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Evaluation of the safety and efficacy of suction-tip forceps, a new tool for laparoscopic surgery, for gastric cancer.

ABSTRACT:

Introduction

Laparoscopic surgery is a minimally invasive surgery; however, obstacles to its functional optimization remain. Surgical ports can accommodate only one instrument at a time so complex exchange manipulations are necessary during surgery which increases operation times and patient risk. We developed a new laparoscopic instrument that functions as both forceps and a suction tube, which renders intraoperative tool exchange unnecessary. This pilot study was undertaken to evaluate the safety and efficacy of this novel dual-function device in laparoscopic surgery for gastric cancer.

Methods

This single-center pilot study assessed patient safety during and after laparoscopic distal gastrectomy for gastric cancer with the suction-forceps using intraoperative video and clinical follow-up, respectively. To evaluate instrument efficacy, we measured the time interval between the start of any bleeding and the start of aspiration ("suction access time") and compared this time with that of a conventional surgical setup.

Results

In total 15 patients participated, with all procedures being successful. No excess tissue damage occurred during surgery. Suction access time was significantly shorter in cases of bleeding when the suction-tip forceps were used for aspiration (2.01 seconds) compared to an ordinary suction tube (12.5 seconds; P < .01).

Conclusion

These findings suggest that our new suction-tip forceps are a useful, safe, and efficacious operative tool. This surgical innovation may considerably simplify gastric laparoscopic surgery. This pilot study was registered with Japan Clinical Trial Registration on 22 June 2017 (registration number: UMIN000027879).

SUBMITTER: Sakurazawa N

PROVIDER: S-EPMC8048834 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceFollowing the US Food and Drug Administration approval for laparoscopic gastric band surgery in 2001, as many as 96 000 devices have been placed annually. The reported rates of reoperation range from 4% to 60% in short-term studies; however, to our knowledge, few long-term population-level data on outcomes or expenditures are known.ObjectiveTo describe the rate of device-related reoperations occurring after laparoscopic gastric band surgery as well as the associated payments in a longitudinal national cohort.Design, settings, and participantsThis retrospective review of 25 042 Medicare beneficiaries who underwent gastric band placement between 2006 and 2013 identifies gastric band-related reoperations, including device removal, device replacement, or revision to a different bariatric procedure (eg, a gastric bypass or sleeve gastrectomy). The rates of reoperation were risk adjusted using a multivariable logistic regression model that included patient age, sex, race/ethnicity, Elixhauser comorbidities, and the year that the operation was performed.Main outcomes and measuresRate of device-related reoperation nationally and across individual hospital referral regions. Thirty-day total episode Medicare payments to hospitals for the index operation and any subsequent reoperations.ResultsOf the 25 042 patients who underwent gastric band placement, 20 687 (82.61%) were white, 18 143 (72.45%) were women, and the mean age was 57.56 years. Patients (mean age, 57.5; 76.2% women) requiring reoperation had lower rates of hypertension (64.9% vs 73.4%; P < .001) and diabetes (40.4% vs 44.6%; P < .001) and were more likely to have their index operation at a for-profit hospital (34.6% vs 22.0%; P < .001). With an average of 4.5-year follow-up, 4636 patients (18.5%) underwent 17 539 reoperations (an average of 3.8 procedures/patient). Hospital referral regions demonstrated a 2.9-fold variation in risk- and reliability-adjusted rates of reoperation (lower quartile average, 13.3%; upper quartile average, 39.1%). During the study period, Medicare paid $470 million for laparoscopic gastric band associated procedures, of which $224 million (47.6%) of the payments were for reoperations. From 2006 to 2013, the proportion of payments from Medicare for reoperations increased from 16.4% to 77.3% of their annual spending on the gastric band device.Conclusions and relevanceAmong Medicare beneficiaries undergoing gastric band surgery, device-related reoperation was common, costly, and varied widely across hospital referral regions. These findings suggest that payers should reconsider their coverage of the gastric band device.