Score prediction of anastomotic leak in colorectal surgery: a systematic review.

OBJECTIVE: Predicting the risk of anastomotic leak (AL) is of importance when defining the optimal surgical strategy in colorectal surgery. Our objective was to perform a systematic review of existing scores in the field. METHODS: We followed the PRISMA checklist (S1 Checklist). Medline, Cochrane Central and Embase were searched for observational studies reporting on scores predicting AL after the creation of a colorectal anastomosis. Studies reporting only validation of existing scores and/or scores based on post-operative variables were excluded. PRISMA 2020 recommendations were followed. Qualitative analysis was performed. RESULTS: Eight hundred articles were identified. Seven hundred and ninety-one articles were excluded after title/abstract and full-text screening, leaving nine studies for analysis. Scores notably included the Colon Leakage Score, the modified Colon Leakage Score, the REAL score, www.anastomoticleak.com and the PROCOLE score. Four studies (44.4%) included more than 1.000 patients and one extracted data from existing studies (meta-analysis of risk factors). Scores included the following pre-operative variables: age (44.4%), sex (77.8%), ASA score (66.6%), BMI (33.3%), diabetes (22.2%), respiratory comorbidity (22.2%), cardiovascular comorbidity (11.1%), liver comorbidity (11.1%), weight loss (11.1%), smoking (33.3%), alcohol consumption (33.3%), steroid consumption (33.3%), neo-adjuvant treatment (44.9%), anticoagulation (11.1%), hematocrit concentration (22.2%), total proteins concentration (11.1%), white blood cell count (11.1%), albumin concentration (11.1%), distance from the anal verge (77.8%), number of hospital beds (11.1%), pre-operative bowel preparation (11.1%) and indication for surgery (11.1%). Scores included the following peri-operative variables: emergency surgery (22.2%), surgical approach (22.2%), duration of surgery (66.6%), blood loss/transfusion (55.6%), additional procedure (33.3%), operative complication (22.2%), wound contamination class (1.11%), mechanical anastomosis (1.11%) and experience of the surgeon (11.1%). Five studies (55.6%) reported the area under the curve (AUC) of the scores, and four (44.4%) included a validation set. CONCLUSION: Existing scores are heterogeneous in the identification of pre-operative variables allowing predicting AL. A majority of scores was established from small cohorts of patients which, considering the low incidence of AL, might lead to miss potential predictors of AL. AUC is seldom reported. We recommend that new scores to predict the risk of AL in colorectal surgery to be based on large cohorts of patients, to include a validation set and to report the AUC.

[Vaginal delivery and perineal trauma : it's time to repair]. / Accouchement par voie basse et traumatisme périnéal : quand vient le temps de la reconstruction.

Perineal injuries can occur during vaginal delivery and they are harmful to anal function, sexuality, and overall quality of life of patients. Among the feared complications, anal incontinence, often difficult to address for both patients and caregivers, has a significant impact and must be looked for during the medical history. Clinical examination of the perineum and additional tests such as endoanal ultrasound and anorectal manometry confirm the diagnosis and guide the management. Treatment often relies on multiple modalities and depends on the interval between obstetric trauma and symptom onset. When indicated, perineal reconstruction surgery restores anatomy and function.

Des lésions périnéales peuvent survenir lors d'un accouchement par voie basse et avoir des conséquences néfastes sur la fonction anale, la sexualité et la qualité de vie globale des patientes. Parmi les complications redoutées, l'incontinence anale, souvent difficile à aborder pour les patientes et les soignants, a un retentissement important et doit être recherchée lors de l'anamnèse. L'examen clinique du périnée et les examens complémentaires tels que l'échographie endoanale et la manométrie anorectale permettent de confirmer le diagnostic et d'orienter la prise en charge. Le traitement repose souvent sur plusieurs modalités et dépend du délai entre le traumatisme obstétrical et la survenue des symptômes. Lorsqu'elle est indiquée, la chirurgie de reconstruction du périnée permet de restaurer l'anatomie et de rétablir la fonction.

StomaCare: quality of life impact after enhanced follow-up of ostomy patients by a home healthcare nursing service-a multicentre, randomized, controlled trial.

AIM: A stoma exposes patients to several complications which could impair their quality of life (QoL). In the last decade, the market for stoma therapy in France has evolved, with a significant increase in the activities of home health providers, meeting a need for patient follow-up and companionship. International studies have demonstrated the impact of the stoma therapist (ST) follow-up on the improvement of an ostomy patient's QoL. However, the impact of home stoma nurse management has not been analysed. In this context we would like to assess the added value on health-related QoL from the enhanced follow-up of ostomy patients by STs. METHODS: This is a randomized, controlled, open, national and multicentre trial (12 centres) which includes patients with an ostomy who benefit from either standard follow-up or from an enhanced and personalized follow-up with, in particular, regular consultations with an ST after discharge. The primary end-point is the 3-month QoL score obtained from the Stoma-QoL questionnaire. The secondary end-points are satisfaction of the care, comparison of QoL scores (Stoma-QoL and EuroQuol EQ-5D) and the economic gains by calculating the consumption of resources between the two arms. There will be a modified intention-to-treat analysis with 6-month follow-up in both study arms. DISCUSSION: The StomaCare trial will be the first randomized controlled study in France to evaluate the impact on QoL of an enhanced follow-up at home of ostomy patients by an ST.

Robot-assisted pelvic floor reconstructive surgery: an international Delphi study of expert users.

BACKGROUND: Robotic surgery has gained popularity for the reconstruction of pelvic floor defects. Nonetheless, there is no evidence that robot-assisted reconstructive surgery is either appropriate or superior to standard laparoscopy for the performance of pelvic floor reconstructive procedures or that it is sustainable. The aim of this project was to address the proper role of robotic pelvic floor reconstructive procedures using expert opinion. METHODS: We set up an international, multidisciplinary group of 26 experts to participate in a Delphi process on robotics as applied to pelvic floor reconstructive surgery. The group comprised urogynecologists, urologists, and colorectal surgeons with long-term experience in the performance of pelvic floor reconstructive procedures and with the use of the robot, who were identified primarily based on peer-reviewed publications. Two rounds of the Delphi process were conducted. The first included 63 statements pertaining to surgeons' characteristics, general questions, indications, surgical technique, and future-oriented questions. A second round including 20 statements was used to reassess those statements where borderline agreement was obtained during the first round. The final step consisted of a face-to-face meeting with all participants to present and discuss the results of the analysis. RESULTS: The 26 experts agreed that robotics is a suitable indication for pelvic floor reconstructive surgery because of the significant technical advantages that it confers relative to standard laparoscopy. Experts considered these advantages particularly important for the execution of complex reconstructive procedures, although the benefits can be found also during less challenging cases. The experts considered the robot safe and effective for pelvic floor reconstruction and generally thought that the additional costs are offset by the increased surgical efficacy. CONCLUSION: Robotics is a suitable choice for pelvic reconstruction, but this Delphi initiative calls for more research to objectively assess the specific settings where robotic surgery would provide the most benefit.

Sacral neuromodulation for refractory ulcerative colitis: safety and efficacy in a prospective observational series of eight patients.

PURPOSE: Ulcerative colitis (UC) treatment is mainly based on immunosuppressive therapy. As anti-inflammatory effects of sacral neuromodulation (SNM) have been previously reported in animal models, we conducted a pilot study aimed at assessing clinical, biological, and endoscopic response but also safety of SNM use in UC refractory to medical therapy. METHODS: Adult patients with histologically proven UC resistant to immunosuppressive therapy were invited to enroll in the study. Primary outcome was the rate of UC remission (UCDAI score ≤ 2, without any criteria > 1) at 8 weeks (W8). Secondary outcomes were biological and endoscopic response also evaluated at W8 and W16. Subsequently, every patient was followed every 6 months. Adverse events were prospectively collected for safety assessment during the follow-up. RESULTS: Eight patients, with mean age 47 years old, suffering from UC for 2-13 years were included. There were no complications in relation to SNM procedure. The acceptance of the device was excellent in all patients. Clinical and endoscopic remission was obtained at W8 in one patient (12.5%) and three other patients (37.5%) were responders at W16. At review (mean follow-up of 4 years), two patients (25%) were in remission and two (25%) were responders. CONCLUSION: SNM application is safe in patients suffering from refractory UC. Effects on disease activity were mainly observed after 16 weeks. Larger prospective studies are mandatory, but SNM could be a way to reinforce medical therapy and reduce the use of immunosuppressive drugs.

[Colorectal cancer: technological revolution]. / Cancer colorectal : révolution technologique.

Colorectal cancer represents 4500 incidental cases in Switzerland per year, with an incidence increasing among the youngest patients. Technological innovation guides the management of colorectal cancer. Artificial intelligence in endoscopy optimizes the detection of small colonic lesions. Submucosal dissection allows treating extensive lesions at an early stage of the disease. The improvement of surgical techniques, notably robotic surgery, allows limiting complications and optimizing organ preservation. Molecular tools are leading to the development of promising targeted therapies for localized or advanced disease. The development of reference centers tends to bring together this expertise.

Le cancer colorectal représente 4500 nouveaux cas par an en Suisse. Son incidence chez les sujets de plus de 50 ans semble se stabiliser, mais chez les plus jeunes elle est en augmentation. La révolution technologique guide sa prise en charge. L'intelligence artificielle en endoscopie optimise la détection de petites lésions coliques. La dissection sous-muqueuse permet de traiter des lésions parfois étendues à un stade précoce de la maladie. L'amélioration des techniques chirurgicales, notamment par robot, vise à limiter les complications et à optimiser la conservation d'organes. Les outils moléculaires aboutissent au développement de thérapies ciblées prometteuses pour les maladies localisées ou celles avancées. Le développement des centres de référence tend à rassembler cette expertise.

Ten-year Evaluation of a Large Retrospective Cohort Treated by Sacral Nerve Modulation for Fecal Incontinence: Results of a French Multicenter Study.

OBJECTIVE: The aim of this study was to assess the effectiveness of sacral nerve modulation (SNM) in a large cohort of patients implanted for at least 10 years, quantify adverse event rates, and identify predictive factors of long-term success. SUMMARY BACKGROUND DATA: Few studies have evaluated the long-term success of SNM. METHODS: Data collected prospectively from patients implanted for fecal incontinence (FI) in 7 French centers between January 1998 and December 2008 were retrospectively analyzed. Patient FI severity scores were assessed before and 10 years after implantation. The main evaluation criterion was the success of SNM defined by the continuation of the treatment without additional therapies. The secondary evaluation criteria were the rate of device revisions and explantations. Preoperative predictors of success at 10 years were sought. RESULTS: Of the 360 patients (27 males, mean age: 59 ± 12 years) implanted for FI, 162 (45%) had a favorable outcome 10 years post-implantation, 115 (31.9%) failed, and 83 (23.1%) were lost to follow-up. The favorable outcome derived from the time-to-event Kaplan-Meier curve at 10 years was 0.64 (95% CI 0.58-0.69). FI severity scores were significantly better 10 years post-implantation compared to preimplantation (7.4 ± 4.3 vs 14.0 ± 3.2; P < 0.0001). During the 10-year follow-up, 233 patients (64.7%) had a surgical revision and 94 (26.1%) were explanted. A history of surgery for FI and sex (male) were associated with an increased risk of an unfavorable outcome. CONCLUSIONS: Long-term efficacy was maintained in approximately half of the FI patients treated by SNM at least 10 years post-implantation.

Surgical closure, mainly with glue injection and anti-tumour necrosis factor α, in fistulizing perianal Crohn's disease: A multicentre randomized controlled trial.

AIM: In patients with fistulizing perianal Crohn's disease (CD), the need for a secondary surgical step is not defined. The aim was to assess the efficacy of surgical closure compared to a single seton removal in patients with drained fistulizing perianal CD treated with adalimumab. METHODS: This was a multicentre, randomized controlled trial, comparing seton removal + surgical closure (closure group) to seton removal alone (control group) with a stratification according to the American Gastroenterological Association classification. The primary end-point was fistula closure at month 12 defined by the association of the following criteria: no seton, absence of a visible external opening, absence of discharge from the tract after finger compression, absence of an internal opening, absence of perianal pain/abscess and absence of fistula-related abnormalities. RESULTS: Among the 64 included patients (262 expected) (48 complex fistula, 75%), 33 were randomized to the closure group and 31 to the control group. In the closure group, 26 patients (78.8%) had glue. At month 12, overall fistula closure was achieved in 35 of the evaluable 58 patients (60%): 18/32 (56%) in the surgery group and 17/26 (65%) in the control group (P = 0.479). In the closure group, fistula closure was observed in 13/25 (52%) and 5/7 (71%) patients with complex and simple fistula respectively (P = 0.426), compared with 12/18 (67%) and 5/8 (63%), respectively in the control group (P = 1.000). CONCLUSIONS: Seton removal alone seems to be no more effective than a secondary surgical step (in particular glue injection) in patients having fistulizing perianal CD controlled by an initial drainage combined with adalimumab. The results should be interpreted with caution.

Surgical Management of Retrorectal Tumors: A French Multicentric Experience of 270 Consecutives Cases.

OBJECTIVE: To report the largest multicentric experience on surgical management of retrorectal tumors (RRT). BACKGROUND: Literature data on RRT is limited. There is no consensus concerning the best surgical approach for the management of RRT. METHODS: Patients operated for RRT in 18 academic French centers were retrospectively included (2000-2019). RESULTS: A total of 270 patients were included. Surgery was performed through abdominal (n = 72, 27%), bottom (n = 190, 70%), or combined approach (n = 8, 3%). Abdominal approach was laparoscopic in 53/72 (74%) and bottom approach was Kraske modified procedures in 169/190 (89%) patients. In laparoscopic abdominal group, tumors were more frequently symptomatic (37/53, 70% vs 88/169, 52%, P = 0.02), larger [mean diameter = 60.5 ± 24 (range, 13-107) vs 51 ± 26 (20-105) mm, P = 0.02] and located above S3 vertebra (n = 3/42, 7% vs 0%, P = 0.001) than those from Kraske modified group. Laparoscopy was associated with a higher risk of postoperative ileus (n = 4/53, 7.5% vs 0%, P = 0.002) and rectal fistula (n = 3/53, 6% vs 0%, P=0.01) but less wound abscess (n = 1/53, 2% vs 24/169, 14%, P = 0.02) than Kraske modified procedures. RRT was malignant in 8%. After a mean follow up of 27 ±39 (1-221) months, local recurrence was noted in 8% of the patients. After surgery, chronic pain was observed in 17% of the patients without significant difference between the 2 groups (15/74, 20% vs 3/30, 10%; P = 0.3). CONCLUSIONS: Both laparoscopic and Kraske modified approaches can be used for surgical treatment of RRT (according to their location and their size), with similar long-term results.

End Colostomy With or Without Mesh to Prevent a Parastomal Hernia (GRECCAR 7): A Prospective, Randomized, Double Blinded, Multicentre Trial.

OBJECTIVE: To evaluate whether systematic mesh implantation upon primary colostomy creation was effective to prevent PSH. SUMMARY OF BACKGROUND DATA: Previous randomized trials on prevention of PSH by mesh placement have shown contradictory results. METHODS: This was a prospective, randomized controlled trial in 18 hospitals in France on patients aged ≥18 receiving a first colostomy for an indication other than infection. Participants were randomized by blocks of random size, stratified by center in a 1:1 ratio to colostomy with or without a synthetic, lightweight monofilament mesh. Patients and outcome assessors were blinded to patient group. The primary endpoint was clinically diagnosed PSH rate at 24 months of the intention-to-treat population. This trial was registered at ClinicalTrials.gov, number NCT01380860. RESULTS: From November 2012 to October 2016, 200 patients were enrolled. Finally, 65 patients remained in the no mesh group (Group A) and 70 in the mesh group (Group B) at 24 months with the most common reason for drop-out being death (n = 41). At 24 months, PSH was clinically detected in 28 patients (28%) in Group A and 30 (31%) in Group B [P = 0.77, odds ratio = 1.15 95% confidence interval = (0.62;2.13)]. Stoma-related complications were reported in 32 Group A patients and 37 Group B patients, but no mesh infections. There were no deaths related to mesh insertion. CONCLUSION: We failed to show efficiency of a prophylactic mesh on PSH rate. Placement of a mesh in a retro-muscular position with a central incision to allow colon passage cannot be recommended to prevent PSH. Optimization of mesh location and reinforcement material should be performed.

A European snapshot of psychosocial characteristics and patients' perspectives of faecal incontinence-do they correlate with current scoring systems?

PURPOSE: To compare the current clinical scoring systems used to quantify the severity of symptoms of faecal incontinence (FI) to patients' subjective scoring of parameters of psychosocial well-being. METHODS: Patients referred to six European centres for investigation or treatment of symptoms of FI between June 2017 and September 2019 completed a questionnaire that captured patient demographics, incontinence symptoms using St. Mark's Incontinence score (SMIS) and ICIQ-B, psychological well-being (HADS, Hospital Anxiety and Depression Scale), and social interaction (a three-item loneliness scale). RESULTS: Three hundred eighteen patients completed questionnaires (62 men, mean age 58.7). Sixty percent of the respondents were aged under 65. Median SMIS was 15 (11-18), ICIQ-B bowel pattern was 8 (6-11) and bowel control was 17 (13-22), similar across all demographic groups; however, younger patients were more likely to experience symptoms of depression and anxiety (HADS score > 10, 65.2% of patients age < 65 vs 54.9% of those ages > = 65, p = 0.03) with lower quality of life (ICIQ-B QoL, median score 19 (14-23)) vs age > = 65 (16 (11-21) (p < 0.005)). On loneliness score 25.5% reported often feeling isolated from others. One of the most significant concerns by patients was the fear and embarrassment related to unpredictable episodes of incontinence. CONCLUSION: The SMIS remains a useful tool for quantifying incontinence symptoms but may underestimate the psychosocial morbidity associated with unpredictable episodes of incontinence. Interventions aimed at decreasing anxiety and to address feelings of disgust may be helpful for a significant number of patients requiring treatment for FI.

Sacral neuromodulation with the InterStim™ system for faecal incontinence: results from a prospective French multicentre observational study.

AIM: The aim of this work was to evaluate the effectiveness, patient satisfaction and quality of life (QoL) and the safety of sacral neuromodulation (SNM) with the InterStimTM system for the treatment of faecal incontinence (FI) and establish whether results published predominantly by expert sites are generalisable. METHOD: This is a prospective, multicentre, observational study that invited all French sites treating FI with the InterStim™ system to enrol subjects indicated for an SNM therapy evaluation. Data were collected at three follow-up visits within 1 and 15 months. Therapeutic effectiveness was evaluated by the reduction in leakages per week and improvements over time in the ability to defer defaecation and QoL (as measured with the Faecal Incontinence Quality of Life score). Safety was assessed through reported adverse events. RESULTS: A total of 221 subjects with a mean age of 62.1 years were tested (184 women) and 178 received a permanent implant. For all implanted subjects with diary data at baseline and follow-up, a reduction in leakage of more than 50% was observed in 80%, 76% and 83% at 1-3, 4-8 and 9-15 months, respectively. The mean number of leakage episodes and urgency improved significantly compared with the baseline (p < 0.0001). Subjects showed improvements in QoL and time to defer defaecation and were generally satisfied with their therapy. The main device-related adverse event was the requirement to undertake reprogramming (in 52% of subjects with actions following an event). The rates of infection (in 6% of subjects) and surgical revision (in 10% of subjects) were in agreement with literature reports. CONCLUSION: This study confirms the clinical effectiveness, safety and positive effect of SNM on QoL as well as high patient satisfaction for the treatment of FI in real-life.

Impact of preoperative enteral nutritional support on postoperative outcome in patients with Crohn's disease complicated by malnutrition: Results of a subgroup analysis of the nationwide cohort registry from the GETAID Chirurgie group.

AIM: Postoperative morbidity is high in patients operated on for Crohn's disease (CD) complicated by malnutrition. This study aimed to evaluate the impact of preoperative enteral nutritional support (PENS) on postoperative outcome in patients with CD complicated by malnutrition included in a prospective nationwide cohort. METHOD: Malnutrition was defined as body mass index <18 kg/m2 and/or albuminaemia <30 g/L and/or weight loss >10%. Failure of PENS was defined as the requirement for additional preoperative parenteral nutrition to PENS. Univariate analysis of the risk factors for PENS failure was performed. Propensity score matching (PSM) was used to compare the outcomes between 'upfront surgery' and 'PENS' groups. The primary endpoint was the rate of intra-abdominal septic morbidity and/or temporary defunctioning stoma. RESULTS: Among 592 patients included, 149 were selected. In the intention-to-treat population including 20 (13.4%) patients with PENS failure after PSM, 78 'upfront surgery' and 71 'PENS'-matched patients were compared, with no significant difference in the primary endpoint. Perforating CD and preoperative intra-abdominal fistula were associated with PENS failure [37.5 vs 16.1% (P = 0.047) and 41.2% vs 16.2% (P = 0.020), respectively]. After exclusion of these 20 patients, PSM was used to compare 45 'upfront surgery' and 51 'PENS'-matched patients, with a significantly decreased rate of intra-abdominal septic complications and/or temporary defunctioning stoma in the PENS group (19.6 vs 42.2%, P = 0.016). CONCLUSION: Preoperative enteral nutritional support is associated with a trend but no conclusive evidence of a reduction in intra-abdominal septic complications and/or requirement for defunctioning stoma. Patients with perforating CD complicated with malnutrition are at risk of PENS failure.

The inhibitory receptor CD94/NKG2A on CD8+ tumor-infiltrating lymphocytes in colorectal cancer: a promising new druggable immune checkpoint in the context of HLAE/ß2m overexpression.

We previously demonstrated that HLA-E/ß2m overexpression by tumor cells in colorectal cancers is associated with an unfavorable prognosis. However, the expression of its specific receptor CD94/NKG2 by intraepithelial tumor-infiltrating lymphocytes, their exact phenotype and function, as well as the relation with the molecular status of colorectal cancer and prognosis remain unknown. Based on a retrospective cohort of 234 colorectal cancer patients, we assessed the expression of HLA-E, ß2m, CD94, CD8, and NKp46 by immunohistochemistry on tissue microarray. The expression profile of HLA-E/ß2m on tumor cells and the density of tumor-infiltrating lymphocytes were correlated to the clinicopathological and molecular features (Microsatellite status, BRAF and RAS mutations). Then, from the primary tumors of 27 prospective colorectal cancers, we characterized by multiparameter flow cytometry the nature (T and/or NK cells) and the co-expression of the inhibitory NKG2A or activating NKG2C chain of ex vivo isolated CD94+ tumor-infiltrating lymphocytes. Their biological function was determined using an in vitro redirected cytolytic activity assay. Our results showed that HLA-E/ß2m was preferentially overexpressed in microsatellite instable tumors compared with microsatellite stable ones (45% vs. 19%, respectively, p = 0.0001), irrespective of the RAS or BRAF mutational status. However, HLA-E/ß2m+ colorectal cancers were significantly enriched in CD94+ intraepithelial tumor-infiltrating lymphocytes in microsatellite instable as well as in microsatellite stable tumors. Those CD94+ tumor-infiltrating lymphocytes mostly corresponded to CD8+ αß T cells, and  to a lesser extent to NK cells, and mainly co-expressed a functional inhibitory NKG2A chain. Finally, a high number of CD94+ intraepithelial tumor-infiltrating lymphocytes in close contact with tumor cells was independently associated with a worse overall survival. In conclusion, these findings strongly suggest that HLA-E/ß2m-CD94/NKG2A represents a new druggable inhibitory immune checkpoint, preferentially expressed in microsatellite instable tumors, but also in a subgroup of microsatellite stable tumors, leading to a new opportunity in colorectal cancer immunotherapies.

Predictive value of inflammatory markers for postoperative recovery following colorectal surgery.

BACKGROUND: Using biological markers to predict serious complications and global postoperative recovery, to ensure safe and timely patient discharge after elective colorectal surgery represents a major challenge. The aim of this study was to demonstrate that C-reactive protein levels < 172 mg/l on postoperative day 3 were associated with postoperative recovery within 5 days. METHODS: This is a prospective study of a consecutive bicentric cohort. Successive patients scheduled for bowel resection with anastomosis, without stoma, were included. The main composite endpoint for overall postoperative recovery included absence of fever, absence of pain > 2 on the visual analog scale, intestinal gas transit, and patient autonomy for mobility and body care. RESULTS: One hundred sixty-height patients, with a mean age of 65 years old, were analyzed. Ninety patients (53%) underwent right colectomy and 131 (77%) were operated on by laparoscopy. Severe postoperative complications were observed in 11 patients (6%). One hundred twenty patients (71%) recovered within 5 days. C-reactive protein levels < 172 mg/L on postoperative day 3 had a negative predictive value of 80% to predict recovery within 5 days. Ninety-five percent of patients with C-reactive protein < 172 mg/L at postoperative day 3 had no severe postoperative complications. CONCLUSION: Levels of C-reactive protein < 172 mg/L at postoperative day 3 corresponded with an early recovery in 80% of cases, thus allowing safe and early discharge without risk of serious complications.

Practical issues encountered while determining Minimal Clinically Important Difference in Patient-Reported Outcomes.

BACKGROUND: Using a real dataset, we highlighted several major methodological issues raised by the estimation of the Minimal Clinically Important Difference (MCID) of a Patient-Reported Outcomes instrument. We especially considered the management of missing data and the use of more than two times of measurement. While inappropriate missing data management and inappropriate use of multiple time points can lead to loss of precision and/or bias in MCID estimation, these issues are almost never dealt with and require cautious considerations in the context of MCID estimation. METHODS: We used the LIGALONGO study (French Randomized Controlled Trial). We estimated MCID on the SF-36 General Health score by comparing many methods (distribution or anchor-based). Different techniques for imputation of missing data were performed (simple and multiple imputations). We also consider all measurement occasions by longitudinal modeling, and the dependence of the score difference on baseline. RESULTS: Three hundred ninety-three patients were studied. With distribution-based methods, a great variability in MCID was observed (from 3 to 26 points for improvement). Only 0.2 SD and 1/3 SD distribution methods gave MCID values consistent with anchor-based methods (from 4 to 7 points for improvement). The choice of missing data imputation technique clearly had an impact on MCID estimates. Simple imputation by mean score seemed to lead to out-of-range estimate, but as missing not at random mechanism can be hypothesized, even multiple imputations techniques can have led to an slight underestimation of MCID. Using 3 measurement occasions for improvement led to an increase in precision but lowered estimates. CONCLUSION: This practical example illustrates the substantial impact of some methodological issues that are usually never dealt with for MCID estimation. Simulation studies are needed to investigate those issues. TRIAL REGISTRATION: NCT01240772 (ClinicalTrials.gov) registered on November 15, 2010.

Functional Results and Quality of Life Following Magnetic Anal Sphincter Augmentation in Severely Incontinent Patients.

OBJECTIVE: Magnetic anal sphincter augmentation is a novel surgical option in the treatment of severe fecal incontinence. This study aimed to analyze functional results, quality of life, and satisfaction after implantation in the mid-term, and to identify factors associated with success of this new treatment. METHODS: All patients, who underwent magnetic anal sphincter augmentation procedure at a single center between December 2008 and January 2016, were consecutively included. Symptom severity [Cleveland Clinic Incontinence Score (CCIS)], quality of life [Fecal-Incontinence Quality of Life Questionnaire (FIQL)], bowel diary data, and patients' satisfaction were assessed before and after implantation. RESULTS: Forty-five patients (43 female), mean (s.d.) age 66.82 (±10.07), were followed for a median of 36 months (range 6-84). Two patients were explanted and 1 lost to follow-up. On a 3-week diary, major leakage rate significantly improved as did CCIS and FIQL. No significant difference was seen for flatus and minor leaks. Postoperative decrease of CCIS by ≥5.5 points correlated best with satisfaction, expressed by 22 patients (48% in intention-to-treat analysis). An independent predictive factor for success after implantation was no previous fecal incontinence surgical treatment. CONCLUSIONS: Satisfaction, functional, and quality of life outcomes improve significantly following magnetic anal sphincter augmentation.

Penetrating Crohn Disease Is Not Associated With a Higher Risk of Recurrence After Surgery: A Prospective Nationwide Cohort Conducted by the Getaid Chirurgie Group.

OBJECTIVE: The aim of this study was to assess recurrence risk factors following ileocolonic resection (ICR) for Crohn disease (CD) in a nationwide cohort study SUMMARY BACKGROUND DATA:: Recurrence rate after ICR for CD can be up to 60%, but its predictive factors have never been evaluated in large prospective cohort studies. METHODS: From 2013 to 2015, 346 consecutive patients undergoing ICR for CD and a postoperative ileocoloscopy within 6 to 12 months after surgery at 19 academic French centers were included prospectively. RESULTS: Twelve-month postoperative endoscopic (Rutgeerts score ≥i2) and clinical recurrence rates were 57.6% [95% confidence interval (CI), 54.2-61.0] and 11.3% (95% CI, 9-13.6), respectively. A total of 185 patients (54%) had a postoperative CD prophylaxis, comprising thiopurine in 69 (20%), or anti-tumor necrosis factor (TNF) therapy in 93 (27%). In multivariate Cox regression analysis, absence of postoperative smoking {odds ratio [OR] = 0.60 (95% CI, 0.40-0.91); P = 0.016}, postoperative prophylaxis [OR = 0.60 (95% CI, 0.41-0.88); P = 0.009], and penetrating disease behavior [OR = 0.58 (95% CI, 0.39-0.86); P = 0.007] were the only independent predictors of reduced endoscopic recurrence risk. Postoperative prophylaxis [OR 0.31 (95% CI, 0.15-0.66); P = 0.002), and penetrating behavior [OR = 00.36 (95% CI, 0.16-0.81); P = 0.013), were the only independent predictors of reduced clinical recurrence risk. Postoperative anti-TNF therapy was associated with a significant reduction of both 12-month risks of endoscopic (P < 0.001) and clinical (P = 0.019) recurrences. CONCLUSION: Absence of postoperative smoking, CD prophylaxis, and penetrating disease behavior could be independent predictors of reduced postoperative recurrence after ICR for CD. Prophylactic anti-TNF therapy reduces both endoscopic and clinical recurrence rates. It suggests that upfront surgery followed by postoperative anti-TNF therapy is probably the best therapeutic approach for complex CD (penetrating disease behavior).

Does A Longer Waiting Period After Neoadjuvant Radio-chemotherapy Improve the Oncological Prognosis of Rectal Cancer?: Three Years' Follow-up Results of the Greccar-6 Randomized Multicenter Trial.

OBJECTIVE: The aim of this study was to report the 3-year survival results of the GRECCAR-6 trial. SUMMARY BACKGROUND DATA: Current data on the effect of an extended interval between radiochemotherapy (RCT) and resection for rectal cancer on the rate of complete pathological response (pCR = ypT0N0) is controversial. Furthermore, its effect on oncological outcomes is unknown. METHODS: The GRECCAR-6 trial was a phase III, multicenter, randomized, open-label, parallel-group, controlled trial. Patients with cT3/T4 or TxN+ tumors of the mid or lower rectum who had received RCT (45-50 Gy with 5-fluorouracil or capecitabine) were included and randomized into a 7- or 11-week waiting period. Primary endpoint was the pCR rate. Secondary endpoints were 3-year overall (OS), disease-free survival (DFS), and recurrence rates. RESULTS: A total of 265 patients from 24 participating centers were enrolled. A total of 253 patients underwent a mesorectal excision. Overall pCR rate was 17% (43/253). Mean follow-up from surgical resection was 32 ±â€Š8 months. Twenty-four deaths occurred with an 89% OS at 3 years. DFS was 68.7% at 3 years (75 recurrences). Three-year local and distant recurrences were 7.9% and 23.8%, respectively. The randomization group had no impact on the 3-year OS (P = 0.8868) or DFS (P = 0.9409). Distant (P = 0.7432) and local (P = 0.3944) recurrences were also not influenced by the waiting period. DFS was independently influenced by 3 factors: circumferential radial margin (CRM) ≤1 mm [hazard ratio (HR) = 2.03; 95% confidence interval (CI), 1.17-3.51], ypT3-T4 (HR = 2.69; 95% CI, 1.19-6.08) and positive lymph nodes (HR = 3.62; 95% CI, 1.89-6.91). CONCLUSION: Extending the waiting period by 4 weeks following RCT has no influence on the oncological outcomes of T3/T4 rectal cancers.

Long-term Outcome of Hirschsprung Disease: Impact on Quality of Life and Social Condition at Adult Age.

BACKGROUND: Hirschsprung disease is a rare congenital disease typically requiring surgical treatment during childhood. Quality of life and social condition at adult age can be impaired by disease-specific sequelae. OBJECTIVE: This study aimed to assess the quality of life and social outcome of adult patients operated on for Hirschsprung disease during childhood. DESIGN: Patients operated on for Hirschsprung disease during childhood were identified and specific questionnaires were sent to them. SETTINGS: Data from 2 referral centers were used. PATIENTS: Patients who completed the questionnaires regarding quality of life and social condition were included. MAIN OUTCOME MEASURES: The Hirschsprung's Disease and Anorectal Malformations Quality of Life disease-specific questionnaire (8 dimensions explored; each scored from 0 to 100 maximum score) and a sociodemographic questionnaire were sent to identified patients. Sociodemographic data were compared with those of the French general population. RESULTS: Thirty-four patients had Hirschsprung disease (men, 76%; mean age, 32 years) were included in the study. Mean total Hirschsprung's Disease and Anorectal Malformations Quality of Life score was 611 of 800 (maximum score 800). The 2 most impaired dimensions were "physical symptoms" and "diarrhea" (62.9/100 and 73.6/100). Fecal continence was only marginally affected (mean score, 89/100). Patients with Hirschsprung disease achieved better educational levels than the French general population. Parental and marital status did not differ between the 2 groups. LIMITATIONS: This study had the limitations inherent to a retrospective study. CONCLUSION: The quality of life of adult patients with Hirschsprung disease sequelae is marginally impaired in this study. Despite the consequences of this congenital abnormality, the condition eventually achieved can be considered as satisfactory. See Video Abstract at http://links.lww.com/DCR/A917.