[Identification and review of low-value clinical practices in General and Digestive Surgery]. / Identificación y revisión de prácticas clínicas de poco valor clínico en Cirugía General y Digestiva.

INTRODUCTION: There are currently widespread clinical practices that, because they do not have been supported by available scientific evidence, are inappropriate for most patients. The objective of the present study was to identify and review these low-value clinical practices in General Surgery. MATERIAL AND METHODS: A systematic review of the specialized databases and the published guidelines with identification of low-value practices in General Surgery was carried out. Of the low-value practices selected for a tertiary and university hospitals through the consensus of expert surgeons, those that do not provide clinical value were identified. RESULTS: In a first search, 4,019 recommendations were found, of which 60 were selected because they were focused on General Surgery. After evaluation by the experts, a total of 29 clinical recommendations were selected to be implemented in a specialty service, which were divided into those corresponding to diagnostic processes (n=9), procedures and surgical technique (n=10) and of perioperative care and medication (n=10). CONCLUSIONS: There is evidence in the literature of some clinical practices that provide little value in General Surgery. The changes referring to do-not-do these practices should be implemented in current clinical practice of this specialty.

Clinical results of infrared coagulation as a treatment of high-grade anal dysplasia: a systematic review.

BACKGROUND: Anal intraepithelial neoplasia (AIN) (or low/high grade squamous intraepithelial neoplasia (L/HSIL)) is the precursor of anal of early invasive anal cancer. Different treatment options for local ablation of localized lesions have been reported. The aim of this study was to analyze the clinical efficacy and safety of infrared coagulation for the treatment of anal dysplasia. METHODS: A search of the literature was performed in 2019 using PubMed and Cochrane to identify all eligible trials published reporting data on the treatment of anal dysplasia with infrared coagulation. The percentage of squamous cell carcinoma of the the anus that developed in the follow-up and results on major complications after treatment were the primary outcomes. RESULTS: Twenty-four articles were identified from which 6 were selected with a total of 360 patients included, with a median age of 41.8 years. Three studies were prospective and 3 retrospective, only one was a randomized trial. All articles included males, 4 articles included HIV-positive women and only one article included non HIV infected males. No patient developed major complications after infrared coagulation therapy. Pain was the most common symptom found after the procedure in the different series and mild bleeding that did not require transfusion was the most common complication occurring in 4 to 78% of patients. Median follow-up was between 4.7 and 69 months. No patient developed squamous cell carcinoma after infrared treatment. Recurrent HSIL varied from 10 to 38%. Two studies reported results from follow-up of untreated patients showing that between 72 and 93% of them had persistent HSIL at last follow-up and 4.8% developed squamous cell carcinoma. CONCLUSIONS: Infrared coagulation is a safe and effective method for ablation of high-grade anal dysplasia that could help prevent anal cancer. Continued surveillance is recommended due to the risk of recurrence.

Surgery for constipation: systematic review and practice recommendations: Graded practice and future research recommendations.

AIM: This manuscript forms the final of seven that address the surgical management of chronic constipation (CC) in adults. The content coalesces results from the five systematic reviews that precede it and of the European Consensus process to derive graded practice recommendations (GPR). METHODS: Summary of review data, development of GPR and future research recommendations as outlined in detail in the 'introduction and methods' paper. RESULTS: The overall quality of data in the five reviews was poor with 113/156(72.4%) of included studies providing only level IV evidence and only four included level I RCTs. Coalescence of data from the five procedural classes revealed that few firm conclusions could be drawn regarding procedural choice or patient selection: no single procedure dominated in addressing dynamic structural abnormalities of the anorectum and pelvic floor with each having similar overall efficacy. Of one hundred 'prototype' GPRs developed by the clinical guideline group, 85/100 were deemed 'appropriate' based on the independent scoring of a panel of 18 European experts and use of RAND-UCLA consensus methodology. The remaining 15 were all deemed uncertain. Future research recommendations included some potential RCTs but also a strong emphasis on delivery of large multinational high-quality prospective cohort studies. CONCLUSION: While the evidence base for surgery in CC is poor, the widespread European consensus for GPRs is encouraging. Professional bodies have the opportunity to build on this work by supporting the efforts of their membership to help convert the documented recommendations into clinical guidelines.

Surgery for constipation: systematic review and clinical guidance: Paper 1: Introduction & Methods.

AIM: This manuscript provides the introduction and detailed methodology used in subsequent reviews to assess the outcomes of surgical interventions with the primary intent of treating chronic constipation in adults and to develop recommendations for practice. METHOD: PRISMA guidance was adhered to throughout. A literature search was performed in public databases between January 1960 and February 2016. Studies that fulfilled strictly-defined PICOS (patients, interventions, controls, outcome, and study design) criteria were included. The process involved two groups of participants: (i): 'a clinical guidance group' of 18 UK experts (including junior support) who performed the systematic reviews and produced summary evidence statements (SES) based strictly on data synthesis in each review. The same group then produced prototype graded practice recommendations (GPRs) based on coalescence of SES and expert opinion; (ii): a European Consensus group of 18 ESCP (European Society of Coloproctology) nominated experts from nine European countries evaluated the appropriateness of each prototype GPR based on published RAND/UCLA methodology. RESULTS: An overview of the search results is provided in this manuscript. A total of 156 studies from 307 full text articles (from 2551 initially screened records) were included, providing data on procedures characterized by: (i) colonic resection (n = 40); (ii) rectal suspension (n = 18); (iii) rectal wall excision (n = 44); (iv) rectovaginal septum reinforcement (n = 47); (v) sacral nerve stimulation (n = 7). The overall quality of evidence was poor with 113/156 (72.4%) studies providing only Oxford level IV evidence. The best evidence was extracted for rectal excisional procedures, where the majority of studies were Oxford level I or II. The five subsequent reviews provide a total of 99 SES (reflecting perioperative variables, efficacy, harms and prognostic variables) that contributed to 100 prototype GPRs covering patient selection, procedural considerations and patient counselling. The final manuscript details the 85/100 GPRs that were deemed appropriate by European Consensus (remaining 15 were all uncertain) and future research recommendations. CONCLUSION: This manuscript and the following 6 papers suggest that the evidence base for surgical management of chronic constipation is currently poor although some expert consensus exists on best practice. Further studies are required to inform future commissioning of treatments and of research funding.

Surgery for constipation: systematic review and practice recommendations: Results III: Rectal wall excisional procedures (Rectal Excision).

AIM: To assess the outcomes of rectal excisional procedures in adults with chronic constipation. METHOD: Standardised methods and reporting of benefits and harms were used for all CapaCiTY reviews that closely adhered to PRISMA 2016 guidance. Main conclusions were presented as summary evidence statements with a summative Oxford Centre for Evidence-Based Medicine (2009) level. RESULTS: Forty-seven studies were identified, providing data on outcomes in 8340 patients. Average length of procedures was 44 min and length of stay (LOS) was 3 days. There was inadequate evidence to determine variations in procedural duration or LOS by type of procedure. Overall morbidity rate was 16.9% (0-61%), with lower rates observed after Contour Transtar procedure (8.9%). No mortality was reported after any procedures in a total of 5896 patients. Although inconsistently reported, good or satisfactory outcome occurred in 73-80% of patients; a reduction of 53-91% in Longo scoring system for obstructive defecation syndrome (ODS) occurred in about 68-76% of patients. The most common long-term adverse outcome is faecal urgency, typically occurring in up to 10% of patients. Recurrent prolapse occurred in 4.3% of patients. Patients with at least 3 ODS symptoms together with a rectocoele with or without an intussusception, who have failed conservative management, may benefit from a rectal excisional procedure. CONCLUSION: Rectal excisional procedures are safe with little major morbidity. It is not possible to advise which excisional technique is superior from the point of view of efficacy, peri-operative variables, or harms. Future study is required.

Use of the Harmonic scalpel for Delorme's procedure.

AIM: There are many surgical techniques that deal with external rectal prolapse but perineal procedures have the advantage of reduced invasiveness. Therefore, despite concerns regarding high recurrence rates, the technique is still used by many surgeons. METHOD: This manuscript and video describe our early clinical experience using the Harmonic scalpel in 11 consecutive patients who underwent a Delorme's procedure for external rectal prolapse. RESULTS: The median age of patients was 76 (range: 30-94) years. There were no intra-operative complications, and the median operative time was 78 min. Intra-operative blood loss was minimal (mean 45 ml; range 20-70 ml). Median length of stay was 2 (range: 0-8) days. Overall morbidity and recurrence were both 18%, with a median follow-up of 15 (range: 1-23) months. Nine patients were operated on by a senior trainee with consultant supervision. CONCLUSION: The advantages of this device are mainly those of ease of mucosal dissection, minimal blood loss and shorter operative time in comparison with published series.

Return to work after general surgery: A comparative study.

PURPOSES: There is scarce information on the time to return to work after general surgery. The aim of this study was to analyze time off work after elective cholecystectomy and to compare the results with those in patients undergoing other surgical interventions. METHODS: Observational and comparative study. Inclusion criteria were: being of working age and undergoing elective laparoscopic cholecystectomy (group 1) or unilateral inguinal hernia or haemorrhoidectomy (group 2). RESULTS: 36 patients were included: 18 patients in each group. Overall, return to work occurred at a mean of 35.7 days, with no significant differences (p=0.656) between groups (group 1: 36.6 days vs. group 2: 35.44 days). The reasons for not returning to work earlier were fear of complications (37.5%), pain control (37.5%), surgeon recommendation (12.5%), and general practitioner recommendation (12.5%). CONCLUSIONS: Time to recovery after laparoscopic cholecystectomy is prolonged. No statistically significant differences with less complex surgical procedures were detected.

Heat-induced gelation mechanism of blood plasma modulated by cysteine.

This work aims to determine changes at molecular level of plasma proteins provoked by adding cysteine (Cys, 0.025% to 0.35% w/v) as a reducing agent and their relationship with the heat-induced gel properties obtained when subsequently the solutions were submitted to a thermal treatment. Results show that adding Cys to plasma solutions at concentrations ≥0.15% actually entails modifications in the secondary structure of their main proteins, that is, serum albumin-α-helix rich-and globulin fraction-ß-sheet rich. Basically, a reduction of the intensity of the infrared (IR) bands assigned to both structures takes place concomitant to an increase of extended structures that seem to act as intermediates for the subsequent protein aggregation process through nonnative intermolecular ß-sheets. Cleavage of disulfide bonds is also evidenced at Cys concentrations ≥0.15% by nonreducing sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE), with the effects being directly proportional to Cys concentration. However, beneficial effects on gel hardness are gradually obtained at Cys concentrations ≤0.15%, that is, when the effects at molecular level are at most just budding, while not more improvements on this textural parameter are obtained at higher Cys concentrations. By contrast, water retention capacity is gradually diminishing as Cys concentration increases, but with a significant reduction only obtained at the highest tested concentration. These results suggest a negative effect of Cys on gel microstructure at high concentrations, which probably can be attributed to protein aggregation taking place at room temperature.

Laparoscopic right colectomy: a systematic review and meta-analysis of observational studies comparing two types of anastomosis.

Because of its technical difficulty, totally laparoscopic right colectomy with intracorporeal anastomosis is performed only by a small number of surgeons and most of them use a laparoscopic-assisted technique with extracorporeal anastomosis. This systematic review aims to evaluate differences in outcomes of patients undergoing right laparoscopic colectomy, either with intracorporeal or extracorporeal anastomosis. Electronic databases were searched for studies published between 1991 and 2012. Randomized controlled trials and case-control studies comparing intracorporeal to extracorporeal anastomosis in laparoscopic right colectomy were included in the systematic review. Meta-analytical models were used to evaluate anastomotic leak rate and short-term overall morbidity. Defined primary outcomes of interest were operating time, conversion rate, return of bowel function, anastomotic leak rate, and length of hospital stay. Randomized controlled trials were not found, confirming the paucity of the literature on this topic. Six case-control studies were identified involving 484 patients undergoing right laparoscopic colectomy, 272 with intracorporeal and 212 with extracorporeal anastomosis. Best outcomes seem to be associated with totally laparoscopic right colectomy with intracorporeal anastomosis, especially in terms of return of bowel function, length of hospital stay, and cosmetic results. However, our meta-analysis did not show a significant difference between the two techniques in terms of anastomotic leak rate (OR 0.98; 95 % CI 0.30-3.15) or for short-term overall morbidity (OR 0.68; 95 % CI 0.41-1.12). Comparative analysis of outcomes is in favor of intracorporeal anastomosis. However, the meta-analysis results do not allow us to draw definitive conclusions. Further prospective randomized trials are necessary to confirm our findings.

[Waiting list in general and digestive surgery: patient expectations, quality of life during waiting time and overall satisfaction]. / Lista de espera en Cirugía General y Digestiva: expectativas del paciente, calidad de vida durante la espera y grado de satisfacción.

INTRODUCTION: The structural resources of the National Health system are limited, and therefore early surgery cannot be performed on all patients. The objective was to analyse the satisfaction perceived by the patient as regards the delay of treatment by waiting list of three types of surgery. The influence of expectations on waiting times, and impaired quality of life due to the clinical symptoms during the delay, were studied. MATERIAL AND METHODS: A prospective study was conducted using a postal questionnaire. We compared the expectations (scale of 1 to 5), the impact on quality of life for symptoms (scale of 1 to 5) and the level of patient satisfaction (scale of 1 to 5) with respect to time on the waitng list for cholelithiasis, inguinal hernia and haemorrhoids. The predictors of patient dissatisfaction were analysed. RESULTS: A total of 57 patients were included. When comparing the characteristics of patients with and without satisfaction over time on the waiting list, days on the waiting list (P=.044), the change in the quality of life due to the symptoms (P=.028), and expectations (P<.001) were significantly different between the two groups. In the multivariate analysis, the expectation was associated with patient dissatisfaction as regards the time on waiting list (OR: 3.14 95% CI: 5.91 to 220.73, P<.001). CONCLUSIONS: The level of patient dissatisfaction is associated with expectations about time in waiting list.

Randomized clinical trial comparing inflammatory and angiogenic response after open versus laparoscopic curative resection for colonic cancer.

BACKGROUND: Several studies have suggested that laparoscopy might confer an oncological advantage in patients undergoing surgery for colonic cancer. A decreased inflammatory and angiogenic response has been proposed. This study compared the local and systemic inflammatory and angiogenic responses after open and laparoscopic surgery for colonic cancer. METHODS: Some 122 patients with colonic cancer were randomized to open or laparoscopic colectomy. Levels of interleukin (IL) 6 and vascular endothelial growth factor (VEGF) were measured in serum and peritoneal fluid at baseline, then at 4, 12, 24 and 48 h and on day 4 after surgery. Samples obtained on day 4 were tested in an in vitro angiogenesis assay, with measurement of number of capillaries per field and capillary length. RESULTS: The serum IL-6 level was lower in the laparoscopic group at 4 h (mean(s.d.) 124(110) versus 244(326) pg/dl after open colectomy; P = 0·027). The serum VEGF concentration was also lower in the laparoscopic group at 48 h and day 4 (430(435) versus 650(686) pg/dl; P = 0·001). Overall, local IL-6 and VEGF levels were significantly higher than serum levels but there were no differences between groups. In vitro, postoperative serum and peritoneal fluid samples were potently angiogenic but there were no differences between open surgery and laparoscopy. Rates of tumour recurrence and survival were similar in the two groups. CONCLUSION: Despite differences in postoperative serum levels of IL-6 and VEGF after open and laparoscopic surgery in patients with colonic cancer, the angiogenic response is comparable in both surgical approaches. REGISTRATION NUMBER: ISRCTN55624793 (http://www.controlled-trials.com).

Faecal incontinence after seton treatment for anal fistulae with and without surgical division of internal anal sphincter: a systematic review.

OBJECTIVE: The challenge of surgery for anal fistula is to eradicate the fistula track while maintaining anal continence. Seton placement is recommended to reduce postoperative faecal incontinence but interestingly a great range of functional impairment after surgery has been published. The aim of this study was to analyse the influence of intra-operative internal anal sphincter division during tight or cutting seton technique for cryptogenic anal fistula, on the results of recurrence and postoperative faecal incontinence. METHOD: A systematic literature review was performed to identify published series from 1966 to May 2007 of patients with anal fistula treated by a tight or cutting seton technique. The published series has been divided in to those where preservation of internal anal sphincter was performed (PIAS group) or where intra-operative surgical division was undertaken in the time of seton placement (SIAS group) .The main endpoints of the review were to study anal fistula recurrence rate and postoperative faecal incontinence. RESULTS: Eighteen studies including 19 series and 448 patients were analysed in detail. Recurrence rate was 5.0% and 3.0% in PIAS and SIAS group respectively. Overall faecal incontinence rate was 5.6% in PIAS group and 25.2% in SIAS group. CONCLUSION: Although based on low-evidence studies, intra-operative preservation of internal anal sphincter at the time of seton insertion for anal fistula seems to reduce the postoperative faecal incontinence without a substantial increase in recurrence rates.

An alternative management for high-risk patients with rectal prolapse.

INDICATION: The management of rectal prolapse in presence of high-risk comorbidities can be challenging. We report the use of an anal plug as a noninvasive alternative in patients with contraindication of surgery. METHOD: This small device opens up in about 30 s to fit the contour of the lower rectum avoiding faecal leakage or in our case, the rectal prolapse. Although the plug is poorly tolerated in some cases, this device may be used up to 12 h per day and no adverse effects have been reported. COMPARISON WITH OTHER METHODS: Nonsurgical alternatives described in the literature, such as sclerotherpy in children, are not routinely used in the adult population. The main advantage of the anal plug is its simplicity and safety as in the series published for the treatment of faecal incontinence no adverse events were described. CONCLUSION: An anal plug for rectal prolapse is an alternative in high-risk patients or during the time before surgical treatment.

Economic evaluation of sacral nerve stimulation for faecal incontinence.

BACKGROUND: Sacral nerve stimulation (SNS) is an established treatment for faecal incontinence in patients who have failed conservative management. This study established the cost-effectiveness of treating patients with SNS compared with non-surgical treatment. METHODS: A decision analysis model was performed. Data from 70 patients were obtained from medical records, bowel habit diaries and Short Form 36 quality of life questionnaires. Direct medical and non-medical costs were ascertained using the 2005/2006 national tariff, national statistics, and medication, pad and device costs. Indirect non-medical costs were also estimated. RESULTS: Incontinence episodes were reduced from a median of 12 per fortnight at baseline to one per fortnight with SNS. Based on direct medical and non-medical costs, the incremental cost-effectiveness ratio (ICER) for SNS was pound25 070 per QALY gained. It cost pound1038 more per year to treat patients with SNS for a median reduction of 286 incontinence episodes, equating to pound3.63 per episode reduced. When indirect non-medical costs were included the ICER was reduced to pound12 959 per QALY gained. CONCLUSION: The ICER of pound25 070 is within the pound30 000 per QALY threshold recommended by the National Institute for Health and Clinical Excellence as an effective use of National Health Service resources with proper justification.

Investigation to predict faecal continence in patients undergoing reversal of a defunctioning stoma (Porridge enema test).

OBJECTIVE: A defunctioning stoma is often performed in cases of major anorectal surgery or sphincter injury. This study aimed to assess the Porridge enema (PE) test as a tool to evaluate function prior to stoma closure. METHOD: Thirty-eight patients underwent PE test at a median of 12.5 months after stoma formation prior to consideration of stoma closure. Outcome was assessed by immediate leakage after PE test on lying, standing, walking and the ability to hold the enema for 30 min. Patients available for follow-up were divided into two groups: group 1 (n = 20) patients with stoma closure performed and group 2 (n = 10) patients where the stoma remains. Eight patients were excluded from analysis as the stoma had not been reversed for reasons unrelated to continence. The results of other investigations performed in these patients were analysed. Finally, we studied the agreement in the interpretation of the test by two investigators blinded to the patient's group and each other's interpretation and to functional results after the stoma was reversed. RESULTS: Anorectal physiology testing and imaging assessment of the anal sphincters was not statistically different between the two groups. There was a significant difference in the percentage of patients in each group that had enema leakage in: lying position (P = 0.002), standing position (P = 0.013), walking (P = 0.002) and ability to defer for 30 min (P = 0.005). There was a good correlation in the interpretation of PE test results by two investigators. Among patients whose stoma was closed and who were evaluated functionally, 55% were fully continent. CONCLUSION: This report suggests that the PE test is a promising tool as part of evaluation of anorectal function prior to stoma reversal.

[Current status of follow-up of the upper digestive tract in familial adenomatous polyposis]. / Estado actual del seguimiento del área gastroduodenal en la poliposis adenomatosa familiar.

Familiar adenomatous polyposis (FAP) is a hereditary disease characterized by the development of multiple adenomatous polyps in the gastrointestinal tract and colorectal cancer in practically all patients who do not receive appropriate treatment. Although the most commonly involved region in this disease is the colorectal area, it is well known that adenomas can also develop in the upper gastrointestinal tract, mainly in the periampullary area of the duodenum. Because of the possibility of malignant transformation of these polyps, adequate monitoring is required, even though the optimal follow-up schedule has not yet been defined. In the present article, we report a case of a gastric adenocarcinoma detected during the follow-up of a patient diagnosed with FAP, as well as a review of the literature on this subject. We stress the need for early detection and appropriate management of this disease. Sufficient information is available to support the use of upper gastrointestinal endoscopy with lateral vision and serial biopsies of the periampullary region in these patients. The first endoscopy in patients with FAP should be performed at the age of 20 years or at diagnosis. Subsequently, a follow-up schedule should be designed, according to the number and histological characteristics of the polyps observed.