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

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


JournalJ Am Coll Surg
Publication date – Aug – 2020
Authors – Anurag Mishra, Lovenish Bains, Gnanaraj Jesudin, Noel Aruparayil, Rajdeep Singh, Shashi
KeywordsAbdominal wall lifting device; Gas insufflation less laparoscopic surgery (GILLS); Surgery in LMICs; isobaric laparoscopy; low resource surgery
Open access – Yes
SpecialityGeneral surgery
World region Southern Asia
Country: India
Language – English
Submitted to the One Surgery Index on August 31, 2020 at 3:41 am
Abstract:

Background: Minimal access surgery [MAS] is not available to most people in the rural areas of Low Middle-Income Countries [LMIC]. This leads to an increase in the morbidity and the economic loss to the poor and the marginalized. The Gasless laparoscopic surgeries [GAL] are possible in rural areas as they could be carried out under spinal-anaesthesia. In most cases, it does not require the logistics of providing gases for pneumoperitoneum and general anaesthesia. The current study compares GAL with conventional Laparoscopic surgeries [COL] for general surgical procedures METHODS: A single-centre, non-blinded randomized control trial [RCT] was conducted to evaluate non – inferiority of GAL versus COL at a teaching hospital in New Delhi. Patients were allocated into two groups and underwent MAS (Cholecystectomies and appendectomies). The procedure was carried out by two surgeons by randomly choosing between GAL and COL. The data was collected by postgraduates and analyzed by a biostatistician.

Results: 100 patients who met the inclusion criteria were allocated into two groups. No significant difference was observed in the mean operating time between GAL group (52.9 min) vs COL group (55 minutes) [p=0.3]. The 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.

Conclusions: No significant differences were found between the two groups. GAL can be classed as non-inferior compared to COL and has the potential to be adopted in low resource settings.

OSI Number – 20646
PMID – 32827645

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