Two Days Versus Five Days of Postoperative Antibiotics for Complex Appendicitis: Cost Analysis of a Randomized, Noninferiority Trial.

OBJECTIVE: To compare costs for 2 days versus 5 days of postoperative antibiotics within the antibiotics after an aPPendectomy In Complex appendicitis trial.Background:Recent studies suggest that restrictive antibiotic use leads to a significant reduction in hospital stays without compromising patient safety. Its potential effect on societal costs remains underexplored. METHODS: This was a pragmatic, open-label, multicenter clinical trial powered for noninferiority. Patients with complex appendicitis (age ≥ 8 years) were randomly allocated to 2 days or 5 days of intravenous antibiotics after appendectomy. Patient inclusion lasted from June 2017 to June 2021 in 15 Dutch hospitals. The final follow-up was on September 1, 2021. The primary trial endpoint was a composite endpoint of infectious complications and mortality within 90 days. In the present study, the main outcome measures were overall societal costs (comprising direct health care costs and costs related to productivity loss) and cost-effectiveness. Direct health care costs were recorded based on data in the electronic patient files, complemented by a telephone follow-up at 90 days. In addition, data on loss of productivity were acquired through the validated Productivity Cost Questionnaire at 4 weeks after surgery. Cost estimates were based on prices for the year 2019. RESULTS: In total, 1005 patients were evaluated in the "intention-to-treat" analysis: 502 patients were allocated to the 2-day group and 503 to the 5-day group. The mean difference in overall societal costs was - €625 (95% CI: -€ 958 to -€ 278) to the advantage of the 2-day group. This difference was largely explained by reduced hospital stay. Productivity losses were similar between the study groups. Restricting postoperative antibiotics to 2 days was cost-effective, with estimated cost savings of €31,117 per additional infectious complication. CONCLUSIONS: Two days of postoperative antibiotics for complex appendicitis results in a statistically significant and relevant cost reduction, as compared with 5 days. Findings apply to laparoscopic appendectomy in a well-resourced health care setting.

2 days versus 5 days of postoperative antibiotics for complex appendicitis: a pragmatic, open-label, multicentre, non-inferiority randomised trial.

BACKGROUND: The appropriate duration of postoperative antibiotics for complex appendicitis is unclear. The increasing global threat of antimicrobial resistance warrants restrictive antibiotic use, which could also reduce side-effects, length of hospital stay, and costs. METHODS: In this pragmatic, open-label, non-inferiority trial in 15 hospitals in the Netherlands, patients with complex appendicitis (aged ≥8 years) were randomly assigned (1:1) to receive 2 days or 5 days of intravenous antibiotics after appendicectomy. Randomisation was stratified by centre, and treating physicians and patients were not masked to treatment allocation. The primary endpoint was a composite endpoint of infectious complications and mortality within 90 days. The main outcome was the absolute risk difference (95% CI) in the primary endpoint, adjusted for age and severity of appendicitis, with a non-inferiority margin of 7·5%. Outcome assessment was based on electronic patient records and a telephone consultation 90 days after appendicectomy. Efficacy was analysed in the intention-to-treat and per-protocol populations. Safety outcomes were analysed in the intention-to-treat population. This trial was registered with the Netherlands Trial Register, NL5946. FINDINGS: Between April 12, 2017, and June 3, 2021, 13 267 patients were screened and 1066 were randomly assigned, 533 to each group. 31 were excluded from intention-to-treat analysis of the 2-day group and 30 from the 5-day group owing to errors in recruitment or consent. Appendicectomy was done laparoscopically in 955 (95%) of 1005 patients. The telephone follow-up was completed in 664 (66%) of 1005 patients. The primary endpoint occurred in 51 (10%) of 502 patients analysed in the 2-day group and 41 (8%) of 503 patients analysed in the 5-day group (adjusted absolute risk difference 2·0%, 95% CI -1·6 to 5·6). Rates of complications and re-interventions were similar between trial groups. Fewer patients had adverse effects of antibiotics in the 2-day group (45 [9%] of 502 patients) than in the 5-day group (112 [22%] of 503 patients; odds ratio [OR] 0·344, 95% CI 0·237 to 0·498). Re-admission to hospital was more frequent in the 2-day group (58 [12%] of 502 patients) than in the 5-day group (29 [6%] of 503 patients; OR 2·135, 1·342 to 3·396). There were no treatment-related deaths. INTERPRETATION: 2 days of postoperative intravenous antibiotics for complex appendicitis is non-inferior to 5 days in terms of infectious complications and mortality within 90 days, based on a non-inferiority margin of 7·5%. These findings apply to laparoscopic appendicectomy conducted in a well resourced health-care setting. Adopting this strategy will reduce adverse effects of antibiotics and length of hospital stay. FUNDING: The Netherlands Organization for Health Research and Development.

Oncological Safety and Potential Cost Savings of Routine vs Selective Histopathological Examination After Appendectomy: Results of the Multicenter, Prospective, Cross-Sectional FANCY Study.

OBJECTIVE: To investigate the oncological safety and potential cost savings of selective histopathological examination after appendectomy. BACKGROUND: The necessity of routine histopathological examination after appendectomy has been questioned, but prospective studies investigating the safety of a selective policy are lacking. METHODS: In this multicenter, prospective, cross-sectional study, inspection and palpation of the (meso)appendix was performed by the surgeon in patients with suspected appendicitis. The surgeon's opinion on additional value of histopathological examination was reported before sending all specimens to the pathologist. Main outcomes were the number of hypothetically missed appendiceal neoplasms with clinical consequences benefiting the patient (upper limit two-sided 95% confidence interval below 3:1000 considered oncologically safe) and potential cost savings after selective histopathological examination. RESULTS: Seven thousand three hundred thirty-nine patients were included. After a selective policy, 4966/7339 (67.7%) specimens would have been refrained from histopathological examination. Appendiceal neoplasms with clinical consequences would have been missed in 22/4966 patients. In 5/22, residual disease was completely resected during additional surgery. Hence, an appendiceal neoplasm with clinical consequences benefiting the patient would have been missed in 1.01:1000 patients (upper limit 95% confidence interval 1.61:1000). In contrast, twice as many patients (10/22) would not have been exposed to potential harm due to re-resections without clear benefit, whereas consequences were neither beneficial nor harmful in the remaining seven. Estimated cost savings established by replacing routine for selective histopathological examination were €725,400 per 10,000 patients. CONCLUSIONS: Selective histopathological examination after appendectomy for suspected appendicitis is oncologically safe and will likely result in a reduction of pathologists' workload, less costs, and fewer re-resections without clear benefit.

Impact of a diverting ileostomy in total mesorectal excision with primary anastomosis for rectal cancer.

BACKGROUND: The role of diverting ileostomy in total mesorectal excision (TME) for rectal cancer with primary anastomosis is debated. The aim of this study is to gain insight in the clinical consequences of a diverting ileostomy, with respect to stoma rate at one year and stoma-related morbidity. METHODS: Patients undergoing TME with primary anastomosis for rectal cancer between 2015 and 2017 in eleven participating hospitals were included. Retrospectively, two groups were compared: patients with or without diverting ileostomy construction during primary surgery. Primary endpoint was stoma rate at one year. Secondary endpoints were severity and rate of anastomotic leakage, overall morbidity rate within thirty days and stoma (reversal) related morbidity. RESULTS: In 353 out of 595 patients (59.3%) a diverting ileostomy was constructed during primary surgery. Stoma rate at one year was 9.9% in the non-ileostomy group and 18.7% in the ileostomy group (p = 0.003). After correction for confounders, multivariate analysis showed that the construction of a diverting ileostomy during primary surgery was an independent risk factor for stoma at one year (OR 2.563 (95%CI 1.424-4.611), p = 0.002). Anastomotic leakage rate was 17.8% in the non-ileostomy group and 17.2% in the ileostomy group (p = 0.913). Overall 30-days morbidity rate was 37.6% in the non-ileostomy group and 56.1% in the ileostomy group (p < 0.001). Stoma reversal related morbidity rate was 17.9%. CONCLUSIONS: The stoma rate at one year was higher in patients with ileostomy construction during primary surgery. The incidence and severity of anastomotic leakage were not reduced by construction of an ileostomy. The morbidity related to the presence and reversal of a diverting ileostomy was substantial.

Assessment of microcirculatory changes in local tissue oxygenation after revascularization for peripheral arterial disease with the Hyperview®, a portable hyperspectral imaging device.

OBJECTIVES: The Hyperview® is a hyperspectral camera, which can be used to assess the microcirculation of patients with peripheral arterial disease (PAD) and/or diabetes mellitus (DM). It measures local tissue oxygenation in concentrations of oxyhemoblobin (OXY), deoxyhemoglobin (DEOXY), and O2-saturation (O2-SAT) in arbitrary units. The aim of this validation study is to assess whether the Hyperview® is able to monitor microcirculatory changes after revascularization in patients with PAD. METHODS: In this prospective observational cohort study, 50 patients with PAD were included who were scheduled for endovascular, hybrid, or open revascularization. The ankle-brachial index (ABI), systolic toe pressure (TP) (in case of DM), and a set of Hyperview® measurements of the plantar region were recorded before and after treatment. Changes in pre- and postoperative measurements were assessed with the paired t-test. RESULTS: Some 38 patients underwent endovascular revascularization and eight patients underwent hybrid or open vascular surgical revascularization. After revascularization, the ABI improved from 0.58 to 0.80 (p < 0.001). OXY increased from 72.6 to 77.8 (p = 0.134). DEOXY decreased from 69.1 to 55.0 (p < 0.001). O2-SAT increased from 51.3 to 58.1 (p < 0.001). TP improved from 50.6 to 61.9 mmHg (p = 0.065) but was measured in only 16 patients. CONCLUSION: The Hyperview® is able to observe changes in the microcirculation after revascularization in terms of DEOXY and O2-SAT. The results of this study are a promising step into the validation of the Hyperview®.

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.

Safety and economic analysis of selective histopathology following cholecystectomy: multicentre, prospective, cross-sectional FANCY study.

BACKGROUND: There is ongoing debate concerning the necessity of routine histopathological examination following cholecystectomy. In order to reduce the pathology workload and save costs, a selective approach has been suggested, but evidence regarding its oncological safety is lacking. METHODS: In this multicentre, prospective, cross-sectional study, all gallbladders removed for gallstone disease or cholecystitis were systematically examined by the surgeon for macroscopic abnormalities indicative of malignancy. Before sending all specimens to the pathologist, the surgeon judged whether histopathological examination was indicated. The main outcomes were the number of patients with hypothetically missed malignancy with clinical consequences (upper limit two-sided 95 per cent c.i. below 3:1000 considered oncologically safe) and potential cost savings of selective histopathological examination. RESULTS: Twenty-two (2.19:1000) of 10 041 specimens exhibited malignancy with clinical consequences. In case of a selective policy, surgeons would have held back 7846 of 10041 (78.1 per cent) gallbladders from histopathological examination. Malignancy with clinical consequences would have been missed in seven of 7846 patients (0.89:1000, upper limit 95% c.i. 1.40:1000). No patient benefitted from the clinical consequences, while two were harmed (futile additional surgery). Of 15 patients in whom malignancy with clinical consequences would have been diagnosed, one benefitted (residual disease radically removed), two potentially benefitted (palliative systemic therapy), and four experienced harm (futile additional surgery). Estimated cost savings established by replacing routine for selective histopathological examination were €703 500 per 10 000 patients. CONCLUSION: Selective histopathological examination following cholecystectomy is oncologically safe and could reduce pathology workload, costs, and futile re-resections.

Antibiotic prophylaxis for acute cholecystectomy: PEANUTS II multicentre randomized non-inferiority clinical trial.

BACKGROUND: Guidelines recommending antibiotic prophylaxis at emergency cholecystectomy for cholecystitis were based on low-quality evidence. The aim of this trial was to demonstrate that omitting antibiotics is not inferior to their prophylactic use. METHODS: This multicentre, randomized, open-label, non-inferiority clinical trial randomly assigned adults with mild-to-moderate acute calculous cholecystitis (immediate cholecystectomy indicated) to 2 g cefazolin administered before incision or no antibiotic prophylaxis. The primary endpoint was a composite of all postoperative infectious complications in the first 30 days after surgery. Secondary endpoints included all individual components of the primary endpoint, other morbidity, and duration of hospital stay. RESULTS: Sixteen of 226 patients (7.1 per cent) in the single-dose prophylaxis group and 29 of 231 (12.6 per cent) in the no-prophylaxis group developed postoperative infectious complications (absolute difference 5.5 (95 per cent c.i. -0.4 to 11.3) per cent). With a non-inferiority margin of 10 per cent, non-inferiority of no prophylaxis was not proven. The number of surgical-site infections was significantly higher in the no-prophylaxis group (5.3 versus 12.1 per cent; P = 0.010). No differences were observed in the number of other complications, or duration of hospital stay. CONCLUSION: Omitting antibiotic prophylaxis is not recommended.

Accuracy of imaging in discriminating complicated from uncomplicated appendicitis in daily clinical practice.

BACKGROUND: Radiologic imaging can accurately diagnose acute appendicitis, but little is known about its discriminatory capacity between complicated and uncomplicated appendicitis. OBJECTIVE: This study aims to investigate the accuracy of imaging in discriminating complicated from uncomplicated appendicitis. METHODS: Data was used from the prospective, nationwide, observational SNAPSHOT appendicitis database, including patients with suspected acute appendicitis who were planned for an appendectomy. Usage of ultrasound (US), CT, MRI or a combination was recorded. Radiological reports were used to group for complicated or uncomplicated appendicitis. The reference standard was based on operative and pathological findings. Primary outcomes were sensitivity and specificity in discriminating complicated from uncomplicated appendicitis. Secondary outcomes were diagnostic accuracy results per imaging modality and for the subgroups age, BMI, and sex. RESULTS: Preoperative imaging was performed in 1964 patients. In 1434 patients (73%), only US was used; in 109 (6%) patients, only CT was used; and 421 (21%) patients underwent US followed by CT or MRI. Overall, imaging workup as practiced, following the national guideline, had a poor sensitivity for complicated appendicitis of only 35%, although specificity was as high as 93%. For US, accuracy for complicated appendicitis was higher in children than in adults; sensitivity 41.2% vs. 26.4% and specificity 94.6% vs. 93.4%, respectively, p = 0.003. For relevant subgroups such as age, sex and BMI, no other differences in the discriminatory performance were found. CONCLUSION: A diagnostic workup with stepwise imaging, using a conditional CT or MRI strategy, poorly discriminates between complicated and uncomplicated appendicitis in daily practice.

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

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

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.

Postoperative Outcomes of Patients With Nonperforated Gangrenous Appendicitis: A National Multicenter Prospective Cohort Analysis.

BACKGROUND: Controversy exists regarding the use of postoperative antibiotics for nonperforated gangrenous appendicitis. OBJECTIVE: The aim of this study was to evaluate the rate of postoperative infectious complications and the effect of postoperative antibiotic use among patients with nonperforated gangrenous appendicitis. DESIGN: This was a prospective cohort study conducted during 2 months. SETTINGS: A national multicenter observational study was conducted in 62 Dutch hospitals. PATIENTS: All of the consecutive patients who had surgery for suspected acute appendicitis were included. Patients were excluded if no appendectomy was performed or appendectomy was performed for pathology other than acute appendicitis. MAIN OUTCOMES MEASURES: Type of appendicitis was categorized as phlegmonous, gangrenous, or perforated. The primary end point was the rate of infectious complications (intra-abdominal abscess and surgical site infection) within 30 days after appendectomy. Univariable and multivariable logistic regression analyses were performed to identify predictors of infectious complications. RESULTS: A total of 1863 patients were included: 1321 (70.9%) with phlegmonous appendicitis, 181 (9.7%) with gangrenous appendicitis, and 361 (19.4%) with perforated appendicitis. Infectious complications were more frequent in patients with gangrenous versus phlegmonous appendicitis (7.2% vs 3.8%; p = 0.03). This association was no longer statistically significant in multivariable analysis (OR = 1.09 (95% CI, 0.49-2.44)). There was no significant difference in infectious complications between ≤24 hours (n = 57) of postoperative antibiotics compared with >24 hours (n = 124; 3.6% vs 8.9%; p = 0.35) in patients with gangrenous appendicitis. LIMITATIONS: Possible interobserver variability in the intraoperative classification of appendicitis was a study limitation. CONCLUSIONS: Patients with nonperforated gangrenous appendicitis are at higher risk of infectious complications than patients with phlegmonous appendicitis, yet gangrenous disease is not an independent risk factor. Postoperative antibiotic use over 24 hours was not associated with decreased infectious complications. See Video Abstract at http://links.lww.com/DCR/A1000. RESULTADOS POSTOPERATORIOS DE PACIENTES CON APENDICITIS GANGRENOSA NO PERFORADA: UN ANÁLISIS DE COHORTE PROSPECTIVO MULTICÉNTRICO NACIONAL:: Existe controversia sobre el uso de antibióticos postoperatorios para la apendicitis gangrenosa no perforada.El objetivo de este estudio fue evaluar la tasa de complicaciones infecciosas postoperatorias y el efecto del uso de antibióticos postoperatorios en pacientes con apendicitis gangrenosa no perforada.Estudio de cohorte prospectivo realizado durante dos meses.Estudio observacional multicéntrico nacional en 62 hospitales holandeses.Todos los pacientes consecutivos sometidos a cirugía por sospecha de apendicitis aguda. Los pacientes fueron excluidos si no se realizó una apendicectomía o si se realizó una apendicectomía para otra patología que no fuera la apendicitis aguda.El tipo de apendicitis se clasificó como flegmonosa, gangrenosa o perforada. El criterio de valoración primario fue la tasa de complicaciones infecciosas (absceso intraabdominal e infección en el sitio quirúrgico) dentro de los 30 días posteriores a la apendicectomía. Se realizaron análisis de regresión logística univariables y multivariables para identificar predictores de complicaciones infecciosas.Se incluyeron un total de 1863 pacientes: 1321 (70,9%) con apendicitis flegmonosa, 181 (9,7%) con apendicitis gangrenosa y 361 (19,4%) con apendicitis perforada. Las complicaciones infecciosas fueron más frecuentes en pacientes con apendicitis gangrenosa frente a flegmonosa (7,2% frente a 3,8%, p = 0,03). Esta asociación ya no fue estadísticamente significativa en el análisis multivariable (OR 1,09; IC del 95%: 0,49 a 2,44). No hubo diferencias significativas en las complicaciones infecciosas entre ≤ 24 h (n = 57) de los antibióticos postoperatorios en comparación con> 24 h (n = 124) (3,6% vs. 8,9%, p = 0,35) en pacientes con apendicitis gangrenosa.Posible variabilidad interobservador en la clasificación intraoperatoria de la apendicitis.Los pacientes con apendicitis gangrenosa no perforada tienen un mayor riesgo de complicaciones infecciosas que los pacientes con apendicitis flegmonosa, aunque la enfermedad gangrenosa no es un factor de riesgo independiente. El uso de antibióticos postoperatorios durante 24 horas no se asoció con una disminución de las complicaciones infecciosas. Vea el Resumen del Video en http://links.lww.com/DCR/A1000.

Propensity Score Adjusted Comparison of Pelviperineal Morbidity With and Without Omentoplasty Following Abdominoperineal Resection for Primary Rectal Cancer.

BACKGROUND: Abdominoperineal resection is associated with a high incidence of perineal complications, and whether this is reduced by an omentoplasty is still unclear. OBJECTIVE: This study aimed to investigate the impact of omentoplasty on pelviperineal morbidity in patients undergoing abdominoperineal resection for rectal cancer. DESIGN: This was a retrospective comparative cohort study using propensity score analyses to reduce potential confounding. SETTING: The study was undertaken in 2 teaching hospitals and 1 university hospital. PATIENTS: Patients who underwent abdominoperineal resection for primary rectal cancer between 2000 and 2017 were included. MAIN OUTCOME MEASURES: The main end points were primary perineal wound healing at 30 days and overall and specific pelviperineal morbidity until the end of the study period. RESULTS: Among 254 included patients, 106 had an omentoplasty. The primary perineal wound healing rate at 30 days was similar for omentoplasty and no omentoplasty (65% vs 60%; p = 0.422), also after adjusting for potential confounding by propensity score analysis (OR, 0.89; 95% CI, 0.45-1.75). Being free from any pelviperineal complication at 6 months (75% vs 79%; p = 0.492), absence of any pelviperineal morbidity until 1 year (54% vs 49%; p = 0.484), and incidence of persistent perineal sinus (6% vs 10%; p = 0.256) were also similar in both groups. The unadjusted higher perineal hernia rate after omentoplasty (18% vs 7%; p = 0.011) did not remain statistically significant after regression analysis including the propensity score (OR, 1.34; 95% CI, 0.46-3.88). Complications related to the omentoplasty itself were observed in 8 patients, of whom 6 required reoperation. LIMITATIONS: This study was limited by the retrospective and nonrandomized design causing some heterogeneity between the 2 cohorts. CONCLUSION: In this multicenter study using propensity score analyses, the use of omentoplasty did not lower the incidence or the duration of pelviperineal morbidity in patients undergoing abdominoperineal resection for rectal cancer, and omentoplasty itself was associated with a risk of reoperation. See Video Abstract at http://links.lww.com/DCR/A918.

Outcome After Redo Surgery for Complicated Colorectal and Coloanal Anastomosis: A Systematic Review.

BACKGROUND: When a colorectal or coloanal anastomosis fails because of persistent leakage or stenosis, or the anastomosis has to be resected for recurrent cancer, constructing a new anastomosis might be an option in selected patients. This is a rare and complex type of redo surgery. OBJECTIVE: The aim of this review was to evaluate the current literature on redo anastomosis for complicated colorectal or coloanal anastomosis. DATA SOURCES: A systematic literature search of MEDLINE, EMBASE, the Cochrane Library, the PROSPERO register, clinicaltrials.gov, and the World Health Organization International Clinical Trials Registry Platform database was performed. STUDY SELECTION: Two reviewers independently screened the available literature. All studies reporting on redo surgery and aiming at reconstruction of a prior low colorectal or coloanal anastomosis for any indication were included. MAIN OUTCOME MEASURES: Primary outcome was successful restoration of continuity. Secondary outcomes were postoperative morbidity, pelvic sepsis, incontinence, and mortality. RESULTS: Nine studies were included, comprising 291 patients, of whom 76% had index surgery for colorectal cancer. Pooled proportions showed an overall success rate of 79% (95% CI, 69-86), with a pooled incidence of major postoperative morbidity of 16% (95% CI, 10-24). The pooled pelvic sepsis rate was 16% (95% CI, 9-27), and the pooled surgical reintervention and readmission rates were 11% (95% CI, 8-17) and 7% (95% CI, 3-15). Five studies reported on incontinence, with a pooled proportion of 17% (95% CI, 10-26). LIMITATIONS: The limitations of this review are the lack of randomized controlled trials and high-quality studies, and the small sample sizes and heterogeneous patient populations in the included studies. CONCLUSIONS: Redo surgery is a valuable treatment option for the complicated colorectal or coloanal anastomosis with 79% successful restoration of bowel continuity in the published literature from experienced tertiary centers.

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

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

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

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

Endoloops or endostapler use in laparoscopic appendectomy for acute uncomplicated and complicated appendicitis : No difference in infectious complications.

BACKGROUND: The most appropriate closure for the appendicular stump with either endoloops or an endostapler in laparoscopic appendectomy remains unclear and under debate because of limited and conflicting evidence. METHODS: In a 2-month prospective, observational, resident-led nationwide cohort study, patients undergoing laparoscopic appendectomy for both uncomplicated and complicated appendicitis were analysed. Logistic regression analyses were performed for identifying the possible effect of stump closure type and other risk factors for infectious complications. RESULTS: Laparoscopic appendectomy for acute appendicitis was performed in 1369 patients in 62 hospitals; endoloops were used in 76.7 % and an endostapler in other patients. Median operating time was not different between endoloop and endostapler use (42.0 vs. 44.0 min, P = 0.243). A superficial surgical site infection was seen in 2.0 % after uncomplicated appendicitis and in 0.8 % after complicated appendicitis. The intra-abdominal abscess rate was 1.9 % after uncomplicated and 11.0 % after complicated appendicitis. No significant effect of stump closure type was observed for any infectious complication (OR 1.05; 95 % CI 0.625-1.766, P = 0.853) or an intra-abdominal abscess (OR OR 0.96; 95 % CI 0.523-1.768, P = 0.899). In multivariable analysis, complicated appendicitis was identified as the only independent risk factor for an intra-abdominal abscess (OR 6.26; 95 % CI 3.454-11.341, P < 0.001). CONCLUSIONS: The infectious complication rate is not influenced by the type of appendicular stump closure with either endoloops or an endostapler in this study. If technically feasible, closure with endoloops is advised for cost considerations.

Laparoscopic appendectomy for chronic right lower quadrant abdominal pain.

PURPOSE: The appendix can be a rare cause for chronic right lower quadrant abdominal pain (RLQAP), even though no objective disorder can be determined to the appendix. This condition can be described as chronic appendicitis or (neurogenic) appendicopathy. After careful selection, elective appendectomy is performed in our centre for this group of patients. METHODS: All patients that underwent an elective appendectomy between 2006 and 2013 were prospectively analysed. Inclusion criterion was chronic RLQAP without abnormalities seen on imaging. Exclusion criterion was pain after conservative treatment of (complicated) appendicitis or an abnormal appendix on imaging like a mass, mucocoele or faecolith. Primary outcome was the effect on the pain postoperatively. RESULTS: In the period of the study, ten patients met the inclusion criteria and underwent an appendectomy for chronic RLQAP. Average preoperative pain score assessed with visual analogue scale (VAS) was 8.6. Preoperative work-up showed no abnormalities. No macroscopic abnormalities were seen during surgery in any of the patients. Histopathological analysis was obtained and showed limited abnormalities in eight of ten patients, mostly suspicion of previous inflammation. Postoperatively, no complications occurred, and at revision after 3 weeks, average VAS was 1.0. Long-term follow-up showed that patients remained free of symptoms; average VAS after a median of 33 months was 1.0. CONCLUSIONS: A significant reduction of pain was achieved after an appendectomy in all patients suffering from chronic RLQAP in this series. Seven out of ten patients were completely free of pain.

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

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