Evaluation of Gasless Laparoscopy as a Tool for Minimal Access Surgery in Low-to Middle-Income Countries: A Phase II Noninferiority Randomized Controlled Study

Abstract

BackgroundMinimal access surgery is not available to most people in rural areas of low-to middle-income countries. This leads to an increase in morbidity and economic loss to the poor and marginalized. Gasless laparoscopic (GAL) procedures are possible in rural areas because they can be performed under spinal anesthesia. In most cases, it does not require the logistics of providing gases for pneumoperitoneum and general anesthesia. The current study compares GAL with conventional laparoscopic (COL) operations for general surgical procedures.MethodsA single-center, nonblinded randomized controlled trial was conducted to evaluate noninferiority of GAL vs COL at a teaching hospital in New Delhi, India. Patients were allocated into 3 groups and underwent minimal access surgery (cholecystectomies and appendectomies). The procedures were performed by 2 surgeons choosing randomly between GAL and COL. The data were collected by postgraduates and analyzed by a biostatistician.ResultsOne hundred patients who met the inclusion criteria were allocated into 2 groups. No significant difference was observed in the mean operating time between the GAL group (52.9 minutes) and the COL group (55 minutes) (p = 0.3). Intraoperative vital signs were better in the GAL group (p < 0.05). The postoperative pain score was slightly higher in the GAL group (p = 0.01); however, it did not require additional analgesics.ConclusionsNo significant differences were found between the 2 groups. GAL can be considered as noninferior compared with COL and has the potential to be adopted in low-resource settings.