Bowel preparation for elective colorectal resection: multi-treatment machine learning analysis on 6241 cases from a prospective Italian cohort.

BACKGROUND: Current evidence concerning bowel preparation before elective colorectal surgery is still controversial. This study aimed to compare the incidence of anastomotic leakage (AL), surgical site infections (SSIs), and overall morbidity (any adverse event, OM) after elective colorectal surgery using four different types of bowel preparation. METHODS: A prospective database gathered among 78 Italian surgical centers in two prospective studies, including 6241 patients who underwent elective colorectal resection with anastomosis for malignant or benign disease, was re-analyzed through a multi-treatment machine-learning model considering no bowel preparation (NBP; No. = 3742; 60.0%) as the reference treatment arm, compared to oral antibiotics alone (oA; No. = 406; 6.5%), mechanical bowel preparation alone (MBP; No. = 1486; 23.8%), or in combination with oAB (MoABP; No. = 607; 9.7%). Twenty covariates related to biometric data, surgical procedures, perioperative management, and hospital/center data potentially affecting outcomes were included and balanced into the model. The primary endpoints were AL, SSIs, and OM. All the results were reported as odds ratio (OR) with 95% confidence intervals (95% CI). RESULTS: Compared to NBP, MBP showed significantly higher AL risk (OR 1.82; 95% CI 1.23-2.71; p = .003) and OM risk (OR 1.38; 95% CI 1.10-1.72; p = .005), no significant differences for all the endpoints were recorded in the oA group, whereas MoABP showed a significantly reduced SSI risk (OR 0.45; 95% CI 0.25-0.79; p = .008). CONCLUSIONS: MoABP significantly reduced the SSI risk after elective colorectal surgery, therefore representing a valid alternative to NBP.

Laparoscopic Eradication of Deep Endometriosis With Segmental Rectosigmoid Resection and Bilateral Posterior Parametrectomy With Nerve-sparing "Touchless" Technique According to the "Negrar Method".

OBJECTIVE: To demonstrate nerve-sparing laparoscopic eradication of deep endometriosis with rectal and parametrial resection based on the Negrar method [1] using the "touchless" technique. DESIGN: Stepwise video case demonstration with narration. SETTING: Tertiary level endometriosis unit. The patient was a 28 year-old nulliparous patient referred for surgery with persistent dysmenorrhea, dyspareunia, and dyschezia despite medical management (progestin-containing hormonal pills). Preoperative ultrasound demonstrated bilateral endometriomas, diffuse adenomyosis, and 35 mm × 17 mm stenosing rectal nodule. Histopathology confirmed 60% stenosis of the rectum secondary to the endometriotic nodule up to submucosal layer with margins free of endometriosis. She was discharged 7 days postoperatively with no postoperative complications. INTERVENTIONS: Laparoscopic nerve-sparing eradication of deep endometriosis with segmental rectosigmoid resection and bilateral posterior parametrectomy [2] according to the "Negrar method" with nerve-sparing "touchless" technique, sliding the nerve bundles laterocaudally, and keeping intact the visceral pelvic fascia covering them, thus without direct contact with the nerves. CONCLUSION: In our experience, based on more than 3000 of these procedures [3], this nerve-sparing procedure, based on identifying the nerves and their laterocaudad dissection, without a direct impact on their fibers but just on their fascial envelopes has proven successful in lowering the rates of postoperative dysfunctions and neural impairment related to neuro-apraxia and edema that occurs by directly affecting them [1]. Although there are no robust data to demonstrate benefit of "touchless" nerve-sparing dissection techniques, neuro-apraxia from compression of neural fibers that has been observed can be minimized [1,4,5].

Early Quality of Life Assessment After Segmental Colorectal Resection for Deep Infiltrating Endometriosis.

STUDY OBJECTIVE: Endometriosis is a benign condition afflicting women of reproductive age that significantly impacts their quality of life (QoL). Given its debilitating symptoms and prevalence, it is essential to define its proper management. In this study, we have assessed patient-reported outcomes among women having undergone segmental colorectal resection for deep infiltrating endometriosis. Any correlation between preoperative nutritional status and overall postoperative complications has also been analyzed. STUDY DESIGN: Prospective observational study. SETTING: Public medical center. PATIENTS: One hundred forty consecutive patients that had undergone segmental colorectal resection for DIE between November 2020 and October 2021 at IRCCS Sacro Cuore Don Calabria Hospital of Negrar of Valpolicella (Verona, Italy). INTERVENTIONS: Patient-reported outcomes were measured using data collected from the MD Anderson Symptom Inventory for gastrointestinal surgery patients and Euro-QoL Group EQ-5D-5L (EQ-5Q-5L) questionnaires, which were administered preoperatively (T0), at discharge (T1) and at 4 to 6 weeks after surgery (T2). Nutritional status was examined through the Mini Nutritional Assessment Short form and Prognostic Nutritional Index. MEASUREMENTS AND MAIN RESULTS: A significant improvement in the EQ-5Q-5L and MDASI-GI scores was noted between T0 and T2 (p <. 001 and p <. 001, respectively.) No statistically significant differences were found in scores at T2 between patients who had experienced postoperative complications and those who had not. No statistically significant association was observed between the presence of malnutrition and overall postoperative complications and their severity. CONCLUSION: This study confirms, through patient-reported outcomes, the pivotal role of surgery in improving the QoL at 4 to 6 weeks of women affected by endometriosis who have previously been unresponsive to medical therapy.

"A Space Odyssey" on Laparoscopic Segmental Rectosigmoid Resection for Deep Endometriosis: A Seventeen-year Retrospective Analysis of Outcomes and Postoperative Complications among 3050 Patients Treated in a Referral Center.

STUDY OBJECTIVE: To evaluate the feasibility of laparoscopic rectosigmoid resection for bowel endometriosis (RSE), reporting surgical and short-term postoperative outcomes in a consecutive large series of patients. DESIGN: A retrospective cohort study. SETTING: Third-level national referral center for deep endometriosis (DE). PATIENTS: 3050 patients with symptomatic RSE requiring surgical treatment. INTERVENTIONS: Nerve-sparing laparoscopic resection for RSE perfomed by a multidisciplinary team. After collecting intraoperative surgical characteristics, postoperative complications were collected by evaluating the risk factors associated with their onset. MEASUREMENTS AND MAIN RESULTS: Clavien-Dindo IIIb postoperative complications were noted in 13.1% of patients, with anastomotic leakage and rectovaginal fistula accounting for 3.0% and 1.9%, respectively. Postoperative bladder impairment was observed in 13.9% of patients during hospital discharge but spontaneously decreased to 4.5% at the first evaluation after 30 days, alongside a statistically significant change towards global symptom improvement. Multivariate analyses were done to identify the risk factors for segmental bowel resection in terms of occurrence of postoperative major complications. Ultralow (≤5 cm from the anal verge), low rectal anastomosis (<8 cm, >5 cm), parametrectomy, vaginal resection, and previous surgeries seemed more related to anastomotic leakage, rectovaginal fistula, and bladder retention. CONCLUSIONS: Laparoscopic rectosigmoid resection for RSE seems an effective and feasible procedure. The surgical complication rate is not negligible but could be reduced by implementing a multidisciplinary approach, an endless improvement in nerve-sparing techniques and surgical anatomy, as well as technological enhancements. Real future challenges will be to reduce the time for the first diagnosis of DE and the likelihood of surgical indications.

Laparoscopic colorectal resection for deep infiltrating endometriosis: can we reliably predict anastomotic leakage and major postoperative complications in the early postoperative period?

BACKGROUND: Anastomotic leakage (AL) and major complications after colorectal resection for deep infiltrating endometriosis (DIE) have a remarkable impact on patient outcomes. The aim of this study is to assess the predictive value of C-reactive protein (CRP), procalcitonin (PCT), white blood cell count (WBCs) and the Dutch Leakage Score (DLS) as reliable markers in the early diagnosis of AL and major complications after laparoscopic colorectal resection for DIE. METHODS: 262 consecutive women undergoing laparoscopic colorectal resection for DIE between September 2017 and September 2018 were prospectively enrolled. WBCs, CRP, PCT and DLS were recorded at baseline and on postoperative day (POD) 2, 3 and 6 then statistically analyzed as predictors of AL and severe postoperative complications. RESULTS: The AL rate was 3.2%. The major morbidity rate was 11.2%. No postoperative mortality was recorded. The postoperative trend of DLS and serum levels of CRP and PCT, but not WBCs, were significantly higher in women developing AL and severe complications. DLS had better sensitivity and specificity than biomarkers on all postoperative days as a predictor of AL and major complications. CRP and PCT have a low positive predictive value (PPV) and a high negative predictive value (NPV) for AL and major complications on POD3 and POD6. The risk of malnutrition was significantly related to AL. CONCLUSIONS: The combination of DLS as a standardized postoperative clinical monitoring system and CRP and PCT as serum biomarkers, allows the exclusion of AL and major complications in the early postoperative period after laparoscopic colorectal resection for DIE, thus ensuring a safe patient discharge.

"The Sword in the Stone": radical excision of deep infiltrating endometriosis with bowel shaving-a single-centre experience on 703 consecutive patients.

BACKGROUND: Laparoscopic segmental bowel resection, disc excision and rectal shaving are described as surgical options for the treatment of bowel endometriosis, but the gold standard has not yet established. The aim of the study is to investigate the efficacy of the laparoscopic bowel shaving technique in terms of pain symptomatology and to analyse early and late postoperative complications. METHODS: Retrospective cohort study of a series of 703 consecutive patients treated between January 2014 and December 2019 in a tertiary care referral centre. All patients underwent laparoscopic bowel shaving with concomitant radical excision of DIE. RESULTS: Bilateral posterolateral parametrectomy and ureterolysis were performed, respectively, in 314 (44.7%) and 318 cases (45.2%). A radical hysterectomy was performed in 107 cases (82.9%). Postoperative complications were infrequent: 17 patients required a reoperation (2.4%) and in this subgroup we registered 2 rectovaginal fistulas (0.3%), 4 patients received blood transfusion (0.6%), 12 patients (1.7%) experienced postoperative fever, 6 patients experienced impaired bladder voiding (0.9%) after 6 months. Median follow-up was 14 months. The study reported good clinical and surgical results, with a regression of symptoms (p < 0.0001) and an overall rate of recurrence of 6.5%. Clinical and instrumental criteria of bowel endometriosis relapse were exclusively detected in 5 patients (0.8%). Eleven patients (1.7%) with relapsed endometriosis were reoperated. CONCLUSIONS: Bowel shaving is a feasible and valuable surgical procedure. It is only the last step of a complex surgery which is aimed to minimize the residual quote of infiltrating nodule and requires a multidisciplinary team to achieve optimal treatment preoperatively, intraoperatively and postoperatively.

ERAS program adherence-institutionalization, major morbidity and anastomotic leakage after elective colorectal surgery: the iCral2 multicenter prospective study.

BACKGROUND: Enhanced recovery after surgery (ERAS) programs influence morbidity rates and length of stay after colorectal surgery (CRS), and may also impact major complications and anastomotic leakage rates. A prospective multicenter observational study to investigate the interactions between ERAS program adherence and early outcomes after elective CRS was carried out. METHODS: Prospective enrolment of patients submitted to elective CRS with anastomosis in 18 months. Adherence to 21 items of ERAS program was measured upon explicit criteria in every case. After univariate analysis, independent predictors of primary endpoints [major morbidity (MM) and anastomotic leakage (AL) rates] were identified through logistic regression analyses including all significant variables, presenting odds ratios (OR). RESULTS: Institutional ERAS protocol was declared by 27 out of 38 (71.0%) participating centers. Median overall adherence to ERAS program items was 71.4%. Among 3830 patients included in the study, MM and AL rates were 4.7% and 4.2%, respectively. MM rates were independently influenced by intra- and/or postoperative blood transfusions (OR 7.79, 95% CI 5.46-11.10; p < 0.0001) and standard anesthesia protocol (OR 0.68, 95% CI 0.48-0.96; p = 0.028). AL rates were independently influenced by male gender (OR 1.48, 95% CI 1.06-2.07; p = 0.021), intra- and/or postoperative blood transfusions (OR 4.29, 95% CI 2.93-6.50; p < 0.0001) and non-standard resections (OR 1.49, 95% CI 1.01-2.22; p = 0.049). CONCLUSIONS: This study disclosed wide room for improvement in compliance to several ERAS program items. It failed to detect any significant association between institutionalization and/or adherence rates to ERAS program with primary endpoints. These outcomes were independently influenced by gender, intra- and postoperative blood transfusions, non-standard resections, and standard anesthesia protocol.

Management and 1-year outcomes of anastomotic leakage after elective colorectal surgery.

PURPOSE: To analyze different types of management and one-year outcomes of anastomotic leakage (AL) after elective colorectal resection. METHODS: All patients with anastomotic leakage after elective colorectal surgery with anastomosis (76/1,546; 4.9%), with the exclusion of cases with proximal diverting stoma, were followed-up for at least one year. Primary endpoints were as follows: composite outcome of one-year mortality and/or unplanned intensive care unit (ICU) admission and additional morbidity rates. Secondary endpoints were as follows: length of stay (LOS), one-year persistent stoma rate, and rate of return to intended oncologic therapy (RIOT). RESULTS: One-year mortality rate was 10.5% and unplanned ICU admission rate was 30.3%. Risk factors of the composite outcome included age (aOR = 1.08 per 1-year increase, p = 0.002) and anastomotic breakdown with end stoma at reoperation (aOR = 2.77, p = 0.007). Additional morbidity rate was 52.6%: risk factors included open versus laparoscopic reoperation (aOR = 4.38, p = 0.03) and ICU admission (aOR = 3.63, p = 0.05). Median (IQR) overall LOS was 20 days (14-26), higher in the subgroup of patients reoperated without stoma. At 1 year, a stoma persisted in 32.0% of patients, higher in the open (41.2%) versus laparoscopic (12.5%) reoperation group (p = 0.04). Only 4 out of 18 patients (22.2%) were able to RIOT. CONCLUSION: Mortality and/or unplanned ICU admission rates after AL are influenced by increasing age and by anastomotic breakdown at reoperation; additional morbidity rates are influenced by unplanned ICU admission and by laparoscopic approach to reoperation, the latter also reducing permanent stoma and failure to RIOT rates. TRIAL REGISTRATION: ClinicalTrials.gov # NCT03560180.

Nerve-sparing laparoscopic disc excision of deep endometriosis involving the bowel: a single-center experience on 371 consecutives cases.

BACKGROUND: Bowel endometriosis is the most common pattern of Deep Endometriosis (DE). Arising from the posterior portion of the cervix and spreading to the recto-vaginal septum, utero-sacral and parametrial ligaments could lead to a distortion of normal pelvic anatomy, causing pain and infertility. Hormonal therapy is the first-line treatment in non-symptomatic patient. Conversely, laparoscopic surgical treatment has to be considered when symptoms relief are not optimal or with signs of bowel occlusion. METHODS: Retrospective experience of consecutive series of patients who referred to a third-level referral center with suspected bowel DE and failure of multiple medical treatments. After an intraoperative evaluation of nodule size with a rectal shaving of its external portion, patients underwent radical DE eradication with concomitant disc excision in rectal nodules < 3 cm with no signs of substantial full-thickness infiltration. RESULTS: A total of 371 patients were considered eligible for analysis, with a median age of 37 years. The median operative time of was 180 min, with an estimated blood loss of 100 mL and a median diameter of removed rectal nodule of 25 mm. Early postoperative procedure-related complications were 47 cases of acute rectal bleeding (12.7%), that were managed by rectal endoscopy, 3 bowel anastomotic dehiscence (0.8%), 8 hemoperitoneum (2.2%) and 3 ureteral fistula (0.8%). 22 patients experienced postoperative hyperpyrexia (5.9%), while 17 women underwent transient bladder deficiency (4.6%). Median follow-up was 60 months with a bowel recurrence rate of 2.2%. There was an improvement of all symptoms in the immediate postoperative follow-up (p < 0.0001). Among all patients with childbearing desire, the pregnancy rate found was 42.2% and was obtained by in vitro fertilization (IVF) techniques in 32% of cases. CONCLUSIONS: Laparoscopic disc excision for bowel endometriosis is an effective surgical treatment in selected residual rectal nodules < 3.0 cm. The concomitant radical DE excision contributes to a significant improvement of symptoms with an acceptable complications' rate.

ICG fluorescence imaging in colorectal surgery: a snapshot from the ICRAL study group.

BACKGROUND: Fluorescence-guided visualization is a recently proposed technology in colorectal surgery. Possible uses include evaluating perfusion, navigating lymph nodes and searching for hepatic metastases and peritoneal spread. Despite the absence of high-level evidence, this technique has gained considerable popularity among colorectal surgeons due to its significant reliability, safety, ease of use and relatively low cost. However, the actual use of this technique in daily clinical practice has not been reported to date. METHODS: This survey was conducted on April 2020 among 44 centers dealing with colorectal diseases and participating in the Italian ColoRectal Anastomotic Leakage (iCral) study group. Surgeons were approximately equally divided based on geographical criteria from multiple Italian regions, with a large proportion based in public (89.1%) and nonacademic (75.7%) centers. They were invited to answer an online survey to snapshot their current behaviors regarding the use of fluorescence-guided visualization in colorectal surgery. Questions regarding technological availability, indications and techniques, personal approaches and feelings were collected in a 23-item questionnaire. RESULTS: Questionnaire replies were received from 37 institutions and partially answered by 8, as this latter group of centers do not implement fluorescence technology (21.6%). Out of the remaining 29 centers (78,4%), fluorescence is utilized in all laparoscopic colorectal resections by 72.4% of surgeons and only for selected cases by the remaining 27.6%, while 62.1% of respondents do not use fluorescence in open surgery (unless the perfusion is macroscopically uncertain with the naked eye, in which case 41.4% of them do). The survey also suggests that there is no agreement on dilution, dosing and timing, as many different practices are adopted based on personal judgment. Only approximately half of the surgeons reported a reduced leak rate with fluorescence perfusion assessment, but 65.5% of them strongly believe that this technique will become a minimum requirement for colorectal surgery in the future. CONCLUSION: The survey confirms that fluorescence is becoming a widely used technique in colorectal surgery. However, both the indications and methods still vary considerably; furthermore, the surgeons' perceptions of the results are insufficient to consider this technology essential. This survey emphasizes the need for further research to reach recommendations based on solid scientific evidence.

Correction to: Standard (8 weeks) vs long (12 weeks) timing to minimally-invasive surgery after NeoAdjuvant Chemoradiotherapy for rectal cancer: a multicenter randomized controlled parallel group trial (TiMiSNAR).

Following publication of the original article [1], the authors reported that the family name of the author, Ludovica Baldari, was misspelled.

Endometriosis Involving the Diaphragm: A Patient-Tailored Minimally Invasive Surgical Treatment.

BACKGROUND: Diaphragmatic endometriosis is a rare presentation of endometriosis and no standardized technique for surgical treatment is available so far. We aim to verify and describe feasibility, safety and post-operative outcomes of patients affected by diaphragmatic endometriosis treated with a minimally invasive video-assisted thoracic approach. METHODS: We prospectively collected data of all patients we operated on at our Institution for diaphragmatic endometriosis between 2015 and 2019. We included all patients with a previous histological diagnosis of pelvic or abdominal endometriosis who have complained chronic thoracic pain or who had two or more episodes of pneumothorax with or without radiological evidence of pleural and diaphragmatic endometriosis. RESULTS: During the study period, we operated on 22 patients, 20 on the right side, one on the left side and one bilaterally. Indication for surgery was based on symptoms and/or radiological evidence of diaphragmatic disease. Diaphragm was resected and reconstructed according to intraoperative findings; in 11 cases, an additional mesh was used to reinforce the suture. According to our experience with VATS, we shift from an open approach to a uniportal VATS technique. CONCLUSIONS: Surgery for diaphragmatic endometriosis can be safely performed using a minimally invasive VATS approach, which is feasible and safe even when more extensive diaphragmatic resections are required, and it allows a lower post-operative pain compared to the open approach. Moreover, uniportal VATS approach guarantees similar outcomes with better cosmetic results.

Total laparoscopic bladder resection in the management of deep endometriosis: "take it or leave it." Radicality versus persistence.

BACKGROUND: Bladder endometriosis (BE) is the most common external site of deep-infiltrating endometriosis (DIE) affecting the urinary tract. Frequently associated with other DIE lesions, it can be strongly related to a ventral spread of adenomyosis. Possible symptoms are urinary frequency, tenesmus and hematuria, and they are frequently related to DIE of the posterior and lateral compartment. Hormonal therapy can be used in non-symptomatic patients; conversely, in other cases surgical treatment is the management of choice. METHODS: Retrospective cohort study of a series of consecutive patients treated between September 2004 and December 2017 in a tertiary care referral center. Only full-thickness detrusor involvement was considered as BE. All patients underwent laparoscopic bladder resection with concomitant radical excision of DIE. RESULTS: BE was found in 264 patients and was associated with simultaneous bowel DIE requiring bowel resection in 140 patients (53%). Twenty-five patients (9.5%) had associated obstructive ureteral signs requiring ureteroneocystostomy. Mean hospital stay and time of catheter removal were 9.7 and 9.1 days, respectively. Postoperative major complications (< 28 days) were observed in 19 patients (7.2%). Follow-up was performed at 1, 6 and 12 months after surgery, with a 2.3% recurrence rate observed. CONCLUSIONS: Laparoscopic partial cystectomy for BE is a feasible and safe technique, and experienced laparoscopic surgeons should consider it the gold standard treatment. Surgical eradication leads to excellent surgical outcomes in terms of reduction of symptoms and recurrence rates, considering the need to maintain an adenomyotic uterus for fertility purposes.

Hybrid Laparoscopic and Endovascular Treatment for Median Arcuate Ligament Syndrome: Case Report and Review of Literature.

Median arcuate ligament syndrome is a rare cause of chronic gastrointestinal ischemia caused by compression of median arcuate ligament on the celiac trunk. A 38-year-old male presented at our institution with unspecific crampy abdominal pain. After several diagnostic examinations, he firstly underwent arcuate ligament resection by laparoscopic approach and 2 months later, he underwent percutaneous transluminal angioplasty with stenting of the stenotic vessel. Postoperatory and follow-up controls showed regular patency of the artery with complete relief of abdominal symptoms. We propose a review of the literature on this uncommon condition, describing different surgical approaches.

A comparative analysis between radiation dose intensification and conventional fractionation in neoadjuvant locally advanced rectal cancer: a monocentric prospective observational study.

PURPOSE: The potential role of neoadjuvant radiation dose intensification in locally advanced rectal cancer (LARC) is still largely debated. In the present study, a comparative analysis between radiation dose intensification and conventional fractionation was performed. MATERIALS AND METHODS: In the current prospective observational study (protocol ID RT-03/2011), 56 patients diagnosed with LARC were enrolled between January 2013 and December 2016. More specifically, 25 patients underwent preoperative conventional radiation dose [i.e., 50.4 Gy in 28 fractions here defined as standard dose radiotherapy (SDR)-group 1], whereas 31 patients were candidate for radiation dose intensification (RDI) (i.e., 60 Gy in 30 fractions-group 2). The primary endpoint was the complete pathological response (pCR) rate. Secondary endpoints were postoperative complications and ChT-RT-related toxicity. RESULTS: No statistical significance was observed in pCR rate (20.8% and 22.6% in SDR and RDI group, respectively, p = 0.342). Of contrast, the RDI group showed a significantly higher primary tumor downstaging in case of T3 tumor compared to SDR group (p = 0.049). Sphincter-preserving surgery was 84% and 93.5% in SDR and RDI groups, respectively (p = 0.25). All patients had R0 margins. No surgical-related death was recorded. No statistically significant difference was observed regarding surgical complications and incomplete mesorectal excision. Acute genitourinary toxicity was significantly higher in RDI group (p = 0.015). CONCLUSIONS: The intensification of the neoadjuvant radiotherapy for LARC seems to produce a major pathological response in T3 tumors. The radiation dose intensification appears probably associated with a higher rate of genitourinary toxicity.

Standard (8 weeks) vs long (12 weeks) timing to minimally-invasive surgery after NeoAdjuvant Chemoradiotherapy for rectal cancer: a multicenter randomized controlled parallel group trial (TiMiSNAR).

BACKGROUND: The optimal timing of surgery in relation to chemoradiation is still controversial. Retrospective analysis has demonstrated in the recent decades that the regression of adenocarcinoma can be slow and not complete until after several months. More recently, increasing pathologic Complete Response rates have been demonstrated to be correlated with longer time interval. The purpose of the trial is to demonstrate if delayed timing of surgery after neoadjuvant chemoradiotherapy actually affects pathologic Complete Response and reflects on disease-free survival and overall survival rather than standard timing. METHODS: The trial is a multicenter, prospective, randomized controlled, unblinded, parallel-group trial comparing standard and delayed surgery after neoadjuvant chemoradiotherapy for the curative treatment of rectal cancer. Three-hundred and forty patients will be randomized on an equal basis to either robotic-assisted/standard laparoscopic rectal cancer surgery after 8 weeks or robotic-assisted/standard laparoscopic rectal cancer surgery after 12 weeks. DISCUSSION: To date, it is well-know that pathologic Complete Response is associated with excellent prognosis and an overall survival of 90%. In the Lyon trial the rate of pCR or near pathologic Complete Response increased from 10.3 to 26% and in retrospective studies the increase rate was about 23-30%. These results may be explained on the relationship between radiation therapy and tumor regression: DNA damage occurs during irradiation, but cellular lysis occurs within the next weeks. Study results, whether confirmed that performing surgery after 12 weeks from neoadjuvant treatment is advantageous from a technical and oncological point of view, may change the current pathway of the treatment in those patient suffering from rectal cancer. TRIAL REGISTRATION: ClinicalTrials.gov NCT3465982.

Colorectal Anastomotic Stenosis: Lessons Learned after 1643 Colorectal Resections for Deep Infiltrating Endometriosis.

STUDY OBJECTIVE: To evaluate the incidence, risk factors, and treatment of colorectal anastomotic stenosis in patients who undergo rectosigmoid resection for deep infiltrating endometriosis (DIE). DESIGN: Retrospective analysis of a prospective database (Canadian Task Force classification III). SETTING: Public medical center. PATIENTS: All women who underwent laparoscopic rectosigmoid resections for DIE at our hospital between January 2002 and December 2016. INTERVENTION: All patients were evaluated clinically and endoscopically at 1 month and 3 months after bowel resection. Stenosis was defined as a lack of passage through the anastomosis of a 12-mm proctoscope. Symptomatic stenosis was defined as the presence of endoscopically confirmed stricture accompanied by at least 2 of the following symptoms: constipation, need to push, tenesmus, and ribbon stools. Only patients with symptomatic stenosis were studied. Demographic data, surgical techniques, and postoperative complications were recorded prospectively. Treatments and outcomes of anastomotic symptomatic strictures were analyzed. MEASUREMENTS AND MAIN RESULTS: A total of 1643 patients underwent laparoscopic rectosigmoid resection at our hospital between January 2002 and December 2016. Among these, 104 patients (6.3%) presented with symptomatic anastomotic stenosis. The median patient age was 27 years (range, 23-44 years), and the median interval between diagnosis and the onset of symptomatic stenosis was 57 days (range, 21-64 days). The only statistically significant predictors of anastomotic stenosis were the presence of ileostomy (p = .01) and previous pelvic surgery (p = .002). Treatment of choice was always conservative. Of the 104 patients in the study cohort, 90 (86.5%) underwent 3 endoscopic dilatations. No patient required reoperation. CONCLUSION: The anastomotic stricture is a recognized complication in patients following intestinal resection for DIE, and protective ileostomy is the sole modifiable factor related to anastomotic stenosis. Endoscopic dilatation is a valid option to treat this complication.

Total Laparoscopic Ureteroneocystostomy for Ureteral Endometriosis: A Single-Center Experience of 160 Consecutive Patients.

STUDY OBJECTIVE: To investigate the efficacy of laparoscopic ureteroneocystostomy in patients with deep infiltrating endometriosis (DIE) with ureteral, parametrial, and bowel involvement. DESIGN: Prospective study (Canadian Task Force classification II-2). SETTING: Tertiary referral center for endometriosis care. PATIENTS: One hundred sixty patients with DIE underwent laparoscopic radical eradication and ureteroneocystostomy between January 2009 and December 2016. INTERVENTIONS: Laparoscopic nerve-sparing radical treatment with ureteroneocystostomy, parametrectomy, and, if necessary, segmental bowel resection. MEASUREMENTS AND MAIN RESULTS: Surgical eradication was radical, and ureteral endometriosis was histologically confirmed in all patients (45.6% intrinsic and 54.4% extrinsic). In 58.7% of patients ureteroneocystostomy was performed with the psoas hitch technique. Bowel resection was performed in 121 patients (75.6%), and 115 of them had a concomitant ileostomy (71.9%). Unilateral parametrectomy was performed on the left side in 61.9% of patients and on the right side in 30% of patients, respectively, whereas bilateral parametrectomy was completed in 33 patients (20.6%). Postoperative complications were infrequent: 7 patients underwent reoperation (4.4%), 8 patients experienced fever (5%), 4 patients required blood transfusion (2.5%), 3 patients had intestinal fistulas (1.9%), and 24 patients experienced impaired bladder voiding (15%) after 6 months. Mean follow-up time was 20.5 months (range, 1-60). The study reported good clinical and surgical results, with a regression of symptoms (p < .001) and recurrence of parametrial endometriosis of 1.2% that required opposite-side ureteroneocystostomy. CONCLUSION: This is the largest documented series of patients with DIE undergoing laparoscopic radical eradication and ureteroneocystostomy. The collected data show that in patients with ureteral endometriosis, this technique is feasible, effective, and safe and provides good results in terms of relapses and symptoms' control.

Linac-based stereotactic body radiation therapy for unresectable locally advanced pancreatic cancer: risk-adapted dose prescription and image-guided delivery.

BACKGROUND: Stereotactic body radiation therapy (SBRT) represents a new treatment option for locally advanced pancreatic cancer (LAPC). An accurate treatment planning with risk-adapted dose prescription with adherence to specific dose constraints for organs at risk (OARs) and the use of daily cone beam CT (CBCT) for image guidance could allow an effective and safe treatment delivery. Here, feasibility and efficacy of SBRT in LAPC treated in our cancer care center are reported. PATIENTS AND METHODS: 33 unresectable LAPC patients underwent SBRT. In order to respect OAR dose constraints, a risk-adapted dose prescription strategy was adopted, choosing between the following schedules: 42 Gy or 45 Gy in 6 daily fractions with a biologically effective dose (BED) > 70 Gy10 or 36 Gy/6 fractions (estimating a BED 57.6 Gy10). SBRT was delivered with volumetric modulated arc technique (VMAT) and flattening filter-free (FFF) mode. Image guidance was performed by means of CBCT before every treatment session. The patients were evaluated at the end of treatment for acute toxicity and at 3, 6, and 12 months for late toxicity and treatment response. RESULTS: At the time of analysis, the median follow-up was 18 months (range 5-34 months). Prior to SBRT, 24 out of 33 patients received induction chemotherapy. Although all patients were previously judged as unresectable, 6 out of 33 (18%) underwent surgery after SBRT; all of them received a BED > 70 Gy10. One-year LC and OS were 81% and 75%, respectively. A total of 12 patients (37%) had an extra-pancreatic progression. No cases of ≥G3 acute or late toxicity were reported. CONCLUSION: In our experience, risk-adapted dose prescription and image-guided SBRT represents an effective treatment option for LAPC patients.

Laparoscopy for primary cytoreduction with multivisceral resections in advanced ovarian cancer: prospective validation. "The times they are a-changin"?

BACKGROUND: Primary cytoreduction is the mainstay of treatment for advanced ovarian cancer (AOC). We developed and prospectively evaluated an algorithm to investigate the possible role of laparoscopic primary cytoreduction (LPC) in carefully selected patients, with AOC. METHODS: From June 2007 to July 2015, all patients with stage III-IV ovarian cancer and clinical conditions allowing aggressive surgery were candidate to primary cytoreduction with the aim of achieving residual tumor (RT) = 0. The possibility of attempting laparoscopic cytoreduction was carefully evaluated using strict selection criteria. The other patients were approached by abdominal primary cytoreduction (APC). At the end of LPC, an ultra-low pubic mini-laparotomy was performed to extract surgical specimens and to accomplish a laparoscopic hand-assisted exploration of the abdominal organs, in order to confirm complete excision of the disease. RESULTS: Of the included 66 patients, 21 were considered eligible for LPC; the remaining 45 underwent APC. Optimal cytoreduction (i.e., RT = 0) was obtained in 95 and 88.4% in the LPC and APC groups, respectively. No intra-operative complication and 4 (19%) early post-operative complications were observed among patients who received LPC. Patients who underwent APC had 17.8 and 46.7% intra- and early post-operative complications, respectively. Median time to initiation of chemotherapy was 15 (range, 10-30) days in the LPC group and 28 (20-35) days in the APC group. After a median follow-up of 51 months, 2-year disease-free survival was 76.2% in the LPC group and 73.4% in the APC group. CONCLUSIONS: After strict selection, a group of patients with AOC may undergo LPC with extremely high rates of optimal cytoreduction, satisfactory perioperative morbidity, a short interval to chemotherapy, and encouraging survival outcomes. Clinical trial registration NCT02980185.