Management of acute and chronic pelvic sepsis after total mesorectal excision for rectal cancer-a 10-year experience of a national referral centre.

AIM: Uncontrolled pelvic sepsis following rectal cancer surgery may lead to dramatic consequences with significant impact on patients' quality of life. The aim of this retrospective observational study is to evaluate management of pelvic sepsis after total mesorectal excision for rectal cancer at a national referral centre. METHOD: Referred patients with acute or chronic pelvic sepsis after sphincter preserving rectal cancer resection, with the year of referral between 2010 and 2014 (A) or between 2015 and 2020 (B), were included. The main outcome was control of pelvic sepsis at the end of follow-up, with healed anastomosis with restored faecal stream (RFS) as co-primary outcome. RESULTS: In total 136 patients were included: 49 in group A and 87 in group B. After a median follow-up of 82 months (interquartile range 35-100) in group A and 42 months (interquartile range 22-60) in group B, control of pelvic sepsis was achieved in all patients who received endoscopic vacuum assisted surgical closure (7/7 and 2/2), in 91% (19/21) and 89% (31/35) of patients who received redo anastomosis (P = 1.000) and in 100% (18/18) and 95% (41/43) of patients who received intersphincteric resection (P = 1.000), respectively. Restorative procedures resulted in a healed anastomosis with RFS in 61% (17/28) of patients in group A and 68% (25/37) of patients in group B (P = 0.567). CONCLUSION: High rates of success can be achieved with surgical salvage of pelvic sepsis in a dedicated tertiary referral centre, without significant differences over time. In well selected and motivated patients a healed anastomosis with RFS can be achieved in the majority.

Gluteal Fasciocutaneous Flap Reconstruction After Salvage Surgery for Pelvic Sepsis.

BACKGROUND: Chronic pelvic sepsis mostly originates from complicated pelvic surgery and failed interventions. This is a challenging condition that often requires extensive salvage surgery consisting of complete debridement with source control and filling of the dead space with well-vascularized tissue. OBJECTIVE: This study aimed to describe the outcomes of gluteal fasciocutaneous flaps for the treatment of secondary pelvic sepsis. DESIGN: Retrospective single-center cohort study. SETTINGS: Tertiary referral center. PATIENTS: Patients who underwent salvage surgery for secondary pelvic sepsis between 2012 and 2020 using a gluteal flap were included in this study. MAIN OUTCOME MEASURES: Percentage of complete wound healing. RESULTS: In total, 27 patients were included, of whom 22 underwent index rectal resection for cancer and 21 had undergone (chemo)radiotherapy. A median of 3 (interquartile range, 1-5) surgical and 1 (interquartile range, 1-4) radiological interventions preceded salvage surgery during a median period of 62 (interquartile range, 20-124) months. Salvage surgery included partial sacrectomy in 20 patients. The gluteal flap consisted of a V-Y flap in 16 patients, superior gluteal artery perforator flap in 8 patients, and a gluteal turnover flap in 3 patients. Median hospital stay was 9 (interquartile range, 6-18) days. During a median follow-up of 18 (interquartile range, 6-34) months, wound complications occurred in 41%, with a reintervention rate of 30%. The median time to wound healing was 69 (interquartile range, 33-154) days, with a complete healing rate of 89% at the end of follow-up. LIMITATIONS: Retrospective design and heterogeneous patient population. CONCLUSIONS: In patients undergoing major salvage surgery for chronic pelvic sepsis, the use of gluteal fasciocutaneous flaps is a promising solution because of the high success rate, limited risks, and relatively simple technique. See Video Abstract at http://links.lww.com/DCR/C160 . RECONSTRUCCIN CON COLGAJO FASCIOCUTNEO GLTEO DESPUS DE UNA CIRUGA DE RESCATE POR SEPSIS PLVICA: ANTECEDENTES:La sepsis pélvica crónica esta causada principalmente por cirugías pélvicas complicadas e intervenciones fallidas. Esta es una condición desafiante que a menudo requiere una cirugía de rescate extensa que consiste en un desbridamiento completo controlando el orígen infeccioso y rellenando el espacio muerto con tejido bien vascularizado, como por ejemplo un colgajo de tejido autólogo. La pared abdominal (colgajo de recto abdominal) o la pierna (colgajo de gracilis) se utilizan principalmente como sitios donantes para esta indicación, mientras que los colgajos glúteos pueden ser alternativas atractivas.OBJETIVO:Describir los resultados de los colgajos fasciocutáneos glúteos en el tratamiento de la sepsis pélvica secundaria.DISEÑO:Estudio de cohortes retrospectivo en un solo centro.AJUSTES:Centro de referencia terciario.PACIENTES:Todos aquellos que se sometieron a cirugía de rescate por sepsis pélvica secundaria entre 2012 y 2020 utilizando un colgajo fasciocutáneo glúteo.PRINCIPALES MEDIDAS DE RESULTADO:El porcentaje de cicatrización completa de la herida.RESULTADOS:En total, se incluyeron 27 pacientes, de los cuales 22 fueron sometidos a resección rectal por cáncer indicada y 21 pacientes que habían recibido (quimio)radioterapia. Una mediana de tres (RIC 1-5) intervenciones quirúrgicas y una (RIC 1-4) intervenciones radiológicas precedieron a la cirugía de rescate durante una mediana de 62 (RIC 20-124) meses.La cirugía de rescate incluyó una resección parcial del sacro en 20 pacientes. El colgajo fasciocutáneo glúteo consistió en la confección de un colgajo en V-Y en 16 pacientes, un colgajo incluyendo la perforante de la arteria glútea superior en 8 y un colgajo de rotación de músculo glúteo en 3 pacientes.La mediana de estancia hospitalaria fue de nueve (RIC 6-18) días. Durante una mediana de seguimiento de 18 (IQR 6-34) meses, se produjeron complicaciones de la herida en el 41%, con una tasa de reintervención del 30%.La mediana de tiempo hasta la cicatrización de la herida fue de 69 (IQR 33-154) días con una tasa de cicatrización completa del 89 % al final del seguimiento cicatricial.LIMITACIONES:Diseño retrospectivo y población heterogénea de pacientes.CONCLUSIONES:En pacientes sometidos a cirugía mayor de rescate por sepsis pélvica crónica, el uso de colgajos fasciocutáneos glúteos es una solución prometedora debido a la alta tasa de éxito, los riesgos limitados y la técnica relativamente simple. Video Resumen en http://links.lww.com/DCR/C160 . (Traducción-Dr. Xavier Delgadillo ).

Cardiac anomalies in children with congenital duodenal obstruction: a systematic review with meta-analysis.

BACKGROUND: Cardiac anomalies occur frequently in patients with congenital duodenal obstruction (DO). However, the exact occurrence and the type of associated anomalies remain unknown. Therefore, the aim of this systematic review is to aggregate the available literatures on cardiac anomalies in patients with DO. METHODS: In July 2022, a search was performed in PubMed and Embase.com. Studies describing cardiac anomalies in patients with congenital DO were considered eligible. Primary outcome was the pooled percentage of cardiac anomalies in patients with DO. Secondary outcomes were the pooled percentages of the types of cardiac anomalies, type of DO, and trisomy 21. A meta-analysis was performed to pool the reported data. RESULTS: In total, 99 publications met our eligibility data, representing 6725 patients. The pooled percentage of cardiac anomalies was 29% (95% CI 0.26-0.32). The most common cardiac anomalies were persistent foramen ovale 35% (95% CI 0.20-0.54), ventricular septal defect 33% (95% CI 0.24-0.43), and atrial septal defect 33% (95% CI 0.26-0.41). The most prevalent type of obstruction was type 3 (complete atresias), with a pooled percentage of 54% (95% CI 0.48-0.60). The pooled percentage of Trisomy 21 in patients with DO was 28% (95% CI 0.26-0.31). CONCLUSION: This review shows cardiac anomalies are found in one-third of the patients with DO regardless of the presence of trisomy 21. Therefore, we recommend that patients with DO should receive preoperative cardiac screening. LEVEL OF EVIDENCE: II.

Pediatric thoracoscopic lung resections: a comprehensive analysis of congenital lesion cases.

BACKGROUND: Congenital lung lesions in pediatric patients may be managed conservatively or by video assisted thoracoscopic surgery (VATS). This study aimed to determine the complications after VATS for congenital lung lesions in children. METHODS: All children undergoing a lung resection between January 2009 and June 2022 were retrospectively identified. Children undergoing a primary open lobectomy or a resection other than a congenital lung lesion were excluded. Both early (<30 days) and late postoperative pulmonary complications were determined. The primary endpoint was postoperative complications within 30 days. RESULTS: In total, 56 patients were included, with a median age of 13 months (IQR 9-37). A VATS lobectomy were performed in 46 patients (82%), an extralobar sequestration in 8 patients (14%), an wedge resection in 1 patient and a segment resection in 1 patient. During the COVID pandemic, fewer resections were performed with an increase in symptomatic patients. A conversion to open occurred in 6 patients (11%), of which a preoperative lung infection was associated with an increased risk thereof(p = 0.004). The median follow-up was 22 months (IQR 7-57) and all patients were alive. A postoperative complication (Clavien Dindo ≥3) occurred in 9 patients and complications without the need of intervention in 6 patients. During follow-up a pneumonia occurred in 11 patients. CONCLUSION: There seems to be a shift towards delayed surgery with an increase in symptomatic congenital lung malformations, which might lead to an increase in postoperative complications.

Cumulative 5-year Results of a Randomized Controlled Trial Comparing Biological Mesh With Primary Perineal Wound Closure After Extralevator Abdominoperineal Resection (BIOPEX-study).

OBJECTIVE: To determine long-term outcomes of a randomized trial (BIOPEX) comparing biological mesh and primary perineal closure in rectal cancer patients after extralevator abdominoperineal resection and preoperative radiotherapy, with a primary focus on symptomatic perineal hernia. SUMMARY BACKGROUND DATA: BIOPEX is the only randomized trial in this field, which was negative on its primary endpoint (30-day wound healing). METHODS: This was a posthoc secondary analysis of patients randomized in the BIOPEX trial to either biological mesh closure (n = 50; 2 dropouts) or primary perineal closure (n = 54; 1 dropout). Patients were followed for 5 years. Actuarial 5-year probabilities were determined by the Kaplan-Meier statistic. RESULTS: Actuarial 5-year symptomatic perineal hernia rates were 7% (95% CI, 0-30) after biological mesh closure versus 30% (95% CI, 10-49) after primary closure (P = 0.006). One patient (2%) in the biomesh group underwent elective perineal hernia repair, compared to 7 patients (13%) in the primary closure group (P = 0.062). Reoperations for small bowel obstruction were necessary in 1/48 patients (2%) and 5/53 patients (9%), respectively (P = 0.208). No significant differences were found for chronic perineal wound problems, locoregional recurrence, overall survival, and main domains of quality of life and functional outcome. CONCLUSIONS: Symptomatic perineal hernia rate at 5-year follow-up after abdominoperineal resection for rectal cancer was significantly lower after biological mesh closure. Biological mesh closure did not improve quality of life or functional outcomes.

Exploring the impact of urogenital organ displacement after abdominoperineal resection on urinary and sexual function.

PURPOSE: This study aimed to establish the functional impact of displacement of urogenital organs after abdominoperineal resection (APR) using validated questionnaires. METHODS: Patients who underwent APR for primary or recurrent rectal cancer (2001-2018) with evaluable pre- and postoperative radiological imaging and completed urinary (UDI-6, IIQ-7) and sexual questionnaires (male, IIEF; female, FSFI, FSDS-R) were included from 16 centers. Absolute displacement of the internal urethral orifice, posterior bladder wall, distal end of the prostatic urethra, and cervix were correlated to urogenital function by calculating Spearman's Rho (ρ). Median function scores were compared between minimal or substantial displacement using median split. RESULTS: There were 89 male and 36 female patients included, of whom 45 and 19 were sexually active after surgery. Absolute displacement of the internal urethral orifice and posterior bladder wall was not correlated with UDI-6 in men (ρ = 0.119 and ρ = 0.022) nor in women (ρ = - 0.098 and ρ = - 0.154). In men with minimal and substantial displacement of the internal urethral orifice, median UDI-6 scores were 10 (IQR 0-22) and 17 (IQR 5-21), respectively, with corresponding scores of 25 (IQR 10-46) and 21 (IQR 16-36) in women. Displacement of the cervix and FSDS-R were correlated (ρ = 0.433) in sexually active patients. CONCLUSION: This first analysis on functional impact of urogenital organ displacement after APR suggests that more displacement of the cervix might be associated with worse sexual function, while the data does not indicate any potential functional impact of bladder displacement. Studies are needed to further explore this underexposed topic.

Mesh, flap or combined repair of perineal hernia after abdominoperineal resection - A systematic review and meta-analysis.

AIM: The aim of this systematic review was to analyse recurrence rates after different surgical techniques for perineal hernia repair. METHOD: All original studies (n ≥ 2 patients) reporting recurrence rates after perineal hernia repair after abdominoperineal resection (APR) were included. The electronic database PubMed was last searched in December 2021. The primary outcome was recurrent perineal hernia. A weighted average of the logit proportions was determined by the use of the generic inverse variance method and random effects model. RESULTS: A total of 19 studies involving 172 patients were included. The mean age of patients was 64 ± 5.6 years and the indication for APR was predominantly cancer (99%, 170/172). The pooled percentage of recurrent perineal hernia was 39% (95% CI: 27%-52%) after biological mesh closure, 29% (95% CI: 21%-39%) after synthetic mesh closure, 37% (95% CI: 14%-67%) after tissue flap reconstruction only and 9% (95% CI: 1%-45%) after tissue flap reconstruction combined with mesh. CONCLUSION: Recurrence rates after mesh repair of perineal hernia are high, without a clear difference between biological and synthetic meshes. The addition of a tissue flap to mesh repair seemed to have a favourable outcome, which warrants further investigation.

Iatrogenic injury of the urinary tract during salvage procedures for pelvic sepsis: Experience of a national referral centre.

AIM: This study aimed to determine the incidence, consequences and outcomes of iatrogenic urinary tract injury (IUI) during salvage surgery for pelvic sepsis. METHOD: Patients who underwent salvage surgery for pelvic sepsis after prior low anterior resection or Hartmann's procedure for rectal cancer were prospectively maintained in a database between 2010 and 2020 and reviewed retrospectively. The primary endpoint was the incidence of IUI. Secondary endpoints were timing of diagnosis (intra- vs. postoperative), reinterventions related to the IUI and healing of IUI. RESULTS: In total 126 consecutive patients were included, and IUI occurred in 13 patients (10%). A ureteric injury occurred in eight patients, bladder injury in four patients and a urethral injury in one patient. All patients with an IUI had radiotherapy as neoadjuvant treatment. The IUI was diagnosed postoperatively in 63% (n = 8/13) with a median duration between surgery and diagnosis of the IUI of 10 days (IQR: 6-15). The median number of reinterventions was five (range 1-31) in the group with a postoperative diagnosis and one (range 0-1) in the group with an intraoperative diagnosis. Four patients required a surgical reintervention, all concerning injuries diagnosed postoperatively. At the end of follow-up, 85% of patients (n = 11/13) had a healed IUI. CONCLUSION: Iatrogenic urinary tract injury is not uncommon in salvage procedures for pelvic sepsis, even in an experienced tertiary referral centre. Most injuries were diagnosed postoperatively which affects the severity of these complications, emphasising the need to improve intraoperative diagnostic modalities.

Quantifying displacement of urogenital organs after abdominoperineal resection for rectal cancer.

AIM: This study aimed to quantify displacement of urogenital organs after abdominoperineal resection (APR), and to explore patient and treatment characteristics associated with displacement. METHOD: Patients from 16 centres who underwent APR for primary or recurrent rectal cancer (2001-2018) with evaluable preoperative and 6-18 months postoperative radiological imaging were included in the study. Anatomical landmarks on sagittal images were related to a coordinate system based on reference lines between fixed bony structures and absolute displacements were calculated using the Pythagorean theorem. Rotation of landmarks was measured relative to a pubic-S5 reference line. RESULTS: There were 248 patients included of which 171 were men and 77 women. The median displacement of the internal urethral orifice was 25 mm in men (maximum 65), and 17 mm in women (maximum 50). Rotation of the internal urethral orifice was in a caudal direction in 160/170 (94%) of men and 65/73 (89%) of women, with a median of 32 degrees (maximum 85) and 33 degrees (maximum 83), respectively. Displacements of the posterior bladder wall, distal end of prostatic urethra and cervix were significantly correlated with the internal urethral orifice. In linear regression analysis, biological mesh reconstruction of the pelvic floor and visceral interposition were significantly associated with increased displacement of the internal urethral orifice, and female gender and any filling of the presacral space with decreased displacement. CONCLUSIONS: Substantial absolute displacement and rotation of urogenital organs after APR for rectal cancer were observed, but with high variability among both men and women, and being significantly associated with reconstructive interventions.

Dorsal approach with tailored partial sacrectomy and gluteal V-Y fasciocutaneous advancement flap for the management of recurrent pelvic sepsis; case report.

BACKGROUND: Pelvic sepsis after surgery for rectal cancer is a severe complication, mostly originating from anastomotic leakage. Complex salvage surgery, during which an omentoplasty is often used for filling of the pelvic cavity, is seldomly required. If this fails, a symptomatic recurrent presacral abscess with a risk of progressive inflammation can develop. Such patients have often undergone multiple surgeries and have disturbed abdominal wall integrity, adhesion formation, and presence of one or two stoma(s). Subsequent salvage surgery via the conventional anterior abdominal approach is therefore less suitable. We describe three cases with a chronic presacral sinus and failure of first salvage surgery. All three patients underwent a prone only approach with tailored sacrectomy. This novel approach provided direct access to the pelvic abscess with optimal exposure for complete and safe debridement. A unilateral or bilateral gluteal V-Y fasciocutaneous advancement flap was created to completely fill the cavity with well vascularized tissue. CASE PRESENTATIONS: Three male patients of 80, 66 and 51 years of age initially underwent low anterior resection with neo-adjuvant radiotherapy for rectal cancer. The first patients underwent intersphincteric resection of the anastomosis with omentoplasty 128 months after index surgery, and second salvage surgery 2 months later. The second patient underwent abdominoperineal resection with omentoplasty for locally recurrent rectal cancer, cystoprostatectomy with revision of the omentoplasty for pelvic sepsis 100 months after index surgery, and second salvage surgery 16 months later. In the third patient, the anastomosis was dismantled with subsequent intersphincteric proctectomy and omentoplasty 20 months after index surgery, and second salvage surgery was performed 93 months later. Second salvage surgery in all three patients was indicated because of symptomatic recurrent pelvic sepsis. Second salvage surgery consisted of sacrectomy, complete debridement of the presacral area, and filling with a gluteal advancement flap. This resulted in favorable postoperative recovery with ultimate healing of the pelvic cavity. CONCLUSION: The dorsal approach with tailored sacrectomy and gluteal V-Y advancement flap is a valuable option in highly selected patients to treat recurrent pelvic sepsis after multiple prior transabdominal interventions for chronic presacral sinus.

Perineal wound closure using gluteal turnover flap or primary closure after abdominoperineal resection for rectal cancer: study protocol of a randomised controlled multicentre trial (BIOPEX-2 study).

BACKGROUND: Abdominoperineal resection (APR) for rectal cancer is associated with high morbidity of the perineal wound, and controversy exists about the optimal closure technique. Primary perineal wound closure is still the standard of care in the Netherlands. Biological mesh closure did not improve wound healing in our previous randomised controlled trial (BIOPEX-study). It is suggested, based on meta-analysis of cohort studies, that filling of the perineal defect with well-vascularised tissue improves perineal wound healing. A gluteal turnover flap seems to be a promising method for this purpose, and with the advantage of not having a donor site scar. The aim of this study is to investigate whether a gluteal turnover flap improves the uncomplicated perineal wound healing after APR for rectal cancer. METHODS: Patients with primary or recurrent rectal cancer who are planned for APR will be considered eligible in this multicentre randomised controlled trial. Exclusion criteria are total exenteration, sacral resection above S4/S5, intersphincteric APR, biological mesh closure of the pelvic floor, collagen disorders, and severe systemic diseases. A total of 160 patients will be randomised between gluteal turnover flap (experimental arm) and primary closure (control arm). The total follow-up duration is 12 months, and outcome assessors and patients will be blinded for type of perineal wound closure. The primary outcome is the percentage of uncomplicated perineal wound healing on day 30, defined as a Southampton wound score of less than two. Secondary outcomes include time to perineal wound closure, incidence of perineal hernia, the number, duration and nature of the complications, re-interventions, quality of life and urogenital function. DISCUSSION: The uncomplicated perineal wound healing rate is expected to increase from 65 to 85% by using the gluteal turnover flap. With proven effectiveness, a quick implementation of this relatively simple surgical technique is expected to take place. TRIAL REGISTRATION: The trial was retrospectively registered at Clinicaltrials.gov NCT04004650 on July 2, 2019.

Randomised controlled trial of transanal endoscopic microsurgery versus endoscopic mucosal resection for large rectal adenomas (TREND Study).

OBJECTIVE: Non-randomised studies suggest that endoscopic mucosal resection (EMR) is equally effective in removing large rectal adenomas as transanal endoscopic microsurgery (TEM), but EMR might be more cost-effective and safer. This trial compares the clinical outcome and cost-effectiveness of TEM and EMR for large rectal adenomas. DESIGN: Patients with rectal adenomas ≥3 cm, without malignant features, were randomised (1:1) to EMR or TEM, allowing endoscopic removal of residual adenoma at 3 months. Unexpected malignancies were excluded postrandomisation. Primary outcomes were recurrence within 24 months (aiming to demonstrate non-inferiority of EMR, upper limit 10%) and the number of recurrence-free days alive and out of hospital. RESULTS: Two hundred and four patients were treated in 18 university and community hospitals. Twenty-seven (13%) had unexpected cancer and were excluded from further analysis. Overall recurrence rates were 15% after EMR and 11% after TEM; statistical non-inferiority was not reached. The numbers of recurrence-free days alive and out of hospital were similar (EMR 609±209, TEM 652±188, p=0.16). Complications occurred in 18% (EMR) versus 26% (TEM) (p=0.23), with major complications occurring in 1% (EMR) versus 8% (TEM) (p=0.064). Quality-adjusted life years were equal in both groups. EMR was approximately €3000 cheaper and therefore more cost-effective. CONCLUSION: Under the statistical assumptions of this study, non-inferiority of EMR could not be demonstrated. However, EMR may have potential as the primary method of choice due to a tendency of lower complication rates and a better cost-effectiveness ratio. The high rate of unexpected cancers should be dealt with in further studies.

Snapshot Study on the Value of Omentoplasty in Abdominoperineal Resection with Primary Perineal Closure for Rectal Cancer.

BACKGROUND: Perineal wound complications are often encountered following abdominoperineal resection (APR). Filling of the pelvic space by omentoplasty (OP) might prevent these complications, but there is scant evidence to support its routine application. OBJECTIVE: The aim of this study was to evaluate the impact of OP on perineal wound complications. METHODS: All patients undergoing APR with primary perineal closure (PPC) for non-locally advanced rectal cancer in 71 Dutch centers in 2011 were selected from a cross-sectional snapshot study. Outcomes were compared between PPC with or without OP, which was based on variability in practice among surgeons. RESULTS: Of 639 patients who underwent APR for rectal cancer, 477 had a non-locally advanced tumor and PPC was performed. Of those, 172 (36%) underwent OP. Patients with OP statistically more often underwent an extralevator approach (32% vs. 14%). Median follow-up was 41 months (interquartile range 22-47). There were no significant differences with or without OP in terms of non-healing of the perineal wound at 30 days (47% vs. 48%), non-healing at the end of follow-up (9% vs. 5%), pelvic abscess (12% vs. 13%) or re-intervention for ileus (5% vs. 3%). Perineal hernia developed significantly more often after OP (13% vs. 7%), also by multivariable analysis (odds ratio 2.61, 95% confidence interval 1.271-5.364; p = 0.009). CONCLUSIONS: In contrast to previous assumptions, OP after APR with PPC appeared not to improve perineal wound healing and seemed to increase the occurrence of perineal hernia. These findings question the routine use of OP for primary filling of the pelvic space.

The occurrence and characteristics of endoscopically unexpected malignant degeneration in large rectal adenomas.

BACKGROUND AND AIMS: Large non-pedunculated rectal polyps are most commonly resected by endoscopic mucosal resection (EMR) or transanal endoscopic microsurgery (TEM). Despite pre-procedural diagnostics, unexpected rectal cancer is incidentally encountered within the resected specimen. This study aimed to compare the diagnostic assessment and procedural characteristics of lesions with and without unexpected submucosal invasion. METHODS: A post-hoc analysis of a multicenter randomized trial (TREND study) was performed in which patients with a non-pedunculated rectal polyp of ≥3 cm without endoscopic suspicion of invasive growth were randomized between EMR and TEM. RESULTS: Unexpected rectal cancer was detected in 13% (27/203) of patients; 15 after EMR and 12 after TEM. Most consisted of low-risk T1 cancers (78%, n = 18). There were no differences in the diagnostic assessment between lesions with and without unexpected submucosal invasion. Diagnostic biopsies revealed similar rates of high-grade dysplasia (28% [7/25] vs 18% [26/144]). When compared with EMR of adenomas, EMR procedures of unexpected cancers had a lower success rate of submucosal lifting (60% vs 93%, P < .001), were more often assessed as endoscopically incomplete (33% vs 10%, P = .01), and were more frequently terminated prematurely (60% vs 8%, P = .001). CONCLUSIONS: Diagnostic assessment of large non-pedunculated rectal polyps revealed similar characteristics between unexpected cancers and adenomas. Unexpected cancers during EMR were non-lifting in 40%, endoscopically assessed as incomplete in 33%, and terminated prematurely in 60%. In treatment-naive patients, these factors should raise suspicion of malignancy and need discussion in a multidisciplinary team meeting for decision on further treatment strategies.

Biological Mesh Closure of the Pelvic Floor After Extralevator Abdominoperineal Resection for Rectal Cancer: A Multicenter Randomized Controlled Trial (the BIOPEX-study).

OBJECTIVE: To determine the effect of biological mesh closure on perineal wound healing after extralevator abdominoperineal resection (eAPR). BACKGROUND: Perineal wound complications frequently occur after eAPR with preoperative radiotherapy for rectal cancer. Cohort studies have suggested that biological mesh closure of the pelvic floor improves perineal wound healing. METHODS: Patients were randomly assigned to primary closure (standard arm) or biological mesh closure (intervention arm). A non-cross-linked porcine acellular dermal mesh was sutured to the pelvic floor remnants in the intervention arm, followed by a layered closure of the ischioanal and subcutaneous fat and skin similar to the control intervention. The outcome of the randomization was concealed from the patient and perineal wound assessor. The primary endpoint was the rate of uncomplicated perineal wound healing defined as a Southampton wound score of less than 2 at 30 days postoperatively. Patients were followed for 1 year. RESULTS: In total, 104 patients were randomly assigned to primary closure (n = 54; 1 dropouts) and biological mesh closure (n = 50; 2 dropouts). Uncomplicated perineal wound healing rate at 30 days was 66% (33/50; 3 not evaluable) after primary closure, which did not significantly differ from 63% (30/48) after biological mesh closure [relative risk 1.056; 95% confidence interval (CI) 0.7854-1.4197; P = 0.7177). Freedom from perineal hernia at 1 year was 73% (95% CI 60.93-85.07) versus 87% (95% CI 77.49-96.51), respectively (P = 0.0316). CONCLUSIONS: Perineal wound healing after eAPR with preoperative radiotherapy for rectal cancer was not improved when using a biological mesh. A significantly lower 1-year perineal hernia rate after biological mesh closure is a promising secondary finding that needs longer follow-up to determine its clinical relevance.

Low Hartmann's procedure or intersphincteric proctectomy for distal rectal cancer: a retrospective comparative cohort study.

PURPOSE: Two non-restorative options for low rectal cancer not invading the sphincter are the low Hartmann's procedure (LH) or intersphincteric proctectomy (IP). The aim of this study was to compare postoperative morbidity with emphasis on pelvic abscesses after LH and IP. METHODS: All patients that had LH or IP for low rectal cancer were included in three centres between 2008 and 2014 in this retrospective cohort study. Follow-up was performed for at least 12 months. RESULTS: A total of 52 patients were included: 40 LH and 12 IP. Median follow-up was 29 months (IQR 23). There were no differences between groups in gender, age and ASA classification. Seven patients in the LH group (18%) and four patients in the IP group (33%) developed a complication within 30-day postoperative with a Clavien-Dindo classification grade III or higher (P = 0.253). Four out of 40 patients (10%) in the LH group and two out of 12 patients (17%) in the IP group developed a pelvic abscess (P = 0.612). Reinterventions were performed in 11 (28%) patients in the LH group and five (42%) patients in the IP group (P = 0.478), with a total number of reinterventions of 13 and 20, respectively. Six and 15 interventions were related to pelvic abscesses, respectively. CONCLUSION: Pelvic abscesses seem to occur in a similar rate after both LH and IP. Previous reports from the literature suggesting that IP might be associated with less infectious pelvic complications compared to LH are not supported by this study, although numbers are small.

Laparoscopic peritoneal lavage or sigmoidectomy for perforated diverticulitis with purulent peritonitis: a multicentre, parallel-group, randomised, open-label trial.

BACKGROUND: Case series suggest that laparoscopic peritoneal lavage might be a promising alternative to sigmoidectomy in patients with perforated diverticulitis. We aimed to assess the superiority of laparoscopic lavage compared with sigmoidectomy in patients with purulent perforated diverticulitis, with respect to overall long-term morbidity and mortality. METHODS: We did a multicentre, parallel-group, randomised, open-label trial in 34 teaching hospitals and eight academic hospitals in Belgium, Italy, and the Netherlands (the Ladies trial). The Ladies trial is split into two groups: the LOLA group comparing laparoscopic lavage with sigmoidectomy and the DIVA group comparing Hartmann's procedure with sigmoidectomy plus primary anastomosis. The DIVA section of this trial is still underway but here we report the results of the LOLA section. Patients with purulent perforated diverticulitis were enrolled for LOLA, excluding patients with faecal peritonitis, aged older than 85 years, with high-dose steroid use (≥20 mg daily), and haemodynamic instability. Patients were randomly assigned (2:1:1; stratified by age [<60 years vs ≥60 years]) using secure online computer randomisation to laparoscopic lavage, Hartmann's procedure, or primary anastomosis in a parallel design after diagnostic laparoscopy. Patients were analysed according to a modified intention-to-treat principle and were followed up after the index operation at least once in the outpatient setting and after sigmoidoscopy and stoma reversal, according to local protocols. The primary endpoint was a composite endpoint of major morbidity and mortality within 12 months. This trial is registered with ClinicalTrials.gov, number NCT01317485. FINDINGS: Between July 1, 2010, and Feb 22, 2013, 90 patients were randomly assigned in the LOLA section of the Ladies trial when the study was terminated by the data and safety monitoring board because of an increased event rate in the lavage group. Two patients were excluded for protocol violations. The primary endpoint occurred in 30 (67%) of 45 patients in the lavage group and 25 (60%) of 42 patients in the sigmoidectomy group (odds ratio 1·28, 95% CI 0·54-3·03, p=0·58). By 12 months, four patients had died after lavage and six patients had died after sigmoidectomy (p=0·43). INTERPRETATION: Laparoscopic lavage is not superior to sigmoidectomy for the treatment of purulent perforated diverticulitis. FUNDING: Netherlands Organisation for Health Research and Development.

Adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with colon cancer at high risk of peritoneal carcinomatosis; the COLOPEC randomized multicentre trial.

BACKGROUND: The peritoneum is the second most common site of recurrence in colorectal cancer. Early detection of peritoneal carcinomatosis (PC) by imaging is difficult. Patients eventually presenting with clinically apparent PC have a poor prognosis. Median survival is only about five months if untreated and the benefit of palliative systemic chemotherapy is limited. Only a quarter of patients are eligible for curative treatment, consisting of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CR/HIPEC). However, the effectiveness depends highly on the extent of disease and the treatment is associated with a considerable complication rate. These clinical problems underline the need for effective adjuvant therapy in high-risk patients to minimize the risk of outgrowth of peritoneal micro metastases. Adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) seems to be suitable for this purpose. Without the need for cytoreductive surgery, adjuvant HIPEC can be performed with a low complication rate and short hospital stay. METHODS/DESIGN: The aim of this study is to determine the effectiveness of adjuvant HIPEC in preventing the development of PC in patients with colon cancer at high risk of peritoneal recurrence. This study will be performed in the nine Dutch HIPEC centres, starting in April 2015. Eligible for inclusion are patients who underwent curative resection for T4 or intra-abdominally perforated cM0 stage colon cancer. After resection of the primary tumour, 176 patients will be randomized to adjuvant HIPEC followed by routine adjuvant systemic chemotherapy in the experimental arm, or to systemic chemotherapy only in the control arm. Adjuvant HIPEC will be performed simultaneously or shortly after the primary resection. Oxaliplatin will be used as chemotherapeutic agent, for 30 min at 42-43 °C. Just before HIPEC, 5-fluorouracil and leucovorin will be administered intravenously. Primary endpoint is peritoneal disease-free survival at 18 months. Diagnostic laparoscopy will be performed routinely after 18 months postoperatively in both arms of the study in patients without evidence of disease based on routine follow-up using CT imaging and CEA. DISCUSSION: Adjuvant HIPEC is assumed to reduce the expected 25 % absolute risk of PC in patients with T4 or perforated colon cancer to a risk of 10 %. This reduction is likely to translate into a prolonged overall survival. TRIAL REGISTRATION NUMBER: NCT02231086 (Clinicaltrials.gov).

Perineal wound healing after abdominoperineal resection for rectal cancer: a systematic review and meta-analysis.

BACKGROUND: Impaired perineal wound healing has become a significant clinical problem after abdominoperineal resection for rectal cancer. The increased use of neoadjuvant radiotherapy and wider excisions might have contributed to this problem. OBJECTIVE: The primary aim of this systematic review with meta-analysis was to determine the impact of radiotherapy and an extralevator approach on perineal wound healing after abdominoperineal resection for rectal cancer. DATA SOURCES: In March 2014, electronic databases were searched. STUDY SELECTION AND INTERVENTIONS: Studies describing any outcome measure on perineal wound healing after abdominoperineal resection for rectal cancer were included. MAIN OUTCOME MEASURES: The primary end point was overall perineal wound problems within 30 days after conventional or extralevator abdominoperineal resection with or without neoadjuvant radiotherapy. Secondary end points were primary wound healing, perineal hernia rate, and the effect of biological mesh closure on perineal wound problems. RESULTS: A total of 32 studies were included. The pooled percentage of perineal wound problems after primary perineal wound closure in patients who did not undergo neoadjuvant radiotherapy was 15.3% (95% CI, 12.1-19.2) after conventional abdominoperineal resection and 14.8% (95% CI, 9.5-22.4) after extralevator abdominoperineal resection. After neoadjuvant radiotherapy, perineal wound problems occurred in 30.2% (95% CI, 19.2-44.0) after conventional abdominoperineal resection and in 37.6% (95% CI, 18.6-61.4) after extralevator abdominoperineal resection. Radiotherapy significantly increased perineal wound problems after abdominoperineal resection (OR, 2.22; 95% CI, 1.45-3.40; p < 0.001). After biological mesh closure of the pelvic floor following extralevator abdominoperineal resection with neoadjuvant radiotherapy, the percentage of perineal wound problems was 7.3% (95% CI, 1.5-29.3). LIMITATIONS: Heterogeneity was high for some analyses. CONCLUSION: Neoadjuvant radiotherapy significantly increases perineal wound problems after abdominoperineal resection for rectal cancer, whereas the extralevator approach seems not to be of significant importance.

Perineal wound healing after abdominoperineal resection for rectal cancer: a two-centre experience in the era of intensified oncological treatment.

PURPOSE: Intensified treatment for distal rectal cancer has improved oncological outcome, but at the expense of more perineal wound complications in patients undergoing an abdominoperineal resection (APR). The aim of this study was to analyse perineal wound healing after APR with primary perineal wound closure over time. METHOD: All patients undergoing APR for primary rectal cancer with primary wound closure between 2000 and 2013 were included and analysed in three consecutive time periods. Both early (<30 days postoperatively) and late perineal wound complications were determined. Independent risk factors of early perineal wound complications were identified using multivariable analysis. RESULTS: A total of 136 patients were identified, of whom 129 patients underwent primary perineal wound closure. The use of neo-adjuvant (chemo)radiotherapy increased from 72 to 91%, and the use of an extralevator approach increased from 9 to 19%. The rate of early perineal wound complications increased from 18 to 31% and was independently associated with an extralevator approach [odds ratio (OR) 3.17; 95% confidence interval (CI) 1.16-8.66] and intra-operative perforation (OR 3.35; 95% CI 1.06-10.57). Perineal wound complications had no impact on local recurrence or 3-year overall survival rate. During a median follow-up of 28 months [interquartile range (IQR) 14-56], a persistent presacral sinus was diagnosed in 10%, and a perineal hernia occurred in 8% of the patients. CONCLUSION: The increased use of an extralevator APR for rectal cancer significantly increased the risk of perineal wound complications over time. Intra-operative perforation was also independently associated with impaired perineal wound healing.