Long-term outcomes of an acellular dermal matrix for the treatment of complex cryptoglandular anal fistula: a pilot study.

BACKGOUND: Effective, standardized treatments for complex anal fistula (CAF) still represent a clinical challenge. Emerging procedures attempted to achieve the healing rates of fistulotomy whilst preserving sphincter function. Acellular dermal matrix (ADM) used as a plug inserted through the fistulous tract is among newer treatment options. Varying success rates have been reported, most with short-term follow-up. The aim of this study was to report the long-term results of ADM-plug for CAF. METHODS: Retrospective analysis of a prospective database of patients treated with CAF. All consecutive patients presenting at two tertiary centers (Vall d'Hebron University Hospital and Bellvitge University Hospital, Barcelona, Spain) between November 2015 and March 2019 with a single, cryptoglandular CAF were evaluated for treatment with an ADM-plug were included. The primary endpoint was absence of discharge at clinical examination at 12 month follow-up. RESULTS: Twenty-two patients were included [7 women and 15 men, median age 56 (33-74) years]. Most patients had high transsphincteric fistulas (63.6%). The median follow-up was 42 (21-53) months. The 12 month success rate was 68.2%, with an overall healing rate of 59.1%. 77.8% of recurrences occurred within 12 months from surgery. One plug extrusion was observed. No major complications or mortality occurred during the follow-up. Patients did not report any worsening of fecal continence. CONCLUSIONS: This pilot study showed that more than half of patients with CAF could benefit from ADM-plug placement, preserving continence. A minimum follow-up of 12 months is recommended, because most recurrences occur during the first year.

Percutaneous tibial nerve stimulation in patients with severe low anterior resection syndrome: randomized clinical trial.

BACKGROUND: Treatment of low anterior resection syndrome (LARS) is challenging. Percutaneous tibial nerve stimulation (PTNS) can improve select bowel disorders. An RCT was conducted to assess the efficacy of PTNS compared with sham stimulation in patients with severe LARS. METHOD: This was a multicentre, double-blind RCT. Patients with major LARS score were allocated to receive PTNS or sham therapy (needle placement simulation without nerve stimulation). The study included 16 sessions of 30 min once a week for 12 consecutive weeks, followed by four additional sessions once a fortnight for the following 4 weeks. The primary endpoint was efficacy of PTNS defined by the LARS score 12 months after treatment. Secondary endpoints included faecal incontinence, quality of life (QoL), and sexual function. RESULTS: Between September 2016 and July 2018, 46 eligible patients were assigned randomly in a 1 : 1 ratio to PTNS or sham therapy. Baseline characteristics were similar. LARS scores were reduced in both groups, but only patients who received PTNS maintained the effect in the long term (mean(s.d.) score 36.4(3.9) at baseline versus 30.7(11.5) at 12 months; P = 0.018; effect size -5.4, 95 per cent c.i. -9.8 to -1.0), with a mean reduction of 15.7 per cent at 12-month follow-up. The faecal incontinence score was improved after 12 months in the PTNS group (mean(s.d.) score 15.4(5.2) at baseline versus 12.5(6.4) at 12 months; P = 0.018). No major changes in QoL and sexual function were observed in either group. There was no therapy-associated morbidity. Three patients discontinued the study, but none owing to study-related issues. CONCLUSION: PTNS has positive effects in some patients with major LARS, especially in those with faecal incontinence. Registration number: NCT02517853 (http://www.clinicaltrials.gov).

International consensus definition of low anterior resection syndrome.

AIM: Low anterior resection syndrome (LARS) is pragmatically defined as disordered bowel function after rectal resection leading to a detriment in quality of life. This broad characterization does not allow for precise estimates of prevalence. The LARS score was designed as a simple tool for clinical evaluation of LARS. Although the LARS score has good clinical utility, it may not capture all important aspects that patients may experience. The aim of this collaboration was to develop an international consensus definition of LARS that encompasses all aspects of the condition and is informed by all stakeholders. METHOD: This international patient-provider initiative used an online Delphi survey, regional patient consultation meetings, and an international consensus meeting. Three expert groups participated: patients, surgeons and other health professionals from five regions (Australasia, Denmark, Spain, Great Britain and Ireland, and North America) and in three languages (English, Spanish, and Danish). The primary outcome measured was the priorities for the definition of LARS. RESULTS: Three hundred twenty-five participants (156 patients) registered. The response rates for successive rounds of the Delphi survey were 86%, 96% and 99%. Eighteen priorities emerged from the Delphi survey. Patient consultation and consensus meetings refined these priorities to eight symptoms and eight consequences that capture essential aspects of the syndrome. Sampling bias may have been present, in particular, in the patient panel because social media was used extensively in recruitment. There was also dominance of the surgical panel at the final consensus meeting despite attempts to mitigate this. CONCLUSION: This is the first definition of LARS developed with direct input from a large international patient panel. The involvement of patients in all phases has ensured that the definition presented encompasses the vital aspects of the patient experience of LARS. The novel separation of symptoms and consequences may enable greater sensitivity to detect changes in LARS over time and with intervention.

Reversal of Hartmann's procedure: a single-centre experience of 533 consecutive cases.

AIM: Hartmann's procedure (HP) is common. However, restoration of intestinal continuity is not so frequent. The aim of this study was to determine predictive factors which might influence outcomes following the reversal of HP. METHOD: All consecutive patients who underwent elective and emergency HP in a single institution between January 1999 and December 2014 were included. Data concerning patient, disease and treatment features were collected. Univariate and multivariate binary logistic regression models were used to determine prognostic factors. RESULTS: A total of 533 consecutive patients underwent HP over the 16-year period. Factors that were associated with a higher probability of reversal were age (< 69 years), American Society of Anesthesiologists (ASA) grade (I or II), indication for HP (likelihood of anastomotic leakage) and length of rectal stump reaching or exceeding the sacral promontory. A reduced probability of intestinal reconstruction was associated with anal incontinence, Stage IV cancer, postoperative transfusion or elective surgery. CONCLUSION: Age, ASA grade, the indication for HP, the length of rectal stump, anal incontinence, tumour stage, postoperative transfusion and elective surgery determine the probability of reversal.

Intraoperative use of ICG fluorescence imaging to reduce the risk of anastomotic leakage in colorectal surgery: a systematic review and meta-analysis.

BACKGROUND: Indocyanine green (ICG) fluorescence imaging has been proven to be an effective tool to assess anastomotic perfusion. The aim of this systematic review and meta-analysis was to evaluate its efficacy in reducing the anastomotic leakage (AL) rate after colorectal surgery. METHODS: PubMed, Scopus, WOS, Google Scholar and Cochrane Library were searched up to January 2017 for studies comparing fluorescence imaging with standard care. ClinicalTrials.gov register was searched for ongoing trials. The primary outcome measure was AL rate with at least 1 month of follow-up. ROBINS-I tool was used for quality assessment. A meta-analysis with random-effects model was performed to calculate odds ratios (ORs) from the original data. RESULTS: One thousand three hundred and two patients from 5 non-randomized studies were included. Fluorescence imaging significantly reduced the AL rate in patients undergoing surgery for colorectal cancer (OR 0.34; CI 0.16-0.74; p = 0.006). Low AL rates were shown in rectal cancer surgery (ICG 1.1% vs non-ICG 6.1%; p = 0.02). There was no significant decrease in the AL rate when colorectal procedures for benign and malignant disease were combined. To date, there are no published randomized control trials (RCTs) on this subject, though 3 ongoing RCTs were identified. CONCLUSIONS: ICG fluorescence imaging seems to reduce AL rates following colorectal surgery for cancer. However, the inherent bias of the non-randomized studies included, and their differences in AL definition and diagnosis could have influenced results. Large well-designed RCTs are needed to provide evidence for its routine use in colorectal surgery.

STARR with Contour Transtar: prospective multicentre European study.

OBJECTIVE: The stapled transanal rectal resection (STARR) in patients with defecation disorders is limited by the shape and capacity of the circular stapler. A new device has been recently developed, the Contour Transtar stapler, in order to improve the safety and effectiveness of the STARR technique. The study has been designed to confirm this declaration. METHOD: From January to June 2007 a prospective European multicentre study of consecutive patients with defecation disorder caused by internal rectal prolapse underwent the new STARR technique. The assessment of perioperative morbidity and functional outcome after 6 weeks, 3 and 12 months was documented by different scores. RESULTS: In all 75 patients, median age 64, the Transtar procedure was performed with 9% intraoperative difficulties, 7% postoperative complications and no mortality. The mean reduction of the ODS score was -15.6 (95%-CI: -17.3 to -13.8, P < 0.0001), mean reduction of SSS was -12.6 (95%-CI: -14.2 to -11.2; P < 0.0001). 41% stated improvement of their continence status by CCF score, only 4 patients (5%) had deterioration. CONCLUSION: The Transtar procedure is technically demanding, with good functional results similar to the conventional STARR.

Outcomes of Hartmann's procedure and subsequent intestinal restoration. Which patients are most likely to undergo reversal?

BACKGROUND: Aim of the study was to describe characteristics and outcomes of Hartmann's procedure (HP) and subsequent intestinal restoration. METHODS: Retrospective study including all patients who underwent HP over a period of 16 consecutive years. We propose a classification and regression tree for a more accurate view of the relationship between the variables related to intestinal restoration and their weighting in the decision to reverse HP. RESULTS: 533 patients were included. Overall morbidity rate of HP was 53.5% and mortality 21.0%. Overall morbidity of the intestinal continuity reconstruction was 47.3% and mortality 0.9%. Patients with a benign disease, aged under 69 years and with low comorbidity, had an 84.4% probability of undergoing intestinal reconstruction. CONCLUSIONS: HP is associated with high morbidity and mortality. Restoration of intestinal continuity involves minor, but frequent, morbidity and a low mortality rate. Age and comorbidities can decrease, and even override, the decision to reverse HP.

Prospective multicentre clinical trial of stapled transanal rectal resection for obstructive defaecation syndrome.

BACKGROUND: This prospective multicentre study assessed the safety and effectiveness of stapled transanal rectal resection (STARR) for treatment of obstructive defaecation syndrome (ODS). METHODS: Between February 2001 and June 2006, 104 patients diagnosed with ODS were treated with STARR. Follow-up was scheduled for 1, 3 and 6 months after surgery, and annually thereafter. Variables related to the patient, surgical technique and outcome were analysed. RESULTS: Mean operating time was 46.7 min. Haemorrhage at the staple line occurred in 55 patients (52.9 per cent). Three patients required surgical revision in the first 48 h owing to persistent bleeding. The median postoperative pain score was 2.4 on a scale from 1 to 10. Mean hospital stay was 2.2 days. The mean constipation score improved from 13.5 before surgery to 5.1 at 1-year follow-up (P = 0.006). Twenty-three patients reported faecal incontinence at 4 weeks after surgery, but only nine still had minor residual incontinence by 1 year. At a median follow-up of 26 (range 12-72) months, ODS had recurred or persisted radiologically and/or clinically in 11 patients. CONCLUSION: STARR is associated with low morbidity and a short hospital stay, and is an effective alternative treatment for ODS.

[Neuroendocrine carcinomas of the colon and rectum. A unit's experience over six years]. / Carcinomas neuroendocrinos de colon y recto. Experiencia de una unidad en seis años.

INTRODUCTION: Neuroendocrine tumours of the colon and rectum are infrequent. They are usually undifferentiated, easy to diagnose for the pathologist and are especially aggressive in their clinical behaviour. Prognosis is usually poor and they have a high tendency to metastase early. MATERIAL AND METHODS: We have reviewed our experience in a Colorectal Unit during a period of six years. Patients with neuroendocrine tumours have been reviewed retrospectively. Carcinoid tumours have not been included in this study. RESULTS: During this period, 2,155 patients have been operated for colorectal cancer and in five patients a neuroendocrine tumour has been found in the specimen. Mean age was 66 years, three male and two female. One tumour was located in the caecum, two in the rectum and two in the sigmoid colon. Two patients had hepatic metastasis at diagnosis. Surgery was performed in all patients and two patients received adjuvant quimiotherapy. A patient died because of post-operative hepatic insufficiency, another at 2 months and another after one year. Two patients are still alive after eight months follow-up. CONCLUSIONS: Neuroendocrine tumours appear to be rare in the colon and rectum. Clinical manifestations are not different from standard adenocarcinoma. When these tumours are diagnosed, they have distance disease, as in two of the five cases, related to a poor prognosis for the patient. Surgery is the treatment that can offer a greater chance of survival to these patients.