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1.
Blood ; 140(8): 900-908, 2022 08 25.
Article in English | MEDLINE | ID: mdl-35580191

ABSTRACT

The clinical benefit of extended prophylaxis for venous thromboembolism (VTE) after laparoscopic surgery for cancer is unclear. The efficacy and safety of direct oral anticoagulants for this indication are unexplored. PROphylaxis of venous thromboembolism after LAParoscopic Surgery for colorectal cancer Study II (PROLAPS II) was a randomized, double-blind, placebo-controlled, investigator-initiated, superiority study aimed at assessing the efficacy and safety of extended prophylaxis with rivaroxaban after laparoscopic surgery for colorectal cancer. Consecutive patients who had laparoscopic surgery for colorectal cancer were randomized to receive rivaroxaban (10 mg once daily) or a placebo to be started at 7 ± 2 days after surgery and given for the subsequent 3 weeks. All patients received antithrombotic prophylaxis with low-molecular-weight heparin from surgery to randomization. The primary study outcome was the composite of symptomatic objectively confirmed VTE, asymptomatic ultrasonography-detected deep vein thrombosis (DVT), or VTE-related death at 28 ± 2 days after surgery. The primary safety outcome was major bleeding. Patient recruitment was prematurely closed due to study drug expiry after the inclusion of 582 of the 646 planned patients. A primary study outcome event occurred in 11 of 282 patients in the placebo group compared with 3 of 287 in the rivaroxaban group (3.9 vs 1.0%; odds ratio, 0.26; 95% confidence interval [CI], 0.07-0.94; log-rank P = .032). Major bleeding occurred in none of the patients in the placebo group and 2 patients in the rivaroxaban group (incidence rate 0.7%; 95% CI, 0-1.0). Oral rivaroxaban was more effective than placebo for extended prevention of VTE after laparoscopic surgery for colorectal cancer without an increase in major bleeding. This trial was registered at www.clinicaltrials.gov as #NCT03055026.


Subject(s)
Colorectal Neoplasms , Laparoscopy , Venous Thromboembolism , Anticoagulants/adverse effects , Colorectal Neoplasms/chemically induced , Colorectal Neoplasms/complications , Colorectal Neoplasms/surgery , Fibrinolytic Agents/adverse effects , Hemorrhage/drug therapy , Humans , Laparoscopy/adverse effects , Rivaroxaban/adverse effects , Venous Thromboembolism/drug therapy , Venous Thromboembolism/etiology , Venous Thromboembolism/prevention & control
2.
Int J Colorectal Dis ; 39(1): 53, 2024 Apr 16.
Article in English | MEDLINE | ID: mdl-38625550

ABSTRACT

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.


Subject(s)
Anastomotic Leak , Colorectal Neoplasms , Humans , Prospective Studies , Anastomosis, Surgical , Anastomotic Leak/etiology , Machine Learning , Colorectal Neoplasms/surgery , Italy/epidemiology
3.
Surg Endosc ; 36(6): 3965-3984, 2022 06.
Article in English | MEDLINE | ID: mdl-34519893

ABSTRACT

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.


Subject(s)
Colorectal Surgery , Enhanced Recovery After Surgery , Anastomotic Leak/epidemiology , Anastomotic Leak/etiology , Anastomotic Leak/prevention & control , Colorectal Surgery/adverse effects , Humans , Institutionalization , Length of Stay , Male , Morbidity , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Postoperative Complications/prevention & control , Prospective Studies
4.
Surg Endosc ; 36(4): 2300-2311, 2022 04.
Article in English | MEDLINE | ID: mdl-33877411

ABSTRACT

INTRODUCTION: There has been an increasing interest for the laparoscopic treatment of early gastric cancer, especially among Eastern surgeons. However, the oncological effectiveness of Laparoscopic Gastrectomy (LG) for Advanced Gastric Cancer (AGC) remains a subject of debate, especially in Western countries where limited reports have been published. The aim of this paper is to retrospectively analyze short- and long-term results of LG for AGC in a real-life Western practice. MATERIALS AND METHODS: All consecutive cases of LG with D2 lymphadenectomy for AGC performed from January 2005 to December 2019 at seven different surgical departments were analyzed retrospectively. The primary outcome was diseases-free survival (DFS). Secondary outcomes were overall survival (OS), number of retrieved lymph nodes, postoperative morbidity and conversion rate. RESULTS: A total of 366 patients with stage II and III AGC underwent either total or subtotal LG. The mean number of harvested lymph nodes was 25 ± 14. The mean hospital stay was 13 ± 10 days and overall postoperative morbidity rate 27.32%, with severe complications (grade ≥ III) accounting for 9.29%. The median follow-up was 36 ± 16 months during which 90 deaths occurred, all due to disease progression. The DFS and OS probability was equal to 0.85 (95% CI 0.81-0.89) and 0.94 (95% CI 0.92-0.97) at 1 year, 0.62 (95% CI 0.55-0.69) and 0.63 (95% CI 0.56-0.71) at 5 years, respectively. CONCLUSION: Our study has led us to conclude that LG for AGC is feasible and safe in the general practice of Western institutions when performed by trained surgeons.


Subject(s)
Laparoscopy , Stomach Neoplasms , Testicular Neoplasms , Follow-Up Studies , Gastrectomy , Humans , Lymph Node Excision , Male , Retrospective Studies , Stomach Neoplasms/pathology , Testicular Neoplasms/surgery , Treatment Outcome
5.
J Surg Oncol ; 124(8): 1338-1346, 2021 Dec.
Article in English | MEDLINE | ID: mdl-34432291

ABSTRACT

BACKGROUND AND OBJECTIVES: In the setting of a minimally invasive approach, we aimed to compare short and long-term postoperative outcomes of patients treated with neoadjuvant therapy (NAT) + surgery or upfront surgery in Western population. METHODS: All consecutive patients from six Italian and one Serbian center with locally advanced gastric cancer who had undergone laparoscopic gastrectomy with D2 lymph node dissection were selected between 2005 and 2019. After propensity score-matching, postoperative morbidity and oncologic outcomes were investigated. RESULTS: After matching, 97 patients were allocated in each cohort with a mean age of 69.4 and 70.5 years. The two groups showed no difference in operative details except for a higher conversion rate in the NAT group (p = 0.038). The overall postoperative complications rate significantly differed between NAT + surgery (38.1%) and US (21.6%) group (p = 0.019). NAT was found to be related to a higher risk of postoperative morbidity in patients older than 60 years old (p = 0.013) but not in patients younger (p = 0.620). Conversely, no difference in overall survival (p = 0.41) and disease-free-survival (p = 0.34) was found between groups. CONCLUSIONS: NAT appears to be related to a higher postoperative complication rate and equivalent oncological outcomes when compared with surgery alone. However, poor short-term outcomes are more evident in patients over 60 years old receiving NAT.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Gastrectomy/mortality , Laparoscopy/mortality , Neoadjuvant Therapy/mortality , Stomach Neoplasms/therapy , Aged , Combined Modality Therapy , Female , Follow-Up Studies , Humans , Length of Stay , Male , Middle Aged , Postoperative Period , Prognosis , Retrospective Studies , Stomach Neoplasms/pathology , Survival Rate
6.
Int J Colorectal Dis ; 36(5): 929-939, 2021 May.
Article in English | MEDLINE | ID: mdl-33118101

ABSTRACT

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.


Subject(s)
Colorectal Surgery , Digestive System Surgical Procedures , Anastomosis, Surgical/adverse effects , Anastomotic Leak/etiology , Anastomotic Leak/surgery , Colorectal Surgery/adverse effects , Humans , Reoperation
7.
BMC Surg ; 21(1): 190, 2021 Apr 10.
Article in English | MEDLINE | ID: mdl-33838677

ABSTRACT

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.


Subject(s)
Colorectal Neoplasms , Colorectal Surgery , Colorectal Neoplasms/diagnostic imaging , Colorectal Neoplasms/surgery , Colorectal Surgery/methods , Humans , Indocyanine Green , Italy , Optical Imaging
8.
Surg Endosc ; 34(7): 2954-2962, 2020 07.
Article in English | MEDLINE | ID: mdl-31451917

ABSTRACT

BACKGROUND: Splenic flexure cancer (SFC), identified as tumors raised in the distal transverse colon and proximal descending colon, accounts for 2 to 5% of all surgically treated colorectal cancers. Despite the fact that the laparoscopic approach has become the gold standard for many colorectal procedures, it has never been extensively investigated in SFC due to lack of an agreed consensus on the appropriate operative procedure. The aim of this multicenter retrospective study is to evaluate the oncologic value of laparoscopic segmental resection with complete mesocolic excision (CME) for cancer located in the splenic flexure. METHODS: All data of consecutive patients who had undergone laparoscopic resection with CME for SFC from January 2005 to December 2017 at five different tertiary centers were retrospectively analyzed. The Kaplan-Meier (KM) test was used to assess the overall survival (OS) and the disease-free survival (DFS) rates after surgery. Univariate Cox regression was used to explore the association between OS and other independent factors. RESULTS: Recurrence was observed in 13 (11.6%) patients and a significant association between disease stage and recurrence (P < 0.001) was found with a higher proportion of stage IV patients in the recurrence group (46.1% vs. 7.1%). During a median follow-up of 43 months (range 12-149), 13 deaths occurred, all of them due to disease progression. KM curves for all stages showed an estimated survival rate of 51% at 148 months. CONCLUSION: Laparoscopic segmental resection with CME appears to be an oncologically safe and effective procedure for treatment of SFC and may be considered as a standard surgical method for elective management of the disease. In the future, routine lymph node mapping could be used to confirm this hypothesis.


Subject(s)
Colon, Transverse/surgery , Colonic Neoplasms/surgery , Laparoscopy/methods , Postoperative Complications/etiology , Aged , Aged, 80 and over , Colectomy/adverse effects , Colectomy/methods , Colonic Neoplasms/mortality , Colonic Neoplasms/pathology , Disease-Free Survival , Female , Follow-Up Studies , Humans , Laparoscopy/adverse effects , Male , Mesocolon/surgery , Middle Aged , Neoplasm Recurrence, Local/pathology , Operative Time , Retrospective Studies , Treatment Outcome
9.
Surg Endosc ; 34(9): 4041-4047, 2020 09.
Article in English | MEDLINE | ID: mdl-31617088

ABSTRACT

BACKGROUND: Following the Food and Drug Administration approval, robot-assisted colorectal surgery has gained more acceptance among surgeons. One of the open issues about robotic surgery is the economic sustainability. The aim of our study is to evaluate the economic sustainability of robotic as compared to laparoscopic right colectomy for the Italian National Health System. METHODS: We performed a retrospective multicentre case-matched study including 94 patients for each group from four different Italian surgical departments. An economic evaluation gathered from a real-world data was performed to assess the sustainability of the robotic approach for right colectomy in the Italian National Health System. In particular, a differential cost analysis between the two procedures was performed. RESULTS: No statistical differences were found between the two groups for postoperative outcomes. After a careful review of the literature on the cost assessment for the operative room, medical devices and hospital stay according with our data, we estimated the followings: (a) the mean operative room cost for robotic group was 2179 ± 476 € vs. 1376 ± 322 € for laparoscopic group; (b) the mean hospital stay cost for robotic group was 3143 ± 1435 € vs. 3292 ± 1123 € for laparoscopic group; and (c) the mean cost for instruments was 6280 € for robotic group vs. 1504 € for laparoscopic group. The total mean cost of robotic right colectomy was 11,576 ± 1915 € vs. 6196 ± 1444 € for laparoscopic right colectomy. CONCLUSION: In conclusion, to date, robotic right colectomy with intracorporeal anastomosis does not provide any significant clinical advantages, which may justify the additional costs, as compared to its laparoscopic counterpart. Further evolution of robotic technology and experience may lead to a reduction of costs, especially if the robotic platform is used in an appropriate healthcare setting.


Subject(s)
Colectomy/economics , Cost-Benefit Analysis , Robotic Surgical Procedures/economics , Adult , Aged , Aged, 80 and over , Female , Humans , Italy , Laparoscopy/economics , Length of Stay , Male , Middle Aged , Postoperative Care , Retrospective Studies
10.
Int J Cancer ; 144(6): 1275-1283, 2019 03 15.
Article in English | MEDLINE | ID: mdl-30325019

ABSTRACT

Telomere deregulation is a hallmark of cancer. Telomere length measured in lymphocytes (LTL) has been shown to be a risk marker for several cancers. For pancreatic ductal adenocarcinoma (PDAC) consensus is lacking whether risk is associated with long or short telomeres. Mendelian randomization approaches have shown that a score built from SNPs associated with LTL could be used as a robust risk marker. We explored this approach in a large scale study within the PANcreatic Disease ReseArch (PANDoRA) consortium. We analyzed 10 SNPs (ZNF676-rs409627, TERT-rs2736100, CTC1-rs3027234, DHX35-rs6028466, PXK-rs6772228, NAF1-rs7675998, ZNF208-rs8105767, OBFC1-rs9420907, ACYP2-rs11125529 and TERC-rs10936599) alone and combined in a LTL genetic score ("teloscore", which explains 2.2% of the telomere variability) in relation to PDAC risk in 2,374 cases and 4,326 controls. We identified several associations with PDAC risk, among which the strongest were with the TERT-rs2736100 SNP (OR = 1.54; 95%CI 1.35-1.76; p = 1.54 × 10-10 ) and a novel one with the NAF1-rs7675998 SNP (OR = 0.80; 95%CI 0.73-0.88; p = 1.87 × 10-6 , ptrend = 3.27 × 10-7 ). The association of short LTL, measured by the teloscore, with PDAC risk reached genome-wide significance (p = 2.98 × 10-9 for highest vs. lowest quintile; p = 1.82 × 10-10 as a continuous variable). In conclusion, we present a novel genome-wide candidate SNP for PDAC risk (TERT-rs2736100), a completely new signal (NAF1-rs7675998) approaching genome-wide significance and we report a strong association between the teloscore and risk of pancreatic cancer, suggesting that telomeres are a potential risk factor for pancreatic cancer.


Subject(s)
Carcinoma, Pancreatic Ductal/genetics , Pancreatic Neoplasms/genetics , Ribonucleoproteins/genetics , Telomerase/genetics , Telomere Shortening/genetics , Telomere/metabolism , Aged , Case-Control Studies , Europe , Female , Genome-Wide Association Study , Humans , Lymphocytes/metabolism , Male , Middle Aged , Polymorphism, Single Nucleotide , Telomerase/metabolism
11.
Surg Endosc ; 31(7): 3048-3055, 2017 07.
Article in English | MEDLINE | ID: mdl-28039651

ABSTRACT

BACKGROUND: Laparoscopy has increasingly become the standard of care for patients who undergo colorectal surgery for both benign and malignant diseases. This growing experience has also resulted in more reports of postoperative complications from the minimally invasive approach to primary colorectal resection. Small bowel obstruction from internal hernias and pre-sacral adhesions is an uncommon but not negligible complication. However, there is little literature specific to this topic with recommendations for different methods to prevent it. We report our original technique of closing the mesenteric defect and covering the pre-sacral fascia by using fibrin sealant to prevent this complication. METHODS: From January 2005 to December 2014, a total of 1079 patients underwent elective laparoscopic left colorectal resection (left hemicolectomy or anterior rectal resection) in our department. In the first 298 procedures, the mesenteric defect was left open, while in the following 781 procedures, it was closed using fibrin sealant with the aim of preventing postoperative small bowel obstruction. RESULTS: Among the first 298 patients, three (1%) required reoperation for small bowel obstruction due to internal hernia (0.33%) or critical pre-sacral adhesions (0.66%). These complications did not occur in the subsequent series in which all 781 patients were treated with fibrin sealant prophylactic closure of the mesenteric defect. CONCLUSION: In our experience, fibrin sealant closure of the mesenteric defect has demonstrated to be safe and effective in preventing postoperative small bowel obstruction that remains a complication both in open and in laparoscopic colorectal surgeries.


Subject(s)
Colorectal Neoplasms/surgery , Fibrin Tissue Adhesive , Tissue Adhesions/prevention & control , Adult , Aged , Aged, 80 and over , Colectomy/economics , Colectomy/methods , Female , Hernia, Abdominal/prevention & control , Humans , Intestinal Obstruction/prevention & control , Italy , Laparoscopy/economics , Laparoscopy/methods , Male , Middle Aged , Postoperative Complications/prevention & control
12.
Surg Innov ; 24(2): 155-161, 2017 Apr.
Article in English | MEDLINE | ID: mdl-28118788

ABSTRACT

BACKGROUND: The aim of this study is to evaluate if 3-dimensional high-definition (3D) vision in laparoscopy can prompt advantages over conventional 2D high-definition vision in hiatal hernia (HH) repair. STUDY DESIGN: Between September 2012 and September 2015, we randomized 36 patients affected by symptomatic HH to undergo surgery; 17 patients underwent 2D laparoscopic HH repair, whereas 19 patients underwent the same operation in 3D vision. RESULTS: No conversion to open surgery occurred. Overall operative time was significantly reduced in the 3D laparoscopic group compared with the 2D one (69.9 vs 90.1 minutes, P = .006). Operative time to perform laparoscopic crura closure did not differ significantly between the 2 groups. We observed a tendency to a faster crura closure in the 3D group in the subgroup of patients with mesh positioning (7.5 vs 8.9 minutes, P = .09). Nissen fundoplication was faster in the 3D group without mesh positioning ( P = .07). CONCLUSIONS: 3D vision in laparoscopic HH repair helps surgeon's visualization and seems to lead to operative time reduction. Advantages can result from the enhanced spatial perception of narrow spaces. Less operative time and more accurate surgery translate to benefit for patients and cost savings, compensating the high costs of the 3D technology. However, more data from larger series are needed to firmly assess the advantages of 3D over 2D vision in laparoscopic HH repair.


Subject(s)
Herniorrhaphy/methods , Imaging, Three-Dimensional/methods , Laparoscopy/methods , Surgery, Computer-Assisted/methods , Adult , Case-Control Studies , Female , Hernia, Hiatal/surgery , Herniorrhaphy/statistics & numerical data , Humans , Imaging, Three-Dimensional/statistics & numerical data , Laparoscopy/statistics & numerical data , Male , Middle Aged , Operative Time , Surgeons/statistics & numerical data , Surgery, Computer-Assisted/statistics & numerical data , Surveys and Questionnaires , Treatment Outcome
13.
Ann Surg ; 263(5): 967-72, 2016 May.
Article in English | MEDLINE | ID: mdl-26528879

ABSTRACT

OBJECTIVES: We designed a multicentric, observational study to test if Procalcitonin (PCT) might be an early and reliable marker of anastomotic leak (AL) after colorectal surgery (ClinicalTrials.govIdentifier:NCT01817647). BACKGROUND: Procalcitonin is a biomarker used to monitor bacterial infections and guide antibiotic therapy. Anastomotic leak after colorectal surgery is a severe complication associated with relevant short and long-term sequelae. METHODS: Between January 2013 and September 2014, 504 patients underwent colorectal surgery, for malignant colorectal diseases, in elective setting. White blood count (WBC), C-reactive protein (CRP) and PCT levels were measured in 3rd and 5th postoperative day (POD). AL and all postoperative complications were recorded. RESULTS: We registered 28 (5.6%) anastomotic leaks. Specificity and negative predictive value for AL with PCT less than 2.7 and 2.3 ng/mL were, respectively, 91.7% and 96.9% in 3rd POD and 93% and 98.3% in 5th POD. Receiver operating characteristic curve for biomarkers shows that in 3rd POD, PCT and CRP have similar area under the curve (AUC) (0.775 vs 0.772), both better than WBC (0.601); in 5th POD, PCT has a better AUC than CRP and WBC (0.862 vs 0.806 vs 0.611). Measuring together PCT and CRP significantly improves AL diagnosis in 5th POD (AUC: 0.901). CONCLUSIONS: PCT and CRP demonstrated to have a good negative predictive value for AL, both in 3rd and in 5th POD. Low levels of PCT, together with low CRP values, seem to be early and reliable markers of AL after colorectal surgery. These biomarkers might be safely added as additional criteria of discharge protocols after colorectal surgery.


Subject(s)
Anastomotic Leak/blood , Calcitonin/blood , Colorectal Neoplasms/surgery , Colorectal Surgery , Protein Precursors/blood , Surgical Wound Dehiscence/blood , Aged , Biomarkers/blood , C-Reactive Protein/metabolism , Calcitonin Gene-Related Peptide , Female , Humans , Leukocyte Count , Male , Predictive Value of Tests , Prospective Studies , Sensitivity and Specificity
15.
Surg Endosc ; 29(7): 1795-803, 2015 Jul.
Article in English | MEDLINE | ID: mdl-25294542

ABSTRACT

BACKGROUND: Laparoscopy has increasingly become the standard of care for patients who undergo colorectal surgery for both benign and malignant disease. On the basis of this growing experience, there is now an expanded role for laparoscopic approach to postoperative complications after primary colorectal resection. However, there is little literature specific to this topic. We report a ten-year experience with laparoscopic treatment of early complications following laparoscopic colorectal surgery. METHODS: From January 2003 to December 2012, a total of 1,292 patients underwent elective laparoscopic colorectal surgery in our department. One hundred and two (7.9%) patients required reoperation for a postoperative complication. Laparoscopy has been also adopted as the preferred procedure for management of postoperative complications. A retrospective review of 84 patients who had relaparoscopy (RL) for postoperative complications, including peritonitis, ureteral injury, bowel obstruction, and bleeding, was performed. RESULTS: Reoperation was carried out laparoscopically in 79 (94.0%) patients. Five (6.0%) conversions were necessary because of massive colonic ischemia, generalized fecal peritonitis, and lack of working space. The most common finding at RL was anastomotic leakage (57.1%) that was managed by peritoneal lavage and ileostomy in 91.7% of cases. Six percent of patients had negative RL. Overall morbidity rate was 25.0%. Five patients required additional surgery: four (5.1%) after RL and one after a converted procedure. There were five (6.0%) deaths from septic shock, myocardial infarction, and pulmonary embolism. CONCLUSIONS: Laparoscopy is a safe and effective tool for management of complications following laparoscopic colorectal surgery. In this setting, RL represents the first step of re-exploration and treatment, with no delay to conversion to open procedure even in skilled laparoscopic hands.


Subject(s)
Colorectal Surgery/adverse effects , Laparoscopy/methods , Postoperative Complications/surgery , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Reoperation , Retrospective Studies , Treatment Outcome
16.
Updates Surg ; 76(1): 107-117, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37851299

ABSTRACT

Retrospective evaluation of the effects of mechanical bowel preparation (MBP) on data derived from two prospective open-label observational multicenter studies in Italy regarding elective colorectal surgery. MBP for elective colorectal surgery remains a controversial issue with contrasting recommendations in current guidelines. The Italian ColoRectal Anastomotic Leakage (iCral) study group, therefore, decided to estimate the effects of no MBP (treatment variable) versus MBP for elective colorectal surgery. A total of 8359 patients who underwent colorectal resection with anastomosis were enrolled in two consecutive prospective studies in 78 surgical centers in Italy from January 2019 to September 2021. A retrospective PSMA was performed on 5455 (65.3%) cases after the application of explicit exclusion criteria to eliminate confounders. The primary endpoints were anastomotic leakage (AL) and surgical site infections (SSI) rates; the secondary endpoints included SSI subgroups, overall and major morbidity, reoperation, and mortality rates. Overall length of postoperative hospital stay (LOS) was also considered. Two well-balanced groups of 1125 patients each were generated: group A (No MBP, true population of interest), and group B (MBP, control population), performing a PSMA considering 21 covariates. Group A vs. group B resulted significantly associated with a lower risk of AL [42 (3.5%) vs. 73 (6.0%) events; OR 0.57; 95% CI 0.38-0.84; p = 0.005]. No difference was recorded between the two groups for SSI [73 (6.0%) vs. 85 (7.0%) events; OR 0.88; 95% CI 0.63-1.22; p = 0.441]. Regarding the secondary endpoints, no MBP resulted significantly associated with a lower risk of reoperation and LOS > 6 days. This study confirms that no MBP before elective colorectal surgery is significantly associated with a lower risk of AL, reoperation rate, and LOS < 6 days when compared with MBP.


Subject(s)
Colorectal Neoplasms , Colorectal Surgery , Humans , Anastomotic Leak/epidemiology , Prospective Studies , Colorectal Surgery/adverse effects , Retrospective Studies , Propensity Score , Surgical Wound Infection/epidemiology , Surgical Wound Infection/prevention & control , Elective Surgical Procedures/methods , Colorectal Neoplasms/surgery , Preoperative Care/methods , Cathartics
17.
BJS Open ; 8(1)2024 01 03.
Article in English | MEDLINE | ID: mdl-38170895

ABSTRACT

BACKGROUND: In Italy, surgeons continue to drain the abdominal cavity in more than 50 per cent of patients after colorectal resection. The aim of this study was to evaluate the impact of abdominal drain placement on early adverse events in patients undergoing elective colorectal surgery. METHODS: A database was retrospectively analysed through a 1:1 propensity score-matching model including 21 covariates. The primary endpoint was the postoperative duration of stay, and the secondary endpoints were surgical site infections, infectious morbidity rate defined as surgical site infections plus pulmonary infections plus urinary infections, anastomotic leakage, overall morbidity rate, major morbidity rate, reoperation and mortality rates. The results of multiple logistic regression analyses were presented as odds ratios (OR) and 95 per cent c.i. RESULTS: A total of 6157 patients were analysed to produce two well-balanced groups of 1802 patients: group (A), no abdominal drain(s) and group (B), abdominal drain(s). Group A versus group B showed a significantly lower risk of postoperative duration of stay >6 days (OR 0.60; 95 per cent c.i. 0.51-0.70; P < 0.001). A mean postoperative duration of stay difference of 0.86 days was detected between groups. No difference was recorded between the two groups for all the other endpoints. CONCLUSION: This study confirms that placement of abdominal drain(s) after elective colorectal surgery is associated with a non-clinically significant longer (0.86 days) postoperative duration of stay but has no impact on any other secondary outcomes, confirming that abdominal drains should not be used routinely in colorectal surgery.


Subject(s)
Colorectal Surgery , Surgical Wound Infection , Humans , Surgical Wound Infection/epidemiology , Surgical Wound Infection/prevention & control , Retrospective Studies , Propensity Score , Colorectal Surgery/adverse effects , Drainage/methods
18.
Surg Endosc ; 27(6): 2131-6, 2013 Jun.
Article in English | MEDLINE | ID: mdl-23355144

ABSTRACT

BACKGROUND: Laparoscopic pancreatic surgery has gradually expanded its applications to include pancreaticoduodenectomy. However, the benefits of the laparoscopic approach are still debated. This article aims to present data regarding the efficacy of laparoscopic pancreaticoduodenectomy in a single center. METHODS: From March 2003 to June 2010, a total of 22 patients underwent pancreaticoduodenectomy with a totally laparoscopic approach, using a five-trocar technique. Reconstruction of the digestive tract was adapted to the aspect of the pancreatic stump, with 6 patients having Wirsung duct occlusion and 16 patients pancreaticodigestive anastomosis. Patient selection, short-term outcomes, oncologic results, and technical issues were retrospectively reviewed. RESULTS: Mean operative time was 392 (range, 327-570) min. Conversion was required in 2 patients (9.1 %) as a result of bleeding and difficult dissection. Major intraoperative complications included an injury to the right hepatic artery (4.5 %). Postoperative mortality was 4.5 %. Surgery-related morbidity occurred in 14 patients (63.6 %) and included bleeding (n = 5), pancreatic fistula (n = 6), biliary fistula (n = 2), and dumping syndrome (n = 1). Pancreatic fistulas occurred in 4 patients with duct occlusion and in 2 patients with pancreaticojejunostomy, and they all healed with conservative treatment. Mean hospital stay was 23 (range, 12-35) days. Pathologic diagnoses were pancreatic ductal adenocarcinoma (n = 11), ampullary adenocarcinoma (n = 8), and duodenal adenocarcinoma (n = 3). The resection margins were all free from disease; the mean number of collected lymph nodes was 15 (range, 14-20). CONCLUSIONS: The complexity of pancreaticoduodenectomy entails some issues, including patient selection and management of the pancreatic stump, that are not related to the approach used. Laparoscopic pancreaticoduodenectomy is feasible, safe, and oncologically adequate, but only if performed in selected cases by highly skilled laparoscopic surgeons. Laparoscopy does not provide any significant advantage over traditional surgery, but it may improve postoperative outcomes in the so-called excellence centers, once the learning curve has been overcome. Multicenter randomized trials are needed.


Subject(s)
Adenocarcinoma/surgery , Duodenal Neoplasms/surgery , Laparoscopy/methods , Pancreatic Neoplasms/surgery , Pancreaticoduodenectomy/methods , Aged , Conversion to Open Surgery/statistics & numerical data , Female , Humans , Intraoperative Complications/etiology , Male , Middle Aged , Operative Time , Patient Selection , Postoperative Complications/etiology , Retrospective Studies , Treatment Outcome
19.
Minim Invasive Ther Allied Technol ; 22(3): 187-90, 2013 Jun.
Article in English | MEDLINE | ID: mdl-22732015

ABSTRACT

Gastrointestinal stromal tumors (GISTs) of the duodenum are rare neoplasms. The optimal surgical procedure is debated and several options ranging from limited resections to pancreaticoduodenectomy have been reported. The laparoscopic approach has been validated for gastric GISTs, but it does not yet represent a standard technique for tumors of the duodenum. We report the case of a localized duodenal GIST that was successfully treated by totally laparoscopic pancreas-preserving subtotal duodenectomy. This procedure may represent a feasible and effective treatment option for localized GISTs of the duodenum. Large series with long-term follow-up are needed.


Subject(s)
Duodenal Neoplasms/surgery , Gastrointestinal Stromal Tumors/surgery , Laparoscopy/methods , Aged , Duodenal Neoplasms/pathology , Duodenum/pathology , Duodenum/surgery , Feasibility Studies , Female , Follow-Up Studies , Gastrointestinal Stromal Tumors/pathology , Humans , Organ Sparing Treatments/methods , Pancreas
20.
Minim Invasive Ther Allied Technol ; 22(5): 271-8, 2013 Sep.
Article in English | MEDLINE | ID: mdl-23134441

ABSTRACT

INTRODUCTION: Laparoscopic total gastrectomy (LTG) is seldom used for gastric cancer because the complex vascularization and lymphatic drainage makes lymphadenectomy and esophagojejunal anastomosis difficult and requires special skills. Our aim was to demonstrate the feasibility and accuracy of LTG in gastric cancer with D2 lymphadenectomy. MATERIAL AND METHODS: Eighty-eight LTG and four laparoscopic remnant gastrectomies (LRGs) were performed over >12 years. The median patient age was 64 years, and the male/female ratio was 1.49/1. Eighty-seven patients had a D2 and only five patients had a D1 lymphadenectomy. We propose the retrospective analysis of intra- and perioperative mortality and morbidity. RESULTS: In only four of 96 cases approached by laparoscopy, a conversion to laparotomy was needed. There were two (2.17%) perioperative deaths in 92 procedures and few complications. Histological data show 79 advanced gastric cancers (AGC), 11 early gastric cancers (EGC), and two gastric diffused lymphomas. The five-year Kaplan-Meier overall survival in patients with EGC and AGC was 100% and 58%, respectively. CONCLUSIONS: The results demonstrate the feasibility of an oncologically correct minimally invasive total gastrectomy. We would like to promote comparisons among different institutions to achieve better standardization of indications and techniques for a laparoscopic approach to gastric cancer.


Subject(s)
Gastrectomy/methods , Laparoscopy/methods , Laparotomy/methods , Stomach Neoplasms/surgery , Adult , Aged , Feasibility Studies , Female , Follow-Up Studies , Humans , Kaplan-Meier Estimate , Lymph Node Excision/methods , Male , Middle Aged , Postoperative Complications/epidemiology , Retrospective Studies , Stomach Neoplasms/pathology , Treatment Outcome
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