Background: Intra-abdominal pressure during laparoscopic insufflation with pressurized carbon dioxide (CO₂) gas is strongly influenced by mechanical ventilation. Resulting pressure fluctuations can destabilize the surgical workspace and potentially cause harm associated with high insufflation pressures. To address this, a novel CO₂ insufflator was developed using a radial fan and a gas reservoir to generate and maintain continuously stable insufflation pressures (radial fan-based insufflator, RFBI). This first-in-human study evaluated its safety and feasibility during laparoscopic surgery. Methods: Adults undergoing elective intraperitoneal laparoscopic procedures were included. All procedures were performed using the RFBI and an 11 mm study trocar. Primary outcomes were safety, defined as the absence of serious or harmful adverse device effects (SADEs or ADEs), and feasibility, defined as completing the procedure without switching to a conventional insufflator. Secondary outcomes included pressure stability at the device outlet and documentation of observed events affecting pressure stability (e.g., trocar insertion/repositioning, leaks, suction, etc.). Results: Twelve patients were enrolled, having a total RFBI insufflation time of 35.9 h in seven different laparoscopic procedures. No SADEs occurred. One ADE occurred while inserting a 5 mm instrument into the 11 mm study trocar that resulted in high air leakage, causing temporary loss of surgical workspace but no harm. All procedures were completed without the need to switch to a conventional insufflator. Pressure remained stable at both target pressures of 10 mmHg (median 10.0 mmHg, interquartile range (IQR) 0.12) and 14 mmHg (median 14.0 mmHg, IQR 0.15). The RFBI rapidly re-established the target pressure after observed events affecting stability, without manual intervention or procedural delay. Conclusion: This first-in-human study demonstrates that RFBI technology is safe, feasible, and capable of maintaining stable insufflation pressures across varied adult laparoscopic procedures. Radial fan-based insufflation effectively compensated for pressure fluctuations from ventilation and surgical events, warranting further evaluation of clinical benefits.

Background: According to Dutch guidelines, locally excised, low-risk, pT1 or ypT0–1 rectal cancer should not necessarily be followed by completion total mesorectal excision (cTME) in contrast to rectal cancers with higher T stages or unfavorable features. This study evaluated cTME after local excision at a national level with possible determinants for decision-making. Methods: All patients in the Dutch Colorectal Audit (DCRA) who underwent local excision of rectal cancer between 2012 and 2015 were included. Guideline adherence for performing cTME was determined with univariate and multivariate analyses to identify factors related to noncompliance. Results: According to the guidelines, of 530 included patients, cTME was indicated in 283 (53%), and among those, was performed in 82 (29%). Guideline adherence for performing cTME improved significantly (P<.001), from 10% in 2012 to 44% in 2015. Lower Charlson comorbidity index in patients with high-risk pT1 rectal cancer and younger patients (aged 61–70 years vs ≥80 years) with pT≥2 rectal cancer were associated with increased performance of cTME (odds ratio [OR], 13.50; 95% CI, 1.39–131.32, and OR, 6.25; 95% CI, 1.83–21.31, respectively). Conclusions: In this population-based study from the Netherlands, only a minority of patients underwent cTME after local excision of rectal cancer with pathologic features indicating the need for further treatment according to the guidelines. Although the percentage of patients undergoing cTME increased over time, the study indicated a tendency toward rectal-preserving treatment with potential oncologic risks.

OBJECTIVE: To investigate the safety of laparoscopic colorectal cancer resections in a nationwide population-based study. BACKGROUND: Although laparoscopic techniques are increasingly used in colorectal cancer surgery, little is known on results outside trials. With the fast introduction of laparoscopic resection (LR), questions were raised about safety. METHODS: Of all patients who underwent an elective colorectal cancer resection in 2010 in the Netherlands, 93% were included in the Dutch Surgical Colorectal Audit. Short-term outcome after LR, open resection (OR), and converted LR were compared in a generalized linear mixed model. We further explored hospital differences in LR and conversion rates. RESULTS: A total of 7350 patients, treated in 90 hospitals, were included. LR rate was 41% with a conversion rate of 15%. After adjustment for differences in case-mix, LR was associated with a lower risk of mortality (odds ratio 0.63, P < 0.01), major morbidity (odds ratio 0.72, P < 0.01), any complications (odds ratio 0.74, P < 0.01), hospital stay more than 14 days (odds ratio 0.71, P < 0.01), and irradical resections (odds ratio 0.68, P < 0.01), compared to OR. Outcome after conversion was similar to OR (P > 0.05). A large variation in LR and conversion rates among hospitals was found; however, the difference in outcome associated with operative techniques was not influenced by hospital of treatment. CONCLUSIONS: Use of laparoscopic techniques in colorectal cancer surgery in the Netherlands is safe and results are better in short-term outcome than open surgery, irrespective of the hospital of treatment. Outcome after conversion was similar to OR.