A comparison between real-time intraoperative voice dictation and the operative report in laparoscopic cholecystectomy: a multicenter prospective observational study.

PURPOSE: The current operative report often inadequately reflects events occurring during laparoscopic cholecystectomy (LC). The addition of intraoperative video recording to the operative report has already proven to add important information. It was hypothesized that real-time intraoperative voice dictation (RIVD) can provide an equal or more complete overview of the operative procedure compared to the narrative operative report (NR) produced postoperatively. METHODS: SONAR is a multicenter prospective observational trial, conducted at four surgical centers in the Netherlands. Elective LCs of patients aged 18 years and older were included. Participating surgeons were requested to dictate the essential steps of LC during surgery. RIVDs and NRs were reviewed according to the stepwise LC guideline of the Dutch Society for Surgery. The cumulative adequacy rates for RIVDs were compared with those of the postoperatively written NR. RESULTS: 79 of 90 cases were eligible for inclusion and available for further analysis. RIVD resulted in a significantly higher adequacy rate compared to NR for the circumferential dissection of the cystic duct and artery (NR 32.5% vs. RIVD 61.0%, P = 0.016). NR had higher adequacy rates in reporting the transection of the cystic duct (NR 100% vs. RIVD 77.9%, P = < 0.001) and the removal of the gallbladder from the liver bed (NR 98.7% vs. RIVD 68.8%, P < 0.001). The total adequacy was not significantly different between the two reporting methods (NR 78.0% vs. RIVD 76.4%, P = 1.00). CONCLUSION: Overall, the adequacy of RIVD is comparable to the postoperatively written NR in reporting surgical steps in LC. However, the most essential surgical step, the circumferential dissection of the cystic duct and artery, was reported more adequately in RIVD.

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.

Implementation of music in colorectal perioperative standard care-barriers and facilitators among patients and healthcare professionals.

AIM: Perioperative anxiety and pain are still prevalent among patients undergoing surgery. Inflammatory bowel disease and colorectal cancer patients are known to have higher anxiety rates than the general population. Perioperatively applied music intervention has been proven to be effective in reducing perioperative anxiety and pain, resulting in a decrease of intra-operative sedative use, postoperative opioid requirement and neurohormonal stress response. IMPROVE evaluates the adherence to music intervention in colorectal perioperative standard care during systematic implementation. METHOD: The Consolidated Framework for Implementation Research (CFIR) was used for implementation in three steps. This study addresses the first step in which barriers and facilitators for implementing perioperative music were identified by surveying patients who underwent colorectal surgery and healthcare professionals involved in perioperative care. Also, perioperative anxiety scores were assessed and data on perioperative pain was collected from the patients' medical records. RESULTS: Fifty patients and 69 professionals (response rate 68.3%) were surveyed. For patients, all domains of the CFIR were facilitating implementation. The median reported preoperative and postoperative anxiety scores were 4.5 (1.0-7.0) and 3.0 (1.0-5.75) respectively. The median postoperative pain score on the first postoperative day was 2.8 (2.0-3.7). Also, for professionals most domains were facilitating, except for some factors related to work climate and culture among nurses. CONCLUSIONS: In this study it was identified that facilitating factors for implementing music in standard perioperative care were more prominent in both patients and healthcare professionals and therefore successful implementation is probable. Also, this study provides a guideline for assessing facilitators and barriers in other settings.

Transanal minimally invasive surgery (TAMIS) versus endoscopic submucosal dissection (ESD) for resection of non-pedunculated rectal lesions (TRIASSIC study): study protocol of a European multicenter randomised controlled trial.

BACKGROUND: In the recent years two innovative approaches have become available for minimally invasive en bloc resections of large non-pedunculated rectal lesions (polyps and early cancers). One is Transanal Minimally Invasive Surgery (TAMIS), the other is Endoscopic Submucosal Dissection (ESD). Both techniques are standard of care, but a direct randomised comparison is lacking. The choice between either of these procedures is dependent on local expertise or availability rather than evidence-based. The European Society for Endoscopy has recommended that a comparison between ESD and local surgical resection is needed to guide decision making for the optimal approach for the removal of large rectal lesions in Western countries. The aim of this study is to directly compare both procedures in a randomised setting with regard to effectiveness, safety and perceived patient burden. METHODS: Multicenter randomised trial in 15 hospitals in the Netherlands. Patients with non-pedunculated lesions > 2 cm, where the bulk of the lesion is below 15 cm from the anal verge, will be randomised between either a TAMIS or an ESD procedure. Lesions judged to be deeply invasive by an expert panel will be excluded. The primary endpoint is the cumulative local recurrence rate at follow-up rectoscopy at 12 months. Secondary endpoints are: 1) Radical (R0-) resection rate; 2) Perceived burden and quality of life; 3) Cost effectiveness at 12 months; 4) Surgical referral rate at 12 months; 5) Complication rate; 6) Local recurrence rate at 6 months. For this non-inferiority trial, the total sample size of 198 is based on an expected local recurrence rate of 3% in the ESD group, 6% in the TAMIS group and considering a difference of less than 6% to be non-inferior. DISCUSSION: This is the first European randomised controlled trial comparing the effectiveness and safety of TAMIS and ESD for the en bloc resection of large non-pedunculated rectal lesions. This is important as the detection rate of these adenomas is expected to further increase with the introduction of colorectal screening programs throughout Europe. This study will therefore support an optimal use of healthcare resources in the future. TRIAL REGISTRATION: Netherlands Trial Register, NL7083 , 06 July 2018.

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.

Transanal Endoscopic Microsurgery with or without Completion Total Mesorectal Excision for T2 and T3 Rectal Carcinoma.

AIM: Transanal endoscopic microsurgery (TEM) is used for the resection of large rectal adenomas and well or moderately differentiated T1 carcinomas. Due to difficulty in preoperative staging, final pathology may reveal a carcinoma not suitable for TEM. Although completion total mesorectal excision is considered standard of care in T2 or more invasive carcinomas, this completion surgery is not always performed. The purpose of this article is to evaluate the outcome of patients after TEM-only, when completion surgery would be indicated. METHODS: In this retrospective multicenter, observational cohort study, outcome after TEM-only (n = 41) and completion surgery (n = 40) following TEM for a pT2-3 rectal adenocarcinoma was compared. RESULTS: Median follow-up was 29 months for the TEM-only group and 31 months for the completion surgery group. Local recurrence rate was 35 and 11% for the TEM-only and completion surgery groups respectively. Distant metastasis occurred in 16% of the patients in both groups. The 3-year overall survival was 63% in the TEM-only group and 91% in the completion surgery group respectively. Three-year disease-specific survival was 91 versus 93% respectively. CONCLUSIONS: Although local recurrence after TEM-only for pT2-3 rectal cancer is worse compared to the recurrence that occurs after completion surgery, disease-specific survival is comparable between both groups. The lower unadjusted overall survival in the TEM-only group indicates that TEM-only may be a valid alternative in older and frail patients, especially when high morbidity of completion surgery is taken into consideration. Nevertheless, completion surgery should always be advised when curation is intended.

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.

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.

Evaluation of a Completion Total Mesorectal Excision in Patients After Local Excision of Rectal Cancer: A Word of Caution.

Background: According to Dutch guidelines, locally excised, low-risk, pT1 or ypT0-1 rectal cancer should not necessarily be followed by completion total mesorectal excision (cTME) in contrast to rectal cancers with higher T stages or unfavorable features. This study evaluated cTME after local excision at a national level with possible determinants for decision-making. Methods: All patients in the Dutch Colorectal Audit (DCRA) who underwent local excision of rectal cancer between 2012 and 2015 were included. Guideline adherence for performing cTME was determined with univariate and multivariate analyses to identify factors related to noncompliance. Results: According to the guidelines, of 530 included patients, cTME was indicated in 283 (53%), and among those, was performed in 82 (29%). Guideline adherence for performing cTME improved significantly (P<.001), from 10% in 2012 to 44% in 2015. Lower Charlson comorbidity index in patients with high-risk pT1 rectal cancer and younger patients (aged 61-70 years vs ≥80 years) with pT≥2 rectal cancer were associated with increased performance of cTME (odds ratio [OR], 13.50; 95% CI, 1.39-131.32, and OR, 6.25; 95% CI, 1.83-21.31, respectively). Conclusions: In this population-based study from the Netherlands, only a minority of patients underwent cTME after local excision of rectal cancer with pathologic features indicating the need for further treatment according to the guidelines. Although the percentage of patients undergoing cTME increased over time, the study indicated a tendency toward rectal-preserving treatment with potential oncologic risks.

Implementation of a New High-Volume Circular Stapler in Stapled Anopexy for Hemorrhoidal Disease: Is Patient's Short-Term Outcome Affected by a Higher Volume of Resected Tissue?

BACKGROUND: Stapled anopexy is a safe technique for the treatment of hemorrhoids but carries a higher risk of recurrence, which might be caused due to the limited volume of resected tissue. In this study, we investigated the introduction of a high-volume circular stapling device; in particular whether an increased amount of resected tissue could affect patients' short-term postoperative outcome. METHODS: Between 2011 and 2015, stapled anopexy was performed for hemorrhoids and/or anal prolapse in 141 patients (n = 25 conventional PPH-3©-stapler versus n = 116 high-volume CHEX©-stapler). In this prospectively collected dataset, operation details and short-term postoperative outcome were compared. RESULTS: With the high-volume stapler, a significantly higher amount of tissue was resected: 9.8 g (range 6.2-11.4) vs. 6.4 g (range 4.9-8.8) with the conventional stapler, p < 0.01. Postoperative short-term outcome did not differ in terms of readmission and complication rates. In all 5 patients who underwent a redo operation for residual hemorrhoids or prolapse, the high-volume stapler was used in the primary operation. CONCLUSION: A high-volume stapling device for stapled anopexy was introduced safely with a significantly higher amount of resected tissue without a worse short-term outcome. However, it remains unclear whether higher stapling volumes may lead to improved long-term outcome with less reinterventions.

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.

Transanal endoscopic surgery for complications of prior rectal surgery.

BACKGROUND: Long-term complications of previous rectal surgery (e.g., enterovisceral fistula, anastomotic stricture, rectal stenosis) can be challenging problems for which transabdominal or transperineal surgery with or without definitive fecal diversion is often required. Transanal endoscopic surgery (TES) might allow for local treatment of these complications, thereby saving patients from otherwise major surgery. PATIENTS AND METHODS: All patients undergoing TES in the IJsselland Hospital (NL) since 1996 were recorded in a prospective database, of which twenty patients were treated for complications after previous rectal surgery. Data on prior treatment, surgical techniques, outcomes, and need for additional surgery were collected. RESULTS: Twenty patients were identified from the database (rectourinary fistula n = 3, rectovaginal fistula n = 5, anastomotic stricture n = 8, and rectal stenosis n = 4). One of the three (33 %) rectourinary fistulas and two of five (40 %) rectovaginal fistulas were successfully treated with TES. Anastomotic strictures were successfully treated in 5/8 (63 %) patients. Strictures after local excision of rectal tumors were successfully treated in 3/4 (75 %) patients. No minor complication and one major complication occurred (rectovaginal fistula after stenoplasty eventually requiring Hartmann's procedure). CONCLUSIONS: Transanal treatment of anastomotic strictures, rectal stenosis, and fistula after prior rectal surgery is safe and effective in a large proportion of patients. TES should be considered as a first step in all patients presenting with these late complications after rectal surgery.

Transanal minimally invasive surgery: impact on quality of life and functional outcome.

BACKGROUND: Transanal minimally invasive surgery (TAMIS) is emerging as an alternative to transanal endoscopic microsurgery. Quality of life (QOL) and functional outcome are important aspects when valuing a new technique. The aim of this prospective study was to assess both functional outcome and QOL after TAMIS. METHODS: From 2011 to 2013, patients were prospectively studied prior to and at least 6 months after TAMIS for rectal adenomas and low-risk T1 carcinomas using a single-site laparoscopy port. Functional outcome was determined using the Faecal Incontinence Severity Index (FISI). Quality of life was measured using functional [Faecal Incontinence Quality of Life (FIQL)] and generic (EuroQol EQ-5D) questionnaires. RESULTS: The study population consisted of 24 patients 13 men, median age 59 (range 42-83) with 24 tumours [median distance from the dentate line 8 cm (range 2-17 cm); median tumour size 6 cm(2) (range 0.25-51 cm(2)); 20 adenomas; 4 low-risk T1 carcinomas]. Post-operative complications occurred in one patient (4 %; grade IIIb according to Clavien Dindo classification). Compared to baseline, FISI remained unaffected (9.8 vs 7.3; P = 0.26), FIQL remained unaffected, and EuroQol EQ-5D improved (EQ-VAS: 77 vs 83; P = 0.04). CONCLUSION: There was no detrimental effect of TAMIS on anorectal function. Overall QOL was improved after TAMIS, probably due to removal of the tumour, and at 6 months was equal to the general population.

Intramucosal carcinoma of the rectum can be safely treated with transanal endoscopic microsurgery; clinical support of the revised Vienna classification.

AIM: The revised Vienna criteria were proposed for classifying rectal neoplasia and subsequent treatment strategies. Restaging intramucosal carcinoma to a non-invasive subgroup seems logical, but clinical support is lacking. In this study, we investigated whether distinction between intramucosal carcinomas (IMC) and rectal adenoma (RA) is of clinical relevance and whether these neoplasms can all be similarly and safely treated by transanal endoscopic microsurgery (TEM). METHODS: All consecutive patients with IMC and RA, treated with TEM between 1996 and 2010 in tertiary referral centre for TEM were included. Long-term outcome of 88 IMC was compared to 356 pure rectal adenomas (RA). Local recurrence (LR) rate was the primary endpoint. Risk factors for LR were analysed. RESULTS: LR was diagnosed in 7/88 patients (8.0 %) with IMC and in 33/356 patients with primary RA (9.3 %; p = 0.700) and LR-free survival did not differ (p = 0.438). Median time to recurrence was 10 months (IQR IMC 5-30; RA 6-16). Overall recurrence occurred mainly in the first 3 years (38/40; 95 %). None of the LR revealed malignancy on pathological evaluation. No differences could be found in complication rates (IMC 9 %; RA 13 %; p = 0.34). Metastases did not occur in either group. Independent risk factors for LR were irradical margins at final histopathology (HR 2.32; 95 % CI 1.17-4.59; p = 0.016) and more proximal tumours (HR 0.84; 95 % CI 0.77-0.92; P = <0.001). CONCLUSION: In this study, IMC of the rectum and RA have similar recurrence rates. This supports the revised Vienna classification. Both entities can be safely treated with TEM.

Randomized controlled multicentre study comparing biological mesh closure of the pelvic floor with primary perineal wound closure after extralevator abdominoperineal resection for rectal cancer (BIOPEX-study).

BACKGROUND: Primary perineal wound closure after conventional abdominoperineal resection (cAPR) for rectal cancer has been the standard of care for many years. Since the introduction of neo-adjuvant radiotherapy and the extralevator APR (eAPR), oncological outcome has been improved, but at the cost of increased rates of perineal wound healing problems and perineal hernia. This has progressively increased the use of biological meshes, although not supported by sufficient evidence. The aim of this study is to determine the effectiveness of pelvic floor reconstruction using a biological mesh after standardized eAPR with neo-adjuvant (chemo)radiotherapy compared to primary perineal wound closure. METHODS/DESIGN: In this multicentre randomized controlled trial, patients with a clinical diagnosis of primary rectal cancer who are scheduled for eAPR after neo-adjuvant (chemo)radiotherapy will be considered eligible. Exclusion criteria are prior radiotherapy, sacral resection above S4/S5, allergy to pig products or polysorbate, collagen disorders, and severe systemic diseases affecting wound healing, except for diabetes. After informed consent, 104 patients will be randomized between standard care using primary wound closure of the perineum and the experimental arm consisting of suturing a biological mesh derived from porcine dermis in the pelvic floor defect, followed by perineal closure similar to the control arm. Patients will be followed for one year after the intervention and outcome assessors and patients will be blinded for the study treatment. The primary endpoint is the percentage of uncomplicated perineal wound healing, defined as a Southampton wound score of less than II on day 30. Secondary endpoints are hospital stay, incidence of perineal hernia, quality of life, and costs. DISCUSSION: The BIOPEX-study is the first randomized controlled multicentre study to determine the additive value of using a biological mesh for perineal wound closure after eAPR with neo-adjuvant radiotherapy compared to primary perineal wound closure with regard to perineal wound healing and the occurrence of perineal hernia. TRAIL REGISTRATION NUMBER: NCT01927497 (Clinicaltrial.gov).

Yield of routine molecular analyses in colorectal cancer patients ≤70 years to detect underlying Lynch syndrome.

Although early detection of Lynch syndrome (LS) is important, a considerable proportion of patients with LS remains unrecognized. We aimed to study the yield of LS detection by routine molecular analyses in colorectal cancer (CRC) patients until 70 years of age. We prospectively included consecutive CRC patients ≤70 years. Tumour specimens were analysed for microsatellite instability (MSI), immunohistochemical mismatch-repair protein expression and MLH1-promoter methylation. Tumours were classified as either: (a) likely caused by LS; (b) sporadic microsatellite-unstable (MSI-H); or (c) microsatellite-stable (MSS). Predictors of LS were determined by multivariable logistic regression. A total of 1117 CRC patients (57% males, median age 61 years) were included. Fifty patients (4.5%, 95% CI 3.4-5.9) were likely to have LS, and 71 had a sporadic MSI-H tumour (6.4%, 95% CI 5.1-8.0). Thirty-five patients likely to have LS (70%) were aged > 50 years. A molecular profile compatible with LS was detected in 10% (15/144) of patients aged ≤50, in 4% (15/377) of those aged 51-60 and in 3% (20/596) of patients > 61 years. Compared to MSS cases, patients likely to have LS were significantly younger (OR 3.9, 95% CI 1.7-8.7) and more often had right-sided CRCs (OR 14, 95% CI 6.0-34). In conclusion, molecular screening for LS in CRC patients ≤70 years leads to identification of a molecular profile compatible with LS in 4.5% of patients, with most of them not fulfilling the age criterion (≤50 years) routinely used for LS assessment. Routine use of MSI testing may be considered in CRC patients up to the age of 70 years, with a central role for the pathologist in the selection of patients.

Colorectal surgeons' learning curve of transanal endoscopic microsurgery.

BACKGROUND: Transanal endoscopic microsurgery (TEM) is a technically demanding key technique in minimally invasive rectal surgery. We investigated the learning curve of colorectal surgeons commencing with TEM. METHODS: All TEM procedures of four colorectal surgeons were analyzed. Procedures were ranked chronologically per surgeon. Outcomes included conversion, postoperative complications, procedure time, and recurrence. Backward multivariable regression analysis identified learning curve effects and other predictors. RESULTS: Four surgeons resected 693 rectal lesions [69.9 % adenoma/25.5 % carcinoma; median size 20 cm(2); interquartile range (IQR) 11-35; 7 ± 4 cm ab ano]. A total of 555 resections (80.1 %) were histopathologically radical (R0). Conversion (4.3 %) was influenced by a learning curve [odds ratio (OR) 0.991 per additional procedure; 95 % confidence interval (CI) 0.984-0.998] and by lesion size. Postoperative complications depended only on the individual surgeon and lesion size in benign lesions (10.4 % complications). A learning curve (OR 0.99; 95 % CI 0.988-0.998) and peritoneal entrance affected complications in malignant lesions (13.3 %). Procedure time [median 55 min (IQR 30-90)] was influenced by a learning curve [B -0.11 (95 % CI -0.14 to -0.09)], individual surgeon, single-piece resection, peritoneal entrance, lesion size, and rectal quadrant. Recurrence of benign lesions (4.5 %) depended on lesion size, R0 resection, and prior resection attempts. Recurrence of malignant lesions (8.9 %) depended on 3D stereoscopic view, lesion size, full-thickness resection, and length of follow-up. Recurrence-free survival of patients operated during the 36th through 80th procedure per surgeon was significantly shorter than in patients operated during procedures 1-35 and 81 onwards. CONCLUSIONS: A surgical learning curve affected conversion rate, procedure time, and complication rate. It did not influence recurrence rates, possibly due to evolving patient populations. This first insight into the learning curve of TEM stresses the importance of quality monitoring and centralisation of care.

Stromal vascular fraction with platelet-rich plasma injection during surgery is feasible and safe in treatment-refractory perianal fistulising Crohn's disease: A pilot study.

BACKGROUND: An unmet need remains for improved management in perianal fistulising Crohn's disease (pCD). Recently, local administration of adipose-derived cells has shown promising results. AIMS: To assess the safety and feasibility of injection of stromal vascular fraction (SVF) with platelet-rich plasma (PRP) in patients with pCD. METHODS: Patients ≥ 18 years with pCD were included and underwent fistula curettage, SVF with PRP injection, and closure of the internal opening. The primary endpoint was safety at 12 months. The secondary outcomes were complete radiological healing at 3 months (absence of fluid-containing tracts on MRI) and partial and complete clinical response at 3 and 12 months (closure of ≥1, respectively, all treated external opening(s)). RESULTS: Twenty-five patients were included (35 [IQR 25-40] years; 14 [56%] female); median CD duration 4 [IQR 2-8] years. Twenty-four (95%) patients had previously undergone fistula surgery. No adverse events were encountered at lipoharvesting sites. Two (8%) patients were readmitted to hospital and six (24%) underwent unplanned re-interventions. Post-operative MRI (n = 24) showed complete radiological healing in nine (37.5%) patients. Partial clinical response was present in 48% (12/25) at 3 months and in 68% (17/25) at 12 months, and complete clinical closure in five (20%) patients at 3 months and in 10 (40%) patients at 12 months. CONCLUSION: Injection with autologous SVF with PRP is feasible and safe in patients with treatment-refractory pCD. Early complete radiological healing was observed in more than one-third of patients, and clinical response in two-thirds of patients at 12 months.