Patient-Reported Bowel, Urinary, and Sexual Outcomes After Laparoscopic-Assisted Resection or Open Resection for Rectal Cancer: The Australasian Laparoscopic Cancer of the Rectum Randomized Clinical Trial (ALaCart).

OBJECTIVE: The aim of this study was to compare patient-reported urinary, bowel, and sexual functioning of ALaCaRT Trial participants randomized to open or laparoscopic surgery for rectal cancer. SUMMARY BACKGROUND DATA: The primary endpoint, noninferiority of laparoscopic surgical resection adequacy, was not established. METHODS: Participants completed QLQ-CR29 at baseline, 3, and 12 months post-surgery. Additionally, women completed Rosen's Female Sexual Functioning Index (FSFI). Men completed the International Index of Erectile Function (IIEF) and QLQ-PR25. We compared the proportions of participants in each group who experienced moderate/severe symptoms/dysfunction at each time-point and compared mean difference scores from baseline to 12 months between groups. All analyses were intention-to-treat. Sexual functioning analyses included only the participants who expressed sexual interest at baseline. RESULTS: Baseline PRO compliance of 475 randomized participants was 88%. At 12 months, a lower proportion of open surgery participants experienced moderate-severe fecal incontinence and sore skin, compared to Laparoscopic participants, and a lower proportion of men randomized to open surgery experienced moderate-severe urinary symptoms. There were no differences at 3 months for bowel or urinary symptoms. Sexual functioning among sexually interested participants was similar between groups at 3 and 12 months; however, a lower proportion of women reported moderate to severe sexual dissatisfaction at 3 months in the open as compared to the laparoscopic group, (Rebecca.mercieca@sydney.edu.au., 95% CI 0.03-0.39). DISCUSSION: Despite the slightly lower proportions of open surgery participants self-reporting moderate-severe symptoms for 3 of 16 urinary/bowel domains, and lack of differences in sexual domains, it remains difficult to recommend one surgical approach over another for rectal resection.

The influence of defaecating proctograms on clinical decision-making in pelvic floor disorders.

AIM: Defaecating proctogram (DP) studies have become an integral part of the evaluation of patients with pelvic floor disorders. However, their impact on treatment decision-making remains unclear. The aim of this study was to assess the concordance of decision-making by colorectal surgeons and the role of the DP in this process. METHOD: Four colorectal surgeons were presented with online surveys containing the complete history, examination and investigations of 106 de-identified pelvic floor patients who had received one of three treatment options: physiotherapy only, anterior Delorme's procedure or anterior mesh rectopexy. The survey assessed the management decisions made by each of the surgeons for the three treatments both before and after the addition of the DP to the diagnostic work-up. RESULTS: After the addition of the DP results; treatment choice changed in 219 (52%) of 424 surgical decisions and interrater agreement improved significantly from κ = 0.26 to κ = 0.39. Three of the four surgeons reported a significant increase in confidence. Agreement with the actual treatments patients received increased from κ = 0.21 to κ = 0.28. Intra-anal rectal prolapse on DP was a significant predictor of a decision to perform anterior mesh rectopexy. CONCLUSION: The DP improves interclinician agreement in the management of pelvic floor disorders and enhances the confidence in treatment decisions. Intra-anal rectal prolapse was the most influential DP parameter in treatment decision-making.

Functional Outcome of Laparoscopic-Assisted Resection Versus Open Resection of Rectal Cancer: A Secondary Analysis of the Australasian Laparoscopic Cancer of the Rectum Trial.

BACKGROUND: Low anterior resection syndrome has a significant impact on the quality of life in rectal cancer survivors. Previous studies comparing laparoscopic to open rectal resection have neglected bowel function outcomes. OBJECTIVE: This study aimed to assess whether there is a difference in the functional outcome between patients undergoing laparoscopic versus open resection for rectal adenocarcinoma. DESIGN: Cross-sectional prevalence of low anterior resection syndrome was assessed in a secondary analysis of the multicenter phase 3 randomized clinical trial, Australasian Laparoscopic Cancer of the Rectum Trial (ACTRN12609000663257). SETTING: There were 7 study subsites across New Zealand and Australia. PATIENTS: Participants were adults with rectal cancer who underwent anterior resection and had bowel continuity. MAIN OUTCOME MEASURES: Postoperative bowel function was evaluated using the validated low anterior resection syndrome score and Bowel Function Instrument. RESULTS: The Australasian Laparoscopic Cancer of the Rectum Trial randomized 475 patients with T1-T3 rectal adenocarcinoma less than 15 cm from the anal verge. A total of 257 participants were eligible for, and invited to, participate in additional follow-up; 163 (63%) completed functional follow-up. Overall cross-sectional prevalence of major low anterior resection syndrome was 49% (minor low anterior resection syndrome 27%). There were no differences in median overall Bowel Function Instrument score nor low anterior resection syndrome score between participants undergoing laparoscopic versus open surgery (66 vs 67, p = 0.52; 31 vs 27, p = 0.24) at a median follow-up of 69 months. LIMITATIONS: The major limitations are a result of conducting a secondary analysis; the likelihood of an insufficient sample size to detect a difference in prevalence between the groups and the possibility of selection bias as a subset of the randomized population was analyzed. CONCLUSIONS: Bowel dysfunction affects a majority of rectal cancer patients for a significant time after the operation. In this secondary analysis of a randomized trial, surgical approach does not appear to influence the likelihood or severity of low anterior resection syndrome. See Video Abstract at http://links.lww.com/DCR/B794. RESULTADO FUNCIONAL DE LA RESECCIN ASISTIDA POR LAPAROSCOPIA VERSUS RESECCIN ABIERTA EN CNCER DE RECTO ANLISIS SECUNDARIO DEL ESTUDIO DE CNCER DE RECTO LAPAROSCPICO DE AUSTRALASIA: ANTECEDENTES:El síndrome de resección anterior baja tiene un impacto significativo en la calidad de vida de los supervivientes de cáncer de recto. Los estudios anteriores que compararon la resección rectal laparoscópica con la abierta no han presentado resultados de la función intestinal.OBJETIVO:Evaluar si existe una diferencia en el resultado funcional entre los pacientes sometidos a resección laparoscópica versus resección abierta por adenocarcinoma de recto.DISEÑO:La prevalencia transversal del síndrome de resección anterior baja se evaluó en un análisis secundario del ensayo clínico aleatorizado multicéntrico de fase 3, Estudio Sobre el Cáncer de Recto Laparoscópico de Australasia (Australasian Laparoscopic Cancer of the Rectum Trial, ACTRN12609000663257).AJUSTE:Siete subsitios de estudio en Nueva Zelanda y Australia.PACIENTES:Los participantes eran adultos con cáncer de recto que se sometieron a resección anterior con anastomosis.PRINCIPALES MEDIDAS DE RESULTADO:La función intestinal posoperatoria se evaluó utilizando el previamente validado puntaje LARS y el Instrumento de Función Intestinal.RESULTADOS:El Estudio Sobre el Cáncer de Recto Laparoscópico de Australasia asignó al azar a 475 pacientes con adenocarcinoma rectal T1-T3 a menos de 15 cm del borde anal. 257 participantes fueron elegibles e invitados a participar en un seguimiento adicional. 163 (63%) completaron el seguimiento funcional. La prevalencia transversal general de LARS mayor fue del 49% (LARS menor 27%). No hubo diferencias en la puntuación media general del Instrumento de Función Intestinal ni en la puntuación LARS entre los participantes sometidos a cirugía laparoscópica versus cirugía abierta (66 frente a 67, p = 0,52; 31 frente a 27, p = 0,24) en una mediana de seguimiento de 69 meses.LIMITACIONES:Las principales limitaciones son el resultado de realizar un análisis secundario; se analizó la probabilidad de un tamaño de muestra insuficiente para detectar una diferencia en la prevalencia entre los grupos y la posibilidad de sesgo de selección como un subconjunto de la población aleatorizada.CONCLUSIONES:La disfunción intestinal afecta a la mayoría de los pacientes con cáncer de recto durante un tiempo significativo después de la operación. En este análisis secundario de un ensayo aleatorizado, el abordaje quirúrgico no parece influir en la probabilidad o gravedad del síndrome de resección anterior baja. Consulte Video Resumen en http://links.lww.com/DCR/B794. (Traducción-Dr. Felipe Bellolio).

Warming and humidification of insufflation carbon dioxide in laparoscopic colonic surgery: a double-blinded randomized controlled trial.

OBJECTIVE: We aimed to test the hypothesis that warming and humidification of insufflation CO2 would lead to reduced postoperative pain and improved recovery by reducing peritoneal inflammation in laparoscopic colonic surgery. SUMMARY BACKGROUND DATA: Warming and humidification of insufflation gas is thought be beneficial in laparoscopic surgery, but evidence in prolonged laparoscopic procedures is lacking. METHODS: We used a multicenter, double-blinded, randomized controlled design. The Study Group received warmed (37 degrees C), humidified (98% RH) insufflation carbon dioxide, and the Control Group received standard gas (19 degrees C, 0% RH). Anesthesia and analgesia were standardized. Intraoperative oesophageal temperature was measured at 15 minutes intervals. At the conclusion of surgery, the primary surgeon was asked to rate camera fogging on a Likert scale. Postoperative opiate usage was determined using Morphine Equivalent Daily Dose (MEDD), and pain was measured using visual analogue scores. Peritoneal and plasma cytokine concentrations were measured at 20 hours postoperatively. Postoperative recovery was measured using defined discharge and complication criteria, and the Surgical Recovery Score. RESULTS: Eighty-two patients were randomized, with 41 in each arm. Groups were well matched at baseline. Intraoperative core temperature was similar in both groups. Median camera fogging score was significantly worse in the Study group (4 vs. 2, P = 0.040). There were marginal differences in pain scores, but no significant differences were detected in MEDD usage, cytokine concentrations, or any recovery parameters measured. CONCLUSION: Warming and humidification of insufflation CO2 does not attenuate the early inflammatory cytokine response, and confers no clinically significant benefit in laparoscopic colonic surgery.

Is laparoscopic colectomy for cancer cost-effective relative to open colectomy?

BACKGROUND: Laparoscopic-assisted colectomy (LAC) for cancer has been shown to be safe, with equivalent long-term survival rates to conventional open colectomy (OC) and better short-term patient outcomes. However, LAC tends to require more operating theatre time and disposable equipment. This study investigated, in the context of the New Zealand public hospital system, the extent to which LAC for cancer is cost-effective relative to OC. METHODS: Estimates of the hospital resources used and patient recovery times for LAC and OC for colorectal cancer were obtained from a meta-analysis of published international randomized controlled trials. Using prices from a representative New Zealand public hospital, the additional resources for LAC (relative to OC) were summed to obtain an estimate of LAC's total incremental (additional) cost. The recovery time savings from LAC were also represented in quality-adjusted life years (QALY), enabling a cost-utility analysis of LAC, which was subjected to a one-way sensitivity analysis. RESULTS: On average, a LAC costs New Zealand public hospitals $1267 (range: $259-$3808; all dollars referred to are New Zealand dollars) more than an OC. Average recovery time savings of 12 and 33 days (from two randomized controlled trials) translate into QALY gains of 0.018 and 0.049. Thus, relative to an OC, an LAC costs $38 and $106 per recovery day saved, or $70 389 and $25 857 (combined range: $14 389-$211 556) per QALY gained. CONCLUSION: LAC for cancer appears to be cost-effective relative to OC (per recovery day saved and QALY gained, respectively) for the lower of the average cost estimates and is probably not cost-effective for the higher estimate. Expected future reductions in operating times, conversion rates and postoperative stays will further improve cost-effectiveness.

Early ileostomy closure: is there a downside?

BACKGROUND: A loop ileostomy is a common adjunct to formation of a low colorectal anastomosis. However, it is not without significant physical and psychological morbidity, and financial cost. Feasibility of early closure during the index admission has previously been reported. This pilot study examines the safety of early closure compared with traditional timing. METHODS: A retrospective audit of consecutive ileostomy closures performed in a tertiary colorectal unit from January 2008 to January 2010. Demographic data, treatment data and complications were collected by a single investigator from a prospective clinical audit database and hospital records. Patients undergoing early closure (within 10 days of the index operation) were compared with the traditional timing group. RESULTS: A total of 93 patients underwent closure of loop ileostomy during the study period (44 female; 49 male). Median patient age was 61 years. Nineteen patients (20%) underwent early closure. There were six wound infections in the early closure group (32%), and five in the traditional timing group (7%) (P = 0.01). There was no significant difference in other complications between the two groups. There was a significantly shorter overall hospital stay in the early closure group with a median stay of 14 days (range 10-26), and in the traditional timing group a median stay of 17 days (range 7-80) (P = 0.05). Seven patients (9%) in the traditional timing group had ileostomy-related complications. CONCLUSION: Early ileostomy closure appears to be associated with an increased wound infection rate but otherwise appears to be a safe alternative to traditional closure in selected patients and may reduce overall hospital stay.

Complex anal fistulas: plug or flap?

BACKGROUND: Rectal mucosal advancement flaps (RMAF) and fistula plugs (FP) are techniques used to manage complex anal fistulas. The purpose of this study was to review and compare the results of these methods of repair. METHODS: A retrospective review of all complex anal fistulas treated by either a RMAF or a FP at Auckland City Hospital from 2004 to 2008. Comparisons were made in terms of successful healing rates, time to failure and the use of magnetic resonance imaging. RESULTS: Overall, 70 operations were performed on 55 patients (55.7% male). The mean age was 44.9 years. Twenty-one patients (30%) had had at least one previous unsuccessful repair. Indications for repair included 57 high cryptoglandular anal (81%), 4 Crohn's anal (6%), 7 rectovaginal (10%), 1 rectourethral (1%) and 1 pouch-vaginal fistula (1%). All patients were followed up with a mean of 4.5 months. Forty-eight RMAFs (69% of total) were performed with 16 successful repairs (33%). Twenty-two FPs (31% of total) were performed with 7 successful repairs (32%, P = 0.9). In failed repairs, there was no difference in terms of mean time to failure (RMAF 4.8 months versus FP 4.1 months, P = 0.62). Magnetic resonance imaging was performed in 21 patients (37%) before the repair. The success rate in these patients was 20%. CONCLUSIONS: The results of treatment of complex anal fistulas are disappointing. The choice of operation of either a RMAF or a FP did not alter the poor healing rates of about one third of patients in each group.