RESUMO
OBJECTIVE: To determine long-term outcomes of a randomized trial (BIOPEX) comparing biological mesh and primary perineal closure in rectal cancer patients after extralevator abdominoperineal resection and preoperative radiotherapy, with a primary focus on symptomatic perineal hernia. SUMMARY BACKGROUND DATA: BIOPEX is the only randomized trial in this field, which was negative on its primary endpoint (30-day wound healing). METHODS: This was a posthoc secondary analysis of patients randomized in the BIOPEX trial to either biological mesh closure (n = 50; 2 dropouts) or primary perineal closure (n = 54; 1 dropout). Patients were followed for 5 years. Actuarial 5-year probabilities were determined by the Kaplan-Meier statistic. RESULTS: Actuarial 5-year symptomatic perineal hernia rates were 7% (95% CI, 0-30) after biological mesh closure versus 30% (95% CI, 10-49) after primary closure (P = 0.006). One patient (2%) in the biomesh group underwent elective perineal hernia repair, compared to 7 patients (13%) in the primary closure group (P = 0.062). Reoperations for small bowel obstruction were necessary in 1/48 patients (2%) and 5/53 patients (9%), respectively (P = 0.208). No significant differences were found for chronic perineal wound problems, locoregional recurrence, overall survival, and main domains of quality of life and functional outcome. CONCLUSIONS: Symptomatic perineal hernia rate at 5-year follow-up after abdominoperineal resection for rectal cancer was significantly lower after biological mesh closure. Biological mesh closure did not improve quality of life or functional outcomes.
Assuntos
Herniorrafia/métodos , Hérnia Incisional/cirurgia , Períneo/cirurgia , Complicações Pós-Operatórias/cirurgia , Protectomia/efeitos adversos , Telas Cirúrgicas , Técnicas de Fechamento de Ferimentos , Adulto , Feminino , Seguimentos , Humanos , Hérnia Incisional/etiologia , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , Estudos Prospectivos , Qualidade de Vida , Neoplasias Retais/cirurgia , Fatores de Tempo , CicatrizaçãoRESUMO
BACKGROUND: There is ongoing debate whether laparoscopic right colectomy is superior to open surgery. The purpose of this study was to address this issue and arrive at a consensus using data from a national database. METHODS: Patients who underwent elective open or laparoscopic right colectomy for colorectal cancer during the period 2009-2013 were identified from the Dutch Surgical Colorectal Audit. Complications that occurred within 30 days after surgery and 30-day mortality rates were calculated and compared between open and laparoscopic resection. RESULTS: In total, 12,006 patients underwent elective open or laparoscopic surgery for right-sided colorectal cancer. Of these, 6,683 (55.7%) underwent open resection and 5,323 (44.3%) underwent laparoscopic resection. Complications occurred within 30 days after surgery in the laparoscopic group in 26.1% of patients and in 32.1% of patients in the open group (p < 0.001). Thirty-day mortality was also significantly lower in the laparoscopic group (2.2 vs. 3.6% p < 0.001). CONCLUSION: In this non-randomized, descriptive study conducted in the Netherlands, open right colectomy seems to have a higher risk for complications and mortality as compared to laparoscopic right colectomy, even after correction for confounding factors.
Assuntos
Colectomia/métodos , Neoplasias do Colo/cirurgia , Laparoscopia , Idoso , Idoso de 80 Anos ou mais , Colectomia/efeitos adversos , Colectomia/mortalidade , Colo Ascendente/cirurgia , Colo Transverso/cirurgia , Bases de Dados Factuais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos , Complicações Pós-Operatórias/etiologia , Reoperação , Estudos RetrospectivosRESUMO
OBJECTIVE: To determine the effect of biological mesh closure on perineal wound healing after extralevator abdominoperineal resection (eAPR). BACKGROUND: Perineal wound complications frequently occur after eAPR with preoperative radiotherapy for rectal cancer. Cohort studies have suggested that biological mesh closure of the pelvic floor improves perineal wound healing. METHODS: Patients were randomly assigned to primary closure (standard arm) or biological mesh closure (intervention arm). A non-cross-linked porcine acellular dermal mesh was sutured to the pelvic floor remnants in the intervention arm, followed by a layered closure of the ischioanal and subcutaneous fat and skin similar to the control intervention. The outcome of the randomization was concealed from the patient and perineal wound assessor. The primary endpoint was the rate of uncomplicated perineal wound healing defined as a Southampton wound score of less than 2 at 30 days postoperatively. Patients were followed for 1 year. RESULTS: In total, 104 patients were randomly assigned to primary closure (n = 54; 1 dropouts) and biological mesh closure (n = 50; 2 dropouts). Uncomplicated perineal wound healing rate at 30 days was 66% (33/50; 3 not evaluable) after primary closure, which did not significantly differ from 63% (30/48) after biological mesh closure [relative risk 1.056; 95% confidence interval (CI) 0.7854-1.4197; P = 0.7177). Freedom from perineal hernia at 1 year was 73% (95% CI 60.93-85.07) versus 87% (95% CI 77.49-96.51), respectively (P = 0.0316). CONCLUSIONS: Perineal wound healing after eAPR with preoperative radiotherapy for rectal cancer was not improved when using a biological mesh. A significantly lower 1-year perineal hernia rate after biological mesh closure is a promising secondary finding that needs longer follow-up to determine its clinical relevance.
Assuntos
Derme Acelular , Diafragma da Pelve/cirurgia , Períneo/cirurgia , Neoplasias Retais/cirurgia , Telas Cirúrgicas , Cicatrização , Abdome/cirurgia , Idoso , Animais , Feminino , Hérnia/prevenção & controle , Humanos , Masculino , Pessoa de Meia-Idade , Períneo/fisiologia , Complicações Pós-Operatórias/prevenção & controle , Estudos Prospectivos , Qualidade de Vida , Radioterapia Adjuvante , Neoplasias Retais/radioterapia , Método Simples-Cego , Infecção da Ferida Cirúrgica/prevenção & controle , SuínosRESUMO
BACKGROUND: While several procedural training curricula in laparoscopic colorectal surgery have been validated and published, none have focused on dividing surgical procedures into well-identified segments, which can be trained and assessed separately. This enables the surgeon and resident to focus on a specific segment, or combination of segments, of a procedure. Furthermore, it will provide a consistent and uniform method of training for residents rotating through different teaching hospitals. The goal of this study was to determine consensus on the key steps of laparoscopic right hemicolectomy and laparoscopic sigmoid colectomy among experts in our University Medical Center and affiliated hospitals. This will form the basis for the INVEST video-assisted side-by-side training curriculum. METHODS: The Delphi method was used for determining consensus on key steps of both procedures. A list of 31 steps for laparoscopic right hemicolectomy and 37 steps for laparoscopic sigmoid colectomy was compiled from textbooks and national and international guidelines. In an online questionnaire, 22 experts in 12 hospitals within our teaching region were invited to rate all steps on a Likert scale on importance for the procedure. RESULTS: Consensus was reached in two rounds. Sixteen experts agreed to participate. Of these 16 experts, 14 (88%) completed the questionnaire for both procedures. Of the 14 who completed the first round, 13 (93%) completed the second round. Cronbach's alpha was 0.79 for the right hemicolectomy and 0.91 for the sigmoid colectomy, showing high internal consistency between the experts. For the right hemicolectomy, 25 key steps were established; for the sigmoid colectomy, 24 key steps were established. CONCLUSION: Expert consensus on the key steps for laparoscopic right hemicolectomy and laparoscopic sigmoid colectomy was reached. These key steps will form the basis for a video-assisted teaching curriculum.
Assuntos
Colectomia/métodos , Técnica Delphi , Laparoscopia/métodos , Colo Sigmoide/cirurgia , Humanos , Países BaixosRESUMO
BACKGROUND: Preoperative placement of self-expanding metal stents is used in patients with obstructing colon carcinoma to prevent an emergency operation. The perceived benefits remain the subject of discussion. The data-evaluating function and complications of stents in relation to radiological position are limited. METHODS: Patients receiving a preoperative stent between 2003 and 2013 were retrospectively analysed in this single-centre study. We analysed radiological deployment, eccentricity and angulation of the stent directly after placement. Endpoints were clinical success (resolution of ileus), complications needing non-elective surgery (blow-out, perforation, persistent ileus, dislocation) and other complications (bleeding, infiltrate). Associations were corrected for other potential influences. RESULTS: Eighty-two patients were included. In 22 patients (26.8%), the stent was placed proximal to the splenic flexure. Clinical success was present in 85.4%. Twenty-two patients (26.8%) had a complication of which 16 (19.5%) underwent urgent surgery for insufficient functioning of the stent; there were two blow-outs (2.4%). A more symmetrically placed stent was associated with clinical success (p = 0.042), with large overlap between groups. However, no association was found with non-elective surgery or complications. Also, angulation and deployment were unassociated with these outcomes. CONCLUSIONS: We could not establish an association between symmetry, angulation or deployment of self-expandable colonic stents with clinical success and complications.
Assuntos
Neoplasias do Colo/complicações , Obstrução Intestinal/terapia , Cuidados Pré-Operatórios/métodos , Stents Metálicos Autoexpansíveis , Adulto , Idoso , Idoso de 80 Anos ou mais , Doenças do Colo/diagnóstico por imagem , Doenças do Colo/etiologia , Doenças do Colo/terapia , Neoplasias do Colo/cirurgia , Feminino , Seguimentos , Humanos , Obstrução Intestinal/diagnóstico por imagem , Obstrução Intestinal/etiologia , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Radiografia , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Primary perineal wound closure after conventional abdominoperineal resection (cAPR) for rectal cancer has been the standard of care for many years. Since the introduction of neo-adjuvant radiotherapy and the extralevator APR (eAPR), oncological outcome has been improved, but at the cost of increased rates of perineal wound healing problems and perineal hernia. This has progressively increased the use of biological meshes, although not supported by sufficient evidence. The aim of this study is to determine the effectiveness of pelvic floor reconstruction using a biological mesh after standardized eAPR with neo-adjuvant (chemo)radiotherapy compared to primary perineal wound closure. METHODS/DESIGN: In this multicentre randomized controlled trial, patients with a clinical diagnosis of primary rectal cancer who are scheduled for eAPR after neo-adjuvant (chemo)radiotherapy will be considered eligible. Exclusion criteria are prior radiotherapy, sacral resection above S4/S5, allergy to pig products or polysorbate, collagen disorders, and severe systemic diseases affecting wound healing, except for diabetes. After informed consent, 104 patients will be randomized between standard care using primary wound closure of the perineum and the experimental arm consisting of suturing a biological mesh derived from porcine dermis in the pelvic floor defect, followed by perineal closure similar to the control arm. Patients will be followed for one year after the intervention and outcome assessors and patients will be blinded for the study treatment. The primary endpoint is the percentage of uncomplicated perineal wound healing, defined as a Southampton wound score of less than II on day 30. Secondary endpoints are hospital stay, incidence of perineal hernia, quality of life, and costs. DISCUSSION: The BIOPEX-study is the first randomized controlled multicentre study to determine the additive value of using a biological mesh for perineal wound closure after eAPR with neo-adjuvant radiotherapy compared to primary perineal wound closure with regard to perineal wound healing and the occurrence of perineal hernia. TRAIL REGISTRATION NUMBER: NCT01927497 (Clinicaltrial.gov).
Assuntos
Bioprótese , Diafragma da Pelve/cirurgia , Períneo/cirurgia , Procedimentos de Cirurgia Plástica/métodos , Neoplasias Retais/cirurgia , Telas Cirúrgicas , Deiscência da Ferida Operatória/cirurgia , Terapia Combinada/efeitos adversos , Feminino , Seguimentos , Humanos , Laparoscopia/métodos , Masculino , Método Simples-Cego , CicatrizaçãoRESUMO
BACKGROUND: Laparoscopic subtotal colectomy (STC) is a complex procedure. It is possible that short-term benefits for segmental resections cannot be attributed to this complex procedure. This study aims to assess differences in short-term results for laparoscopic versus open STC during a 15-year single-institute experience. METHODS: We reviewed consecutive patients undergoing laparoscopic or open elective or subacute STC from January 1997 to December 2012. RESULTS: Fifty-six laparoscopic and 50 open STCs were performed. The operation time was significantly longer in the laparoscopic group, median 266 min (range 121-420 min), compared to 153 min (range 90-408 min) in the open group (p < 0.001). Median hospital stay showed no statistical difference, 14 days (range 1-129 days) in the laparoscopic and 13 days (range 1-85 days) in the open group. Between-group postoperative complications were not statistically different. CONCLUSIONS: Laparoscopic STC has short-term results similar to the open procedure, except for a longer operation time. The laparoscopic approach for STC is therefore only advisable in selected patients combined with extensive preoperative counseling.
Assuntos
Colectomia/estatística & dados numéricos , Doenças Inflamatórias Intestinais/cirurgia , Laparoscopia/estatística & dados numéricos , Fístula Anastomótica/etiologia , Colecistectomia/estatística & dados numéricos , Colecistite/etiologia , Colecistite/cirurgia , Colectomia/efeitos adversos , Feminino , Humanos , Laparoscopia/efeitos adversos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/epidemiologia , Estudos Prospectivos , Reoperação , Resultado do TratamentoRESUMO
INTRODUCTION: In early rectal cancer, organ sparing treatment strategies such as local excision have gained popularity. The necessity of radical surgery is based on the histopathological evaluation of the local excision specimen. This study aimed to describe diagnostic variability between pathologists, and its impact on treatment allocation in patients with locally excised early rectal cancer. MATERIALS AND METHODS: Patients with locally excised pT1-2 rectal cancer were included in this prospective cohort study. Both quantitative measures and histopathological risk factors (i.e. poor differentiation, deep submucosal invasion, and lymphatic- or venous invasion) were evaluated. Interobserver variability was reported by both percentages and Fleiss' Kappa- (ĸ) or intra-class correlation coefficients. RESULTS: A total of 126 patients were included. Ninety-four percent of the original histopathological reports contained all required parameters. In 73 of the 126 (57.9%) patients, at least one discordant parameter was observed, which regarded histopathological risk factors for lymph node metastases in 36 patients (28.6%). Interobserver agreement among different variables varied between 74% and 95% or ĸ 0.530-0.962. The assessment of lymphovascular invasion showed discordances in 26% (ĸ = 0.530, 95% CI 0.375-0.684) of the cases. In fourteen (11%) patients, discordances led to a change in treatment strategy. CONCLUSION: This study demonstrated that there is substantial interobserver variability between pathologists, especially in the assessment of lymphovascular invasion. Pathologists play a key role in treatment allocation after local excision of early rectal cancer, therefore interobserver variability needs to be reduced to decrease the number of patients that are over- or undertreated.
Assuntos
Procedimentos Cirúrgicos do Sistema Digestório , Neoplasias Retais , Humanos , Estudos Prospectivos , Estadiamento de Neoplasias , Neoplasias Retais/cirurgia , Neoplasias Retais/patologia , Metástase LinfáticaRESUMO
PURPOSE: A steep learning curve exists for surgeons to become skilled in laparoscopic colon resection. Our institute offers a proctored training programme. The purpose of this descriptive study was to evaluate whether the course resulted in adoption of laparoscopic colorectal surgery into clinical practice, explore post-course practice patterns and analyse the outcome of surgical performance. METHODS: Between 2003 and 2008, 26 surgeons were trained by our institute. The course consisted of 24 elective laparoscopic resections under direct supervision. A questionnaire and a prospective post-course web-based registration were used to analyse the effect of the training and the outcome of surgical performance. RESULTS: The response rate of the questionnaire was 85%. The majority had not performed any laparoscopic colon resections before attending the course. All 24 respondents successfully implemented laparoscopy into daily practice. After the course, 70% of all sigmoid resections were performed laparoscopically in contrast with 0% of all transverse colon resections. The results of the trainees after following the course are equal to results of other studies. CONCLUSIONS: A proctored training programme, consisting of 24 supervised cases, is safe and feasible. For adequate monitoring, participating in a post-course registry should be obligatory.
Assuntos
Colo/cirurgia , Procedimentos Cirúrgicos Eletivos/educação , Implementação de Plano de Saúde , Laparoscopia/educação , Bases de Dados como Assunto , HumanosRESUMO
PURPOSE: Some authors state that elective laparoscopic recto-sigmoid resection is more difficult for diverticular disease as compared with malignancy. For this reason, starting laparoscopic surgeons might avoid diverticulitis, making the implementation phase unnecessary long. The aim of this study was to determine whether laparoscopic resection for diverticular disease should be included during the implementation phase. METHODS: All consecutive patients who underwent an elective laparoscopic recto-sigmoid resection in our hospital for diverticulitis or cancer from 2003 to 2007 were analysed. RESULTS: A total of 256 consecutive patients were included in this prospective cohort study. One hundred and fifty-one patients were operated on for diverticulitis and 105 for cancer. There was no significant difference in operation time (168 vs. 172 min), blood loss (189 vs. 208 ml), conversion rates (9.9% vs. 11.4%), hospital stay (8 vs. 8 days), total number of peroperative (2.3% vs. 1.6%) or postoperative complications (21.9% vs. 26.9%). The occurrence of anastomotic leakages was associated with higher American Society of Anesthesiologists (ASA) classification, which differed between the groups (86.8% vs. 64.8% ASA I-II, p < 0.001). CONCLUSION: Since there are no differences in operation time, blood loss, conversion rate and total complications, there is no need to avoid laparoscopic recto-sigmoid resection for diverticular disease early in the learning curve.
Assuntos
Colo Sigmoide/cirurgia , Neoplasias do Colo/cirurgia , Procedimentos Cirúrgicos do Sistema Digestório/educação , Doença Diverticular do Colo/cirurgia , Laparoscopia/efeitos adversos , Idoso , Estudos de Coortes , Educação Médica , Procedimentos Cirúrgicos Eletivos , Feminino , Humanos , Laparoscopia/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Estudos ProspectivosRESUMO
BACKGROUND: Recently, excellent results are reported on laparoscopic lavage in patients with purulent perforated diverticulitis as an alternative for sigmoidectomy and ostomy.The objective of this study is to determine whether LaparOscopic LAvage and drainage is a safe and effective treatment for patients with purulent peritonitis (LOLA-arm) and to determine the optimal resectional strategy in patients with a purulent or faecal peritonitis (DIVA-arm: perforated DIVerticulitis: sigmoidresection with or without Anastomosis). METHODS/DESIGN: In this multicentre randomised trial all patients with perforated diverticulitis are included. Upon laparoscopy, patients with purulent peritonitis are treated with laparoscopic lavage and drainage, Hartmann's procedure or sigmoidectomy with primary anastomosis in a ratio of 2:1:1 (LOLA-arm). Patients with faecal peritonitis will be randomised 1:1 between Hartmann's procedure and resection with primary anastomosis (DIVA-arm). The primary combined endpoint of the LOLA-arm is major morbidity and mortality. A sample size of 132:66:66 patients will be able to detect a difference in the primary endpoint from 25% in resectional groups compared to 10% in the laparoscopic lavage group (two sided alpha = 5%, power = 90%). Endpoint of the DIVA-arm is stoma free survival one year after initial surgery. In this arm 212 patients are needed to significantly demonstrate a difference of 30% (log rank test two sided alpha = 5% and power = 90%) in favour of the patients with resection with primary anastomosis. Secondary endpoints for both arms are the number of days alive and outside the hospital, health related quality of life, health care utilisation and associated costs. DISCUSSION: The Ladies trial is a nationwide multicentre randomised trial on perforated diverticulitis that will provide evidence on the merits of laparoscopic lavage and drainage for purulent generalised peritonitis and on the optimal resectional strategy for both purulent and faecal generalised peritonitis. TRIAL REGISTRATION: Nederlands Trial Register NTR2037.
Assuntos
Diverticulite/complicações , Perfuração Intestinal/cirurgia , Lavagem Peritoneal/métodos , Peritonite/cirurgia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Anastomose Cirúrgica , Colectomia , Colostomia , Feminino , Humanos , Perfuração Intestinal/etiologia , Laparoscopia , Pessoa de Meia-Idade , Peritonite/etiologia , Resultado do TratamentoRESUMO
OBJECTIVE: To evaluate the effect of learning the laparoscopic sigmoid resection procedure on resident surgeons; establish a minimum number of cases before a resident surgeon could be expected to achieve proficiency with the procedure; and examine if an analysis could be used to measure and support the clinical evaluation of the surgeon's competence with the procedure. DESIGN: Retrospective analysis of data which was prospective entered in the database. PARTICIPANTS: From 2003 to 2007 all patients who underwent a laparoscopic sigmoid resection carried out by senior residents, who completed the procedure as the primary surgeon proctored by an experienced surgeon, were included in the study. A cumulative sum control chart (CUSUM) analysis was used evaluate performance. The procedure was defined as a failure if major intra-operative complications occurred such as intra abdominal organ injury, bleeding, or anastomotic leakage; if an inadequate number of lymph nodes (<12 nodes) were removed; or if conversion to an open surgical procedure was required. RESULTS: Thirteen residents performed 169 laparoscopic sigmoid resections in the period evaluated. A significant majority of the resident surgeons were able to consistently perform the procedure without failure after 11 cases and determined to be competent. One resident was not determined to be competent and the CUSUM score supported these findings. CONCLUSIONS: We concluded that at least 11 cases are required for most residents to obtain necessary competence with the laparoscopic sigmoid resection procedure. Evaluation with the CUSUM analysis can be used to measure and support the clinical evaluation of the resident surgeon's competence with the procedure.
Assuntos
Colo Sigmoide/cirurgia , Internato e Residência , Laparoscopia/educação , Curva de Aprendizado , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos RetrospectivosRESUMO
BACKGROUND: The incidence of patients who present with acute obstructive colon carcinoma and synchronous liver metastases is increasing. CASE DESCRIPTION: Two men aged 70 and 71 both had acute obstructive colon carcinoma with synchronous liver metastases. Both patients underwent successful stent placement that solved the colonic obstruction. Five weeks later the first patient underwent an elective surgical procedure at which both the colon carcinoma and the liver metastases were resected. The second patient had more widespread metastases and first received chemotherapy. After six courses of chemotherapy the liver metastases became resectable and he underwent a two-stage liver resection with a left-sided hemicolectomy. CONCLUSION: These cases illustrate that placing a stent can be an alternative to an acute operation, and thus can save the patient from an emergency laparotomy with creation of a stoma that needs closure afterwards. In addition stent placement is a good starting point for an intended curative treatment trajectory, also in the setting of synchronous liver metastases accompanying the acute obstructive carcinoma.