Sacral nerve stimulation versus the magnetic sphincter augmentation device for adult faecal incontinence: the SaFaRI RCT.

BACKGROUND: Preliminary studies using the FENIX™ (Torax Medical, Minneapolis, MN, USA) magnetic sphincter augmentation device suggest that it is safe to use for the treatment of adult faecal incontinence, but efficacy data are limited. OBJECTIVE: To compare FENIX with sacral nerve stimulation for the treatment of adult faecal incontinence in terms of safety, efficacy, quality of life and cost-effectiveness. DESIGN, SETTING AND PARTICIPANTS: Multicentre, parallel-group, unblinded, randomised trial comparing FENIX with sacral nerve stimulation in participants suffering moderate to severe faecal incontinence. INTERVENTIONS: Participants were randomised on an equal basis to either sacral nerve stimulation or FENIX. Follow-up occurred 2 weeks postoperatively and at 6, 12 and 18 months post randomisation. MAIN OUTCOME AND MEASURE: The primary outcome was success, defined as device in use and ≥ 50% improvement in Cleveland Clinic Incontinence Score at 18 months post randomisation. Secondary outcomes included complication rates, quality of life and cost-effectiveness. Between 30 October 2014 and 23 March 2017, 99 participants were randomised across 18 NHS sites (50 participants to FENIX vs. 49 participants to sacral nerve stimulation). The median time from randomisation to FENIX implantation was 57.0 days (range 4.0-416.0 days), and the median time from randomisation to permanent sacral nerve stimulation was 371.0 days (range 86.0-918.0 days). A total of 45 out of 50 participants underwent FENIX implantation and 29 out of 49 participants continued to permanent sacral nerve stimulation. The following results are reported, excluding participants for whom the corresponding outcome was not evaluable. Overall, there was success for 10 out of 80 (12.5%) participants, with no statistically significant difference between the two groups [FENIX 6/41 (14.6%) participants vs. sacral nerve stimulation 4/39 (10.3%) participants]. At least one postoperative complication was experienced by 33 out of 45 (73.3%) participants in the FENIX group and 9 out of 40 (22.5%) participants in the sacral nerve stimulation group. A total of 15 out of 50 (30%) participants in the FENIX group ultimately had to have their device explanted. Slightly higher costs and quality-adjusted life-years (incremental = £305.50 and 0.005, respectively) were observed in the FENIX group than in the sacral nerve stimulation group. This was reversed over the lifetime horizon (incremental = -£1306 and -0.23 for costs and quality-adjusted life-years, respectively), when sacral nerve stimulation was the optimal option (net monetary benefit = -£3283), with only a 45% chance of FENIX being cost-effective. LIMITATIONS: The SaFaRI study was terminated in 2017, having recruited 99 participants of the target sample size of 350 participants. The study is, therefore, substantially underpowered to detect differences between the treatment groups, with significant uncertainty in the cost-effectiveness analysis. CONCLUSIONS: The SaFaRI study revealed inefficiencies in the treatment pathways for faecal incontinence, particularly for sacral nerve stimulation. The success of both FENIX and sacral nerve stimulation was much lower than previously reported, with high postoperative morbidity in the FENIX group. FUTURE WORK: Further research is needed to clarify the treatment pathways for sacral nerve stimulation and to determine its true clinical and cost-effectiveness. TRIAL REGISTRATION: Current Controlled Trials ISRCTN16077538. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 18. See the NIHR Journals Library website for further project information.

Faecal incontinence is a distressing condition for patients, and surgery is recommended if symptoms are having an effect on quality of life. One of the treatments recommended for faecal incontinence by the National Institute for Health and Care Excellence is sacral nerve stimulation, which aims to improve continence by stimulating the nerves to the back passage. A newer treatment involves surgery to implant a string of magnetic beads around the anal canal using the FENIX™ device (Torax Medical, Minneapolis, MN, USA). The aim of this study was to assess the benefits and risks of the FENIX device compared with sacral nerve stimulation. The SaFaRI study aimed to recruit 350 participants with faecal incontinence, but was stopped early because of the manufacturer withdrawing the FENIX device for strategic reasons. In total, we recruited 99 participants. Fifty participants were allocated to receive the FENIX device and 49 participants were allocated to receive sacral nerve stimulation. The observed success rates with both devices were low: at 18 months following their entry into the study, 6 out of 41 (14.6%) participants in the FENIX group and 4 out of 39 (10.3%) participants in the sacral nerve stimulation group had the device both in use and producing a benefit. A total of 5 out of 50 (10.0%) participants allocated to receive the FENIX device did not have a device implanted, and 15 out of 45 (33.3%) participants who did have the FENIX device implanted needed to have it removed because of complications during the 18-month follow-up period. A total of 21 out of 49 (42.9%) participants allocated to receive sacral nerve stimulation did not have a permanent sacral nerve stimulation device implanted, and 0 of the 28 who did have a permanent sacral nerve stimulation device implanted needed to have it removed during the 18-month follow-up period. The costs associated with the FENIX device were higher because of a greater number of participants experiencing complications, meaning that the FENIX device is unlikely to be cost-effective in the treatment of faecal incontinence compared with sacral nerve stimulation.

Quality assurance in flexible sigmoidoscopy: medical and nonmedical endoscopists.

PURPOSE: The clinical assessment of position in colon and hence completion during flexible sigmoidoscopy (FS) is believed to be inaccurate. The technique of applying endomucosal clips with follow-up X-ray has previously been used for establishing completion in colonoscopy. Furthermore, we have now trained non-healthcare professionals (non-medical endoscopists, NME) to perform FS, but there is no data on assessment of their performance of FS. We performed this study with the aims of determining accuracy of endoscopists' clinical impression regarding actual position of endoscope in colon during FS, comparing medical (ME) and NME in terms of clinical accuracy, and to determine role of endomucosal clips with follow-up X-rays in documenting completion and hence quality assurance. METHODS: All patients undergoing elective FS, except those with surgical resection, were included, after ethics approval. During FS, endoscopist applied an endomucosal clip at most proximal bowel reached and endoscopists recorded their independent opinion about position of clip. Post procedure, all patients underwent an abdominal X-ray, reported by consultant radiologist, blinded to outcome of FS. X-ray results were compared with endoscopist findings. Complete FS was defined as one where descending colon was reached. RESULTS: Fifty-one patients, with median age of 55 years, participated in study. The endoscopists were accurate in their assessment of position in colon in 38 patients (75%). The attending nurse was accurate in only 31% of cases. The crude and corrected completion rates were 73% and 84%, respectively. There was no correlation between length of endoscope and its position in colon. There were no differences between NME and ME in terms of clinical accuracy. CONCLUSION: This study has shown that clinical impression of endoscopist during FS regarding position is not very accurate, implying need for regular quality assurance. The technique of applying endomucosal clips with follow-on abdominal X-ray is an excellent objective measure of quality assurance in FS. NME can perform FS with comparable completion rates and accuracy.

Mesorectal grades predict recurrences after curative resection for rectal cancer.

PURPOSE: Local recurrence after curative excision for rectal cancer is frequently regarded as a failure of surgery. The macroscopic quality of the excised mesorectum after total mesorectal excision has been proposed as a means of assessment of the adequacy of surgery. This study was designed to determine the utility of mesorectal grading in prediction of local and overall recurrence after curative surgery. METHODS: All patients undergoing resection for primary adenocarcinoma of the rectum had a mesorectal grading prospectively applied to their resection specimens, according to the classification proposed by Quirke et al. (Grades 1-3; 3 is the best). The outcome of patients undergoing potentially curative surgery from 2001 to 2003 was reviewed. Prognostic significance of mesorectal grades was determined by multivariate regression analyses. RESULTS: A total of 130 patients with a median follow-up of 26 (range, 17-42) months were studied. The local and overall recurrences were 8.4 and 15 percent, respectively. The mesorectum was reported as Grade 3 in 61 patients (47 percent), Grade 2 in 52 patients (40 percent), and Grade 1 in 17 patients (13 percent). Patients with Grade 1 mesorectum had 41 percent local recurrence and 59 percent overall recurrence, respectively. However, patients with Grade 2 and Grade 3 mesorectum had 5.7 and 1.6 percent local recurrences, respectively, and 17 and 1.6 percent overall recurrence, respectively. By Cox's regression analysis, grade of mesorectum independently influenced both local and overall recurrences. CONCLUSIONS: The macroscopic quality of mesorectum after curative excision of rectal cancer is an important predictor of local and overall recurrences. The mesorectal grades may be of value in decisions regarding postoperative adjuvant therapy.

Anterior anal sphincter repair for fecal incontinence: Good longterm results are possible.

BACKGROUND: Anterior anal sphincter repair (ASR) is standard treatment for fecal incontinence resulting from an obstetrically damaged anal sphincter. Longterm results of repair have generally been shown to be poor. This review of single-unit series aimed to determine longterm outcomes of primary ASR for patients with fecal incontinence from obstetrically damaged anal sphincter. STUDY DESIGN: This study included patients undergoing ASR from 1995 to 1999. We perform standard overlapping ASR, but external and internal sphincters are repaired separately. The internal sphincter is sutured by direct method and only if damaged. Telephone interview was conducted with all patients, after which questionnaires, including SF-36 survey, Fecal Incontinence Quality of Life Scale questions, and Wexner score-type questions, were sent at median followup of 7 years. Demographic data, anorectal physiology, and data on short-term followup (median 12 months) were prospectively collected. RESULTS: Sixty-four of 72 patients returned questionnaires and the operation was considered a success in 80% of patients at median followup of 84 months. Six patients underwent additional procedures for incontinence and 58 patients were analyzed. Fourteen patients reported complete continence to stool and flatus (20%). Continence had improved from median Wexner score of 14 to 7 (p < 0.001). Ninety-five percent of patients were satisfied with their operation. There was substantial improvement in all aspects of Fecal Incontinence Quality of Life Scale questionnaire and SF-36. None of the anorectal physiology variables were of value in predicting outcomes. CONCLUSIONS: We have shown that good longterm results can be achieved with anterior anal sphincter repair. The independent muscle repair technique could explain the improved outcomes.

Transanal endoscopic microsurgery: where are we now?

AIMS: This review of literature aimed to assess the role and establish the current status of transanal endoscopic microsurgery (TEM) in the management of benign and malignant rectal lesions. METHODS: A review of the literature was undertaken through the Medline database and by cross-referencing previous publications, thus identifying 54 relevant publications on TEM in the management of rectal lesions. Aggregated results of various parameters were calculated but statistical comparisons deemed unsuitable due to heterogeneity of data. RESULTS: The TEM procedure is associated with good functional results, morbidity of 4% and zero procedure-related mortality. The local recurrence rates after TEM excision is 4.5% (range 0-14) for benign rectal lesions, 6% (0-13) for T(1) cancers, 14% (range 0-50) for T(2) cancers and 20% (range 14-67%) for T(3) cancers. Local recurrences after TEM can be surgically salvaged with good disease free survival rates. CONCLUSIONS: The TEM procedure clearly offers the benefits of good exposure of the operative field allowing extremely precise dissection and access to high rectal lesions unresectable by other methods. For pTis and low risk pT(1) lesions, the oncological results are comparable to the more traditional formal resection. The routine use of TEM for high-risk pT(1) and higher stage lesions is not an oncologically sound choice at the present moment.