Journal of the American College of Surgeons • July 2021 • Use and Cost-Effectiveness of Gasless Laparoscopy: The Road Ahead

Anurag Mishra, MS, FACS, Lovenish Bains, MS, FACS, Jesudian Gnanaraj, MS, MCh, Noel Aruparayil, MD 2021-06-16 01:40:51

Thank you for your interest and appreciative comments on our article “Evaluation of Gasless Laparoscopy as a Tool for Minimal Access Surgery in Low-to Middle-Income Countries: A Phase II Noninferiority Randomized Controlled Study.”¹

Most studies on gasless laparoscopy evaluating its efficacy, safety, and cost-effectiveness were conducted in high-income countries.^2-4 It was imperative for us to establish the clinical efficacy of the technique before discussing its use and cost-effectiveness in rural settings and low-to middle-income countries. Gasless laparoscopy vs open surgical technique would be a better comparator for cost-effectiveness studies to demonstrate the advantages of minimally invasive surgery in resource-limited settings. Open surgery was not a relevant comparator in our tertiary center, where conventional laparoscopy is the standard treatment for our patients. We look forward to studying cost-effectiveness in appropriate settings in the near future.

In our study, the 2 proficient surgeons were able to adjust the number and position of additional ports at their discretion. In cholecystectomy cases, a modification of standard American technique, which is a standard 4-port technique,⁵ was used; the umbilical port site was used for the laparoscope and the left-hand instrument of the operating surgeon, obviating the need for a right upper abdominal port. Therefore, a total of 3 ports were used. As ports might not be needed in gasless laparoscopic procedures, there is no clash of the trocars at the umbilical site, which is another advantage of gasless operation. Another modification was to insert the EndoClip applicator through the umbilical port, avoiding the need for a 10-mm port at the epigastrium. The energy source was always used through the epigastric port, avoiding any inadvertent coupling injury. In our study, 47 of 50 cases (94%) did not require any extra port. Three cases (6%) needed to be converted to open/conventional approach due to complex anatomy (n = 2) or inadequate space (n = 1). Surgeons who are proficient with the French technique or single-port cholecystectomy have been performing the entire procedure from a single umbilical incision.⁶ This technique of gasless laparoscopy gives enough flexibility for the surgeon to decide the number and position of ports. The only factor to keep in mind is to avoid any port over the site of ring.

It is well documented in published literature that conventional laparoscopy causes changes in vitals, including heart rate, mean arterial pressure, systolic blood pressure, end-tidal CO2, and systemic vascular resistance. These changes are attributed to increased intra-abdominal pressure and pneumoperitoneum using gas.^7,8 A detailed study done in the Indian population analyzed the effect of abdominal pressure on various hemodynamic parameters and concluded that heart rate, mean arterial pressure, systolic blood pressure, and end-tidal CO2 are all affected by increases in abdominal pressure more or less equally.⁸ In our study, we wanted to learn whether or not the same changes are there in the gasless approach, with a hypothesis that the gasless approach would have significantly less variation. After much discussion, we decided to note the trends in heart rate, systolic blood pressure, and endtidal CO2 during the procedures in both arms. The main end point of interest was variation in each parameter. When choosing parameters, we kept in mind which were commonly used by rural surgeons to stay contextual and relevant.

We thank you for pointing out the typographic error. We agree that the line should read “noninferiority margin of 10%,” not 1%. We have communicated the same to the Journal for correction.

We are delighted to find other authors taking interest in this technique and are sure that more critical studies on this subject will certainly improve access to minimal access surgery in resource-limited and rural areas worldwide.

¹ Mishra A, Bains L, Jesudin G, et al. Evaluation of gasless laparoscopy as a tool for minimal access surgery in low- to middleincome countries: a phase II noninferiority randomized controlled study. J Am Coll Surg 2020;231:511—519.

² Wang Y, Cui H, Zhao Y, Wang ZQ. Gasless laparoscopy for benign gynecological diseases using an abdominal wall-lifting system. J Zhejiang Univ Sci B 2009;10:805—812.

³ Song TB, Yao J. Comparative study of gasless and pneumoperitoneum laparoscopic cholecystectomy. J Laparosc Surg 2010; 15:489—492.

⁴ Lv W, Yan T, Zhang JH, et al. One-hole, double-view depending on gasless and clinical application of laparoscopic cholecystectomy observation. Shandong Med J 2012;52:70—72.

⁶ Rao PP, Bhagwat SM, Rane A, Rao PP. The feasibility of single port laparoscopic cholecystectomy: a pilot study of 20 cases. HPB 2008;10:336—340.

⁷ Atkinson TM, Giraud GD, Togioka BM, et al. Cardiovascular and ventilatory consequences of laparoscopic surgery. Circulation 2017;135:700—710.

⁸ Umar A, Mehta KS, Mehta N. Evaluation of hemodynamic changes using different intra-abdominal pressures for laparoscopic cholecystectomy. Indian J Surg 2013;75:284—289.