Impact of diverting ileostomy on functional outcome and quality of life after restorative proctocolectomy and ileal pouch anal anastomosis.

AIM: Diverting ileostomy (DS) after restorative proctocolectomy (RPC) can be omitted in selected patients. Its omission could improve functional outcomes and quality of life (QoL), as has been demonstrated in patients after proctectomy. The aim of this study was to report the impact of diverting ileostomy on functional outcomes and QoL after ileal pouch-anal anastomosis (IPAA). METHODS: This was a retrospective study including all patients operated (2015-2020) for RPC with IPAA. Functional outcome was evaluated by validated scores (LARS, Wexner, Öresland, pouch functional score [PFS] and the ileoanal pouch syndrome severity [IPSS] score). Global health-related QoL was evaluated with the SF-36. We also analysed demographic characteristics, morbidity, correlation between functional outcomes and QoL. RESULTS: Among 179 eligible patients, 150 responded (84%): S- (no stoma = 78; 52%) and S+ (had stoma = 72; 48%). Overall morbidity and anastomotic leak rates were 46% and 9.3%, respectively without difference between the groups. Medians for the functional scores were comparable between the S- and S+ group, respectively: 18 [12.5-31] versus 18 [11-31], p = 0.48 for LARS; 9 [7-11] versus 9 [7-12], p = 0.23 for Wexner's score; 6 [3-13] versus 8 [5-11], p = 0.22 for Öresland's score, 6 [3-13] versus 6.8 [4-12], p = 0.174 for PFS score, and 40 [35-45] versus 46 [42-51], p = 0.045 for IPSS score. The SF-36 summary score was comparable between the two groups without any difference in eight specific health dimensions. After propensity score matching, results were still comparable between the two groups for all scores. Linear regression found a significant correlation between all QoL domains and all functional scores (p < 0.001). CONCLUSION: DS for IPAA does not alter either functional outcomes or QoL and can be omitted in selected patients.

Early ileal resection in Crohn's disease is not associated with severe long-term outcomes: The ERIC study.

BACKGROUND: Early complicated Crohn's disease (CD) may require ileal resection as first-line treatment. AIM: To evaluate the long-term outcomes of patients who underwent early ileal resection. METHODS: We conducted a retrospective study in two inflammatory bowel diseases (IBD) referral centres, including patients with ileocaecal resection and segmental ileal resection within 5 years of CD diagnosis. Early resection was defined as within 6 months of diagnosis, intermediate resection between 6 months and 2 years, and late resection between 2 and 5 years. The primary outcome was the cumulative risk of a second ileal surgery. Secondary outcomes included the use of postoperative treatments and morphological recurrence after initial surgery (Rutgeerts score ≥i2, or recurrence on imaging). RESULTS: Among 393 patients who underwent ileal resection within 5 years of diagnosis, 130, 128 and 135, respectively, had early, intermediate and late resection. The cumulative risk of second surgery at 10 years was not significantly different in the early resection group (25.0% [95% CI 17.4-35.2]), than the intermediate (16.8% [95% CI 10.5-26.2]; p = 0.17) or late resection group (22.7% [95% CI 15.1-33.3]; p = 0.83). The early resection group required fewer postoperative treatments than the late resection group with median survivals without treatments of 3.7 and 0.9 years, respectively (p = 0.002). Patients who had early resection had significantly less morphological recurrence than the late resection group (p = 0.02). CONCLUSION: Early ileal resection in CD is not associated with a higher risk of a second resection. It may be associated with reduced use of medical treatments and fewer morphological recurrences.

Impact of primary endoscopic resection on oncological outcomes after esophagectomy for cancer: a retrospective propensity score-based cohort study.

BACKGROUND: Esophageal cancer posed significant global health challenges, particularly due to poor survival rates, especially in advanced stages. Primary endoscopic resection had emerged as an alternative treatment for early esophageal cancer, aiming to preserve organ function and reduce surgical morbidity. METHODS: This retrospective multicenter cohort study included 334 patients with early esophageal cancer (T1a-b, N0) from 30 French-speaking European centers between 2000 and 2010. Patients underwent either primary endoscopic resection followed by esophagectomy (E group, n = 36) or esophagectomy alone (S group, n = 298). Cox proportional hazards models adjusted for TNM stage and propensity score weighting were used to assess the impact of primary endoscopic resection on recurrence-free survival (RFS), overall survival (OS), and postoperative complications. RESULTS: Primary endoscopic resection did not significantly influence RFS (adjusted HR 0.92, 95% CI 0.31 to 2.68, p = 0.88) or OS (adjusted HR 1.06, 95% CI 0.35 to 3.13, p = 0.92) compared to esophagectomy alone. Initial higher thromboembolic complications in the endoscopic resection group were not significant after adjustment (adjusted OR 4.73, 95% CI 0.34 to 64.27, p = 0.24). CONCLUSIONS: Primary endoscopic resection followed by esophagectomy for early esophageal cancer did not alter oncological outcomes or overall survival in this retrospective cohort. These findings supported the role of primary endoscopic resection as a safe initial treatment strategy, warranting validation in larger prospective studies. REGISTRATION: Our study was registered retrospectively on the Clinicaltrials.com website under the identifier NCT01927016. We acknowledge the importance of prospective registration and regret that this was not done before the commencement of the study.

SafeHeal Colovac Colorectal Anastomosis Protection Device evaluation (SAFE-2) pivotal study: an international randomized controlled study to evaluate the safety and effectiveness of the Colovac Colorectal Anastomosis Protection Device.

AIM: Although proximal faecal diversion is standard of care to protect patients with high-risk colorectal anastomoses against septic complications of anastomotic leakage, it is associated with significant morbidity. The Colovac device (CD) is an intraluminal bypass device intended to avoid stoma creation in patients undergoing low anterior resection. A preliminary study (SAFE-1) completed in three European centres demonstrated 100% protection of colorectal anastomoses in 15 patients, as evidenced by the absence of faeces below the CD. This phase III trial (SAFE-2) aims to evaluate the safety and effectiveness of the CD in a larger cohort of patients undergoing curative rectal cancer resection. METHODS: SAFE-2 is a pivotal, multicentre, prospective, open-label, randomized, controlled trial. Patients will be randomized in a 1:1 ratio to either the CD arm or the diverting loop ileostomy arm, with a recruitment target of 342 patients. The co-primary endpoints are the occurrence of major postoperative complications within 12 months of index surgery and the effectiveness of the CD in reducing stoma creation rates. Data regarding quality of life and patient's acceptance and tolerance of the device will be collected. DISCUSSION: SAFE-2 is a multicentre randomized, control trial assessing the efficacy and the safety of the CD in protecting low colorectal anastomoses created during oncological resection relative to standard diverting loop ileostomy. TRIAL REGISTRATION: NCT05010850.

What is the rate of definitive stoma after subtotal colectomy for inflammatory bowel disease? A nationwide study of 1860 patients.

AIM: Some patients with inflammatory bowel disease (IBD) require subtotal colectomy (STC) with ileostomy. The recent literature reports a significant number of patients who do not undergo subsequent surgery and are resigned to living with a definitive stoma. The aim of this work was to analyse the rate of definitive stoma and the cumulative incidence of secondary reconstructive surgery after STC for IBD in a large national cohort study. METHOD: A national retrospective study (2013-2021) was conducted on prospectively collected data from the French Medical Information System Database (PMSI). All patients undergoing STC in France were included. The association between definitive stoma and potential risk factors was studied using univariate and multivariate analyses. RESULTS: A total of 1860 patients were included (age 45 ± 9 years; median follow-up 30 months). Of these, 77% (n = 1442) presented with ulcerative colitis. Mortality and morbidity at 90 days after STC were 5% (n = 100) and 47% (n = 868), respectively. Reconstructive surgery was identified in 1255 patients (67%) at a mean interval of 7 months from STC. Seveny-four per cent (n = 932) underwent a completion proctectomy with ileal pouch anal anastomosis and 26% (n = 323) an ileorectal anastomosis. Six hundred and five (33%) patients with a definitive stoma had an abdominoperineal resection (n = 114; 19%) or did not have any further surgical procedure (n = 491; 81%). Independent risk factors for definitive stoma identified in multivariate analysis were older age, Crohn's disease, colorectal neoplasia, postoperative complication after STC, laparotomy and a low-volume hospital. CONCLUSION: We found that 33% of patients undergoing STC with ileostomy for IBD had definitive stoma. Modifiable risk factors for definitive stoma were laparotomy and a low-volume hospital.

Short- and long-term morbidity after Taylor flap (oblique rectus abdominis flap) for perineal reconstruction after abdominoperineal resection: A single-center series of 140 patients.

BACKGROUND: Abdominoperineal resection (APR) leads to a substantial loss of tissue and a high rate of complications. The Taylor flap is a musculocutaneous flap used in reconstruction after APR. OBJECTIVES: We aimed to analyze the short and long-term morbidity of reconstruction with a Taylor flap (oblique rectus abdominis flap) after APR and to identify the risk factors for postoperative complications. METHODS: We retrospectively included all patients who had undergone APR with immediate reconstruction with a Taylor flap in our department between July 2000 and June 2018. Demographics, oncological data, treatment, and short- and long-term morbidity were reviewed. RESULTS: Among the 140 patients included, we identified early minor complications in 42 patients (30%) and 14 early major complications (10%). Total necrosis of the flap requiring its removal occurred in four patients (2.8%). Eleven patients (7.9%) presented with a midline incision hernia, and seven (5%) presented with a subcostal incision hernia. No perineal hernia was found. No risk factors for the complications were identified. CONCLUSION: The Taylor flap is a safe procedure with few complications and limited donor site morbidity. Moreover, it prevents perineal hernias. These results confirm that the Taylor flap is a well-suited procedure for reconstruction after APR.

Rectovaginal Fistula: What Is the Role of Martius Flap and Gracilis Muscle Interposition in the Therapeutic Strategy?

BACKGROUND: Although numerous treatments exist for the management of rectovaginal fistula, none has demonstrated its superiority. The role of diverting stoma remains controversial. A few series include Martius flap in the armamentarium. OBJECTIVE: Determine the role of gracilis muscle interposition and Martius flap in the surgical management of rectovaginal fistula. DESIGN: Retrospective cohort study of a pooled prospectively maintained database from 3 centers. PATIENTS: All consecutive eligible patients with rectovaginal fistula undergoing Martius flap and gracilis muscle interposition were included from 2001 to 2022. MAIN OUTCOME MEASURES: Success was defined by the absence of stoma and rectovaginal fistula. RESULTS: Sixty-two patients were included with 55 Martius flap and 24 gracilis muscle interposition performed after failures of 164 initial procedures. Total length of stay was longer for gracilis muscle interposition by 2 days ( p = 0.01) without a significant difference in severe morbidity (20% vs 12%, p = 0.53). Twenty-seven percent of the Martius flap interpositions were performed without a stoma, which did not have an impact on overall morbidity ( p = 0.763). Per patient immediate success rates were not significantly different between groups (35% vs 31%, p > 0.99). The success of gracilis muscle interposition after the failure of the Martius flap was not significantly different from an initial gracilis muscle interposition ( p > 0.99). After simple perineal procedures, the immediate success rate rose to 49.4% (49% vs 50%, p > 0.99). After a median follow-up of 23 months, no significant difference was detected in success rate between the 2 procedures (69% vs 69%, p > 0.99). Smoking was the only negative predictive factor ( p = 0.02). LIMITATIONS: By its retrospective nature, this study is limited in its comparison. CONCLUSIONS: This novel comparison between Martius flap and gracilis muscle interposition suggests that Martius flap presents several advantages, including shorter length of stay, similar morbidity, and similar success rate. Proximal diversion via a stoma for Martius flap does not appear mandatory. Gracilis muscle interposition could be reserved as a salvage procedure after Martius flap failure. See Video Abstract . FSTULA RECTOVAGINAL CUL ES EL ROL DEL COLGAJO DE MARTIUS Y LA INTERPOSICIN DEL MSCULO GRACILIS EN LA ESTRATEGIA TERAPUTICA: ANTECEDENTES:Si bien existen numerosos tratamientos para el manejo de la fistula rectovaginal, ninguno ha demostrado su superioridad. El papel del estoma de derivación sigue siendo controvertido. Pocas series incluyen colgajo de Martius en el armamento.OBJETIVO:Determinar el rol de la interposición del músculo gracilis y del colgajo de Martius, en el manejo quirúrgico de la fístula rectovaginal.DISEÑO:Estudio de cohorte retrospectivo de una base de datos mantenida prospectivamente en 3 centros.AJUSTES/PACIENTES:Se incluyeron todos los pacientes elegibles consecutivos con fistula rectovaginal sometidos a colgajo de Martius y la interposición del músculo gracilis desde 2001 hasta 2022.RESULTADOS PRINCIPALES:El éxito se definió por la ausencia de estoma y fistula rectovaginal.RESULTADOS:Se incluyeron 62 pacientes con 55 colgajo de Martius y 24 con interposición del músculo gracilis realizados después de fracasos de 164 procedimientos iniciales. La duración total de la estancia hospitalaria fue dos días más larga para la interposición del músculo gracilis ( p = 0,01) sin una diferencia significativa en la morbilidad grave (20% frente a 12%, p = 0,53). El 27% de los colgajos de Martius se realizaron sin estoma, sin impacto en la morbilidad global ( p = 0,763). Las tasas de éxito inmediato por paciente no fueron significativamente diferentes entre los grupos (35% vs. 31%, p = 1,0). El éxito de la interposición del músculo gracilis después del fracaso del colgajo de Martius no fue significativamente diferente de una interposición del músculo gracilis inicial (p = 1,0). La tasa de éxito inmediato aumentó al 49,4% (49% frente a 50%, p = 1,0) después de procedimientos perineales simples. Después de una mediana de seguimiento de 23 meses, no se detectaron diferencias significativas en la tasa de éxito entre los dos procedimientos (69 % frente a 69 %, p = 1,0). El tabaquismo fue el único factor predictivo negativo ( p = 0,02).LIMITACIONES:Por su naturaleza retrospectiva, este estudio tiene limitaciones en su comparación.CONCLUSIÓN:Esta novedosa comparación entre colgajo de Martius y la interposición del músculo gracilis sugiere que el colgajo de Martius presenta varias ventajas, incluida una estancia prolongada más corta, una morbilidad similar y un éxito. La derivación proximal a través de un estoma para el colgajo de Martius no parece obligatoria. La interposición del músculo gracilis podría reservarse como procedimiento de rescate después de una falla de colgajo de Martius. (Traducción-Dr. Aurian Garcia Gonzalez ).

Management of adult intestinal stomas: The 2023 French guidelines.

AIM: Digestive stoma are frequently performed. The last French guidelines have been published twenty years ago. Our aim was to update French clinical practice guidelines for the perioperative management of digestive stoma and stoma-related complications. METHODS: A systematic literature review of French and English articles published between January 2000 and May 2022 was performed. Only digestive stoma for fecal evacuation in adults were considered. Stoma in children, urinary stoma, digestive stoma for enteral nutrition, and rare stoma (Koch, perineal) were not included. RESULTS: Guidelines include the surgical landmarks to create digestive stoma (ideal location, mucocutaneous anastomosis, utility of support rods, use of prophylactic mesh), the perioperative clinical practice guidelines (patient education, preoperative ostomy site marking, postoperative equipment, prescriptions, and follow-up), the management of early stoma-related complications (difficulties for nursing, high output, stoma necrosis, retraction, abscess and peristomal skin complications), and the management of late stoma-related complications (stoma prolapse, parastomal hernia, stoma stenosis, late stoma retraction). A level of evidence was assigned to each statement. CONCLUSION: These guidelines will be very useful in clinical practice, and allow to delete some outdated dogma.

[An update on total neoadjuvant treatment of adenocarcinoma of the rectum]. / Actualisation des données sur le traitement néoadjuvant total de l'adénocarcinome du rectum.

A major advance has been made in the management of rectal cancer, with the emergence in 2021 of total neoadjuvant treatment. The main publications from the RAPIDO and PRODIGE-23 trials reported a significant improvement in progression-free survival and the pathological complete response rate. The aim of this review is to synthesize recent data on neoadjuvant treatment of rectal cancer, to explain the long-term results of the RAPIDO and PRODIGE-23 trials, and to put them into perspective, considering current advances in de-escalation strategies. The update of the 5-year survival data from the RAPIDO trial highlights an increased risk of loco-regional relapse, with 11.7% of relapses in the experimental group and 8.1% in the control group, while the update of the PRODIGE-23 trial confirms the benefits of this treatment regimen, with a significant improvement in overall survival. In addition, the results of the OPRA and PROPSPECT trials confirm the benefit of total neoadjuvant treatment with induction chemotherapy, as well as the possibility of surgical de-escalation in the OPRA trial and radiotherapy in the PROSPECT trial. The challenge for the future is to identify patients who require total neoadjuvant treatment with the aim of curative surgery to obtain a cure without local or distant relapse, and those for whom therapeutic de-escalation can be envisaged.

MIRO study: Do the results of a randomized controlled trial apply in a real population?

BACKGROUND: The aim of our study was to evaluate the external validity of the MIRO randomized controlled trial findings in a similar nationwide setting "real life" population, especially the benefit of a hybrid approach in esophageal resection for pulmonary complication. The external validity of randomized controlled trial findings to the general population with the same condition remains problematic because of the inherent selection bias and rigid inclusion criteria. METHODS: This study was a cohort study from a National Health Database (Programme de Medicalisation des Systemes d'Informations) between 2010 and 2022. All adult patients operated on using Ivor Lewis resection for esophageal cancer were included. We first validated the detection algorithm of postoperative complications in the health database. Then, we assessed the primary outcome, which was the comparison of postoperative severe pulmonary complications, leak rate, and 30-day mortality between the 2 surgical approaches (hybrid versus open) over a decade. RESULTS: Between 2010 and 2012, 162 of 205 patients in the MIRO trial were anonymously identified in the health care database. No difference between randomized controlled trials and healthcare database measurements was found within severe respiratory complications (24% vs 22%, respectively) nor within leak rate (10% vs 9%, respectively). After application of selection criteria according to the MIRO trial, 3,852 patients were included between 2013 and 2022. The hybrid approach was a protective factor against respiratory complications after adjustment for confounding variables (odds ratio = 0.83; 95% confidence interval = 0.71-0.98, P = .025). No significant difference in the 30-day mortality rate or 30-day leakage rate between the types of approach was reported. CONCLUSION: This national cohort study demonstrates the external validity of the MIRO randomized controlled trial findings in a real-life population within France.

Impact of interhospital competition on mortality of patients operated on for colorectal cancer faced to hospital volume and rurality: A cross-sectional study.

INTRODUCTION: Contradictions remain on the impact of interhospital competition on the quality of care, mainly the mortality. The aim of the study is to evaluate the impact of interhospital competition on postoperative mortality after surgery for colorectal cancer in France. METHODS: We conducted a retrospective cross-sectional study from 2015 to 2019. Data were collected from a National Health Database. Patients operated on for colorectal cancer in a hospital in mainland France were included. Competition was measured using number of competitors by distance-based approach. A mixed-effect model was carried out to test the link between competition and mortality. RESULTS: Ninety-five percent (n = 152,235) of the 160,909 people operated on for colorectal cancer were included in our study. The mean age of patients was 70.4 ±12.2 years old, and female were more represented (55%). A total of 726 hospitals met the criteria for inclusion in our study. Mortality at 30 days was 3.6% and we found that the mortality decreases with increasing of the hospital activity. Using the number of competitors per distance method, our study showed that a "highly competitive" and "moderately competitive" markets decreased mortality by 31% [OR: 0.69 (0.59, 0.80); p<0.001] and by 12% respectively [OR: 0.88 (0.79, 0.99); p<0.03], compared to the "non-competitive" market. High hospital volume (100> per year) was also associated to lower mortality rate [OR: 0.74 (0.63, 0.86); p<0.001]. CONCLUSIONS: The results of our studies show that increasing hospital competition independently decreases the 30-day mortality rate after colorectal cancer surgery. Hospital caseload, patients' characteristics and age also impact the post-operative mortality.

Pathogenic alterations in PIK3CA and KMT2C are frequent and independent prognostic factors in anal squamous cell carcinoma treated with salvage abdominoperineal resection.

The management of anal squamous cell carcinoma (ASCC) has yet to experience the transformative impact of precision medicine. Conducting genomic analyses may uncover novel prognostic biomarkers and offer potential directions for the development of targeted therapies. To that end, we assessed the prognostic and theragnostic implications of pathogenic variants identified in 571 cancer-related genes from surgical samples collected from a homogeneous, multicentric French cohort of 158 ASCC patients who underwent abdominoperineal resection treatment. Alterations in PI3K/AKT/mTOR, chromatin remodeling, and Notch pathways were frequent in HPV-positive tumors, while HPV-negative tumors often harbored variants in cell cycle regulation and genome integrity maintenance genes (e.g., frequent TP53 and TERT promoter mutations). In patients with HPV-positive tumors, KMT2C and PIK3CA exon 9/20 pathogenic variants were associated with worse overall survival in multivariate analysis (Hazard ratio (HR)KMT2C = 2.54, 95%CI = [1.25,5.17], P value = .010; HRPIK3CA = 2.43, 95%CI = [1.3,4.56], P value = .006). Alterations with theragnostic value in another cancer type was detected in 43% of patients. These results suggest that PIK3CA and KMT2C pathogenic variants are independent prognostic factors in patients with ASCC with HPV-positive tumors treated by abdominoperineal resection. And, importantly, the high prevalence of alterations bearing potential theragnostic value strongly supports the use of genomic profiling to allow patient enrollment in precision medicine clinical trials.

Impact of preoperative uni- or multimodal prehabilitation on postoperative morbidity: meta-analysis.

BACKGROUND: Postoperative complications occur in up to 43% of patients after surgery, resulting in increased morbidity and economic burden. Prehabilitation has the potential to increase patients' preoperative health status and thereby improve postoperative outcomes. However, reported results of prehabilitation are contradictory. The objective of this systematic review is to evaluate the effects of prehabilitation on postoperative outcomes (postoperative complications, hospital length of stay, pain at postoperative day 1) in patients undergoing elective surgery. METHODS: The authors performed a systematic review and meta-analysis of RCTs published between January 2006 and June 2023 comparing prehabilitation programmes lasting ≥14 days to 'standard of care' (SOC) and reporting postoperative complications according to the Clavien-Dindo classification. Database searches were conducted in PubMed, CINAHL, EMBASE, PsycINFO. The primary outcome examined was the effect of uni- or multimodal prehabilitation on 30-day complications. Secondary outcomes were length of ICU and hospital stay (LOS) and reported pain scores. RESULTS: Twenty-five studies (including 2090 patients randomized in a 1:1 ratio) met the inclusion criteria. Average methodological study quality was moderate. There was no difference between prehabilitation and SOC groups in regard to occurrence of postoperative complications (OR = 1.02, 95% c.i. 0.93 to 1.13; P = 0.10; I2 = 34%), total hospital LOS (-0.13 days; 95% c.i. -0.56 to 0.28; P = 0.53; I2 = 21%) or reported postoperative pain. The ICU LOS was significantly shorter in the prehabilitation group (-0.57 days; 95% c.i. -1.10 to -0.04; P = 0.03; I2 = 46%). Separate comparison of uni- and multimodal prehabilitation showed no difference for either intervention. CONCLUSION: Prehabilitation reduces ICU LOS compared with SOC in elective surgery patients but has no effect on overall complication rates or total LOS, regardless of modality. Prehabilitation programs need standardization and specific targeting of those patients most likely to benefit.

Stoma-free survival after anastomotic leak following rectal cancer resection: worldwide cohort of 2470 patients.

BACKGROUND: The optimal treatment of anastomotic leak after rectal cancer resection is unclear. This worldwide cohort study aimed to provide an overview of four treatment strategies applied. METHODS: Patients from 216 centres and 45 countries with anastomotic leak after rectal cancer resection between 2014 and 2018 were included. Treatment was categorized as salvage surgery, faecal diversion with passive or active (vacuum) drainage, and no primary/secondary faecal diversion. The primary outcome was 1-year stoma-free survival. In addition, passive and active drainage were compared using propensity score matching (2 : 1). RESULTS: Of 2470 evaluable patients, 388 (16.0 per cent) underwent salvage surgery, 1524 (62.0 per cent) passive drainage, 278 (11.0 per cent) active drainage, and 280 (11.0 per cent) had no faecal diversion. One-year stoma-free survival rates were 13.7, 48.3, 48.2, and 65.4 per cent respectively. Propensity score matching resulted in 556 patients with passive and 278 with active drainage. There was no statistically significant difference between these groups in 1-year stoma-free survival (OR 0.95, 95 per cent c.i. 0.66 to 1.33), with a risk difference of -1.1 (95 per cent c.i. -9.0 to 7.0) per cent. After active drainage, more patients required secondary salvage surgery (OR 2.32, 1.49 to 3.59), prolonged hospital admission (an additional 6 (95 per cent c.i. 2 to 10) days), and ICU admission (OR 1.41, 1.02 to 1.94). Mean duration of leak healing did not differ significantly (an additional 12 (-28 to 52) days). CONCLUSION: Primary salvage surgery or omission of faecal diversion likely correspond to the most severe and least severe leaks respectively. In patients with diverted leaks, stoma-free survival did not differ statistically between passive and active drainage, although the increased risk of secondary salvage surgery and ICU admission suggests residual confounding.

Does KONO-S anastomosis reduce recurrence in Crohn's disease compared to conventional ileocolonic anastomosis? A nationwide propensity score-matched study from GETAID Chirurgie Group (KoCoRICCO study).

BACKGROUND AND AIMS: Postoperative recurrence is a major concern in Crohn's disease. The Kono-S anastomosis has been described to reduce the rate of recurrence. However, the level of evidence for its effectiveness remains low. The KoCoRICCO study aimed to compare outcomes between Kono-S anastomosis and conventional anastomosis in two nationwide prospective cohorts. METHODS: Adult patients with Crohn's disease who underwent ileocolonic resection with Kono-S anastomosis were prospectively included in seven referral centers between 2020 and 2022. Patients with conventional side-to-side anastomosis were enrolled from a previously published cohort. A propensity score analysis was performed to compare recurrence at first endoscopy in a matched 1:2 ratio population. RESULTS: A total of 433 patients with ileocolonic anastomosis were enrolled, of whom 155 had a Kono-S anastomosis. Before matching, both groups were unbalanced for preoperative, intraoperative, and postoperative characteristics. After matching patients with available endoscopic follow-up, endoscopic recurrence ≥i2 was found in 47.5% of the Kono-S group and 44.3% of the conventional side-to-side group (p=0.6745). CONCLUSIONS: The KoCoRICCO study suggests that Kono-S anastomosis does not reduce the risk of endoscopic recurrence in Crohn's disease compared to conventional side-to-side anastomosis. Further research with a longer follow-up is necessary to determine whether there is a potential benefit on surgical recurrence.

Local excision after neoadjuvant chemoradiotherapy for mid and low rectal cancer: a multicentric French study from the GRECCAR group.

AIM: A complete or subcomplete tumour response (CTR) is observed in 10%-25% of patients with mid/low rectal cancer after neoadjuvant chemoradiotherapy (CRT). The aim of our study was to report a multicentric French experience in local excision (LE) after CRT. METHOD: All patients who underwent LE for mid/low rectal cancer with suspected CTR after CRT, from 2006 to 2019 in seven GRECCAR centres were included. LE was considered adequate if the specimen showed a ypT0/Tis/T1R0 tumour, otherwise, a completion total mesorectal excision (TME) was discussed. Morbi-mortality, functional results and oncological outcomes were studied. RESULTS: A total of 257 patients were included. LE specimens showed 36% ypT0, 4% ypTis and 19% ypT1. Thus, 108 patients (42%) had theoretical indication of completion TME, which was performed in only 42 patients. Overall, 30-day morbidity after LE was 11%, including 2% Clavien-Dindo grade III or IV complications. After completion TME, 47% described major low anterior resection syndrome versus 5% after LE alone (p < 0.001). After a mean follow-up of 4 years (range 2-6 years), the recurrence rate was 11% after LE, 32% after completion TME and 20% in patients for whom completion TME was indicated but not performed (p = 0.021). CONCLUSION: TME remains the gold standard for mid/low rectal cancer after CRT. LE in selected patients is safe for operative and functional, but also oncological, results. However, completion TME was indicated in 42% of patients after LE, highlighting the difficulty of the preoperative diagnosis of CTR after CRT.

International standardization and optimization group for intersphincteric resection (ISOG-ISR): modified Delphi consensus on anatomy, definition, indication, surgical technique, specimen description and functional outcome.

AIM: Intersphincteric resection (ISR) is an oncologically complex operation for very low-lying rectal cancers. Yet, definition, anatomical description, operative indications and operative approaches to ISR are not standardized. The aim of this study was to standardize the definition of ISR by reaching international consensus from the experts in the field. This standardization will allow meaningful comparison in the literature in the future. METHOD: A modified Delphi approach with three rounds of questionnaire was adopted. A total of 29 international experts from 11 countries were recruited for this study. Six domains with a total of 37 statements were examined, including anatomical definition; definition of intersphincteric dissection, intersphincteric resection (ISR) and ultra-low anterior resection (uLAR); indication for ISR; surgical technique of ISR; specimen description of ISR; and functional outcome assessment protocol. RESULTS: Three rounds of questionnaire were performed (response rate 100%, 89.6%, 89.6%). Agreement (≥80%) reached standardization on 36 statements. CONCLUSION: This study provides an international expert consensus-based definition and standardization of ISR. This is the first study standardizing terminology and definition of deep pelvis/anal canal anatomy from a surgical point of view. Intersphincteric dissection, ISR and uLAR were specifically defined for precise surgical description. Indication for ISR was determined by the rectal tumour's maximal radial infiltration (T stage) below the levator ani. A new surgical definition of T3isp was reached by consensus to define T3 low rectal tumours infiltrating the intersphincteric plane. A practical flowchart for surgical indication for uLAR/ISR/abdominoperineal resection was developed. A standardized ISR surgical technique and functional outcome assessment protocol was defined.

Evaluation of the SafeHeal Colovac+ anastomosis protection device after low anterior resection for rectal cancer: the safe anastomosis feasibility evaluation (SAFE) 2019 trial.

BACKGROUND: Protective ileostomy (PI) is the current standard of care to protect the anastomosis after low anterior resection (LAR) for rectal cancer, but is associated with significant morbidity. Colovac is an anastomosis protection device designed to shield the anastomosis from fecal content. A second version (Colovac+) was developed to limit the migration risk during the implantation period. The objective of this clinical trial was to evaluate the preliminary efficacy and safety of the Colovac+. METHODS: This was a prospective, multicenter, pilot study aiming to enroll 15 patients undergoing LAR with Colovac+ placement. After 10 days, a CT scan was performed to evaluate the anastomosis and the Colovac+ was retrieved endoscopically. During the 10-day implantation and 3-month follow-up period, we collected data regarding predefined efficacy and safety endpoints. The primary endpoint was the rate of major (Clavien-Dindo III-V) postoperative complications related to the Colovac+ or LAR procedure. RESULTS: A total of 25 patients were included (68% male), of whom 15 were consecutively treated with the Colovac+ and Vacuum Loss Alert System. The Colovac+ was successfully implanted in all 15 patients. No major discomfort was reported during the implantation period. The endoscopic retrieval was performed in 14/15 (93%) patients. The overall major postoperative morbidity rate was 40%, but none of the reported complications were related to the Colovac+. A device migration occurred in 2 (13%) patients, but these were not associated with AL or stoma conversion. Overall, Colovac+ provided effective fecal diversion in all 15 patients and was able to avoid the PI in 11/15 (73%) patients. CONCLUSIONS: Colovac+ provides a safe and effective protection of the anastomosis after LAR, and avoids the PI in the majority (73%) of patients. The improved design reduces the overall migration rate and limits the clinical impact of a migration.