A Randomized Controlled Trial of Topical Analgesia Posthemorrhoidectomy (TAPH Trial).

BACKGROUND: Postoperative pain remains the greatest problem after hemorrhoidectomy. Pain is hypothesized to arise from bacterial infection, sphincter spasm, and local inflammation. OBJECTIVE: This trial was conducted to assess the effects of metronidazole, diltiazem, and lidocaine on posthemorrhoidectomy pain. DESIGN: A double-blinded randomized controlled factorial trial. SETTINGS: This multicenter trial was conducted in Auckland, New Zealand. PATIENTS: A total of 192 participants were randomly assigned (1:1:1:1) into 4 parallel arms. INTERVENTIONS: Participants were randomly assigned into 1 of 4 groups receiving topical treatment with 10% metronidazole, 10% metronidazole + 2% diltiazem, 10% metronidazole + 4% lidocaine, or 10% metronidazole + 2% diltiazem + 4% lidocaine. Participants were instructed to apply treatment to the anal verge 3 times daily for 7 days. MAIN OUTCOME MEASURES: The primary outcome was pain on the visual analog scale on day 4. The secondary outcomes included analgesia usage, pain during bowel movement, and functional recovery index. RESULTS: There was no significant difference in the pain and recovery scores when diltiazem or lidocaine was added to metronidazole (score difference between presence and absence of diltiazem in the formulation: -3.69; 95% CI, -13.3 to 5.94; p = 0.46; between presence and absence of lidocaine: -5.67; 95% CI, -15.5 to 3.80; p = 0.24). The combination of metronidazole + diltiazem + lidocaine did not further reduce pain. Secondary analysis revealed a significant difference between the best (metronidazole + lidocaine) and worst (metronidazole + diltiazem + lidocaine) groups in both pain and functional recovery scores. There were no significant differences in analgesic usage, complications, or return to work between the groups. No clinically important adverse events were reported. The adverse event rate did not change in the intervention groups. LIMITATIONS: Topical metronidazole was used in the control group rather than a pure placebo. CONCLUSIONS: There was no significant difference in pain when topical diltiazem, lidocaine, or both were added to topical metronidazole. See Video Abstract . CLINICALTRIALSGOV IDENTIFIER: NCT04276298. ENSAYO CONTROLADO ALEATORIZADO DE ANALGESIA TPICA POSTERIOR A HEMORROIDECTOMA ENSAYO TAPH: ANTECEDENTES:El dolor postoperatorio sigue siendo el mayor problema tras hemorroidectomía. La hipótesis es que el dolor se debe a infección bacteriana, el espasmo esfínteriano e inflamación local.OBJETIVO:Se realizó un ensayo factorial aleatorizado y controlado para evaluar los efectos del metronidazol, el diltiazem y la lidocaína en el dolor posthemorroidectomía.DISEÑO:Ensayo factorial controlado aleatorizado doble ciego.ESCENARIO:Se realizó un ensayo multicéntrico en Auckland, Nueva Zelanda.PACIENTES:Se aleatorizó a 192 participantes (1:1:1:1) en cuatro brazos paralelos.INTERVENCIONES:Los participantes se asignaron aleatoriamente a uno de los cuatro grupos que recibieron tratamiento tópico con metronidazol al 10% (M), metronidazol al 10% + diltiazem al 2% (MD), metronidazol al 10% + lidocaína al 4% (ML), o metronidazol al 10% + diltiazem al 2% + lidocaína al 4% (MDL). Se indicó a los participantes que lo aplicaran en el margen anal 3 veces al día durante 7 días.PRINCIPALES MEDIDAS DE RESULTADO:El resultado primario fue el dolor en la escala analógica visual en el día 4. Los resultados secundarios incluyeron el uso de analgesia, el dolor al defecar y el índice de recuperación funcional.RESULTADOS:No hubo diferencias significativas en las puntuaciones de dolor y recuperación cuando se añadió diltiazem o lidocaína al metronidazol (diferencia de puntuación entre la presencia y la ausencia de D en la formulación: -3.69; IC del 95%: -13.3; 5.94; p = 0.46; entre la presencia y la ausencia de L: -5.67; IC del 95%: -15.5; 3.80; p = 0.24). La combinación de MDL no redujo más el dolor. El análisis secundario reveló una diferencia significativa entre los grupos mejor (ML) y peor (MDL) tanto en las puntuaciones de dolor como en las de recuperación funcional. No hubo diferencias significativas en el uso de analgésicos, las complicaciones o la reincorporación al trabajo entre los grupos. No se notificaron eventos adversos clínicamente importantes. La tasa de eventosadversos no cambió en los grupos de intervención.LIMITACIONES:Se utilizó metronidazol tópico en el grupo de control, en lugar de un placebo puro.CONCLUSIONES:No hubo diferencias significativas en el dolor cuando se añadió diltiazem tópico o lidocaína, o ambos, al metronidazol tópico. ( Traducción-Dr. Jorge Silva Velazco )Identificador de registro del ensayo clínico:NCT04276298.

Causes and costs of delayed closure of ileostomies in rectal cancer patients in Australasian units.

BACKGROUND: Defunctioning loop ileostomies (DLIs) are a frequent adjunct to rectal cancer surgery. Delayed closure of DLIs is common and associated with increased morbidity. The reasons for delayed DLI closure are often unknown. The economic burden of delayed DLI closure is not quantified. The present study aimed to determine the reasons for, and economic burden of, delayed DLI closure. METHODS: Clinical and economic data were audited from a prospective database of patients in two Australasian colorectal cancer centres. Patients treated at each unit with low/ultra-low anterior resection for rectal cancer with formation of DLI between January 2014 and December 2019 were included. Post-operative complication rate, stoma-related complication rate and costs of hospital admissions and stoma care were recorded and analysed. Multivariate linear regression analysis was used to investigate risk factors for delay to closure. RESULTS: 146 patients underwent low/ultra-low anterior resection with DLI; 135 patients (92.5%) underwent reversal. The median duration to reversal was 7 months (IQR 4.5-9.5). Sixty-six percent of patients underwent reversal >6 months after their index surgery. Neoadjuvant and adjuvant chemotherapy were associated with delayed reversal (P < 0.001). Non-English speakers waited longer for DLI closure (P = 0.028). The costs of outpatient stoma care (P < 0.001), post-operative care (P = 0.004), and total cost of treatment (P = 0.014) were significantly higher in the delayed closure group, with a total cost of treatment difference of $3854 NZD per patient. CONCLUSIONS: Causes of delay include systemic factors and demographic factors that can be addressed directly, addressing such causes may alleviate a significant economic burden.

Changing the routine: a move to patient initiated follow up to improve surgical outpatient clinic.

INTRODUCTION: Patient initiated follow up (PIFU) allows patients to initiate a hospital follow up appointment on an 'as required' basis in contrast to the traditional physician-initiated model. We present a clinical pathway for patients referred with rectal bleeding at a large tertiary public hospital in South Auckland, New Zealand and demonstrate the utility of PIFU and its impact on reducing follow up appointments. METHOD: The purpose of the pathway was to allow standardized care by the clinicians and allow for PIFU. Two separate protocols were developed - 'Painful PR bleeding' and 'Painless PR bleeding'. A new clinic (NC) was started following these protocols, and this was compared to historical controls (HC). The primary outcome was the rate of follow up appointments. RESULTS: There were 133 patients in the NC and 135 in the HC, with significantly less follow ups in the NC (6% versus 45%, p < 0.0001). A small percentage of patients in the NC group were directly discharged (10%) whilst 70% of patients were discharged with a PIFU card. Thirty phone calls were made using PIFU, with 10 patients returning to clinic and 20 requiring advice and reassurance only. At 5 year follow up, there was a single colorectal malignancy found in both groups. CONCLUSION: Initiating a protocol that includes patient initiated follow up vastly reduces the need for routine return to clinic for the majority of patients, without sacrificing patient care. A protocolised approach to clinic for other areas in general surgery should be considered.

Fast-track surgery may reduce complications following major colonic surgery.

PURPOSE: Fast-track (enhanced recovery) care pathways for colonic surgery are becoming increasingly popular; however, there have been concerns regarding protocol compliance, high readmission rates, and also the true impact on morbidity rates with these protocols. This study was conducted to assess the impact of a fast-track program for colonic surgery on hospital stay, complications, and readmission rates. METHODS: From December 2005 to March 2007, consecutive patients undergoing colonic surgery were prospectively studied. The comparison group consisted of a comorbidity-matched group of patients who had undergone similar surgery before establishment of the fast-track program. RESULTS: Fifty patients were included in each group. Groups were comparable at baseline. The fast-track group received significantly smaller amounts of intraoperative and postoperative intravenous fluids, were fed earlier, mobilized earlier, passed flatus earlier, and were discharged earlier than the comparison group (4 vs. 6.5 days, P < 0.001). The numbers of patients with urinary infections (2 vs. 12, P = 0.008), ileus (5 vs. 18, P = 0.005), and cardiopulmonary complications (11 vs. 21, P = 0.032) were significantly lower in the fast-track group. There was no difference in the rate of readmission. CONCLUSION: Fast-track is a safe and effective approach for reducing hospital stay and morbidity following major colonic surgery.