Robotic Placement of the FENIX Continence Restoration System in a Patient with Previous Radiation to the Pelvis: A Case Report.

Fecal incontinence (FI) is a disabling problem affecting women. Conservative treatment includes dietary modification, antimotility agents, and pelvic floor physical therapy. If conservative medical management is unsuccessful, surgical intervention may be required. Surgical options include rectal sphincteroplasty, bulking agent injection, radiofrequency anal sphincter remodeling, and sacral nerve stimulation therapy. Recently, a new therapy for FI, the FENIX Continence Restoration System (Torax Medical, Inc., Shoreview, MN), has become available. The FENIX device is placed through a perineal incision; however, pelvic radiation and previous anal carcinoma are both contraindications. We report the case of a 62-year-old woman with FI after anal carcinoma. Treatment included surgery, chemotherapy, and pelvic radiation. Initially, she was treated with conservative therapy and sacral nerve stimulation, which were only partially effective. A physical examination showed perineal skin changes consistent with previous radiation, which increased the patient's risk of infection and a nonhealing wound. Therefore, a robotic approach was used to place the FENIX device and improve the patient's quality of life. Our case sets a precedent for expanding the treatment options of FI in patients with previous pelvic radiation and using a robotic approach for the placement of the FENIX device.

Effects of preoperative chemoradiotherapy on anal sphincter functions and quality of life in rectal cancer patients.

PURPOSE: Deterioration of anorectal function after long-course preoperative chemoradiotherapy combined with surgery for rectal cancer is poorly defined. We conducted a prospective study to evaluate the acute and long term effects of preoperative chemoradiotherapy on anorectal function and quality of life of the patients. METHODS: There were 26 patients in surgery group and 31 patients in preoperative chemoradiotherapy group. Anorectal function and quality of life of the patients were assessed by anorectal manometry, incontinence score, quality of life questionnaire. RESULTS: Significant lower resting pressures in both groups and lower maximal squeeze pressures in the preoperative chemoradiotherapy group were observed after postsurgical evaluations compared with the paired pretreatment ones. In the surgery group, both the Wexner continence score, FIQL score, and the rectoscopy score were comparable before and after surgery, whereas significant worsening in the Wexner score was observed in the preoperative chemoradiotherapy group postoperatively (P < 0.01). Significant reduction in anal canal resting pressures and squeeze pressures, Wexner score, and FIQL score were observed immediately after the completion of preoperative chemoradiotherapy. Significant lower maximal squeeze pressures and worsening of the Wexner scores were observed in the preoperative chemoradiotherapy group compared to the surgery group during the postoperative assessments (P < 0.05 and P < 0.01, respectively). CONCLUSIONS: Both total mesorectal excision and preoperative chemoradiotherapy may adversely affect the anorectal function. Careful selection of the patients who will benefit from neoadjuvant therapy and identifying the patients with a high risk of developing functional problems may help to improve functional outcomes for the treatment of rectal cancer.

Pre-operative chemo-radiotherapy improves the sphincter preservation rate in patients with rectal cancer located within 3 cm of the anal verge.

AIMS: To evaluate whether pre-operative chemo-radiotherapy (CRT) improves the sphincter preservation rate for distal rectal cancers within 3 cm of the anal verge. METHODS: Between January 2001 and December 2004, 49 patients underwent surgery with or without pre-operative CRT for primary rectal adenocarcinoma within 3 cm of the anal verge. Clinical data were retrospectively reviewed, including stage workups, surgical records and pathology records to determine sphincter preservation rate and the factors influencing sphincter preservation. RESULTS: Of 49 patients with rectal tumours within 3 cm of the anal verge, 31 underwent pre-operative CRT followed by surgery (CRT group), and 18 underwent surgery alone (non-CRT group). Sphincter preservation was possible in 11 of 31 CRT patients, and only one of 18 non-CRT patients (p=0.036). The factors most influencing sphincter preservation were reduction in tumour size (p=0.005) and downstaging (p=0.001) following pre-operative CRT. CONCLUSION: We could observe that sphincter preservation was improved in CRT group with statistical significance when compared to non-CRT group in our study patients with rectal cancer within 3 cm of the anal verge.

[Influence of preoperative (hyperthermic) radiochemotherapy on manometric anal sphincter function in locally advanced rectal cancer]. / Einfluss einer präoperativen (hyperthermen) Radiochemotherapie auf die manometrisch erfasste Analsphinkterfunktion beim lokal fortgeschrittenen Rektumkarzinom.

BACKGROUND AND PURPOSE: Preoperative radiochemotherapy (RCT) followed by curative surgery is a well-accepted therapeutic option in the treatment of advanced rectal cancer. Usually, the anal sphincter is located in the irradiation area of a preoperative RCT regime. The aim of this study is to evaluate the influence of preoperative RCT on anal sphincter function. PATIENTS AND METHODS: Between 1994 and 2000, 102 patients with rectal cancer stage uT3/uT4 were analyzed. All patients underwent radiotherapy with 45 Gy (5 x 1.8 Gy) including two cycles of 5-fluorouracil (5-FU)/leucovorin (folinic acid) chemotherapy. 46 patients were treated additionally with up to five sessions of locoregional hyperthermia. The sphincter function was analyzed by perfusion manometry before preoperative therapy and 4 weeks after pretreatment had been finished. For statistics, the Wilcoxon signed rank test and Mann-Whitney U-test were used (SPSS 9.0 for Windows((R))). RESULTS: The mean value of all 102 patients showed a significant reduction of the mean maximum resting pressure from 97 to 89 mmHg (p = 0.02). For the mean maximal squeeze pressure no significant difference could be shown (178 vs. 176 mmHg). For patients with distal (

The addition of continuous infusion 5-FU to preoperative radiation therapy increases tumor response, leading to increased sphincter preservation in locally advanced rectal cancer.

PURPOSE: To compare the outcome from preoperative chemoradiation (CXRT) and from radiation therapy (RT) in the treatment of rectal cancer in two large, single-institutional experiences. PATIENTS AND METHODS: Between 1978 and 1995, 403 patients with localized, nonmetastatic, clinically staged T3 or T4 rectal cancer patients were treated with preoperative RT alone at two institutions. Patients at institution 1 (n = 207) were treated with pelvic CXRT exclusively, and patients at institution 2 were treated (except for 8 given CXRT) with pelvic RT alone (n = 196). In addition, a third group (n = 61) was treated with CXRT at institution 2 between 1998 and 2000 after a policy change. Both institutions delivered 45 Gy in five fractions as a standard dose, but institution 2 used 20 Gy in five fractions in selected cases (n = 26). At both institutions, concurrent chemotherapy consisted of a continuous infusion of 5-fluorouracil (5-FU) at a dosage of 1500 mg/m(2)/week. The end points were response, sphincter preservation (SP), relapse-free survival (RFS), pelvic disease control (PC), and overall survival (OS). RESULTS: Median follow-up was 63 months for all living patients at institution 1 and in the primary group of institution 2. Multivariate analysis of the patients in these groups showed that the use of concurrent chemotherapy improved tumor response (T-stage downstaging, 62% vs. 42%, p = 0.001, and pathologic complete response, 23% vs. 5% p < 0.0001), but did not significantly improve LC, RFS, or OS. Follow-up for the secondary group at institution 2 was insufficient to allow the analysis of these endpoints. In the subset of patients receiving 45 Gy who had rectal tumors < or /=6 cm from the anal verge (institution 1: n = 132; institution 2 primary: n = 79; institution 2 secondary: n = 33), there was a significant improvement in SP with the use of concurrent chemotherapy (39% at institution 1 compared with 13% in the primary group at institution 2, p < 0.0001). A logistic regression analysis of clinical prognostic factors indicated that the use of concurrent chemotherapy independently influenced SP in these low tumors (p = 0.002). This finding was supported by a 36% SP rate in the secondary group at institution 2. Thus SP increased after the addition of chemotherapy at institution 2. CONCLUSIONS: The use of concurrent 5-FU with preoperative radiation therapy for T3 and T4 rectal cancer independently increases tumor response and may contribute to increased SP in patients with low rectal cancer.

Management of late complications of pelvic radiation in the rectum and anus: a review.

PURPOSE: Radiotherapy has become one of the most important treatment modalities for human malignancy. Tumors affecting the organs of the pelvis are increasingly being irradiated for local treatment benefit, with the subsequent complication of anorectal injury of varying extent. The aim of this review is to determine how to manage the consequences of long-term effects of radiotherapy on the rectum and anus. METHODS: A comprehensive search of the literature with manual cross-referencing was performed using the MEDLINE, PubMed, and Cochrane Databases. RESULTS: Long-term manifestations of injury caused by pelvic radiotherapy include abscess and fistula formation, stricture, mucus discharge, urgency, tenesmus, diarrhea, increased risk of cancer, and most commonly, bleeding. Most patients present with several symptoms; however, usually one symptom dominates. CONCLUSIONS: Many of these symptoms are self-limiting, and mucosal complications may often be treated by nonsurgical methods such as topical formalin application, endoscopic argon plasma coagulation, and hyperbaric oxygen therapy. Conservative measures have not been shown to be of benefit if symptoms persist. Structural abnormalities and septic complications are likely to require surgery. Modern techniques in the delivery of radiotherapy help minimize the likelihood of rectal complications.

Epidermoid carcinoma of the anal canal. Results of curative-intent radiation therapy in a series of 270 patients.

BACKGROUND: Epidermoid carcinoma of the anal canal is an uncommon disease, and most institutions have only a small series of patients. The current study of a large series of patients treated with radiation therapy in a single institution evaluates the outcome, prognostic factors, and the late complications for these patients. METHODS: From 1972 to 1991, 270 patients with anal canal epidermoid carcinoma without evident distant metastasis were irradiated with curative intent in the Radiotherapy Department of Tenon Hospital. The sex ratio was 1 man/5.7 women, with a mean age of 67.5 years. The histology included 59.6% well-differentiated epidermoid carcinoma, 32.2% moderately or poorly differentiated epidermoid carcinoma, and 8.2% cloacogenic. The T-classification was: T1: 8.5%; T2: 51.1%; T3: 30.4%; T4: 10%. Abnormal inguinal lymph nodes were present in 12.5% of the patients. Patients were irradiated by external beam. They received a first course of photon irradiation consisting of (mostly 18 mV or 25 mVl; some Co60 or 6 mV) 40-45 Gy (box technique) in the pelvis for 4-5 weeks. After a rest of 4-6 weeks, a second course of 15-20 gy in 2 weeks was given through a perineal field by an electron beam of suitable energy. When rectal involvement was important, a four-field, small box technique was used. Fourteen patients were given a booster irradiation of 30 Gy by interstitial brachytherapy (Iridium 192 sources), and four patients were treated with interstitial brachytherapy alone, to a mean dose of 62.5 Gy. RESULTS: At 5 and 10 years, determinate survival rates were: T1: 86% and 86%; T2: 86.2% and 82.5%; T3: 60.1% and 56.8%; T4: 45% and 45%, respectively. The overall local control rate was 80%. The overall anal conservation rate was 67%. In 154 patients (57%), the anus had maintained its normal function. At 5 and 10 years, determinate survival was 76% and 73.7%, respectively, for N0 and 53.5 and 53.5% for clinically involved inguinal lymph nodes. According to the log-rank test, survival comparisons between T2 and T3 classifications and of tumor sizes less than or equal to 4 cm in length and greater than or equal to 5 cm in length were significant (P = 0.0001 and P < 0.0001, respectively). The presence of clinical abnormal inguinal lymph nodes had a significant negative influence on survival rates (P = 0.047). Multivariate analysis indicated that T-classification and tumor size in centimeters were the only predictive variables. Nonpredictive variables included nodal status, histology, age, total dose, overall treatment time, and irradiation technique. The grade 3 complication rate requiring surgical treatment was 27/270 (10%), considering all patients (27/190 represents a 14% rate for patients who had local tumor control after radiation therapy alone without secondary salvage amputation). There was no significant relationship between complication rate and the aforementioned variables. Because of the homogeneity of the irradiation doses, no significant relationship was found between dose, local control rate, or complication rate. CONCLUSIONS: After radiation therapy, recognizing the distinction between tumor sizes of less than or equal to 4 cm in length and more than 4 cm in length (which is not considered in TNM Classification criteria [International Union Against Cancer, 1987]) could help to improve treatment strategies. For tumors more than 4 cm in length and/or with clinically involved lymph nodes, the treatment should be more extensive with combined chemotherapy and radiation therapy, but the increased local control with the addition of cytotoxic chemotherapy to irradiation has not been proven.