Evolution in Laparoscopic Gastrectomy From a Randomized Controlled Trial Through National Clinical Practice.

OBJECTIVE: To examine the influence of the LOGICA RCT (randomized controlled trial) upon the practice and outcomes of laparoscopic gastrectomy within the Netherlands. BACKGROUND: Following RCTs the dissemination of complex interventions has been poorly studied. The LOGICA RCT included 10 Dutch centers and compared laparoscopic to open gastrectomy. METHODS: Data were obtained from the Dutch Upper Gastrointestinal Cancer Audit (DUCA) on all gastrectomies performed in the Netherlands (2012-2021), and the LOGICA RCT from 2015 to 2018. Multilevel multivariable logistic regression analyses were performed to assess the effect of laparoscopic versus open gastrectomy upon clinical outcomes before, during, and after the LOGICA RCT. RESULTS: Two hundred eleven patients from the LOGICA RCT (105 open vs 106 laparoscopic) and 4131 patients from the DUCA data set (1884 open vs 2247 laparoscopic) were included. In 2012, laparoscopic gastrectomy was performed in 6% of patients, increasing to 82% in 2021. No significant effect of laparoscopic gastrectomy on postoperative clinical outcomes was observed within the LOGICA RCT. Nationally within DUCA, a shift toward a beneficial effect of laparoscopic gastrectomy upon complications was observed, reaching a significant reduction in overall [adjusted odds ratio (aOR):0.62; 95% CI: 0.46-0.82], severe (aOR: 0.64; 95% CI: 0.46-0.90) and cardiac complications (aOR: 0.51; 95% CI: 0.30-0.89) after the LOGICA trial. CONCLUSIONS: The wider benefits of the LOGICA trial included the safe dissemination of laparoscopic gastrectomy across the Netherlands. The robust surgical quality assurance program in the design of the LOGICA RCT was crucial to facilitate the national dissemination of the technique following the trial and reducing potential patient harm during surgeons learning curve.

Potential Risk and Safety Measures in Laparoscopy in COVID-19 Positive Patients.

Background. During the COVID-19 pandemic the question arises if laparoscopy, as an aerosol forming procedure, poses a potential risk for viral transmission of SARS-CoV-2 to healthcare workers. Methods. A literature search was conducted using PubMed, Embase and MEDLINE. Articles reporting information regarding COVID-19 or other relevant viruses and laparoscopy, surgical smoke, aerosols and viral transmission were included. Results. Although aerosols produced during laparoscopy do not originate from the respiratory tract, the main transmission route of SARS-CoV-2, research did show SARS-CoV-2 to be present in other body fluids. The transmission risk via this route is however considered very low. As previous research showed potential viral transmission during laparoscopy for viruses that spread through contaminated body fluids, there might be a potential risk of SARS-CoV-2 transmission during laparoscopy, albeit considered very small. Conclusion. Due to the small risk compared to widely known benefits of laparoscopy, there is no reason to replace laparoscopy by laparotomy due to COVID-19 infection. To avoid the potential small risk of viral transmission, additional safety measures are advised.

DIRECT trial. Diverticulitis recurrences or continuing symptoms: Operative versus conservative treatment. A multicenter randomised clinical trial.

BACKGROUND: Persisting abdominal complaints are common after an episode of diverticulitis treated conservatively. Furthermore, some patients develop frequent recurrences. These two groups of patients suffer greatly from their disease, as shown by impaired health related quality of life and increased costs due to multiple specialist consultations, pain medication and productivity losses.Both conservative and operative management of patients with persisting abdominal complaints after an episode of diverticulitis and/or frequently recurring diverticulitis are applied. However, direct comparison by a randomised controlled trial is necessary to determine which is superior in relieving symptoms, optimising health related quality of life, minimising costs and preventing diverticulitis recurrences against acceptable morbidity and mortality associated with surgery or the occurrence of a complicated recurrence after conservative management.We, therefore, constructed a randomised clinical trial comparing these two treatment strategies. METHODS/DESIGN: The DIRECT trial is a multicenter randomised clinical trial. Patients (18-75 years) presenting themselves with persisting abdominal complaints after an episode of diverticulitis and/or three or more recurrences within 2 years will be included and randomised. Patients randomised for conservative treatment are treated according to the current daily practice (antibiotics, analgetics and/or expectant management). Patients randomised for elective resection will undergo an elective resection of the affected colon segment. Preferably, a laparoscopic approach is used.The primary outcome is health related quality of life measured by the Gastro-intestinal Quality of Life Index, Short-Form 36, EQ-5D and a visual analogue scale for pain quantification. Secondary endpoints are morbidity, mortality and total costs. The total follow-up will be three years. DISCUSSION: Considering the high incidence and the multicenter design of this study, it may be assumed that the number of patients needed for this study (n = 214), may be gathered within one and a half year.Depending on the expertise and available equipment, we prefer to perform a laparoscopic resection on patients randomised for elective surgery. Should this be impossible, an open technique may be used as this also reflects the current situation. TRIAL REGISTRATION: (Trial register number: NTR1478).

[Dutch College of General Practitioners' practice guideline 'Diverticulitis' from a surgical perspective]. / NHG-standaard 'Diverticulitis' vanuit chirurgisch perspectief.

Diverticulitis is a common disease which, in the Netherlands, leads to approximately 13,500 hospitalizations annually. This figure represents merely 12% of actual cases encountered by general practitioners. The combined factors of older age, pain in the left lower abdomen which increases on movement, an elevated C-reactive protein level, the absence of vomiting and a prior episode of diverticulitis are highly predictive for this clinical diagnosis. This prediction model has been developed in secondary care centres. Its diagnostic value has yet to be proven in general practice.

Surgical reintervention after failed antireflux surgery: a systematic review of the literature.

BACKGROUND: Outcome and morbidity of redo antireflux surgery are suggested to be less satisfactory than those of primary surgery. Studies reporting on redo surgery, however, are usually much smaller than those of primary surgery. The aim of this study was to summarize the currently available literature on redo antireflux surgery. MATERIAL AND METHODS: A structured literature search was performed in the electronic databases of MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials. RESULTS: A total of 81 studies met the inclusion criteria. The study design was prospective in 29, retrospective in 15, and not reported in 37 studies. In these studies, 4,584 reoperations in 4,509 patients are reported. Recurrent reflux and dysphagia were the most frequent indications; intraoperative complications occurred in 21.4% and postoperative complications in 15.6%, with an overall mortality rate of 0.9%. The conversion rate in laparoscopic surgery was 8.7%. Mean(+/-SEM) duration of surgery was 177.4 +/- 10.3 min and mean hospital stay was 5.5 +/- 0.5 days. Symptomatic outcome was successful in 81.1% and was equal in the laparoscopic and conventional approach. Objective outcome was obtained in 24 studies (29.6%) and success was reported in 78.3%, with a slightly higher success rate in case of laparoscopy than with open surgery (85.8% vs. 78.0%). CONCLUSION: This systematic review on redo antireflux surgery has confirmed that morbidity and mortality after redo surgery is higher than after primary surgery and symptomatic and objective outcome are less satisfactory. Data on objective results were scarce and consistency with regard to reporting outcome is necessary.