Towards Response ADAptive Radiotherapy for organ preservation for intermediate-risk rectal cancer (preRADAR): protocol of a phase I dose-escalation trial.

INTRODUCTION: Organ preservation is associated with superior functional outcome and quality of life (QoL) compared with total mesorectal excision (TME) for rectal cancer. Only 10% of patients are eligible for organ preservation following short-course radiotherapy (SCRT, 25 Gy in five fractions) and a prolonged interval (4-8 weeks) to response evaluation. The organ preservation rate could potentially be increased by dose-escalated radiotherapy. Online adaptive magnetic resonance-guided radiotherapy (MRgRT) is anticipated to reduce radiation-induced toxicity and enable radiotherapy dose escalation. This trial aims to establish the maximum tolerated dose (MTD) of dose-escalated SCRT using online adaptive MRgRT. METHODS AND ANALYSIS: The preRADAR is a multicentre phase I trial with a 6+3 dose-escalation design. Patients with intermediate-risk rectal cancer (cT3c-d(MRF-)N1M0 or cT1-3(MRF-)N1M0) interested in organ preservation are eligible. Patients are treated with a radiotherapy boost of 2×5 Gy (level 0), 3×5 Gy (level 1), 4×5 Gy (level 2) or 5×5 Gy (level 3) on the gross tumour volume in the week following standard SCRT using online adaptive MRgRT. The trial starts on dose level 1. The primary endpoint is the MTD based on the incidence of dose-limiting toxicity (DLT) per dose level. DLT is a composite of maximum one in nine severe radiation-induced toxicities and maximum one in three severe postoperative complications, in patients treated with TME or local excision within 26 weeks following start of treatment. Secondary endpoints include the organ preservation rate, non-DLT, oncological outcomes, patient-reported QoL and functional outcomes up to 2 years following start of treatment. Imaging and laboratory biomarkers are explored for early response prediction. ETHICS AND DISSEMINATION: The trial protocol has been approved by the Medical Ethics Committee of the University Medical Centre Utrecht. The primary and secondary trial results will be published in international peer-reviewed journals. TRIAL REGISTRATION NUMBER: WHO International Clinical Trials Registry (NL8997; https://trialsearch.who.int).

Risk factors of postoperative intensive care unit admission during the COVID-19 pandemic: A multicentre retrospective cohort study.

Background: During the Coronavirus disease 2019 (COVID-19) pandemic, intensive care unit (ICU) capacity was scarce. Since surgical patients also require ICU admission, determining which factors lead to an increased risk of postoperative ICU admission is essential. This study aims to determine which factors led to an increased risk of unplanned postoperative ICU admission during the COVID-19 pandemic. Methods: This multicentre retrospective cohort study investigated all patients who underwent surgery between 9 March 2020 and 30 June 2020. The primary endpoint was the number of surgical patients requiring postoperative ICU admission. The secondary endpoint was to determine factors leading to an increased risk of unplanned postoperative ICU admission, calculated by multivariate analysis with odds ratios (OR's) and 95% confidence (CI) intervals. Results: One hundred eighty-five (4.6%) of the 4051 included patients required unplanned postoperative ICU admission. COVID-19 positive patients were at an increased risk of being admitted to the ICU compared to COVID-19 negative (OR 3.14; 95% CI 1.06-9.33; p = 0.040) and untested patients (OR 0.48; 95% CI 0.32-0.70; p = 0.001). Other predictors were male gender (OR 1.36; 95% CI 1.02-1.82; p = 0.046), body mass index (BMI) (OR 1.05; 95% CI 1.02-1.08; p = 0.001), surgical urgency and surgical discipline. Conclusion: A confirmed COVID-19 infection, male gender, elevated BMI, surgical urgency, and surgical discipline were independent factors for an increased risk of unplanned postoperative ICU admission. In the event of similar pandemics, postponing surgery in patients with an increased risk of postoperative ICU admission may be considered.

Patient- and physician-reported radiation-induced toxicity of short-course radiotherapy with a prolonged interval to surgery for rectal cancer.

AIM: A prolonged interval (>4 weeks) between short-course radiotherapy (25 Gy in five fractions) (SCRT-delay) and total mesorectal excision for rectal cancer has been associated with a decreased postoperative complication rate and offers the possibility of organ preservation in the case of a complete tumour response. This prospective cohort study systematically evaluated patient-reported bowel dysfunction and physician-reported radiation-induced toxicity for 8 weeks following SCRT-delay. METHOD: Patients who were referred for SCRT-delay for intermediate risk, oligometastatic or locally advanced rectal cancer were included. Repeated measurements were done for patient-reported bowel dysfunction (measured by the low anterior resection syndrome [LARS] questionnaire and categorized as no, minor or major LARS) and physician-reported radiation-induced toxicity (according to Common Terminology Criteria for Adverse Events version 4.0) before start of treatment (baseline), at completion of SCRT and 1, 2, 3, 4, 6 and 8 weeks thereafter. RESULTS: Fifty-one patients were included; 31 (61%) were men and the median age was 67 years (range 44-91). Patient-reported bowel dysfunction and physician-reported radiation-induced toxicity peaked at weeks 1-2 after completion of SCRT and gradually declined thereafter. Major LARS was reported by 44 patients (92%) at some time during SCRT-delay. Grade 3 radiation-induced toxicity was reported in 17 patients (33%) and concerned predominantly diarrhoea. No Grade 4-5 radiation-induced toxicity occurred. CONCLUSION: During SCRT-delay, almost every patient experiences temporary mild-moderate radiation-induced toxicity and major LARS, but life-threatening toxicity is rare. SCRT-delay is a safe alternative to SCRT-direct surgery that should be proposed when counselling rectal cancer patients on neoadjuvant strategies.

Functional Dyspepsia and Irritable Bowel Syndrome are Highly Prevalent in Patients With Gallstones and Are Negatively Associated With Outcomes After Cholecystectomy: A Prospective, Multicenter, Observational Study (PERFECT - Trial).

OBJECTIVE: To determine the prevalence of FD and IBS in patients eligible for cholecystectomy and to investigate the association between presence of FD/ IBS and resolution of biliary colic and a pain-free state. SUMMARY BACKGROUND DATA: More than 30% of patients with symptomatic cholecystolithiasis reports persisting pain postcholecystectomy. Coexistence of FD/IBS may contribute to this unsatisfactory outcome. METHODS: We conducted a multicenter, prospective, observational study (PERFECT-trial). Patients ≥18 years with abdominal pain and gallstones were included at 5 surgical outpatient clinics between 01/2018 and 04/2019. Follow-up was 6 months. Primary outcomes were prevalence of FD/IBS, and the difference between resolution of biliary colic and pain-free state in patients with and without FD/IBS. FD/IBS was defined by the Rome IV criteria, biliary colic by the Rome III criteria, and pain-free by an Izbicki Pain Score ≤10 and visual analogue scale ≤4. RESULTS: We included 401 patients with abdominal pain and gallstones (assumed eligible for cholecystectomy), mean age 52 years, 76% females. Of these, 34.9% fulfilled criteria for FD/IBS. 64.1% fulfilled criteria for biliary colic and 74.9% underwent cholecystectomy, with similar operation rates in patients with and without FD/IBS. Postcholecystectomy, 6.1% of patients fulfilled criteria for biliary colic, with no significant difference between those with and without FD/IBS at baseline (4.9% vs 8.6%, P = 0.22). Of all patients, 56.8% was pain-free after cholecystectomy, 40.7% of FD/IBS-group vs 64.4% of no FD/IBS-group, P < 0.001. CONCLUSIONS: One third of patients eligible for cholecystectomy fulfil criteria for FD/IBS. Biliary colic is reported by only a few patients postcholecys-tectomy, whereas nonbiliary abdominal pain persists in >40%, particularly in those with FD/IBS precholecystectomy. Clinicians should take these symptom-dependent outcomes into account in their shared decision-making process. TRIAL REGISTRATION: The Netherlands Trial Register NTR-7307. Registered on 18 June 2018.

Impact of Dose-Escalated Chemoradiation on Quality of Life in Patients With Locally Advanced Rectal Cancer: 2-Year Follow-Up of the Randomized RECTAL-BOOST Trial.

PURPOSE: Dose-escalated chemoradiation (CRT) for locally advanced rectal cancer did not result in higher complete response rates but initiated more tumor regression in the randomized RECTAL-BOOST trial (Clinicaltrials.gov NCT01951521). This study compared patient reported outcomes between patients who received dose-escalated CRT (5 × 3 gray boost + CRT) or standard CRT for 2 years after randomization. METHODS AND MATERIALS: Patients with locally advanced rectal cancer who were participating in the RECTAL-BOOST trial filled out European Organisation for Research and Treatment of Cancer QLQ-C30 and CR29 questionnaires on quality of life (QoL) and symptoms at baseline, 3, 6, 12, 18, and 24 months after start of treatment. Between-group differences in functional QoL domains were estimated using a linear mixed-effects model and expressed as effect size (ES). Symptom scores were compared using Mann-Whitney U test. RESULTS: Patients treated with dose-escalated CRT (boost group, n = 51) experienced a significantly stronger decline in global health at 3 and 6 months (ES -0.4 and ES -0.4), physical functioning at 6 months (ES -1.1), role functioning at 3 and 6 months (ES -0.8 and ES -0.6), and social functioning at 6 months (ES -0.6), compared with patients treated with standard CRT (control group, n = 64). The boost group reported significantly more fatigue at 3 and 6 months (83% vs 66% respectively 89% vs 76%), pain at 3 and 6 months (67% vs 36% respectively 80% vs 44%), and diarrhea at 3 months (45% vs 29%) compared with the control group. From 12 months onwards, QoL and symptoms were similar between groups, apart from more blood/mucus in stool in the boost group. CONCLUSIONS: In patients with locally advanced rectal cancer, dose-escalated CRT resulted in a transient deterioration in global health, physical, role, and social functioning and more pain, fatigue and diarrhea at 3 and 6 months after start of treatment compared with standard CRT. From 12 months onwards, the effect of dose-escalated CRT on QoL largely resolved.

Factors affecting 30-day postoperative complications after emergency surgery during the COVID-19 outbreak: A multicentre cohort study.

INTRODUCTION: Coronavirus disease 2019 (COVID-19) has influenced (surgical) care worldwide. Measures were taken to prioritize surgical care in order to maintain capacity for COVID-19 healthcare. However, the influence of these measures on emergency surgery is limited. Therefore, the aim of this study is to describe the trends in emergency surgery and determine the factors influencing the risk of postoperative complications during the first wave of the COVID-19 pandemic. METHODS: This multicentre retrospective cohort study investigated all emergency patients operated on from March 9th to June 30th, 2020. The primary endpoint was identifying the number of emergency surgical procedures performed. Secondary endpoints were determining the number of postoperative complications and factors determining the risk of postoperative complications, which were calculated by multivariate analysis with odds ratio (OR) and 95% confidence (CI) intervals. RESULTS: In total, 1399 patients who underwent an emergency surgical procedure were included. An increase in the number of emergency vascular and trauma surgical procedures occurred during the study period. In contrast, the number of emergency general and oncological surgical procedures performed remained stable. An increased age (OR 1.01, 95% CI 1.00-1.02; p = 0.024), American Society of Anaesthesiologists (ASA) (OR 1.34, 95% CI 1.09-1.64; p = 0.005), and surgical discipline were independent predictors for an increased risk of postoperative complications. CONCLUSION: The performance of emergency vascular and trauma surgical procedures increased. The performance of emergency general and oncological surgical procedures remained stable. In addition, increased age, ASA, and surgical discipline were independent predictors for an increased risk of postoperative complications.

Effect of the COVID-19 Pandemic on Surgical Breast Cancer Care in the Netherlands: A Multicenter Retrospective Cohort Study.

BACKGROUND: Coronavirus disease 2019 (COVID-19) has put a strain on regular healthcare worldwide. In the Netherlands, the national screening programs, including for breast cancer, were halted temporarily. This posed a challenge to breast cancer care, because ∼40% of cases are detected through national screening. Therefore, the aim of the present study was to evaluate the effects of the COVID-19 pandemic on the surgical care of patients with breast cancer in the Netherlands. MATERIALS AND METHODS: The present multicenter retrospective cohort study investigated the effects of COVID-19 on patients with breast cancer who had undergone surgery from March 9 to May 17, 2020. The primary endpoints were the number of surgical procedures performed during the study period, tumor characteristics, surgery type, and route of referral. The secondary endpoint was the incidence of postoperative complications during the study period. RESULTS: A total of 217 consecutive patients with breast cancer requiring surgery were included. We found an overall decrease in the number of patients with breast cancer who were undergoing surgery. The most significant decline was seen in surgery for T1-T2 and N0 tumors. A decline in the number of referrals from both the national screening program and general practitioners was observed. The incidence of postoperative complications remained stable during the study period. CONCLUSIONS: The temporary halt of the national screening program for breast cancer resulted in fewer surgical procedures during the study period and a pronounced decrease in surgery of the lower tumor stages.

Efficacy of Dose-Escalated Chemoradiation on Complete Tumor Response in Patients with Locally Advanced Rectal Cancer (RECTAL-BOOST): A Phase 2 Randomized Controlled Trial.

PURPOSE: Pathologic complete tumor response after chemoradiation in patients with locally advanced rectal cancer (LARC) is associated with a favorable prognosis and allows organ-sparing treatment strategies. In the RECTAL-BOOST trial, we aimed to investigate the effect of an external radiation boost to the tumor before chemoradiation on pathologic or sustained clinical complete tumor response in LARC. METHODS AND MATERIALS: This multicenter, nonblinded, phase 2 randomized controlled trial followed the trials-within-cohorts design, which is a pragmatic trial design allowing cohort participants to be randomized for an experimental intervention. Patients in the intervention group are offered the intervention (and can either accept or refuse this), whereas patients in the control group are not notified about the randomization. Participants of a colorectal cancer cohort referred for chemoradiation of LARC to either of 2 radiation therapy centers were eligible. Patients were randomized to no boost or an external radiation boost (5 × 3 Gy) without concurrent chemotherapy, directly followed by standard pelvic chemoradiation (25 × 2 Gy with concurrent capecitabine). The primary outcome was pathologic complete response (ie, ypT0N0) in patients with planned surgery at 12 weeks, or, as surrogate for pathologic complete response, a 2-year sustained clinical complete response for patients treated with an organ preservation strategy. Analyses were intention to treat. The study was registered with ClinicalTrials.gov, number NCT01951521. RESULTS: Between September 2014 and July 2018, 128 patients were randomized. Fifty-one of the 64 (79.7%) patients in the intervention group accepted and received a boost. Compared with the control group, fewer patients in the intervention group had a cT4 stage and a low rectal tumor (31.3% vs 17.2% and 56.3% vs 45.3%, respectively), and more patients had a cN2 stage (59.4% vs 70.3%, respectively). Rate of pathologic or sustained clinical complete tumor response was similar between the groups: 23 of 64 (35.9%; 95% confidence interval [CI], 24.3-48.9) in the intervention group versus 24 of 64 (37.5%; 95% CI, 25.7-50.5) in the control group (odds ratio [OR] = 0.94; 95% CI, 0.46-1.92). Near-complete or complete tumor regression was more common in the intervention group (34 of 49; 69.4%) than in the control group (24 of 53; 45.3%; (OR = 2.74, 95% CI 1.21-6.18). Grade ≥3 acute toxicity was comparable: 6 of 64 (9.4%) in the intervention group versus 5 of 64 (7.8%) in the control group (OR = 1.22; 95% CI, 0.35-4.22). CONCLUSIONS: Dose escalation with an external radiation therapy boost to the tumor before neoadjuvant chemoradiation did not increase the pathologic or sustained clinical complete tumor response rate in LARC.

Health-related quality of life in rectal cancer patients undergoing neoadjuvant chemoradiation with delayed surgery versus short-course radiotherapy with immediate surgery: a propensity score-matched cohort study.

BACKGROUND: Neoadjuvant chemoradiation with delayed surgery (CRT-DS) and short-course radiotherapy with immediate surgery (SCRT-IS) are two commonly used treatment strategies for rectal cancer. However, the optimal treatment strategy for patients with intermediate-risk rectal cancer remains a discussion. This study compares quality of life (QOL) between SCRT-IS and CRT-DS from diagnosis until 24 months after treatment. METHODS: In a prospective colorectal cancer cohort, rectal cancer patients with clinical stage T2-3N0-2M0 undergoing SCRT-IS or CRT-DS between 2013 and 2017 were identified. QOL was assessed using EORTC-C30 and EORTC-CR29 questionnaires before the start of neoadjuvant treatment (baseline) and at 3, 6, 12, 18 and 24 months after. Patients were 1:1 matched using propensity sore matching. Between- and within-group differences in QOL domains were analyzed with linear mixed-effects models. Symptoms and sexual interest at 12 and 24 months were compared using logistic regression models. RESULTS: 156 of 225 patients (69%) remained after matching. The CRT-DS group reported poorer emotional functioning at 3, 6, 12, 18 and 24 months (mean difference with SCRT-IS: -9.4, -12.1, -7.3, -8.0 and -7.9 respectively), and poorer global health, physical-, role-, social- and cognitive functioning at 6 months (mean difference with SCRT-IS: -9.1, -9.8, -14.0, -9.2 and -12.6, respectively). Besides emotional functioning, all QOL domains were comparable at 12, 18 and 24 months. Within-group changes showed a significant improvement of emotional functioning after baseline in the SCRT-IS group, whereas only a minor improvement was observed in the CRT-DS group. Symptoms and sexual interest in male patients at 12 and 24 months were comparable between the groups. CONCLUSIONS: In rectal cancer patients, CRT-DS may induce a stronger decline in short-term QOL than SCRT-IS. From 12 months onwards, QOL domains, symptoms and sexual interest in male patients were comparable between the groups. However, emotional functioning remained higher after SCRT-IS than after CRT-DS.

Effect of Neoadjuvant Therapy and Rectal Surgery on Health-related Quality of Life in Patients With Rectal Cancer During the First 2 Years After Diagnosis.

INTRODUCTION: Rectal cancer surgery with neoadjuvant therapy is associated with substantial morbidity. The present study describes the course of quality of life (QOL) in rectal cancer patients in the first 2 years after the start of treatment. PATIENTS AND METHODS: We performed a prospective study within a colorectal cancer cohort including rectal cancer patients who were referred for neoadjuvant chemoradiation or short-course radiotherapy and underwent rectal surgery. QOL was assessed using the European Organization for Research and Treatment of Cancer core questionnaire (EORTC QLQ-C30) and colorectal cancer questionnaire (EORTC QLQ-CR29) before treatment and after 3, 6, 12, 18, and 24 months. The outcomes were compared with the QOL scores from the Dutch general population and stratified by low anterior resection and abdominoperineal resection. Postoperative bowel dysfunction after low anterior resection was measured using the low anterior resection syndrome score. RESULTS: Of the 324 patients, 272 (84%) responded to at least 2 questionnaires and were included in the present study. Compared with pretreatment levels, the strongest decline was observed in physical, role, and social functioning at 3 and 6 months after the start of treatment. Global health and cognitive functioning declined to a lesser extend, and emotional functioning gradually improved over the time. Within 24 months, the QOL scores had recovered toward the pretreatment levels in most patients. Compared with the general population, physical, role, social, and cognitive functioning and symptoms of fatigue and insomnia remained significantly worse in patients on longer-term. After low anterior resection, major bowel dysfunction was reported by 44% to 60% of the patients. Increasing urinary incontinence and severe complaints of impotence were observed in patients who had undergone abdominoperineal resection. CONCLUSION: Rectal cancer treatment is associated with a significant decline in QOL during the first 6 months after the diagnosis. Within 2 years, most patients return toward pretreatment functioning but could still experience poorer functioning and treatment-related symptoms compared with the general population. These findings support shared decision-making and emphasize the need for postoperative supportive care and novel treatment approaches.

[Ileo-anal pouch for inflammatory intestinal disease]. / Ileo-anale pouch voor inflammatoir darmlijden.

The surgical treatment of choice for ulcerative colitis is colectomy followed by ileostomy or the construction of an ileo-anal pouch, which results in an improvement in quality of life. The pouch can be constructed in one operation after a total colectomy or in two steps: first, constructing an ileostomy after a subtotal colectomy and second, constructing the pouch after a proctectomy. The most common pouch-related diseases include surgical complications such as abscesses, fistulas and leaks, and inflammatory complications like pouchitis, cuffitis and Crohn's disease of the pouch. The most important diagnostic tool to differentiate between the often difficult to distinguish pouch-related diseases is a pouchoscopy. There are no evidence-based treatment strategies for pouch-related diseases due to the lack of large randomized placebo-controlled trials. Pouch-related diseases can lead to pouch failure which may require surgical reintervention with revision or excision of the pouch.

The ileo neo rectal anastomosis: long-term results of surgical innovation in patients after ulcerative colitis and familial adenomatous polyposis.

PURPOSE: Restorative proctocolectomy with ileo neo rectal anastomosis (INRA) combines cure of ulcerative colitis (UC) or familial adenomatous polyposis (FAP) with restoration of intestinal continuity. Evaluation of long-term results was needed to determine if there is a place for INRA in the armamentarium of a surgeon besides the ileal pouch anal anastomosis (IPAA). METHODS: All patients with INRA were included in the analysis. Patient demographics and clinical and follow-up data (morbidity, dietary problems, defecation frequency, fecal continence, anal and neorectal physiology, and neorectal mucosa assessment) were registered prospectively. RESULTS: Seventy-nine patients were enrolled, and in 58 patients (50 UC, 8 FAP), INRA was successful. In 21 patients, intraoperative conversion to IPAA was needed. In 49 patients with INRA, a functional reservoir was achieved. No pelvic sepsis or bladder or sexual dysfunction occurred. Thirteen patients experienced episodes of reservoir inflammation. Median bowel movements of six (5, 8) with a nocturnal defecation frequency of one were recorded with fecal continence or minor incontinence. Anal manometry and neorectal physiology showed a decrease in resting pressure and an increase in squeeze pressure and maximum tolerated volume. The median follow-up was 8.1 years (6.7, 10.1). CONCLUSIONS: This is an example of a surgical innovation with a theoretical potential to be superior to the current technique. This potential was not confirmed in short- and long-term evaluations. Hence, IPAA is currently the best available alternative to a conventional ileostomy.

Stages and evaluation of surgical innovation: a clinical example of the ileo neorectal anastomosis after ulcerative colitis and familial adenomatous polyposis.

AIM: So far, not many clinical examples that follow the IDEAL (Idea, Development, Evaluation, Assessment, and Long-term study) recommendations for evaluating and reporting surgical innovation and adoption are available. METHODS: In this article, all IDEAL stages will be described for a recent surgical innovation, the ileo neorectal anastomosis (INRA), a procedure restoring intestinal continuity after colectomy. RESULTS: INRA showed that the technique of small-bowel transposition with a vascular pedicle is feasible, with good long-term results. From the patient's point of view, no distinct advantage for INRA was found, with morbidity and functional results being in range with the gold standard ileal pouch anal anastomosis. CONCLUSION: The adoption of the IDEAL recommendations-that is, by performing evidence-based surgical studies-will improve surgical science, with the consequence that progress in surgical care continues and interventions become safer and more efficient and allow a better quality of life in surgical patients.

[Primary torsion of the omentum majus]. / Primaire torsie van het omentum majus.

BACKGROUND: Primary torsion of the omentum majus is a rare condition. The clinical picture can mimic other causes of acute abdominal pain. The condition is therefore often not recognised and the diagnosis is made only perioperatively. CASE DESCRIPTION: A 32-year-old man visited the emergency department with acute abdominal pain. During surgery, the pain turned out to be caused by an ischaemic segment of the omentum majus, resulting in torsion. In retrospect, the patient had been suffering from recurrent attacks of similar abdominal pain for years without a satisfactory diagnosis. CONCLUSION: In any patient with episodes of recurrent, localised, stabbing abdominal pain, possibly related to exercise and without any other clear diagnosis, the diagnosis 'torsion of the omentum majus' should be considered.

Open versus laparoscopic (assisted) ileo pouch anal anastomosis for ulcerative colitis and familial adenomatous polyposis.

BACKGROUND: Restorative proctocolectomy with ileo pouch anal anastomosis (IPAA) is the main surgical treatment for patients with ulcerative colitis (UC) and familial adenomatous polyposis (FAP). With the advancements of minimal-invasive surgery this demanding operation is increasingly being performed laparoscopically. Therefore, the presumed benefits of the laparoscopic approach need to be systematically evaluated. OBJECTIVES: To compare the beneficial and harmful effects of laparoscopic versus open IPAA for patients with UC and FAP. SEARCH STRATEGY: We searched The Cochrane IBD/FBD Group Specialized Trial Register (April 2007), The Cochrane Library (Issue 1, 2007), MEDLINE (1990 to April 2007), EMBASE (1990 to April 2007), ISI Web of Knowledge (1990 to April 2007) and the web casts of the American Society of Colon and Rectal Surgeons (ASCRS) (up to 2006) for all trials comparing open versus laparoscopic IPAA. SELECTION CRITERIA: All trials in patients with UC or FAP comparing any kind of laparoscopic IPAA versus open IPAA. No language limitations were applied. DATA COLLECTION AND ANALYSIS: Two authors independently performed selection of trials and data extraction. The methodological quality of all included trials was evaluated to assess bias risk. Analysis of RCTs and non-RCTs was performed separately. Analyses were based on the intention-to-treat principle. Authors were requested additional information in case of missing data. Sensitivity and subgroup analyses were performed if appropriate. MAIN RESULTS: Eleven trials included 607 patients of whom 253 (41%) in the laparoscopic IPAA group. Only one of the included trials was a randomised controlled trial. There were no significant differences in mortality or complications between the two groups. Reoperation and readmission rates were not significantly different. Operative time was significantly longer in the laparoscopic group both in the RCT and meta-analysis of non-RCTs (weighted mean difference (WMD) 91 minutes; 95% Confidence Interval (CI) 53 to 130). There were no significant differences between the two groups regarding postoperative recovery parameters. Total incision length was significantly shorter in the laparoscopic group, while two trials evaluating cosmesis found significantly higher cosmesis scores in the laparoscopic group. Other long-term outcomes were poorly reported. AUTHORS' CONCLUSIONS: The laparoscopic IPAA is a feasible and safe procedure. Short-term advantages of the laparoscopic approach seem to be limited and their clinical significance is arguable. Large high-quality trials focusing on differences regarding specific postoperative complications, cosmesis, quality of life and costs are needed.