nCRT group reported more major LARS (64.4% vs. 38.6%, p < 0.001) and worse QOL. Long-course neoadjuvant radiation (OR 2.20, 95% CI 1.24-3.91; p = 0.007), height of anastomosis (OR 0.74, 95% CI 0.63-0.88; p < 0.001), and diverting ileostomy (OR 2.59, 95% CI 1.27-5.30; p = 0.009) were independent risk factors for major LARS. CONCLUSIONS: Long-course neoadjuvant radiation, along with low anastomosis, are likely independent risk factors for postoperative bowel function and QOL. Our findings might have implications for alleviating LARS and improving QOL by informing selection of neoadjuvant treatment.

Fecal incontinence and radiation dose on anal sphincter in patients with locally advanced rectal cancer (LARC) treated with preoperative chemoradiotherapy: a retrospective, single-institutional study

Background. The objective of the study is to determine the correlations among the variables of dose and the sphincter function (SF) in patients with locally advanced rectal cancer treated with preoperative capecitabine/radiotherapy followed by low anterior resection (LAR) + TME. Methods. We retrospectively reviewed 92 consecutive patients with LARC treated at our center with LAR from 2006 and more than 2 years free from disease. We re-contoured the anal sphincters (AS) of patients with the help of the radiologist. SF was assessed with the Wexner scale (0-20 points, being punctuation inversely proportional to annal sphincter functionality). All questionnaires were filled out between January 2010 and December 2012. Dosimetric parameters that have been studied include V20, V30, V40, V50, mean dose (Dmean), minimum dose (Dmin), D90 (dose received by 90% of the sphincter) and D98. Statistical analysis. The correlations among the variables of dose and SF were studied by the Spearman correlation coefficient. Differences in SF relating to maximum doses to the sphincter were assessed by the Mann-Whitney test. Results. Mean Wexner score was 5.5 points higher in those patients with V20 > 0 compared to those for which V20 = 0 (p = 0.008). In a multivariate regression model, results suggest that the effect of V20 on poor anal sphincter control is independent of the effect of distance, with an adjusted OR of 3.42. Conclusions. In order to improve the SF in rectal cancer treated with preoperative radiotherapy/capecitabine followed by conservative surgery, the maximum radiation dose to the AS should be limited, when possible, to <20 Gy (AU)

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Endorectal ultrasound and real-time elastography in patients with fecal incontinence following anorectal surgery: a prospective comparison evaluating short- and long-term outcomes in irradiated and non-irradiated patients.

BACKGROUND AND AIMS: Transanal real-time elastography (RTE) was demonstrated to yield valuable information regarding elastic properties of the anal sphincter in patients with fecal incontinence. We studied the role of RTE findings as a risk factor for the outcome of patients with fecal incontinence following anorectal surgery in irradiated and non-irradiated individuals and compared these observations with conventional B-mode/color Doppler EUS.  PATIENTS AND METHODS: 90 patients with postsurgical fecal incontinence were included in this prospective monocentric study. Baseline and follow-up (after 3 weeks and 1 year) assessment included an incontinence severity score questionnaire, rectal manometry, B-mode/color Doppler EUS and RTE with quantitation of the sphincter elastograms. RESULTS: 81 patients could be finally assessed, in 24 patients (29.6%) a pathological elastogram with predominantly hard elements was found; logistic regression analysis revealed no significant association with the short- and long-term clinical outcome nor were any differences seen between irradiated and non-irradiated patients. Defined sphincter defects as seen with conventional EUS were significanntly associated with a worse short- and long-term outcome: odds ratio ORshort-term: 1.414 (1.107 - 1.807, p = 0.0101); ORlong-term: 1.675 (95% CI: 1.133 - 2.477; p = 0.0294). Submucosal thickening and hypervascularization were found more frequently in the irradiated group (p < 0.01). CONCLUSION: RTE with quantitation of sphincter elastic properties yields no further diagnostic and prognostic information compared to conventional EUS in irradiated and non-irradiated patients and, therefore, cannot be regarded as a new tool in the assessment of those patients. Our data further confirm the view that defined sphincter defects may be a major risk factor for an unfavorable outcome.

[New horizons in the treatment of fecal incontinence].

Fecal incontinence affects the quality of life, and causes significant embarrassment. Incontinence mostly affects elderly females. The majority of affected individuals do not seek medical attention because of embarrassment and unawareness of treatment options. Assessment of the severity of incontinence and its effect on the quality of life and evaluation of the anatomy and function of the pelvic floor, rectum and anus, are essential for the proper selection of treatment options. In mild to moderate incontinence, non-invasive treatment with diet and biofeedback may be worthwhile. Invasive treatments include minor procedures, such as "bulking" of the internal sphincter, using injectable agents or radiofrequency energy, and major surgical procedures such as neosphincter operations using the gracilis muscle or artificial bowel sphincter. This review focuses on the new treatment modalities of fecal incontinence.

Temperature-controlled radiofrequency energy (SECCA) to the anal canal for the treatment of faecal incontinence offers moderate improvement.

BACKGROUND AND AIM: Faecal incontinence is a devastating complaint. Even after conservative treatment, many patients still remain incontinent. Few patients have a sphincter defect suitable for repair. Other emerging surgical therapies like dynamic gracilis plasty, neuromodulation or artificial bowel sphincter, carry side effects and show only moderate improvement. Temperature-controlled radiofrequency energy (SECCA) has shown promising results in the USA. Local tightening seems to be the mode of action with possible increased rectal sensitivity. We investigated the effectiveness of radiofrequency and possible changes in the anal sphincter with 3D-ultrasound in patients with faecal incontinence. PATIENTS AND METHODS: Eleven women, mean age 61 years (49-73) with long-standing faecal incontinence were included. Patients with large sphincter defects and anal stenosis were excluded. The SECCA procedure was performed under conscious sedation and local anaesthesia. Oral antibiotics were given. In four quadrants on four or five levels (depending upon length of the anus) radiofrequency was delivered with multiple needle electrodes. Patients were evaluated at 0, 6 weeks, 3 and 6 months and 1 year. Three-dimensional anal ultrasound was performed at 0 (before and after the procedure), 6 weeks and 3 months. Anal manometry and rectal compliance measurement were performed at 0 and 3 months. RESULTS: At 3 months, six of 11 patients improved, which persisted during follow-up of 1 year. The Vaizey score changed from 18.8 to 15.0 (P=0.03) and in those improved from 18.3 to 11.5 (P=0.03). Anal manometry and rectal compliance showed no significant changes, there was a tendency to increased rectal sensitivity concerning urge and maximal tolerated volume (both P=0.3). Responders compared with nonresponders showed no difference in test results. Side effects were local haematoma (2), bleeding 3 days (1), pain persisting 1-3 weeks (4) and laxatives-related diarrhoea during 1-3 weeks (4). CONCLUSION: The SECCA procedure seems to be promising for patients with faecal incontinence with a persisting effect after 1 year. No significant changes in tests were found.

Radio-frequency energy delivery to the anal canal for the treatment of fecal incontinence.

PURPOSE: In this prospective study we investigated the feasibility, safety, and efficacy of radio-frequency energy delivery deep to the mucosa of the anal canal for the treatment of fecal incontinence. METHODS: We studied ten patients with fecal incontinence of varying causes. All patients underwent anoscopy, anorectal manometry, endorectal ultrasound, and pudendal nerve terminal motor latency testing at baseline and six months. The Cleveland Clinic Florida scale for fecal incontinence (Wexner, 0-20), fecal incontinence-related quality of life score, and Short Form 36 were administered at baseline, 1, 2, 3, 6, and 12 months. Using conscious sedation and local anesthesia, we delivered temperature-controlled radio-frequency energy via an anoscopic device with multiple needle electrodes to create thermal lesions deep to the mucosa of the anal canal. RESULTS: Ten females (age, 55.9 +/- 9.2 years; range, 44-74) were enrolled and treated. Median discomfort by visual analog scale (0-10) was 3.8 during and 0.9 two hours after the procedure. Bleeding occurred in four patients (14-21 days after procedure), spontaneous resolution (n = 3) and anoscopic suture ligation (n = 1). At 12 months, the median Wexner score improved from 13.5 to 5 (P < 0.001), with 80 percent of patients considered responders. All parameters in the fecal incontinence-related quality of life were improved (lifestyle (from 2.3 to 3.4), coping (from 1.4 to 2.7), depression (from 2.2 to 3.5), and embarrassment (from 1.3 to 2.8); P < 0.05 for all parameters). Protective pad use was eliminated in five of the seven baseline users. At six months, there was a significant reduction in both initial and maximum tolerable rectal distention volumes. Anoscopy was normal at six months. CONCLUSION: Radio-frequency energy delivery to the anal canal for treatment of fecal incontinence is a new modality that, in this study group, safely improved Wexner and fecal incontinence-related quality of life scores, eliminated protective pad use in most patients, and improved patient quality of life.