Endoscopic vacuum therapy and early surgical closure after pelvic anastomotic leak: meta-analysis of bowel continuity rates.

BACKGROUND: Endoscopic vacuum therapy (EVT) with or without early surgical closure (ESC) is considered an effective option in the management of pelvic anastomotic leakage. This meta-analysis evaluated the effectiveness of EVT in terms of stoma reversal rate and the added value of ESC. METHODS: A systematic search of PubMed, MEDLINE, and the Cochrane Library was conducted in November 2021 to identify articles on EVT in adult patients with pelvic anastomotic leakage. The primary outcome was restored continuity rate. Following PRISMA guidelines, a meta-analysis was undertaken using a random-effects model. RESULTS: Twenty-nine studies were included, accounting for 827 patients with leakage who underwent EVT. There was large heterogeneity between studies in design and reported outcomes, and a high risk of bias. The overall weighted mean restored continuity rate was 66.8 (95 per cent c.i. 58.8 to 73.9) per cent. In patients undergoing EVT with ESC, the calculated restored continuity rate was 82 per cent (95 per cent c.i. 50.1 to 95.4) as compared to 64.7 per cent (95 per cent c.i. 55.7 to 72.7) after EVT without ESC. The mean number of sponge exchanges was 4 (95 per cent c.i. 2.7 to 4.6) and 9.8 (95 per cent c.i. 7.3 to 12.3), respectively. Sensitivity analysis showed a restored continuity rate of 81 per cent (95 per cent c.i. 55.8 to 99.5) for benign disease, 69.0 per cent (95 per cent c.i. 57.3 to 78.7) for colorectal cancer, and 65 per cent (95 per cent c.i. 48.8 to 79.1) if neoadjuvant radiotherapy was given. CONCLUSION: EVT is associated with satisfactory stoma reversal rates that may be improved if it is combined with ESC.

Local Recurrence and Disease-Free Survival After Transanal Total Mesorectal Excision: Results From the International TaTME Registry.

BACKGROUND: The oncologic safety of transanal total mesorectal excision (TaTME) for rectal cancer has recently been questioned, with high local recurrence (LR) rates reported in Dutch and Norwegian experiences. The objective of this study was to evaluate the oncologic safety of TaTME in a large cohort of patients with primary rectal cancer, primarily in terms of LR, disease-free survival (DFS), and overall survival (OS). PATIENTS AND METHODS: This was a prospective international registry cohort study, including all patients who underwent TaTME for primary rectal adenocarcinoma from February 2010 through December 2018. The main endpoints were 2-year LR rate, pattern of LR, and independent risk factors for LR. Secondary endpoints included 2-year DFS and OS rates. Kaplan-Meier survival analysis was used to calculate actuarial LR, DFS, and OS rates. RESULTS: A total of 2,803 patients receiving primary TaTME were included, predominantly men (71%) with a median age of 65 years (interquartile ratio, 57-73 years). After a median follow-up of 24 months (interquartile ratio, 12-38 months), the 2-year LR rate was 4.8% (95% CI, 3.8%-5.8%) with a unifocal LR pattern in 99 of 103 patients (96%). Independent risk factors for LR were male sex, threatened resection margin on baseline MRI, pathologic stage III cancer, and a positive circumferential resection margin on final histopathology. The 2-year DFS and OS rates were 77% (95% CI, 75%-79%) and 92% (95% CI, 91%-93%), respectively. CONCLUSIONS: This largest TaTME cohort to date supports the oncologic safety of the TaTME technique for rectal cancer in patients treated in units that contributed to an international registry, with an acceptable 2-year LR rate and a predominantly unifocal LR pattern.

Influence of Minimally Invasive Resection Technique on Sphincter Preservation and Short-term Outcome in Low Rectal Cancer in the Netherlands.

BACKGROUND: Transanal and robotic-assisted total mesorectal excision are techniques that can potentially overcome challenges encountered with a pure laparoscopic approach in patients with rectal cancer. OBJECTIVE: The aim of this study was to evaluate the proportion and predictive factors of restorative procedures and subsequent short-term outcomes of 3 minimally invasive techniques to treat low rectal cancer. DESIGN: This is a nationwide observational comparative registry study. SETTINGS: Patients with rectal cancer were selected from the mandatory Dutch ColoRectal Audit. PATIENTS: Patients with low rectal cancer (≤5 cm) who underwent curative minimally invasive total mesorectal excision between 2015 and 2018 were included. MAIN OUTCOME MEASURES: The primary outcomes measured were the proportion of restorative procedure, positive circumferential resection margin, and postoperative complications. RESULTS: A total of 3466 patients were included for analysis, of which 33% underwent a restorative procedure. Resections were performed laparoscopically in 2845 patients, transanally in 448 patients, and were robot-assisted in 173 patients, with a proportion of restorative procedures of 28%, 66%, and 40%. The transanal approach was independently associated with a restorative procedure (OR, 4.11; 95% CI, 3.21-5.26; p < 0.001). Independent risk factors for a nonrestorative procedure, irrespective of the surgical technique, were age >75 years, ASA physical status ≥3, BMI >30, history of abdominal surgery, clinical T4-stage, mesorectal fascia ≤1 mm, neoadjuvant therapy, and having a procedure in 2015 to 2016 versus 2017 to 2018. The circumferential resection margin involvement was similar for all 3 groups (5.4%, 5.1%, and 5.1%). Short-term postoperative complications were less favorable for the newer techniques than for the laparoscopic approach. LIMITATIONS: This study was limited because of the registry's variables and different group sizes. CONCLUSION: Patients with low rectal cancer in the Netherlands are more likely to receive a restorative procedure with a transanal approach, compared with a laparoscopic or robotic procedure. Short-term oncological outcomes are comparable between the 3 minimally invasive techniques. See Video Abstract at http://links.lww.com/DCR/B608. INFLUENCIA DE LA TCNICA DE RESECCIN MINIMAMENTE INVASIVA CON PRESERVACIN DE ESFNTERES EN LA RESOLUCIN A CORTO PLAZO EN CANCER DE TERCIO INFERIOR DE RECTO EN LOS PASES BAJOS: ANTECEDENTES:La excisión mesorrectal transanal y asistida por robot son técnicas que potencialmente pueden superar algunos obstáculos que podemos encontrar en un abordaje exclusivamente laparoscópico en pacientes con cáncer de recto.OBJECTIVOS:El objetivo de este estudio es evaluar la proporción y los factores de predicción positivos de los procedimientos restauradores y los resultados subsecuentes a corto plazo de tres técnicas mínimamente invasivas para tratar el cáncer de tercio inferior de recto.DISEÑO:Es un estudio comparativo observacional del registro nacional.ESCENARIO:Pacientes con cáncer de recto seleccionados del Registro Oficial de la Auditoría Holandesa Colo-rectal.PACIENTGES:Pacientes con cáncer de tercio inferior de recto (≤5 centimetros) sometidos a excision mesorrectal total mínimamente invasiva curativa.PRINCIPALES PARAMETROS DE EFECTIVIDAD:Proporción de procedimientos restauradores, margen de resección circunferencial positivo y complicaciones postoperatorias.RESULTADOS:Se incluyeron un total de 3,466 pacientes para análisis, de los cuales 33% fueron sometidos a procedimiento restaurador. Las resecciones fueron laparoscópica en 2,845 pacientes, transanal en 448 y asistidas por robot en 173, con una proporción de procedimientos restauradores en 28%, 66% y 40% respectivamente. El abordaje transanal se correlacionó en forma independiente con el procedimiento restaurador (OR 4.11; 95% CI 4.11; 95% CI 3.21-5.26; p<0.001). Los factores de riesgo independientes para un procedimiento no restaurador, sin tomar en cuenta la técnica quirúrgica fueron: edad >75, American Society of Anesthesiologist ≥3, índice de masa corporal >30, antecedente de cirugía abdominal, Estadio clínico T4, fascia mesorrectal ≤1 millimetro, terapia neoadyuvante y haber sido sometido al procedimiento en 2015-2016 y no en 2017-2018. El margen circunferencial de resección involucrado fue similar para los tres grupos (5.4%, 5.1% y 5.1%). Las complicaciones postquirúrgicas a corto plazo fueron menos favorables para las técnicas nuevas comparadas con el abordaje laparoscópico.LIMTANTES:El estudio tiene la limitación de las variables dependientes del registro y la diferencia entre el número de pacientes en cada grupo.CONCLUSION:Los pacientes con cáncer de tercio inferior de recto en Holanda se tratan con mayor frecuencia mediante un procedimiento restaurador transanal en comparación con los abordajes laparoscópico o robótico. Los resultados favorables desde el punto de vista oncológico a corto plazo son comparables entre las tres técnicas de invasión mínima. Consulte Video Resumenhttp://links.lww.com/DCR/B608.

A systematic review and meta-analysis on complications of transanal total mesorectal excision.

AIM: Transanal total mesorectal excision (TaTME) is a surgical approach for treating mid to low rectal cancer as well as other colorectal diseases. Since the procedure is difficult to master, perioperative complications of TaTME should be examined precisely, especially during the early implementation phase of this procedure. The primary aim of this review was to determine a pooled morbidity and anastomotic leakage (AL) rate after TaTME surgery, and the secondary aim was to show the completeness of reporting of complications among the included studies, as well as the correlation between completeness and reported incidence of complications. METHOD: A systematic review of literature was conducted using Medline, Embase and Cochrane databases, searching for observational studies reporting on complications after TaTME. Studies published between 1 January 2010 and 15 October 2019 were included. Meta-analysis on the proportion of morbidity, AL and intraoperative complications was performed. RESULTS: Forty-one studies (2446 TaTME cases), consisting of 27 noncomparative studies and 14 comparative studies, were included, after screening 1711 possible studies. The pooled rates of overall morbidity and AL were 30.0% (95% CI 26.4%-34.0%) and 6.8% (95% CI 5.2%-8.9%), respectively. Subgroup analysis showed that the morbidity rate in studies that reported 30-day results (35.5%; 95% CI 31.8%-39.4%) was significantly higher than the rate in studies that did not define the follow-up length for complications (23.4%; 95% CI 17.8%-30.1%; p = 0.003). The rates of intraoperative urethral injury, rectal injury, vaginal injury and bladder injury were 0.3% (95% CI 0.1%-1.7%), 0.4% (95% CI 0.1%-2.2%), 0.3% (95% CI 0.1%-0.8%) and 0.3% (95% CI 0.1%-1.7%), respectively. CONCLUSION: This meta-analysis shows that pooled perioperative complication rates were within acceptable ranges. However, the significant difference in overall morbidity rate between the studies with 30-day results and the studies without a specified follow-up time, indicates a large under-reporting of complications in many studies.

Does oncological outcome differ between restorative and nonrestorative low anterior resection in patients with primary rectal cancer?

AIM: Nonrestorative low anterior resection (n-rLAR) (also known as low Hartmann's) is performed for rectal cancer when a poor functional outcome is anticipated or there have been problems when constructing the anastomosis. Compared with restorative LAR (rLAR), little oncological outcome data are available for n-rLAR. The aim of this study was to compare oncological outcomes between rLAR and n-rLAR for primary rectal cancer. METHOD: This was a nationwide cross-sectional comparative study including all elective sphincter-saving LAR procedures for nonmetastatic primary rectal cancer performed in 2011 in 71 Dutch hospitals. Oncological outcomes of patients undergoing rLAR and n-rLAR were collected in 2015; the data were evaluated using Kaplan-Meier survival analysis and the results compared using log-rank testing. Uni- and multivariable Cox regression analysis was used to evaluate the association between the type of LAR and oncological outcome measures. RESULTS: A total of 1197 patients were analysed, of whom 892 (75%) underwent rLAR and 305 (25%) underwent n-rLAR. The 3-year local recurrence (LR) rate was 3% after rLAR and 8% after n-rLAR (P < 0.001). The 3-year disease-free survival and overall survival rates were 77% (rLAR) vs 62% (n-rLAR) (P < 0.001) and 90% (rLAR) vs 75% (n-rLAR) (P < 0.001), respectively. In multivariable Cox analysis, n-rLAR was independently associated with a higher risk of LR (OR = 2.95) and worse overall survival (OR = 1.72). CONCLUSION: This nationwide study revealed that n-rLAR for rectal cancer was associated with poorer oncological outcome than r-LAR. This is probably a noncausal relationship, and might reflect technical difficulties during low pelvic dissection in a subset of those patients, with oncological implications.

Predictive Factors and Risk Model for Positive Circumferential Resection Margin Rate After Transanal Total Mesorectal Excision in 2653 Patients With Rectal Cancer.

OBJECTIVE: The aim of this study was to determine the incidence of, and preoperative risk factors for, positive circumferential resection margin (CRM) after transanal total mesorectal excision (TaTME). BACKGROUND: TaTME has the potential to further reduce the rate of positive CRM for patients with low rectal cancer, thereby improving oncological outcome. METHODS: A prospective registry-based study including all cases recorded on the international TaTME registry between July 2014 and January 2018 was performed. Endpoints were the incidence of, and predictive factors for, positive CRM. Univariate and multivariate logistic regressions were performed, and factors for positive CRM were then assessed by formulating a predictive model. RESULTS: In total, 2653 patients undergoing TaTME for rectal cancer were included. The incidence of positive CRM was 107 (4.0%). In multivariate logistic regression analysis, a positive CRM after TaTME was significantly associated with tumors located up to 1 cm from the anorectal junction, anterior tumors, cT4 tumors, extra-mural venous invasion (EMVI), and threatened or involved CRM on baseline MRI (odds ratios 2.09, 1.66, 1.93, 1.94, and 1.72, respectively). The predictive model showed adequate discrimination (area under the receiver-operating characteristic curve >0.70), and predicted a 28% risk of positive CRM if all risk factors were present. CONCLUSION: Five preoperative tumor-related characteristics had an adverse effect on CRM involvement after TaTME. The predicted risk of positive CRM after TaTME for a specific patient can be calculated preoperatively with the proposed model and may help guide patient selection for optimal treatment and enhance a tailored treatment approach to further optimize oncological outcomes.

Ferric carboxymaltose infusion versus oral iron supplementation for preoperative iron deficiency anaemia in patients with colorectal cancer (FIT): a multicentre, open-label, randomised, controlled trial.

BACKGROUND: A third of patients with colorectal cancer who are eligible for surgery in high-income countries have concomitant anaemia associated with adverse outcomes. We aimed to compare the efficacy of preoperative intravenous and oral iron supplementation in patients with colorectal cancer and iron deficiency anaemia. METHODS: In the FIT multicentre, open-label, randomised, controlled trial, adult patients (aged 18 years or older) with M0 stage colorectal cancer scheduled for elective curative resection and iron deficiency anaemia (defined as haemoglobin level of less than 7·5 mmol/L (12 g/dL) for women and less than 8 mmol/L (13 g/dL) for men, and a transferrin saturation of less than 20%) were randomly assigned to either 1-2 g of ferric carboxymaltose intravenously or three tablets of 200 mg of oral ferrous fumarate daily. The primary endpoint was the proportion of patients with normalised haemoglobin levels before surgery (≥12 g/dL for women and ≥13 g/dL for men). An intention-to-treat analysis was done for the primary analysis. Safety was analysed in all patients who received treatment. The trial was registered at ClincalTrials.gov, NCT02243735, and has completed recruitment. FINDINGS: Between Oct 31, 2014, and Feb 23, 2021, 202 patients were included and assigned to intravenous (n=96) or oral (n=106) iron treatment. Treatment began a median of 14 days (IQR 11-22) before surgery for intravenous iron and 19 days (IQR 13-27) for oral iron. Normalisation of haemoglobin at day of admission was reached in 14 (17%) of 84 patients treated intravenously and 15 (16%) of 97 patients treated orally (relative risk [RR] 1·08 [95% CI 0·55-2·10]; p=0·83), but the proportion of patients with normalised haemoglobin significantly increased for the intravenous treatment group at later timepoints (49 [60%] of 82 vs 18 [21%] of 88 at 30 days; RR 2·92 [95% CI 1·87-4·58]; p<0·0001). The most prevalent treatment-related adverse event was discoloured faeces (grade 1) after oral iron treatment (14 [13%] of 105), and no treatment-related serious adverse events or deaths were observed in either group. No differences in other safety outcomes were seen, and the most common serious adverse events were anastomotic leakage (11 [5%] of 202), aspiration pneumonia (5 [2%] of 202), and intra-abdominal abscess (5 [2%] 202). INTERPRETATION: Normalisation of haemoglobin before surgery was infrequent with both treatment regimens, but significantly improved at all other timepoints following intravenous iron treatment. Restoration of iron stores was feasible only with intravenous iron. In selected patients, surgery might be delayed to augment the effect of intravenous iron on haemoglobin normalisation. FUNDING: Vifor Pharma.

Contemporary snapshot of tumor regression grade (TRG) distribution in locally advanced rectal cancer: a cross sectional multicentric experience.

Pre-operative chemoradiotherapy (CRT) followed by surgical resection is still the standard treatment for locally advanced low rectal cancer. Nowadays new strategies are emerging to treat patients with a complete response to pre-operative treatment, rendering the optimal management still controversial and under debate. The primary aim of this study was to obtain a snapshot of tumor regression grade (TRG) distribution after standard CRT. Second, we aimed to identify a correlation between clinical tumor stage (cT) and TRG, and to define the accuracy of magnetic resonance imaging (MRI) in the restaging setting. Between January 2017 and June 2019, a cross sectional multicentric study was performed in 22 referral centers of colon-rectal surgery including all patients with cT3-4Nx/cTxN1-2 rectal cancer who underwent pre-operative CRT. Shapiro-Wilk test was used for continuous data. Categorical variables were compared with Chi-squared test or Fisher's exact test, where appropriate. Accuracy of restaging MRI in the identification of pathologic complete response (pCR) was determined evaluating the correspondence with the histopathological examination of surgical specimens.In the present study, 689 patients were enrolled. Complete tumor regression rate was 16.9%. The "watch and wait" strategy was applied in 4.3% of TRG4 patients. A clinical correlation between more advanced tumors and moderate to absent tumor regression was found (p = 0.03). Post-neoadjuvant MRI had low sensibility (55%) and high specificity (83%) with accuracy of 82.8% in identifying TRG4 and pCR.Our data provided a contemporary description of the effects of pre-operative CRT on a large pool of locally advanced low rectal cancer patients treated in different colon-rectal surgical centers.

A nationwide study on the adoption and short-term outcomes of transanal total mesorectal excision in the UK.

BACKGROUND: The interest and adoption of transanal total mesorectal excision (TaTME) is growing worldwide, but evidence on nationwide implementation and short-term outcomes is scarce. This study aims to evaluate national results for this relatively new technique in the UK. METHODS: All TaTME procedures performed in the UK and recorded on the international TaTME registry between January 2013 and January 2018 were analyzed. Surgeons who received training on TaTME in the UK were sent a survey regarding their experience with implementation of TaTME in their unit. Primary endpoint was a composite for "optimal pathology" (free resection margin (R0) and TME specimen with no major defects and no rectal wall perforations). Secondary outcomes included 30-day clinical course and survey outcomes. RESULTS: Forty-two hospitals entered 513 cases over a 5-year period; 28 of 42 hospitals (66.7%) performed ten cases or less. The indication for surgery was cancer in 364 (71.0%) cases. Optimal pathology was achieved in 295 (92.8%), with an involved resection margin (R1) rate of 13 of 513 (4.1%). A Clavien-Dindo ≥III within 30 days was 13.4% (N.=45) and 6.8% (N.=10) in the cancer and benign groups, respectively. Based on the survey (response rate 68 of 86; 79%), 76.1% of the surgeons implemented TaTME in their unit after receiving training, all of whom experienced difficulties with performing TaTME. CONCLUSIONS: This study reports acceptable nationwide short-term outcomes of TaTME. However, adoption occurred in a rapid and non-standardized manner. A structured TaTME training program is therefore recommended.

Three-Year Nationwide Experience with Transanal Total Mesorectal Excision for Rectal Cancer in the Netherlands: A Propensity Score-Matched Comparison with Conventional Laparoscopic Total Mesorectal Excision.

BACKGROUND: Transanal total mesorectal excision (TaTME) is a relatively new and demanding technique for rectal cancer treatment. Results from national datasets are absent and comparative data with laparoscopic TME (lapTME) are scarce. Therefore, this study aimed to evaluate the initial TaTME experience in the Netherlands, by comparing outcomes with conventional lapTME. STUDY DESIGN: Patients with rectal cancer who underwent curative TaTME or lapTME were selected from the nationwide and mandatory Dutch ColoRectal Audit (DCRA), between January 2015 and December 2017. Primary outcome was circumferential resection margin (CRM) involvement. Secondary outcomes included operative details and short-term (<30 days) clinical course. Propensity score matching was performed for 7 factors. RESULTS: There were 3,777 patients included for analysis (TaTME, n = 416, lapTME, n = 3361). Transanal TME was performed in 38 hospitals and lapTME in 90 hospitals. Before matching, the patient category within the TaTME group was technically more challenging in terms of tumor height and preoperative threatened margins. After 1:1 matching, 396 patients were included in each group, with comparable baseline characteristics. Circumferential resection margin involvement was 4.3% after TaTME and 4.0% after lapTME (p = 1.000). Conversion rate was significantly lower in TaTME (1.5% vs 8.6%, p < 0.001). Anastomotic leak rate was not significantly different (16.5% vs 12.2%, p = 0.116). Other postoperative outcomes were also comparable between the groups. Significant independent risk factors for CRM involvement in TaTME were preoperative threatened margin on MRI (odds ratio [OR] 5.48, 95% CI 1.33 to 22.54) and conversion (OR 30.12, 95% CI 3.70 to 245.20). CONCLUSIONS: This first nationwide study shows early experience with adoption of TaTME in the Netherlands. Considering that current data represent initial TaTME experience, acceptable short-term outcomes were demonstrated when compared with the well-established lapTME.