Open versus laparoscopic gastrectomy for advanced gastric cancer: a propensity score matching analysis of survival in a western population-on behalf of the Italian Research Group for Gastric Cancer.

BACKGROUND: Oncologic outcomes after laparoscopic gastrectomy for advanced gastric cancer in the West have been poorly investigated. The aim of the present study was to compare survival outcomes in patients undergoing curative-intent laparoscopic and open gastrectomy for advanced gastric cancer in several centres belonging to the Italian Research Group for Gastric Cancer. METHODS: Data of patients operated between 2015 and 2018 were retrospectively analysed. Propensity Score Matching was performed to balance baseline characteristics of patients undergoing laparoscopic and open gastrectomy. The primary endpoint was 3-year overall survival. Secondary endpoints were 3-year disease-free survival and short-term outcomes. Multivariable regression analyses for survival were conducted. RESULTS: Data were retrieved from 20 centres. Of the 717 patients included, 438 patients were correctly matched, 219 per group. The 3-year overall survival was 73.6% and 68.7% in the laparoscopic and open group, respectively (p = 0.40). When compared with open gastrectomy, laparoscopic gastrectomy showed comparable 3-year disease-free survival (62.8%, vs 58.9%, p = 0.40), higher rate of return to intended oncologic treatment (56.9% vs 40.2%, p = 0.001), similar 30-day morbidity/mortality. Prognostic factors for survival were ASA Score ≥ 3, age-adjusted Charlson Comorbidity Index ≥ 5, lymph node ratio ≥ 0.15, p/ypTNM Stage III and return to intended oncologic treatment. CONCLUSIONS: Laparoscopic gastrectomy for advanced gastric cancer offers similar rates of survival when compared to open gastrectomy, with higher rates of return to intended oncologic treatment. ASA score, age-adjusted Charlson Comorbidity Index, lymph node ratio, return to intended oncologic treatment and p/ypTNM Stage, but not surgical approach, are prognostic factors for survival.

Prospective observational study of abdominal wall reconstruction with THT technique in primary midline defects with diastasis recti: clinical and functional outcomes in 110 consecutive patients.

INTRODUCTION: Surgical treatment of diastasis recti is still a matter of debate. Open approaches such as abdominoplasty, which offer the possibility to combine reparation of the diastasis with abdominal cosmetic surgery, are challenged by the emerging less-invasive laparoscopic or robotic techniques that offer shorter recovery for patients. However, evidence in favour of one of the two approaches concerning both short- and long-term complications and functional results is still lacking. In this paper, we analysed clinical and functional results of a new endo-laparoscopic technique for midline reconstruction (THT technique) in patients with primary abdominal wall defects associated with diastasis recti. METHODS: Prospective observational study on 110 consecutive patients was submitted to endo-laparoscopic reconstruction of the abdominal wall with linear staplers. Morbidity and relapse rates with clinical and radiological follow-up were recorded at 1, 6, 12, and 24 months after the operation. Data regarding the impact of surgery on patients' quality of life (EuraHSQol) on chronic low back pain (Oswestry Disability Index, ODI) and urinary stress incontinence (Incontinence Severity Index, ISI) were gathered. RESULTS: After a mean follow-up of 14 months, the morbidity rate was 9.1% and no recurrences were recorded. 6-month follow-up ultrasound showed a rectus muscles mean distance of 6.7 mm; EuraHSQol, ODI, and ISI scores significantly improved in 93%, 77%, and 63% of the cases, respectively. CONCLUSIONS: The THT technique proved to be a feasible, safe, and effective alternative for corrective surgery of primary midline hernias associated with diastasis recti. Short- and mid-term results are encouraging but need to be confirmed by further studies with longer follow-up. The achieved midline reconstruction offers a significant improvement of patients' perceived quality of life through reduction of abdominal wall pain, bulging, low back pain, and urinary stress incontinence.

Enhanced recovery pathways in colorectal surgery: a consensus paper by the Associazione Chirurghi Ospedalieri Italiani (ACOI) and the PeriOperative Italian Society (POIS).

Enhanced Recovery After Surgery (ERAS) pathway is a multi-disciplinary, patient-centered protocol relying on the implementation of the best evidence-based perioperative practice. In the field of colorectal surgery, the application of ERAS programs is associated with up to 50% reduction of morbidity rates and up to 2.5 days reduction of postoperative hospital stay. However, widespread adoption of ERAS pathways is still yet to come, mainly because of the lack of proper information and communication. Purpose of this paper is to support the diffusion of ERAS pathways through a critical review of the existing evidence by members of the two national societies dealing with ERAS pathways in Italy, the PeriOperative Italian Society (POIS) and the Associazione Italiana Chirurghi Ospedalieri (ACOI), showing the results of a consensus development conference held at Matera, Italy, during the national ACOI Congress on June 10, 2019.

Gastric GISTs: Analysis of c-Kit, PDGFRA and BRAF mutations in relation to prognosis and clinical pathological characteristics of patients - A GIRCG study.

BACKGROUND: Gastric gastrointestinal stromal tumors (GISTs) represent a subgroup of GISTs with a better prognosis than those located in other areas. In this retrospective study we performed a molecular characterization of a large series of patients with gastric GISTs in relation to clinical-pathological characteristics and prognosis. METHODS: DNA was extracted from paraffin-embedded sections from 221 gastric GIST patients submitted to surgery. Exons 9, 11, 13 and 17 of KIT, exons 12 and 18 of PDGFRA and exons 11 and 15 of BRAF were analyzed by direct sequencing. Cox regression analysis adjusted for clinical-pathological factors was performed to evaluate KIT and PDGFRA mutations in relation to the composite endpoint of relapse or death. RESULTS: KIT and PDGFRA mutations were observed in 119 (53.8%) and 56 (25.3%) patients, respectively, whereas 46 (20.8%) patients had wild type (wt) disease. Univariable analyses showed that a high Miettinen risk category and the presence of ulceration and KIT deletions were associated with increased risk of relapse or death (p < 0.001; p = 0.0389 and p = 0.002, respectively). After adjusting for Miettinen risk score, KIT deletions remained an independent prognostic factor (HRadj = 2.65, 95% CI [1.15-6.13], p = 0.023). Moreover, KIT deletions in exon 11 codons 557, 558 or 559 were associated with a higher risk of relapse or death than wt tumors (HRadj = 3.29 95% CI [1.64-6.64], p = 0.001). CONCLUSIONS: KIT deletions in exon 11, especially those involving codons 557, 558 or 559, were correlated with a more aggressive gastric GIST phenotype and increased risk of relapse or death.

[Contribution of intraoperative radiotherapy in the control of local recurrences of rectal cancer]. / L'apporto della radioterapia intraoperatoria nel controllo della recidiva locale del cancro del retto.

Local recurrence (LR) is a major problem following curative resection of rectal cancer. Intraoperative radiation therapy (IORT) is considered an ideal boost technique for increasing the dose of radiation therapy within a restricted area without introducing a significant toxicity. The aim of this study is to present the results of a multimodality treatment containing external beam irradiation, chemotherapy, surgical resection, and IORT delivered by a movable linear accelerator (NOVAC7, Hitesys SpA, Italia), employed in a "traditional" operating room.

Antibiotic prophylaxis in elective laparoscopic cholecystectomy. Lack of need or lack of evidence?

BACKGROUND: The need to administer antibiotic prophylaxis (ABP) during laparoscopic cholecystectomy (LC) is still a matter of significant controversy. The purpose of this study was to resolve this issue by performing a meta-analysis of the available randomized controlled trials (RCT) on this topic. METHODS: Papers identified via a systematic literature search were evaluated according to standard criteria. Data regarding the patient sample, study methods, and outcomes were abstracted and summarized across studies. The outcome measures were the rates of all perioperative infections, the rates of surgical site infections, and the rates of infections at other sites. Results were examined for 974 patients randomized to ABP or placebo prior to LC in six RCT published from 1997 to 2001. RESULTS: The cumulative rates of all infections were 2.8% in the ABP group and 4.4% in the placebo group. The pooled odds ratio (OR) (95% confidence interval [CI]) was 0.69 (0.34-1.43; p = 0.32). The cumulative rates of surgical site infections were 2.1% in the ABP group and 2.9% in the placebo group. The pooled OR (95% CI) was 0.82 (0.36-1.86; p = 0.63). The cumulative rates of infections at other sites were 0.7% in the ABP group and 1.5% in the placebo group. Pooled OR (95% CI) was 0.82 (0.18-1.90; p = 0.37). No significant heterogeneity was found in any data pooling. CONCLUSIONS: Based on the available evidence, there appears to be no need to administer routine ABP to low-risk patients during LC. However, the number of patients enrolled to date into RCT is insufficient to avoid a type II error. A large and well-designed trial is urgently needed to find a conclusive answer to this question.

Bile duct injuries during laparoscopic cholecystectomy: a 1994-2001 audit on 13,718 operations in the area of Rome.

BACKGROUND: Bile duct injuries (BDIs) during laparoscopic cholecystectomy (LC) still are reported with greater frequency than during open cholecystectomy (OC). METHODS: In 1999, a retrospective study evaluating the incidence of BDIs during LC in the area of Rome from 1994 to 1998 (group A) was performed. In addition, a prospective audit was started, ending in December 2001 (group B). RESULTS: In group A, 6,419 LCs were performed (222 were converted to OC; 3.4%). In group B, 7,299 LCs were performed (225 were converted to OC; 3.1%). Seventeen BDIs (0.26%) occurred in group A and 16 (0.22%) in group B. Overall, mortality and major morbidity rates were 12.1% and 30.3%, respectively, without significant differences between the two groups. CONCLUSIONS: The incidence and clinical relevance of BDIs during LC in the area of Rome appeared to be stable over the past 8 years and were not influenced by the use of a prospective audit, as compared with a retrospective survey.

Evidence-based medicine: open and laparoscopic bariatric surgery.

BACKGROUND: The aim of this study was to perform an evidence-based analysis of the literature on open and laparoscopic surgery for morbid obesity. METHODS: Human studies on surgery for morbid obesity were conducted. Multiple publications of the same studies, abstracts, and case reports were reviewed. Current Contents, MEDLINE, EMBASE, and Cochrane Library databases were investigated. RESULTS: Open Roux-en-Y gastric by pass (RYGB) for morbidly obese patients and long-limb RYGB for superobese patients are highly effective procedures. Randomized controlled trials comparing malabsorptive procedures with other bariatric operations are needed. The long-term efficacy of adjustable silicone gastric banding (ASGB) still is undetermined because of poor evidence. Laparoscopic RYGB is as safe as its open counterpart, although its long-term results are lacking. Laparoscopic ASGB is less invasive than open ASGB, although its efficacy cannot be determined because of poor evidence. Laparoscopic vertical banded gastroplasty (VBG) is becoming unpopular since the decreasing trend of open VBG. Laparoscopic biliopancreatic diversion with duodenal switch is feasible, but needs further studies. CONCLUSIONS: Randomized controlled trials comparing the various laparoscopic operations are strongly needed.

Major and minor injuries during the creation of pneumoperitoneum. A multicenter study on 12,919 cases.

BACKGROUND: Lap Group Roma was established in 1999 to promote and control the development of laparoscopic surgery in the area of Rome and its province. Complications during the creation of pneumoperitoneum were given a high priority of investigation, and a retrospective enquiry was immediately carried out. METHODS: A questionnaire about all laparoscopic surgical practice performed from January 1994 to December 1998 was sent to the supervisors of 28 centers of general surgery in the area of Rome and its province participating to the Lap Group Roma, requesting demographics, type of procedure for the creation of pneumoperitoneum, type and timing of operation, and major vascular, visceral, and minor vascular injuries related to the creation of pneumoperitoneum. RESULTS: The questionnaire was returned by 57% of the centers, for a total of 12,919 laparoscopic procedures. The type of procedure used to create the pneumoperitoneum involved a standard closed approach (Veress needle + first trocar) in 82% of the cases, an open (Hasson) approach in 9% of the cases, and the use of an optical trocar in 9% of the cases. There were seven major vascular injuries (0.05%), eight visceral lesions (0.06%), and nine minor vascular lesions (0.07%), for an overall morbility of 0.18%. There was no death related to these complications. The rate of complications differed significantly (p < 0.0001) depending on the type of approach used. It was 0.27% with the optical trocar (3 of 1,009 cases), 0.18% with the closed approach (20 of 10,664 cases), and 0.09% with the open approach (1 of 1,135 cases). CONCLUSIONS: There is no foolproof technique for the creation of pneumoperitoneum, and this inquiry confirms the need of a constant search for prevention and early treatment of complications encountered during this obligatory phase of any laparoscopic approach. A well-conducted and prolonged prospective audit of clinical practice could help in identifying the risk factors that can make an alternative approach (open or video controlled) preferable to the widely used closed approach.

Preoperative lymphoscintigraphy and sentinel lymph node biopsy in papillary thyroid cancer. A pilot study.

BACKGROUND AND OBJECTIVES: Lymphadenectomy for papillary thyroid cancer is a matter of debate. After showing its usefulness as a prognostic factor in both melanoma and breast cancer, the concept of sentinel lymph node biopsy was also recently applied to differentiated thyroid cancer. To date, all attempts to locate and remove the sentinel node were based on the intraoperative injection of a vital dye. The feasibility and the technical details of using preoperative lymphoscintigraphy coupled with intraoperative vital dye and gamma probe scanning were investigated and discussed. METHODS: Six patients diagnosed with papillary thyroid cancer were submitted to preoperative lymphoscintigraphy with (99m)Tc-labelled colloidal albumin at different dosages. The operation consisted in a total thyroidectomy with sentinel lymph node biopsy guided by intraoperative injection of a vital dye (Blu Patent V, 2.5%) and scanning with a hand-held gamma probe. Lymph node dissection was completed in the area in which the sentinel node was located. RESULTS: The sentinel node was identified using all the three methods in all cases (100%). Considering one of the methods alone, identification rates were 66, 50, and 83% for preoperative lymphoscintigraphy, vital dye, and probe scanning, respectively. One sentinel node was identified in four cases and two in the other two cases. The optimal dosage of the tracer appeared to be at 22 MBq. CONCLUSIONS: These results underline the necessity to use the combination of nuclear medicine imaging and lymphatic vital dye in order to enhance the identification rate of sentinel node also in thyroid cancer. It is now necessary to check the diagnostic accuracy of this procedure through a controlled trial involving a more extended lymph node dissection in the neck.

Evaluation of the Maruyama computer program accuracy for preoperative estimation of lymph node metastases from gastric cancer.

Controversy still exists about the optimal lymph node (LN) dissection for potentially curable gastric cancer. For rational LN dissection it is important to know the incidence of metastasis at each LN station. For this purpose a computer program was developed using data from 4302 primary gastric cancers treated at the National Cancer Center Hospital in Tokyo between 1969 and 1989. To evaluate the accuracy of the computer program, the differences between the individual reports generated by the computer and the stored data were investigated in 282 Italian patients submitted to curative gastrectomy and D2 or more extended LN dissections for gastric cancer. Receiver operating characteristic (ROC) analysis was used to assess the sensitivity and specificity of the program for predicting LN metastases in each of the 16 regional LN stations. The computer program showed good predictive ability for LN metastases in most of the 16 LN stations, as the areas under the curve ranged from 0.741 (station 15) to 0.944 (station 8), with a mean of 0.856. A critical cutoff point of 18% of the program's expected percentage was the value maximizing the validity of the prediction. Using an "absolute" cutoff point of 0%, the overall rate of false-negative (FN) predictions in 176 N+ patients was 11.9%; of these, 11 (6.2%) were absolute FNs, in which the program totally failed to estimate LN metastases; the remaining 10 cases (5.7%) were relative FNs because the specific prediction was positive for a different depth of stomach invasion. The low number of D3/D4 lymph-adenectomies in the historical database may affect the low estimate of metastases to N3/N4 nodes generated by the program. Based on these data, the program predicts with good accuracy the extent of LN metastases from gastric cancer, but it is not recommended for directing the surgeon to perform more extensive lymphadenectomy.

[Routine use of open laparoscopy: technique and results in 1006 consecutive cases]. / Uso routinario della laparoscopia aperta: tecnica e risultati in 1.006 casi consecutivi.

Blind insertion of the Veress needle and/or the first trocar is one of the most frequent causes of laparoscopic surgery complications. Nevertheless, the closed technique is still more preferred than the open one. The Authors retrospectively analyzed 1006 consecutive laparoscopic procedures in which Hasson's technique was routinely utilized. The overall complication rate was 2.2%, but the vast majority of complications occurred during the learning curve (6% vs. 1.9%). The Authors conclude that after the first 50 cases the open technique is a quick and safe procedure.

Pre-operative angiography in gastric cancer surgery with extended lymphadenectomy.

BACKGROUND/AIMS: The value of pre-operative angiographic evaluation in patients undergoing gastric cancer surgery with extended lymphadenectomy was assessed in a prospective study comparing exposed and unexposed groups of patients. METHODOLOGY: During the period from July 1991 to October 1997, 76 patients (Group A--exposed) were pre-operatively submitted to a digital subtraction angiography (DSA) after informed consent. Concurrently, 94 patients (Group B--unexposed) were included as an unexposed reference group. All patients underwent total or subtotal gastrectomy with D2 lymphadenectomy according to the guidelines proposed by the Japanese Research Society for Gastric Cancer (JRSGC). RESULTS: In 34 (45%) exposed patients (Group A), DSA detected an atypical vascular anatomy. Major anatomical variations of the celiac axis, its branches and the superior mesenteric artery were discovered in 4 subjects (5%). Vascular anomalies affecting the surgical tactics of lymphadenectomy were detected in less than 8% of patients. Five post-operative deaths (6.6%) were registered between patients of the Group A, exposed to pre-operative angiography, 8 in the unexposed Group B (8.5%). Post-operative morbidity was significantly higher (P = 0.038) in the Group B (34%) in comparison to Group A (20%) but no difference in risk of individual complications was detected. CONCLUSIONS: Although useful in the presence of major vascular anomalies, it appears that pre-operative angiography did not significantly reduce intra- and post-operative complications associated with radical gastrectomy combined with extended lymphadenectomy. Arteriography is therefore not routinely recommendable but its use is mandatory in specific operations for gastric cancer.

Routine use of open laparoscopy: 1,006 consecutive cases.

Blind insertion of the Veress needle and of the first trocar is a significant cause of laparoscopic surgery complications. Despite this risk, the closed technique is still more popular than the open one. The authors retrospectively evaluated 1006 consecutive laparoscopic operations in which Hasson's technique was routinely performed. The overall complication rate was 2.2%, but the vast majority of complications occurred during the first 50 cases (6% vs. 1.9%). They conclude that after a learning phase of about 50 cases, Hasson's technique is a quick and safe procedure.

Prospective evaluation of total parathyroidectomy and autotransplantation for the treatment of secondary hyperparathyroidism.

OBJECTIVE: To evaluate the clinical effectiveness of total parathyroidectomy with autotransplantation for the treatment of hyperparathyroidism and the recurrence rate of hyperparathyroidism after this procedure. DESIGN: A prospective study of total parathyroidectomy and autotransplantation in 19 consecutive patients with severe secondary (renal) hyperparathyroidism. SETTING: University hospital department of surgery. PATIENTS: Nineteen patients operated on for the treatment of secondary hyperparathyroidism between March 1993 and March 1996. Eighteen had been receiving longterm hemodialysis, and 1 had a functioning renal graft. INTERVENTION: Total parathyroidectomy and autotransplantation of excised parathyroid tissue into the brachioradialis muscle of the arm opposite that in which the arteriovenous fistula had been placed for dialysis. MAIN OUTCOME MEASURES: Clinical and biochemical improvement, morbidity, mortality, and recurrence rates of hyperparathyroidism after the procedure. RESULTS: The conditions of 13 (72%) of 18 patients followed up improved, and the clinical and laboratory variables indicating secondary hyperparathyroidism returned to normal. One patient died 50 days after surgery. In 2 patients (10%), mild hypoparathyroidism developed, and in 1 patient (5%), persistent hyperparathyroidism developed and required reoperation. In 2 patients (10%), recurrent hyperparathyroidism developed, and 1 (5%) required reoperation. CONCLUSIONS: Total parathyroidectomy with autotransplantation effectively relieves the symptoms of hyperparathyroidism, and the recurrence rate of hyperparathyroidism is low. Because all procedures used resulted in good control of clinical and biochemical variables, the method used for the surgical treatment of secondary hyperparathyroidism depends on the surgeon's preference.