An analysis of randomized controlled trials on anal fistula conducted between 2000 and 2020 based on the Fragility Index and Reverse Fragility Index.

AIM: The aim of this work was to evaluate the robustness of randomized controlled trials (RCTs) on anal fistula management using the news tools of Fragility Index (FI), Reverse Fragility Index (RFI) and their corresponding fragility quotients. METHOD: A systematic search was conducted based on the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines which utilized MEDLINE, EMBASE, Cochrane Library and Web of Science databases. Inclusion criteria included RCTs related to the management of anal fistula published from 2000 to 2022 with dichotomous outcomes measures and 1:1 allocation. Calculation of FI and RFI was performed by creating 2 × 2 contingency tables by successively changing one nonevent to an event for each outcome measure until the result was made nonsignificant or significant, respectively. The Fragility Quotients were calculated by dividing the FI or RFI by the total sample size. Fragile results were defined as those with a FI or RFI equal to or less than the number of patients lost to follow-up. Additionally, those with a FI or RFI less than 3 were also considered fragile. Studies were considered extremely fragile if FI was ≤1 or FQ was ≤0.01. RESULTS: There were 36 RCTs that met our criteria, with 3223 patients. Among these, 19 (53%) were positive RCTs (p < 0.005) and 17 (47%) were negative RCTs (p > 0.05). The median FI was 2 (0-5). The analysis by categorical subgroup showed a strong correlation between FI and the p-value (p = 0.000) and the number of events (p = 0.011). The median RFI was 5 (3.5-9.5) and the subgroup analysis showed a strong correlation between RFI and the p-value (p = 0.000), sample size (0.021) and number needed to treat/number needed to harm (0.000). We considered 63.2% of positive RCTs to be fragile and 35.3% of negative RCTs. CONCLUSIONS: In the present study we demonstrated the lack of robustness of study findings in published RCTs in the field of anal fistula.

Patterns of recurrence/persistence of criptoglandular anal fistula after the LIFT procedure. Long-term observacional study. / Patrones de recurrencia/persistencia en la operación de LIFT para la fístula anal de origen criptoglandular. Estudio observacional a largo plazo.

OBJECTIVE: To study the recurrence/persistence rate of complex cripotoglandular anal fistula after the LIFT procedure and analyse the patterns of recurrence/persistence. PATIENTS AND METHODS: Observational study of patients with transe-sphincteric or supra-sphincteric anal fistula treated using the LIFT procedure from December 2008 to April 2016. Variables studied included clinical characteristics, surgical technique and results. Clinical cure was defined and imaging studies were used in doubtful cases. Wexner's score was used for continence evaluation. The minimum follow-up time was one year. RESULTS: A total of 55 patients were operated on: 53 with a trans-sphincteric fistula and 2 supra-sphincteric. There were 16 failures (29%): 7 complete fistulas (original), 6 intersphincteric (downstage), and 3 external residual tracts. A posterior location and complexity of the tract were risk factors for recurrence/persistence. The presence of a seton did not improve results. No case presented decrease of continence (Wexner 0). Nine patients presented minor complications (9%): 4 intersphincteric wounds with delayed closure and one external hemorrhoidal thrombosis. The median time to closure of the external opening was 5 weeks (IR 2-6). Intersphincteric wounds closed in 4-8 weeks. CONCLUSION: In our experience, the LIFT technique is a safe and reproducible procedure with low morbidity, no repercussion on continence and a success rate over 70%. There are 3types of recurrence: the intersphincteric fistula, the original fistulatula (trans- or supra-sphincteric) and the residual external tract. Considering the types of recurrence, only 12,7% of patients need more complex surgery to solve their pathology. The rest of the recurrences/persistence were solved by simple procedures (fistulotomy in intersphincteric forms and legrado in residual tracts).

Characteristics and oncological results of epidermoid anal carcinoma: Comparison analysis between immunocompetent and immunosuppressed patients.

OBJECTIVE: Most evidence, including recent randomized controlled trials, analysing anal squamous cell carcinoma (SCC) do not consider immunocompromise patient population. The aim of this study was to compare clinical and oncological outcomes among immunocompetent and immunocompromised patients with anal squamous cell carcinoma. METHOD: Multicentric retrospective comparative study including 2 cohorts of consecutive patients, immunocompetent and immunocompromised, diagnosed with anal SCC. This study evaluated clinical characteristics, clinical response to radical chemoradiotherapy (CRT) and long-term oncological results including both local and distant recurrence, overall survival (OS) and disease-free survival (DFS). RESULTS: A total of 84 patients, 47 (55.6%) female, diagnosed with anal SCC from January 2012 to December 2017 were included, 22 (26%) and 62 (74%) patients in immunocompromised and immunocompetent groups respectively. Patients in immunocompromised group were significantly younger (53 vs. 61 years; P = 0.001), with smaller tumoral size (P = 0.044) and reported higher rates of substance abuse including tobacco use (P = 0.034) and parenteral drug consumption (P = 0.001). No differences were found in administered therapies (P = 301) neither in clinical response to chemoradiotherapy (83 vs. 100%). Moreover, similar 5-year OS (60 vs. 64%; P = 0.756) and DFS (65 vs. 68%; P = 0.338) were observed. CONCLUSION: The present study shows no significant differences in long-term oncological results among immunocompetent and immunocompromised patients diagnosed with anal SCC, with a similar oncologic treatment. This evidence might be explained due to the close monitoring and adequate therapeutic control of HIV positive patients.

LIFT procedure for posterior fistula-in-ano. Are outcomes good enough? A systematic review and meta-analysisis of observational studies. / Procedimiento LIFT en fístulas anales de localización posterior. ¿Son buenos los resultados? Revisión sistemática y metaanálisis de estudios observacionales.

INTRODUCTION: Efficacy of the ligation of intersphincteric fistula tract (LIFT) procedure for posterior fistula-in-ano remains under debate. However, there is scarcity of quality evidence analysing this issue. Thus, the aim of this study is to evaluate outcomes of LIFT surgery in patients with posterior anal fistula. MATERIAL AND METHODS: Systematic review and meta-analysis to evaluate efficacy of LIFT procedure for posterior anal fistula. MEDLINE (PubMed), EMBASE, Scopus, Web of Science, Cochrane Library and Google Scholar data sources were searched for key-words (MeSH terms): "LIFT" OR "Ligation of the intersphincteric fistula tract" AND "posterior anal fistula" OR "posterior fistula-in-ano". Original, observational and experimental, non-language restriction studies published from January 2000 to March 2020 and reporting outcomes on LIFT procedure for posterior anal fistula were reviewed. Quality and potential biases were assessed using Newcastle-Ottawa scale, following AHRQ recommendations. Additional sensitivity analysis and publication bias evaluation (Beg and Egger's tets) were performed. RESULTS: No significant differences were found in recurrence rate among patients undergoing LIFT procedure for posterior fistula-in-ano in contrast to other locations (OR 1.36 [IC 95% 0.60-3.07]; p=.46). I2 test value was 77%, expressing a fair heterogeneity among included studies. The weighed median for overall recurrence was 37.8% (RI 18.3-47.7%); with a weighed median of 47.1% (RI 30.7 - 63.7%) and 36.3% (RI 15.8-51.3%) (p=.436) respectively for recurrence after LIFT for posterior fistula and fistula in other locations. There was not clear evidence about the sample size ("n") of included studies nor the disparities in quality assessment of those, could justify the observed heterogeneity. No significant publication bias was found. CONCLUSION: This systematic review and meta-analysis suggests that there are no clear data in the literature for not performing the LIFT procedure in posteriorly located fistulas.

Early-rectal Cancer Treatment: A Decision-tree Making Based on Systematic Review and Meta-analysis.

Local excision (LE) has arisen as an alternative to total mesorectal excision for the treatment of early rectal cancer. Despite a decreased morbidity, there are still concerns about LE outcomes. This systematic-review and meta-analysis design is based on the "PICO" process, aiming to answer to three questions related to LE as primary treatment for early-rectal cancer, the optimal method for LE, and the potential role for completion treatment in high-risk histology tumors and outcomes of salvage surgery. The results revealed that reported overall survival (OS) and disease-specific survival (DSS) were 71%-91.7% and 80%-94% for LE, in contrast to 92.3%-94.3% and 94.4%-97% for radical surgery. Additional analysis of National Database studies revealed lower OS with LE (HR: 1.26; 95%CI, 1.09-1.45) and DSS (HR: 1.19; 95%CI, 1.01-1.41) after LE. Furthermore, patients receiving LE were significantly more prone develop local recurrence (RR: 3.44, 95%CI, 2.50-4.74). Analysis of available transanal surgical platforms was performed, finding no significant differences among them but reduced local recurrence compared to traditional transanal LE (OR:0.24;95%CI, 0.15-0.4). Finally, we found poor survival outcomes for patients undergoing salvage surgery, favoring completion treatment (chemoradiotherapy or surgery) when high-risk histology is present. In conclusion, LE could be considered adequate provided a full-thickness specimen can be achieved that the patient is informed about risk for potential requirement of completion treatment. Early-rectal cancer cases should be discussed in a multidisciplinary team, and patient's preferences must be considered in the decision-making process.

Characteristics and oncological results of epidermoid anal carcinoma: Comparison analysis between immunocompetent and immunosuppressed patients. / Características y resultados oncológicos del carcinoma epidermoide de ano: análisis comparativo entre los pacientes inmunocompetentes y los inmunodeprimidos.

OBJECTIVE: Most evidence, including recent randomized controlled trials, analysing anal squamous cell carcinoma (SCC) do not consider immunocompromise patient population. The aim of this study was to compare clinical and oncological outcomes among immunocompetent and immunocompromised patients with anal squamous cell carcinoma. METHOD: Multicentric retrospective comparative study including 2 cohorts of consecutive patients, immunocompetent and immunocompromised, diagnosed with anal SCC. This study evaluated clinical characteristics, clinical response to radical chemoradiotherapy (CRT) and long-term oncological results including both local and distant recurrence, overall survival (OS) and disease-free survival (DFS). RESULTS: A total of 84 patients, 47 (55.6%) female, diagnosed with anal SCC from January 2012 to December 2017 were included, 22 (26%) and 62 (74%) patients in immunocompromised and immunocompetent groups respectively. Patients in immunocompromised group were significantly younger (53 vs. 61 years; P=0.001), with smaller tumoral size (P=0.044) and reported higher rates of substance abuse. including tobacco use (P=0.034) and parenteral drug consumption (P=0.001). No differences were found in administered therapies (P=301) neither in clinical response to chemoradiotherapy (83 vs. 100%). Moreover, similar 5-year OS (60 vs. 64%; P=0.756) and DFS (65 vs. 68%; P=0.338) were observed. CONCLUSION: The present study shows no significant differences in long-term oncological results among immunocompetent and immunocompromised patients diagnosed with anal SCC, with a similar oncologic treatment. This evidence might be explained due to the close monitoring and adequate therapeutic control of HIV positive patients.

Laparoscopy-induced severe renal failure after appendectomy.

Laparoscopy has gained importance in the abdominal emergency surgery field. Acute appendicitis is one of the major indications for emergency surgery, being laparoscopy the gold standard approach. We report a case of a 39-years-old female presenting with acute kidney injury (AKI) after laparoscopy. Differential diagnosis was considered with prerenal AKI etiology due to sepsis and low fluid input, however this was ruled out due to absence of electrolyte imbalance and no correlation with septic parameters. Laparoscopy CO2 pneumoperitoneum can potentially lead to multiple organ failure, including renal. Laparoscopy induced AKI is related with both hormonal stimuli for renal vasoconstriction and increased intra-abdominal pressure, causing hypoxemia and tubular renal injury. In conclusion, very few cases of laparoscopy induced AKI in young patients with no previous renal disease have been reported. Surgeons must consider this complication in the differential diagnosis of postoperative AKI.

The use of seton as a bridge to definitive ligation of the intersphincteric fistula tract procedure for fistula-in-ano: a systematic review and meta-analysis

Background: There is still controversy over the usefulness of seton placement prior to the ligation of the intersphincteric fistula tract (LIFT) surgery in the management of anal fistula. Objective: To evaluate the impact of preoperative seton placement on the outcomes of LIFT surgery for the management of fistula-in-ano. Design: systematic review and meta-analysis. Data Sources: A search was performed on the MEDLINE (PubMed), EMBASE, Scopus, Web of Science, Cochrane Library and Google Scholar databases. Study Selection: Original studies without language restriction reporting the primary healing rates with and without seton placement as a bridge to definitive LIFT surgery were included. Intervention: The intervention assessed was the LIFT with and without prior seton placement. Main Outcome Measures: The main outcome was defined as the primary healing rate with and without the use of seton as a bridge to definitive LIFT surgery. Results: Ten studiesmet the criteria for systematic review, all retrospective,with a pooled study population of 772 patients. There were no significant differences in the percentages of recurrence between patients with and without seton placement (odds ratio [OR] 1.02; 95% confidence interval [CI] 0.73-1.43: p=0.35). The I2 value was 9%, which shows the homogeneity of the results among the analyzed studies. The 10 included studies demonstrated a weighted average overall recurrence of 38% (interquartile range [IQR] 27-42.7%), recurrence with the use of setonwas 40%(IQR26.6-51.2%), and without its use, the recurrence rate was 51.3% (IQR 31.3-51.3%) Limitations: The levels of evidence found in the available literature were relatively fair, as indicated after qualitative evaluation using the Newcastle-Ottawa scale and the Attitude Heading Reference System (AHRS) evidence levels. Conclusions: Our meta-analysis suggests that the placement of seton as a bridge treatment prior to LIFT surgery does not significantly improve long-term anal fistula healing outcomes. Ligation of the intersphincteric fistula tract surgery can be performed safely and effectively with no previous seton placement. International prospective register of systematic reviews-PROSPERO registration number: CDR42020149173. (AU)

Local irrigation with silver nitrate, a non-surgical approach for persistent anal fistula / Irrigação local com nitrato de prata, uma abordagem não cirúrgica para fístula anal persistente

ABSTRACT Purpose: Treatment of persistent anal fistula implies a major challenge for surgeons, with risk of additional recurrence and potential continence impairment. We present a non-surgical treatment based on irrigation with silver nitrate 1% solution. Methods: This is a prospective study including patients with persistent anal fistula after surgery, who were treated with silver nitrate 1% solution irrigation from May 2015 to March 2017. Patients with evidence of abscess, presence of >1 external opening and those with bowel inflammatory disease were excluded. 3-5 cc of silver nitrate 1% solution were instilled through a catheter. The procedure was repeated on a weekly basis, conducting a maximum of 7 sessions per patient. Results: 18 patients (13 male, 72.2%) with a median age of 48 years old (IQR 41-55) were treated using silver nitrate 1% solution. A median of 5 sessions per patient was performed (IQR 3-6). The median follow-up period was 18 months (IQR 9-25). After the described period 8 patients' (44.4%) presented complete resolution of the fistula, 2 patients' (11.2%) were classified as partial healing and in 8 patients' (44.4%) the treatment was considered to fail. 6 patients' experienced self-limited pain during instillation, with persistence up to 24 h in 2 of them. Conclusions: Treatment with silver nitrate 1% solution is a minimally invasive procedure, with a favourable safety profile, that can be performed in an outpatients' basis achieving a complete healing rate of 44.4%. Therefore, this method should be considered for the treatment of recurrent or persistent anal fistula.

RESUMO Objetivo: O tratamento da fístula anal persistente é um grande desafio para os cirurgiões, com risco de recorrência adicional e potencial comprometimento da continência. Os autores apresentam um tratamento não cirúrgico baseado na irrigação com solução de nitrato de prata a 1%. Métodos: Este foi um estudo prospectivo incluindo pacientes com fístula anal persistente após a cirurgia que foram tratados com irrigação com solução de nitrato de prata a 1% entre maio de 2015 e março de 2017. Pacientes com evidência de abscesso, presença de mais de uma abertura externa e aqueles com doença inflamatória intestinal foram excluídos. Usando um cateter, instilou-se 3 a 5 cc. de solução de nitrato de prata a 1%. O procedimento foi repetido semanalmente, em um máximo de sete sessões por paciente. Resultados: Um total de 18 pacientes (13 homens, 72,2%) com idade mediana de 48 anos (IQR 41-55) foram tratados com solução de nitrato de prata a 1%. Uma mediana de cinco sessões por paciente foi realizada (IQR 3-6). A mediana do período de acompanhamento foi de 18 meses (IQR 9-25). Após o período descrito, oito pacientes (44,4%) apresentaram resolução completa da fístula, dois pacientes (11,2%) foram classificados como cicatrização parcial e em oito pacientes (44,4%) o tratamento falhou. Seis pacientes apresentaram dor autolimitada durante a instilação, que persistiu por até 24 horas em dois deles. Conclusões: O tratamento com solução de nitrato de prata a 1% é um procedimento minimamente invasivo, com perfil de segurança favorável, que pode ser realizado em regime ambulatorial, atingindo taxa de cura completa de 44,4%. Portanto, este método deve ser considerado para o tratamento da fístula anal recorrente ou persistente.

[A single rectal diclofenac dose reduces post-haemorrhoidectomy urine retention: results of a randomised, controlled clinical study]. / Una sola dosis de diclofenaco intrarrectal reduce la retención urinaria tras la cirugía de las hemorroides. Resultados de un estudio clínico controlado y aleatorizado.

INTRODUCTION: Post-surgical urinary retention requiring a catheter has a mean incidence of 15% (1% to 52%) in the post-operative period after anal surgery. The primary objective of this study was to assess the efficacy of topical rectal Diclofenac in reducing post-surgical haemorrhoidectomy urinary retention. Its impact on the reduced need for post-surgery analgesia has also been assessed as a secondary objective. PATIENTS AND METHOD: The 157 patients intervened for symptomatic haemorrhoids were randomised into two groups: Group with 100 mg diclofenac anal suppository after surgery; and Control group without diclofenac. Haemorrhoidectomy was performed with diathermy, without pedicle ligatures and with hyperbaric spinal anaesthesia. No anal dressings were used and the use of drips was restricted during the post-operative period. Metamizole and diclofenac were used as post-surgical intravenous analgesia in all patients. Meperidine was chosen as rescue analgesia. The descriptive variables evaluated in the patient series were: age, sex, grade and number of haemorrhoid groups, and post-surgical complications. The response variables were: need or not for a urethral catheter, post-surgical pain (Visual Analogue Scale) VAS and rescue analgesia requirements. RESULTS: The 86 males (54.6%) and 71 females (45.4%), with a mean age of 54 years (26-82 years) were randomised into 2 groups: 73 (46.5%) in the diclofenac group and 84 (53.5% in the control group. Of the haemorrhoidectomies performed, 95 were open and 63 were closed. There were no differences as regards the distribution by, age, sex, haemorrhoid grade or in the number of haemorrhoid groups extirpated. Only 1 (1.3%) patient in the diclofenac group and 8 (9.5%) in the control group (p = 0.028) had urine retention. Rescue analgesia was required by 9 (12.3%) patients in the study group compared to 20 (33.3%) in the control group (p = 0.002). The assessment of the magnitude of therapeutic effect of diclofenac gave an RRR of 85.6% (95% CI, 12.3-98.2), RAR, 8.2% (95% CI, 1.3-15) and an NNT of 13 (95% CI, 7-77). CONCLUSIONS: The placing of a 100 mg diclofenac suppository at the end of a haemorrhoidectomy reduces urinary retention and rescue analgesia requirements.