Availability of evidence and comparative effectiveness for surgical versus drug interventions: an overview of systematic reviews and meta-analyses.

OBJECTIVES: This study aims to examine the prevalence of comparisons of surgery to drug regimens, the strength of evidence of such comparisons and whether surgery or the drug intervention was favoured. DESIGN: Systematic review of systematic reviews (umbrella review). DATA SOURCES: Cochrane Database of Systematic Reviews. ELIGIBILITY CRITERIA: Systematic reviews attempt to compare surgical to drug interventions. DATA EXTRACTION: We extracted whether the review found any randomised controlled trials (RCTs) for eligible comparisons. Individual trial results were extracted directly from the systematic review. SYNTHESIS: The outcomes of each meta-analysis were resynthesised into random-effects meta-analyses. Egger's test and excess significance were assessed. RESULTS: Overall, 188 systematic reviews intended to compare surgery versus drugs. Only 41 included data from at least one RCT (total, 165 RCTs) and covered a total of 103 different outcomes of various comparisons of surgery versus drugs. A GRADE assessment was performed by the Cochrane reviewers for 87 (83%) outcomes in the reviews, indicating the strength of evidence was high in 4 outcomes (4%), moderate in 22 (21%), low in 27 (26%) and very low in 33 (32%). Based on 95% CIs, the surgical intervention was favoured in 38/103 (37%), and the drugs were favoured in 13/103 (13%) outcomes. Of the outcomes with high GRADE rating, only one showed conclusive superiority in our reanalysis (sphincterotomy was better than medical therapy for anal fissure). Of the 22 outcomes with moderate GRADE rating, 6 (27%) were inconclusive, 14 (64%) were in favour of surgery and 2 (9%) were in favour of drugs. There was no evidence of excess significance. CONCLUSIONS: Though the relative merits of surgical versus drug interventions are important to know for many diseases, high strength randomised evidence is rare. More randomised trials comparing surgery to drug interventions are needed.

Desgarro agudo del esfínter anal postparto con reparación inmediata / Immediate repair of acute postpartum anal sphincter tear: case report

Las lesiones obstétricas del esfínter anal pueden ocurrir durante el parto vaginal espontáneamente o secundariamente a la episiotomía. Su riesgo se estima en un 26% y son la causa más frecuente de incontinencia anal en mujeres jóvenes. Las lesiones de grado 4 de Sultan, también llamadas cloaca traumática, implican la ruptura completa del esfínter y la comunicación de la cavidad vaginal con el canal anal. La reparación es siempre quirúrgica, para lo que se han descrito diferentes técnicas, aunque ninguna ha demostrado ser superior. Presentamos el caso de una paciente primípara de 23 años con una cloaca traumática posparto. La reparación quirúrgica se realizó de inmediato con una técnica de overlapping. El postoperatorio fue sin complicaciones y al año presenta continencia anal completa. (AU)

Obstetric anal sphincter injuries can occur spontaneously or as a consequence of an episiotomy during vaginal delivery. Their risk is estimated at 26% and they are the most frequent cause of anal incontinence in young women. Sultan grade 4 injuries, also called traumatic cloaca, involve complete rupture of the sphincter and communication of the vaginal cavity with the anal canal. The repair is always surgical, for which different techniques have been described, although none have proven to be superior. We present the case of a 23-year-old primiparous patient with a postpartum traumatic cloaca. Surgical repair was performed immediately with an overlapping technique. The postoperative period was without complications and one year later she presents complete anal continence. (AU)

The effect of Trolox on the rabbit anal sphincterotomy repair.

INTRODUCTION: Fecal incontinence (FI) is caused by external anal sphincter injury. Vitamin E is a potential strategy for anal sphincter muscle repair via its antioxidant, anti-inflammatory, anti-fibrotic, and protective properties against myocyte loss. Thus, we aimed to evaluate the water-soluble form of vitamin E efficacy in repairing anal sphincter muscle defects in rabbits. METHODS: Twenty-one male rabbits were equally assigned to the intact (without any intervention), control (sphincterotomy), and Trolox (sphincterotomy + Trolox administration) groups. Ninety days after sphincterotomy, the resting and squeeze pressures were evaluated by manometry, and the number of motor units in the sphincterotomy site was calculated by electromyography. Also, the amount of muscle and collagen in the injury site was investigated by Mallory's trichrome staining. RESULTS: Ninety days after the intervention, the resting and squeeze pressures in the intact and Trolox groups were significantly higher than in the control group (P = 0.001). Moreover, the total collagen percentage of the sphincterotomy site was significantly lower in the Trolox group than in the control group (P = 0.002), and the total muscle percentage was significantly higher in the Trolox group compared to the control group (P = 0.001). Also, the motor unit number was higher in the Trolox group than in the control group (P = 0.001). CONCLUSION: Trolox administration in the rabbit sphincterotomy model can decrease the amount of collagen and increase muscle, leading to improved anal sphincter electromyography and manometry results. Therefore, Trolox is a potential treatment strategy for FI.

Chemical sphincterotomy in posthemorrhoidectomy pain relief: a meta-analysis.

PURPOSE: This study aims to evaluate the pain relief function of chemical sphincterotomy in patients undergoing haemorrhoid surgery and compare, through a meta-analysis, the different drugs used to treat this condition. METHODS: We conducted a search in databases including PubMed, EMBASE and Web of Science. The methodological quality was evaluated using the Revised Cochrane risk-of-bias tool for randomized trials (ROB2). The pain score was assessed using a visual analogue scale (VAS) on day 1, day 2, and day 7, and a meta-analysis was conducted based on the use of random effects models. In addition, the subgroup analysis was evaluated based on the kind of experimental drugs. Heterogeneity and publication bias were assessed. RESULTS: Fourteen studies with a total of 681 patients were included in this meta-analysis, and all studies were randomized controlled trials RCTs. Chemical sphincterotomy showed better pain relief function than placebo on day 1 (SMD: 1.16, 95% CI 0.52 to 1.80), day 2 (SMD: 2.12, 95% CI 1.37 to 2.87) and day 7 (SMD: 1.97, 95% CI 1.17 to 2.77) after surgery. In the subgroup meta-analysis, we found that different drugs for chemical sphincterotomy provided different pain relief. CONCLUSION: Chemical sphincterotomy effectively relieves pain after haemorrhoidectomy, and calcium channel blockers have the best effect.

Extracorporeal shock wave lithotripsy and endoscopic pancreatic stenting without pancreatic sphincterotomy for the treatment of pancreatolithiasis: a case series.

Endoscopic therapy and extracorporeal shock wave lithotripsy (ESWL) are recommended as the first choice in treating pancreatolithiasis. Endoscopic therapy is generally performed using endoscopic pancreatic sphincterotomy (EPST). Herein, we report our experience implementing a treatment protocol, combining endoscopic therapy and ESWL without EPST, for pancreatolithiasis. The inpatient treatment plan was performed every 3 months with a set number of sessions of ESWL with endoscopic pancreatic stenting (EPS) implanted or replaced. Finally, treatment was terminated when the stone was removed after implantation of a 10-Fr stent and crushed to approximately 3 mm or after spontaneous stone discharge. Eight patients were included in this study; the median time to stone disappearance was 208.5 days. The median number of inpatient treatment cycles, endoscopic retrograde cholangiopancreatography, and ESWL sessions was 2.5, 3, and 3, respectively. No serious adverse events were observed in all patients. Therefore, combining ESWL and EPS without EPST can safely treat pancreatolithiasis.

Risk of post-sphincterotomy bleeding with antiplatelet and anticoagulant use: a propensity-matched analysis of the U.S. Collaborative Network.

BACKGROUND AND AIMS: GI bleeding after ERCP is a serious adverse event and most commonly occurs after endoscopic biliary and/or pancreatic sphincterotomy. Although the strength of available evidence for post-sphincterotomy GI bleeding risk is high for therapeutic warfarin and heparin, it remains unknown for antiplatelet agents like clopidogrel and prasugrel. We conducted a retrospective United States-based, propensity-matched cohort study to assess the risk of post-sphincterotomy bleeding in patients receiving anticoagulant (AC) and antiplatelet (APT) therapy. METHODS: We analyzed the U.S. Collaborative Network in the TriNetX platform through December 27, 2022, to include patients receiving APT and AC therapy who underwent ERCP within 7 days of hospitalization. One-to-one propensity score matching was performed. The primary outcome was the incidence of GI bleeding within 7 days of sphincterotomy. Secondary outcomes included need for blood transfusion, intensive care unit care, and all-cause mortality within 30 days of bleeding. RESULTS: Overall, 2806 patients (1806 in the AC cohort and 1000 in the APT cohort) underwent ERCP with sphincterotomy. One-to-one propensity score matching was performed for age, body mass index ≥30 kg/m2, gender, race, ethnicity, diabetes mellitus, nicotine dependence, presence and severity of chronic kidney disease, cirrhosis, and thrombocytopenia between the cohorts. Patients in both cohorts had an increased risk of post-sphincterotomy bleeding compared with matched control subjects (adjusted odds ratios of 3.6 [95% confidence interval, 2.58-5.06] and 2.2 [95% confidence interval, 1.43-3.56], respectively). Although heparin bridging therapy and concurrent use of aspirin did not further increase the risk of GI bleeding, resumption of AC within 24 hours' postprocedure did. Neither cohort of patients was at an increased risk for blood transfusion, intensive care unit care, or all-cause mortality. CONCLUSIONS: Our database analysis shows that patients receiving AC and APT therapy are at a higher risk of post-sphincterotomy bleeding compared with matched control subjects. An appropriate drug cessation period or alternative biliary decompression modalities may be used in these patients.

Riesgo de eventos tromboembólicos en función del manejo de la terapia anticoagulante y antiagregante en pacientes sometidos a colangiopancreatografía retrógrada endoscópica / Risk of thromboembolic events in relation to the management of anticoagulant and antiagregant therapy in patients subjected to endoscopic retrograde cholangiopancreatography

Antecedentes y objetivosLas principales guías de práctica clínica recomiendan un adecuado manejo periprocedimiento de los fármacos antitrombóticos en caso de realización de técnicas invasivas. El principal objetivo de este estudio fue evaluar si existe mayor riesgo de eventos tromboembólicos por la supresión o la disminución de la dosis de anticoagulantes o antiagregantes en pacientes sometidos a una colangiopancreatografía retrógrada endoscópica (CPRE). Pacientes y métodos: Se realizó un estudio observacional prospectivo que incluyó 644CPRE realizadas con intención terapéutica durante el año 2019 en el Hospital Universitario Reina Sofía con un seguimiento de 30días posprocedimiento. Resultados: Seis pacientes presentaron un evento tromboembólico, no hallando diferencias entre la incorrecta retirada/reintroducción del tratamiento antitrombótico y una mayor proporción de eventos tromboembólicos o hemorrágicos tras el procedimiento (p>0,05). La incidencia de eventos trombóticos fue significativamente mayor en pacientes en tratamiento con heparina o apixabán (p=0,001), así como con antecedente de fibrilación auricular (p=0,05), valvulopatía reumática (p=0,037) y tromboembolismo pulmonar recurrente (p=0,035), siendo este además un factor de riesgo independiente. Asimismo, la incidencia de hemorragia en los 30días postesfinterotomía fue significativamente menor en aquellos con implantación de prótesis biliar (p=0,04).Conclusiones: El inadecuado manejo periprocedimiento de la terapia antitrombótica no se asocia a un aumento significativo de la incidencia de eventos tromboembólicos en los 30días posteriores a la CPRE. No obstante, se aconseja seguir las recomendaciones para una adecuada suspensión/reintroducción de fármacos antitrombóticos, realizando una vigilancia y un seguimiento estrechos tras el procedimiento en pacientes con factores que aumenten el riesgo trombótico.(AU)

Background and objectives: The main clinical practice guidelines recommend adequate periprocedural withdrawal and reintroduction of antithrombotic drugs in case of invasive techniques. The main objective of this study was to assess whether, in patients receiving anticoagulant or antiplatelet therapy, the suppression or reduction of the pharmacological dose for the performance of endoscopic retrograde cholangiopancreatography (ERCP) implies a greater risk of thromboembolic events. Patients and methods: A prospective observational study was carried out, which included 644ERCP performed with therapeutic intention during 2019 at the Reina Sofía University Hospital with follow-up during the 30days after the endoscopic intervention. Results: Six patients presented a thromboembolic event, finding no differences between the incorrect withdrawal/reintroduction of antithrombotic treatment and a higher proportion of thromboembolic or hemorrhagic events after the procedure (P>.05). The incidence of thrombotic events was significantly higher in patients treated with heparin or apixaban (P=.001), as well as with a history of atrial fibrillation (P=.05), rheumatic valve disease (P=.037) and recurrent pulmonary embolism (P=.035), this being also an independent risk factor. Likewise, the incidence of hemorrhage in the 30days post-sphincterotomy was significantly lower in those with implantation of a biliary prosthesis (P=.04). Conclusions: Inadequate periprocedural management of antithrombotic therapy is not associated with a significant increase in the incidence of thromboembolic events in the 30days after ERCP. However, close follow-up and surveillance during the days after this is essential in those patients with a condition that significantly increases the risk of thrombosis.(AU)

A simulation curriculum for laparoscopic common bile duct exploration, balloon sphincterotomy, and endobiliary stenting: Associations with resident performance and autonomy in the operating room.

BACKGROUND: Laparoscopic common bile duct exploration is safe and effective for managing choledocholithiasis, but laparoscopic common bile duct exploration is rarely performed, which threatens surgical trainee proficiency. This study tests the hypothesis that prior operative or simulation experience with laparoscopic common bile duct exploration is associated with greater resident operative performance and autonomy without adversely affecting patient outcomes. METHODS: This longitudinal cohort study included 33 consecutive patients undergoing laparoscopic common bile duct exploration in cases involving postgraduate years 3, 4, and 5 general surgery residents at a single institution during the implementation of a laparoscopic common bile duct exploration simulation curriculum. For each of the 33 cases, resident performance and autonomy were rated by residents and attendings, the resident's prior operative and simulation experience were recorded, and patient outcomes were ascertained from electronic health records for comparison among 3 cohorts: prior operative experience, prior simulation experience, and no prior experience. RESULTS: Operative approach was similar among cohorts. Overall morbidity was 6.1% and similar across cohorts. The operative performance scores were higher in prior experience cohorts according to both residents (3.0 [2.8-3.0] vs 2.0 [2.0-3.0]; P = .01) and attendings (3.0 [3.0-4.0]; P < .001). The autonomy scores were higher in prior experience cohorts according to both residents (2.0 [2.0-3.0] vs 2.0 [2.0-2.0]; P = .005) and attendings (2.5 [2.0-3.0] vs 2.0 [1.0-2.0]; P = .001). Prior simulation and prior operative experience had similar associations with performance and autonomy. CONCLUSION: Simulation experience with laparoscopic common bile duct exploration was associated with greater resident operative performance and autonomy, with effects that mimic prior operative experience. This illustrates the potential for simulation-based training to improve resident operative performance and autonomy for laparoscopic common bile duct exploration.

Comparison between Transpancreatic Sphincterotomy and Needle-Knife Precut in Difficult Cannulation of Endoscopic Retrograde Cholangiopancreatography: An Up-To-Date Meta-Analysis and Systematic Review.

BACKGROUND: Selective cannulation, which is essential for endoscopic retrograde cholangiopancreatography (ERCP), may be difficult. The aim of this study was to compare transpancreatic sphincterotomy (TPS) and needle-knife precut (NKP) in difficult cannulation during ERCP. METHODS: PubMed, Embase, Web of Science, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov were searched for relevant studies from January 1990 to April 2022. A meta-analysis focusing on cannulation success and post-ERCP complications was performed using Review Manager. RESULTS: Seventeen eligible studies involving 2,340 patients were included. Our results showed that the TPS group had a higher cannulation success rate (odds ratio [OR] 0.48, 95% confidence interval [CI] 0.27-0.87, p = 0.02) and less bleeding (OR 1.94, 95% CI: 1.09-3.47, p = 0.03) compared with the NKP group. There was no significant difference between NKP and TPS in the rates of post-ERCP pancreatitis (OR 0.83, 95% CI: 0.59-1.18, p = 0.30), perforation (OR 2.04, 95% CI: 0.69-6.03, p = 0.20), and adverse events (OR 1.29, 95% CI: 0.94-1.77, p = 0.12). CONCLUSION: TPS appears to be associated with a higher cannulation success rate and less bleeding than those with NKP, with equal post-ERCP pancreatitis, perforation, and adverse event rates between TPS and NKP. Further large-scale trials are warranted to support our findings.

Design and execution of sham-controlled endoscopic trials in acute pancreatitis: Lessons learned from the SHARP trial.

Using the ongoing NIDDK-funded multicenter randomized clinical trial, Sphincterotomy for Acute Recurrent Pancreatitis (SHARP) as an example, this article discusses the rationale and key aspects of study design that need to be considered when conducting a clinical trial of endoscopic therapy in acute pancreatitis. SHARP, the first trial using a sham ERCP in the placebo group, is designed to address a decades long controversy in clinical pancreatology, i.e. whether minor papilla sphincterotomy benefits patients with idiopathic acute recurrent pancreatitis who also have pancreas divisum. Although the trial has already enrolled and randomized over 5 times the number of subjects enrolled in the only randomized trial in this area published in 1992 (107 vs. 19), recruitment has been challenging and we are at ∼46% of target recruitment. The review discusses the challenges in the execution of the trial and strategies the SHARP team has used to address these, which investigators planning or considering treatment trials in pancreatitis may find helpful. It will also inform the general gastroenterologists the importance of discussing and referring potentially eligible subjects to centers participating in clinical trials. Developing evidence-based treatment will provide a solid scientific basis for physicians to recommend evidence-based treatments for pancreatitis.

Esfinteroplastia anatómica mediante reconstrucción combinada del esfínter anal interno y externo en el tratamiento quirúrgico de la incontinencia anal / Anatomic sphincteroplasty with combined reconstruction of internal and external anal muscles in the anal incontinence surgical treatment

Los estudios que evalúan la efectividad de la esfinteroplastia clásica muestran una mejoría de alrededor del 75% a corto plazo, constatándose un deterioro en el tiempo con resultados satisfactorios a largo plazo de alrededor del 50%. Tras introducir la realización de la reparación por separado del esfínter anal interno y el externo, se publicaron tasas de éxito del 80%, observando que estos resultados se mantenían a largo plazo. Pensamos que la introducción de modificaciones en la técnica quirúrgica desde una mentalidad anatómica y reconstructiva, que hemos denominado «esfinteroplastia anatómica mediante reconstrucción combinada de esfínter anal interno y externo», puede obtener muy buenos resultados clínicos y manométricos en el seguimiento a corto y medio plazo. Asimismo, el aumento de longitud de la barrera presiva generada por la técnica puede colaborar a que estos resultados se mantengan más estables a lo largo del tiempo que con la técnica clásica (AU)

Several groups studying the results of the classic sphincteroplasty show improvement of 75% of patients treated in a short-term follow-up, with a worsening of this data in the long-term follow-up down to an improvement of 50% of the patients. Some other groups published more optimistic results, showing an 80% success rate without any deterioration of the technique over time after introducing a separate repair of the internal and external muscles. We think that the introduction of some modifications in the classic technique, named “anatomic sphincteroplasty with combined reconstruction of external and internal anal sphincter muscles” may obtain very good clinical and anorectal manometric results both in a short and mid-term follow-up. In addition, increasing the pressive length in the anal canal may contribute to maintain more stable results over time (AU)

Development of upper gastrointestinal cancer in patients with symptomatic gallstones, cholecystectomy, and sphincterotomy: A nationwide cohort study.

BACKGROUND AND OBJECTIVE: Exposures of gallstones and treatments thereof in relation to development of cancer have not been explored before in long-term follow-up studies. Our objective was to determine whether symptomatic gallstones, cholecystectomy, or sphincterotomy were associated with development of upper gastrointestinal cancers. METHODS: This is a nationwide cohort study of persons born in Denmark 1930-1984 included from age 30 years with long-term follow-up (1977-2014). Exposures were hospital admissions with gallstones, cholecystectomy, and sphincterotomy. Time-varying covariates were included in analyses to allow the impact of exposures to change with time. Follow-up periods were 2-5 and > 5 years. Hazard ratios (HR) with 95% confidence intervals (CI) were reported. RESULTS: A total of 4,465,962 persons were followed. We found positive associations between sphincterotomy and biliary (>5 years HR 4.34, CI [2.17-8.70]), gallbladder (2-5 years HR 20.7, CI [8.55-50.1]), and pancreatic cancer (2-5 years HR 3.68, CI [2.09-6.49]). Cholecystectomy was positively associated with duodenal (2-5 years HR 2.94, CI [1.31-6.58]) and small bowel cancer (2-5 years HR 2.75, CI [1.56-4.87]). Inverse associations were seen for cholecystectomy and biliary (>5 years HR 0.60, CI [0.41-0.87]), pancreatic (>5 years HR 0.45 CI [0.35-0.57]), esophageal (>5 years HR 0.57, CI [0.43-0.74]), and gastric cancer (>5 years HR 0.68, CI [0.55-0.86]) and for gallstones and pancreatic cancer (>5 years HR 0.66, CI [0.47-0.93]). Gallstones were positively associated with gallbladder (>5 years HR 3.51, CI [2.02-6.10]) and small bowel cancer (2-5 years HR 3.21, CI [1.60-6.45]). CONCLUSIONS: A positive association between sphincterotomy and biliary cancer was identified. Cholecystectomy seems to be inversely associated with biliary, pancreatic, esophageal, and gastric cancer. Associations should be explored in similar large cohorts.

[Angiocholitis on hepatic hydatid cyst fistulised in the main bile duct: two case reports]. / Angiocholite sur kyste hydatique hépatique fistulisé dans la voie biliaire principale: à propos de 2 cas.

Hydatid cyst is a zoonosis that frequently affects the liver, which is endemic in several countries such as Morocco. The hepatic hydatidosis can be complicated by angiocholitis, currently, the treatment of choice is endoscopic retrograde cholangio-pancreatography with sphincterotomy. We report two clinical cases of angiocholitis on hepatic hydatid cyst fistulised in the main bile duct which were treated endoscopically with a favourable outcome. Early diagnosis and adequate management can improve the prognosis of these patients.