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Leiomyosarcomas (LMSs) are rare tumors originating from the muscular layer. We performed a literature review of cases of confirmed rectal leiomyosarcomas (rLMSs) to clarify the history of such an infrequent tumor arising at such an uncommon location. In this research local recurrence was related to poorly differentiated rLMS and no other association between recurrence and any criteria was found. Concerning overall survival (OS), rLMS patients developing recurrence presented shorter longevity compared with the group without.
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Leiomiossarcoma , Neoplasias Retais , Humanos , Leiomiossarcoma/cirurgia , Leiomiossarcoma/patologia , Reto/cirurgia , Reto/patologia , Neoplasias Retais/cirurgia , Neoplasias Retais/patologia , Pelve/patologiaRESUMO
PURPOSE: Defecation disorders (DD) can sometimes affect the outcomes of pelvic or colorectal surgery. The aim of the present study is to evaluate the role of sacral neuromodulation for the treatment of constipation and other evacuation disorders after surgery. METHODS: A retrospective analysis in all the consecutive patients that underwent sacral nerve modulation (SNM) for DD arisen or worsened after pelvic or colorectal surgery was performed from January 2010 to December 2020. DD were defined starting from Rome IV Criteria, and according to manometric results, all patients were further divided into the two subgroups: inadequate defecatory propulsion and dyssynergic defecation. Cleveland Clinic Constipations Score (CCCS) and SF-36 have been evaluated in the time. RESULTS: Thirty-seven patients have been included in the study. Twenty-seven out of thirty-seven (73.3%) patients had experienced sufficient benefits to implant the definitive device, and 22 patients (59.4% of tested and 81.5% of permanently implanted) still had the device functioning after a mean follow-up of 6.3 years. The most represented manometric pattern was inadequate propulsive function (59% of patients). CCCS at preoperative assessment for all patients was 17.5 with a reduction to 10.4 at the first year of follow-up (p < 0.001). CONCLUSION: SNM appears to be a feasible, safe, and well-tolerated procedure with durable benefit in the long-term treatment of defecatory dysfunction after pelvic or colorectal surgery for benign diseases.
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Defecação , Terapia por Estimulação Elétrica , Humanos , Estudos Retrospectivos , Resultado do Tratamento , Constipação Intestinal/etiologia , Constipação Intestinal/cirurgia , Terapia por Estimulação Elétrica/métodosRESUMO
BACKGROUND: Early colorectal cancer (ECC) is defined as T1NXM0 colorectal cancer (CRC). Although a non-negligible number of T1-CRCs presents metastatic lymph-nodes, local excision is increasingly proposed as alternative to radical resection. Several criteria have been suggested to identify low-risk T1-CRC, but recommendations on this topic are still heterogeneous. This study aims to identify criteria associated with N+ T1-CRC, to select patients to undergo (or not) local excision. METHODS: A retrospective analysis of demographic, clinical, and histology criteria of 122 consecutive T1-CRC patients undergoing radical resection at Parma University Hospital between 2000 and 2018 has been performed. RESULTS: Lymph-node metastasis (LNM) was observed in 15/122 patients (12.3%). No LNM was observed among well-differentiated (G1) tumors (0/37), while 10/65 (15.4%) G2 cases as well as 5/20 (25%) G3 patients presented LNM. G1 was associated with absence of LNM (p = 0.013). After excluding G1 patients, the rate of N + T1-CRC was 17.6% (15/85). LNM was observed in 4/8 (50%) patients with lymphovascular invasion (LVI) and in 11/77 (14.2%) without LVI. LVI resulted being associated with LNM (p < 0.042). LNM was reported in 28.3% of cases with a tumor infiltration >4.25 mm (13/46), compared to 5.1% in cases with an infiltration ≤4.25 mm (2/39) (p = 0.012). In Cox regression analysis, the higher hazard ratio (HR) was reported for the LVI + and infiltration >4.25 mm (HR 24.849). CONCLUSIONS: In patients with ECC (pT1NXM0), good differentiation (G1), absence of lymphovascular invasion (LVI-), and tumor radial infiltration ≤4.25 mm may allow performing local resection and avoiding radical surgery.
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Neoplasias Colorretais , Gastrectomia , Humanos , Estudos Retrospectivos , Invasividade Neoplásica , Fatores de Risco , Metástase Linfática , Gastrectomia/métodos , Neoplasias Colorretais/cirurgia , Neoplasias Colorretais/patologiaRESUMO
Surgery remains the cardinal treatment in colorectal cancers but changes in bowel habits after rectal cancer surgery are common and disabling conditions that affect patients' quality of life. Low anterior resection syndrome is a disorder of bowel function after rectal resection resulting in a lowering of the QoL and recently has been defined by an international working group not only by specified symptoms but also by their consequences. This review aims to explore an extensive bibliographic research on preventive strategies for LARS. All "modifiable variables," quantified by the LARS Score, such as type of anastomosis, neoadjuvant therapy, surgical strategy, and diverting stoma, were evaluated, while "non-modifiable variables" such as age, sex, BMI, ASA, preoperative TMN, tumor height, and type of mesorectal excision were excluded from the comparative analysis. The role of defunctioning stoma, local excision, neoadjuvant radiotherapy, and non operative management seems to significantly affect risk of LARS, while type of anastomosis and surgical TME approach do not impact on LARS incidence or gravity in the long term period. Although it is established that some variables are associated with a greater onset of LARS, in clinical practice, technical difficulties and oncological limits often make difficult the application of some prevention plans. Transtomal irrigations, intraoperative neuromonitoring, pelvic floor rehabilitation before stoma closure, and early transanal irrigation represent new arguments of study in preventive strategies which could, if not eliminate the symptoms, at least mitigate them.
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Protectomia , Neoplasias Retais , Humanos , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Qualidade de Vida , Neoplasias Retais/cirurgia , SíndromeRESUMO
PURPOSE: In colorectal cancer (CRC), lymphovascular invasion (LVI) is a predictor of poor outcome and its analysis is nowadays recommended. Literature is still extremely heterogeneous, and we hypothesize that, within such a group of patients, there are any further predictors of survival. METHODS: A total of 2652 patients with I-III-stage CRC undergoing resection between 2002 and 2018 were included in a retrospective analysis of demographic, clinical, and histology with the aim of defining the impact of LVI on overall survival (OS) and its relationship with other prognostic factors. RESULTS: Overall, 5-year-OS was 62.6% (77-month-median survival). LVI was found in 558 (21%) specimens and resulted associated with 44.9%-5-year-OS (44 months) vs. 64.1% (104 months) of LVI cases. At multivariate analysis, LVI (p = 0.009), T3-4 (p < 0.001), and N ≠ 0 (p < 0.001) resulted independent predictors of outcome. LVI resulted as being associated with older age (p < 0.013), T3-4 (p < 0.001), lower grading (p < 0.001), N ≠ 0 (p < 0.001), mucinous histology (p < 0.001), budding (p < 0.001), and PNI (p < 0.001). Within the LVI + patients, T3-4 (p = 0.009) and N ≠ 0 (p < 0.001) resulted as independent predictors of shortened OS. In particular, N-status impacted the prognosis of patients with T3-4 tumors (p = 0.020), whereas it did not impact the prognosis of patients with T1-2 tumors (p = 0.393). Three groups (T1-2anyN, T3-4N0, T3-4 N ≠ 0), with distinct outcome (approximately 70%-, 52%-, and 35%-5-year-OS, respectively), were identified. CONCLUSIONS: LVI is associated with more aggressive/more advanced CRC and is confirmed as predictor of poor outcome. By using T- and N-stage, a simple algorithm may easily allow re-assessing the expected survival of patients with LVI + tumors.
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Adenocarcinoma , Neoplasias Colorretais , Adenocarcinoma/cirurgia , Idoso , Neoplasias Colorretais/patologia , Humanos , Invasividade Neoplásica/patologia , Estadiamento de Neoplasias , Prognóstico , Estudos RetrospectivosRESUMO
INTRODUCTION: Complicated diaphragmatic hernia (DH) can be congenital or acquired. Congenital diaphragmatic hernias (CDH) are rare and often can be asymptomatic until adulthood. Traumatic diaphragmatic hernia (TDH) is a complication that occurs in about 1-5% of victims of road accidents and in 10-15% of penetrating traumas of the lower chest. CDH and TDH are potentially life-threatening conditions, and the management in emergency setting still debated. This study aims to evaluate the surgical treatment options in emergency setting. METHODS: A bibliographic research reporting the item "emergency surgery" linked with "traumatic diaphragmatic rupture" and "congenital diaphragmatic hernia" was performed. Several parameters were recorded including sex, age, etiology, diagnosis, treatment, site and herniated organs. RESULTS: The research included 146 articles, and 1542 patients were analyzed. Most of the complicated diaphragmatic hernias occurred for a diaphragmatic defect due to trauma, only 7.2% occurred for a congenital diaphragmatic defect. The main diagnostic method used was chest X-ray and CT scan. Laparotomic approach still remains predominant compared to the minimally invasive approach. CONCLUSION: Surgery is the treatment of choice and is strongly influenced by the preoperative setting, performed mainly with X-ray and CT scan. Minimally invasive approach is safe and feasible but is highly dependent on the surgeon's expertise, especially in emergency setting.
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Emergências , Hérnia Diafragmática Traumática/cirurgia , Hérnias Diafragmáticas Congênitas/cirurgia , Adulto , Feminino , Hérnia Diafragmática Traumática/diagnóstico por imagem , Hérnias Diafragmáticas Congênitas/diagnóstico por imagem , Humanos , Laparotomia , Masculino , Radiografia , Tomografia Computadorizada por Raios X , Ferimentos Penetrantes/diagnóstico por imagem , Ferimentos Penetrantes/cirurgiaRESUMO
Acute diverticulitis (AD) is associated with relevant morbidity/mortality and is increasing worldwide, thus becoming a major issue for national health systems. AD may be challenging, as clinical relevance varies widely, ranging from asymptomatic picture to life-threatening conditions, with continuously evolving diagnostic tools, classifications, and management. A 33-item-questionnaire was administered to residents and surgeons to analyze the actual clinical practice and to verify the real spread of recent recommendations, also by stratifying surgeons by experience. CT-scan remains the mainstay of AD assessment, including cases presenting with recurrent mild episodes or women of child-bearing age. Outpatient management of mild AD is slowly gaining acceptance. A conservative management is preferred in non-severe cases with extradigestive air or small/non-radiologically drainable abscesses. In severe cases, a laparoscopic approach is preferred, with a non-negligible number of surgeons confident in performing emergency complex procedures. Surgeons are seemingly aware of several options during emergency surgery for AD, since the rate of Hartmann procedures does not exceed 50% in most environments and damage control surgery is spreading in life-threatening cases. Quality of life and history of complicated AD are the main indications for delayed colectomy, which is mostly performed avoiding the proximal vessel ligation, mobilizing the splenic flexure and performing a colorectal anastomosis. ICG is spreading to check anastomotic stumps' vascularization. Differences between the two experience groups were found about the type of investigation to exclude colon cancer (considering the experience only in terms of number of colectomies performed), the size of the peritoneal abscess to be drained, practice of damage control surgery and the attitude towards colovesical fistula.
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PURPOSE: Pneumatosis intestinalis is a radiological finding with incompletely understood pathogenesis. To date, there are no protocols to guide surgical intervention. METHODS: A systematic review of literature, according to PRISMA criteria, was performed. Medline and PubMed were consulted to identify articles reporting on the items "emergency surgery, pneumatosis coli, and pneumatosis intestinalis" from January 2010 up to March 2022. This study has not been registered in relevant databases. RESULTS: A total of 1673 patients were included. The average age was 67.1 ± 17.6 years. The etiology was unknown in 802 (47.9%) patients. Hemodynamic instability (246/1673-14.7% of the patients) was associated with bowel ischemia, necrosis, or perforation (p = 0.019). Conservative management was performed in 824 (49.2%) patients. Surgery was performed 619 (36.9%) times, especially in unstable patients with bowel ischemia signs, lactate levels greater than 2 mmol/L, and PVG (p = 0.0026). In 155 cases, surgery was performed without pathological findings. CONCLUSIONS: Many variables should be considered in the approach to patients with pneumatosis intestinalis. The challenge facing the surgeons is in truly identifying those who really would benefit and need surgical intervention. The watch and wait policy as a first step seems reasonable, reserving surgery only for patients who are unstable or with high suspicion of bowel ischemia, necrosis, or perforation.
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Different types of lasers have been applied for various proctological conditions. We discuss about published articles regarding the application of lasers, with concern about evidence-based use of these techniques and technologies. We performed a literature search about laser treatments for proctological conditions. 55 studies were included for the final revision. Meta-analysis of data was not performed because of heterogeneity of study designs and outcome measures. A scoping review was performed. Laser treatments for hemorrhoids require a shorter operative time and show less postoperative pain and bleeding compared to conventional hemorrhoidectomy, but are more expensive. Studies are heterogeneous in design, endpoints, postoperative assessment, length of follow-up and outcome measures. Only 3 RCTs are available and only three studies evaluate long-term outcomes. FiLaC (fistula laser closure) was initially described in 2011 for the treatment of anal fistula. In the published studies the reported healing rates vary between 20 and 82%, and the ideal indication is yet to be defined. Studies with long-term follow-up are lacking. SiLaT (sinus laser treatment) applied the technology used for FiLaC to the treatment of pilonidal sinus disease. This technique had less perioperative pain and shorter hospital stay, but a lower primary healing rate when compared to traditional techniques. Available data is very limited, and no randomized trials are published to date. Laser assisted techniques are a viable, minimally invasive, but expensive option for the treatment of several proctological conditions. Further researches are needed to assess if patients could benefit of their use, and for what indication.
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Hemorroidectomia , Hemorroidas , Humanos , Hemorroidectomia/efeitos adversos , Hemorroidas/cirurgia , Lasers , Avaliação de Resultados em Cuidados de Saúde , Dor Pós-Operatória/etiologia , Resultado do TratamentoRESUMO
Anal diseases are very common and, in most of the cases, require surgery of minor or medium complexity, and, therefore, are among the most accessible diseases for surgeons in training. Aim of this study is to investigate the status of the training in proctology in Italy. A 31-items questionnaire was administered to residents and young specialists (≤ 2 years) in general surgery, using mailing lists, and the social media accounts of the Italian Society of Colorectal Surgery. Answers from 338 respondents (53.8% males) were included in the final analysis. Overall, 252 respondents (74.5%) were residents and 86 (25.5%) young specialists. Two hundred and fifty-five (75.4%) respondents practiced proctology for the first time early on during their postgraduate training, but only 19.5% did it continuously for ≥ 24 months. Almost all respondents (334; 98.8%) had the chance to participate in proctological procedures, 205 (60.5%) as first surgeon. This percentage decreases according to the complexity of the surgery. In fact, only 11 (3.3%) and 24 (7.1%) of the respondents were allowed to be the first surgeon in more complex proctological diseases such as surgery for rectal prolapse and fecal incontinence. The present survey suggests that, in Italy, most surgeons in training deal with anal diseases. However, only few of them could achieve sufficient professional skills in the management of proctological diseases to be able to practice autonomously as young specialists.
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Cirurgia Colorretal , Cirurgia Geral , Cirurgiões , Masculino , Humanos , Feminino , Inquéritos e Questionários , Itália , Cirurgia Geral/educaçãoRESUMO
BACKGROUND: The management of recurrent diverticulitis after initial non-operative treatment remains controversial. Recurrences after medical treatment have been described up to 36% but only 3 to 5% develop complicated disease. AIM: To investigate the effectiveness of conservative treatment during a prolonged follow-up after first episode of complicated diverticulitis. METHODS: This retrospective single-center study describes the conservative management and outcomes of 207 with complicated acute colonic diverticulitis treated at Parma University Hospital from 1 January 2012 until 31 December 2019. The follow-up was performed until December 2020. Diverticulitis severity was staged according to WSES CT driven classification for acute diverticulitis. RESULTS: We enrolled 207 patients (118 males, 89 females). The mean age was 59 ± 14.5 years. CT scan of the abdomen was always performed. Almost all patients were treated with bowel rest and antibiotics (98.5%). Percutaneous drainage of abscessed diverticulitis was performed 12 times (5.7%). Average follow-up was 48 ± 28.8 months. 79 patients had new episodes of diverticulitis (38.1%) and 23 patients had high severity new episodes (11.1%). 11 patients underwent surgery (7.7%). Lower CT-Stages showed a higher recurrence rate (P = 0.002). Grade III diverticulitis showed a lower recurrence rate (P = 0.007). Patients with chronic NSAID use showed a higher incidence of high severity new episodes (P = 0.039). No recurrence rate differences were noted among patients with or without home therapy (P > 0.05). CONCLUSIONS: Non-operative treatment is an effective and safe option in selected patients with complicated diverticulitis. The recurrence's severity is generally lower than the previous episodes and this can justify the conservative management.
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Doença Diverticular do Colo , Diverticulite , Masculino , Feminino , Humanos , Adulto , Pessoa de Meia-Idade , Idoso , Doença Diverticular do Colo/complicações , Doença Diverticular do Colo/diagnóstico por imagem , Doença Diverticular do Colo/terapia , Tratamento Conservador/métodos , Resultado do Tratamento , Estudos Retrospectivos , Diverticulite/complicaçõesRESUMO
Amyand's hernia (AH) is a rare condition in which the appendix is found in the sac of an inguinal hernia. It occurs in only 1% of adult inguinal hernias. The herniated appendix can occasionally range varying degrees of acute inflammation up to neoplastic transformation. An appendiceal tumor can be rarely described inside the AH sac. We describe a case of gangrenous appendicitis in AH and offer a review of the literature on AH when presenting with appendicitis associated with appendiceal cancer. As of 2022, only nine cases of AH presenting with appendicitis associated with appendiceal cancer have been reported by the pertinent literature. In order of decreasing frequency, AH, AH-related appendicitis and AH-related appendicitis associated with appendiceal cancer are three rare conditions. Particular attention should be kept in each situation as diagnosis is achieved postoperatively most of the times.
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Neoplasias do Apêndice , Apendicite , Apêndice , Hérnia Inguinal , Adulto , Neoplasias do Apêndice/complicações , Neoplasias do Apêndice/patologia , Apendicite/complicações , Apendicite/cirurgia , Apêndice/patologia , Coleta de Dados , Hérnia Inguinal/complicações , Hérnia Inguinal/cirurgia , HumanosRESUMO
BACKGROUND: Spontaneous kidney allograft rupture (KAR) is a severe complication of kidney transplant. KAR occurs when no identifiable injuries noted at the time of the organ retrieval are present. KAR is associated with acute rejection, renal vein thrombosis, severe acute tubular necrosis, or trauma. In recent years, the introduction of hypothermic machine perfusion (HMP) has provided an excellent option for kidney allograft preservation reducing the incidence of delayed graft function. On the other hand, HMP can also represent a potentially traumatic event for a fragile graft, especially one belonging to expanded criteria donor. CASE PRESENTATION: Here, to our knowledge, we report the first case of KAR after the use of HMP, which occurred in 60-year-old women undergoing a single kidney transplant from a donation after brain death donor belonging to the expanded criteria donor category. The allograft was perfused for 240 minutes with HMP with passive oxygenation. The post-transplant course was unremarkable with early graft function, but on post operatory day 14 the patient complained of severe pain over the transplant site. A computed tomography scan showed a massive fluid collection in the perigraft region. Immediate surgical exploration showed 2 lacerations of 10 cm and 5 cm length at the upper and midpole of the kidney, requiring transplantectomy. Histologically, the graft did not show features of acute rejection. CONCLUSIONS: In the presented case, the repair and salvage of the kidney allograft was not possible. However, the review of the pertinent literature does not report another case linking HMP to KAR.
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Função Retardada do Enxerto , Preservação de Órgãos , Feminino , Humanos , Pessoa de Meia-Idade , Função Retardada do Enxerto/etiologia , Preservação de Órgãos/métodos , Sobrevivência de Enxerto , Perfusão/métodos , Doadores de Tecidos , RimRESUMO
BACKGROUND AND AIM: Primary colonic leiomyosarcoma (cLMS) is a rare malignancy of muscularis mucosae or muscularis propria showing highly aggressive behaviour and poor prognosis. To date, making a preoperative diagnosis and performing the most appropriate treatment represent laborious tasks for the clinicians. On the one hand, in fact, cLMS diagnosis is often difficult to achieve preoperatively because of the low specificity of clinical, radiological and bioptical features: for these motives, the diagnosis is usually obtained at postoperative histology/immune-histochemistry. On the other hand, although surgery represents the mainstay of multi-modal treatment, in the current era of minimally invasive surgery the optimal approach to cLMS is debated: in the absence of a standardized and unanimous algorithm, in fact, laparoscopy is usually proposed for small tumors, whereas laparotomy for masses exceeding 4 cm in diameter. Our aim was to elucidate such two aspects by reporting our experience. METHODS: We present the case of a 51-year-old man affected with a 6-cm LMS of the sigmoid colon. RESULTS: Preoperative diagnosis was achieved through a preoperative echo-endoscopic biopsy. The lesion was successfully and safely managed by laparoscopic surgery. CONCLUSIONS: Our case suggests that a preoperative diagnosis of cLMS is possible in an appropriate setting. Moreover, laparoscopy seems to be a safe and successful approach to resect cancers even larger than the common 4 centimetres proposed by the current literature.
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Neoplasias do Colo , Laparoscopia , Leiomiossarcoma , Colo Sigmoide/cirurgia , Neoplasias do Colo/diagnóstico , Neoplasias do Colo/cirurgia , Humanos , Laparotomia , Leiomiossarcoma/diagnóstico , Leiomiossarcoma/cirurgia , Masculino , Pessoa de Meia-IdadeRESUMO
BACKGROUND/AIM: Liquid biopsy (LB) is a promising non-invasive tool to detect cancer. Over the last few years, exosomes recruited from LB have attracted the attention of researchers for their involvement in cancer. We focused on the role of LB exosomes in gastric cancer (GC). MATERIALS AND METHODS: We investigated the world literature on exosome-encapsulated functional biomarkers (non-coding RNAs and DNAs) taken from GC patients' LBs. Only the studies exploring serum, intraperitoneal fluid or gastric lavage were included. RESULTS: As of 2022, fifty articles with an overall count of 3552 GC patients were investigated. Given the statistically significant associations with the clinicopathological categories of tumor depth, lymph node metastasis, staging class and tumor size, most exosome-mediated microRNAs, long non-coding RNAs and circular RNAs proved to exert a potentially important bioclinical role in terms of diagnosis, screening, prognosis and therapeutic targets. CONCLUSION: In the future, resorting to exosomal biomarkers taken from LB of affected patients could revolutionize the non-invasive fight against GC.
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Exossomos , Neoplasias Gástricas , Biomarcadores Tumorais/genética , Exossomos/genética , Humanos , Biópsia Líquida , Prognóstico , Neoplasias Gástricas/diagnóstico , Neoplasias Gástricas/genéticaRESUMO
Diaphragmatic hernia (DH) can be congenital or acquired. DH is a potentially life-threatening condition and the management in emergency setting remain unclear. Nonspecific symptoms can delay the diagnosis. We report a case of a 63-year-old man admitted for abdominal pain and nausea. He was successfully treated with damage control surgery.
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Hérnias Diafragmáticas Congênitas , Abdome , Dor Abdominal , Dor no Peito , Hérnias Diafragmáticas Congênitas/complicações , Hérnias Diafragmáticas Congênitas/diagnóstico por imagem , Hérnias Diafragmáticas Congênitas/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , NáuseaRESUMO
Background: Laparoscopic partial splenectomy (LPS) may allow avoiding total splenectomy (TS) complications and maximizing the advantages of mini-invasive approach. The objective of this review is to assess feasibility and safety of LPS, to compare this approach with alternative options. Materials and Methods: A literature review of articles reporting LPS is performed. Several parameters, including age, indication, surgical technique, devices used for splenic section/hemostasis, adverse outcomes, including morbidity/mortality, conversions to open surgery, conversions to TS, operative time (OT), and hospital stay (HS), are analyzed. Articles comparing LPS' results with those of open partial splenectomy and laparoscopic TS are also analyzed. Results: Fifty-nine articles reporting 457 LPS were included. Patients' characteristics varied widely, concerning age and indications, including hematological disease (hereditary spherocytosis, drepanocytosis), splenic focal masses, and trauma. Several technical options are reported. Mean OT and HS are 128 ± 43.7 minutes and 4.9 ± 3.8 days, respectively. No mortality and 5.7% morbidity are reported. Conversion rates to open surgery and to TS are 3.9% and 3.7%, respectively. Conclusions: In conclusion LPS is feasible and safe, with no mortality, low morbidity, and low conversion rates to laparotomy and to TS. LPS may be accomplished by various techniques and tools. Major complications are sporadically reported, thus potential risks should not be underestimated.