key: cord-0911947-6cd7dolj authors: Mishra, Anurag; Bains, Lovenish; Jesudin, Gnanaraj; Aruparayil, Noel; Singh, Rajdeep; Shashi title: 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 date: 2020-08-19 journal: J Am Coll Surg DOI: 10.1016/j.jamcollsurg.2020.07.783 sha: 567f39d15f43da45ec6fcf59e420a9939fcc4ea2 doc_id: 911947 cord_uid: 6cd7dolj 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. The invention of laparoscopy in the late 20th Century revolutionized the way surgery is performed. It indeed is a significant milestone invention which transformed surgical practice. However, the benefits of minimal access surgery (MAS) are not available to the majority of the rural population in India and similar Low and Middle-Income Countries (LMICs). Although no formal access to care study is available for India, it is estimated that only 2% population in LMIC can access affordable MAS services [1, Price] . Open surgery is the first line of treatment for conditions like the acute abdomen, gall stone disease, appendicitis. Lack of any access to surgery leads to prolonged illness, deaths and loss of livelihood for poor people [ Dare 2] . Hence, MAS has the potential to provide better access to surgery in such settings. The recurring cost of expensive laparoscopic instruments, logistics of providing medicalgrade gases in remote areas and non-availability of general anaesthesia (GA) [3, Rosenbaum] make it difficult to adopt MAS in low resource settings. The Gas Insufflation Less Laparoscopic Surgeries [GAL] offers a solution to the challenges associated with conventional laparoscopy [COL] . It mechanically elevates the abdominal wall and allows laparoscopic visualization through a single incision, providing diagnostic and therapeutic procedures. Ideally, for low resource settings, the ideal comparison should be between open surgery and GAL. However, considering the ethical issues, we planned a non-inferiority study to compare GAL using Stan Laparoscopy Positioner device [SLP] (Fig 1) with conventional laparoscopy (COL) for general surgical procedures. The study was conducted as a single centre, non-blinded Non-inferiority, Randomized Controlled Study. Ethical clearance was granted by the institutional ethical committee on J o u r n a l P r e -p r o o f The chosen sample size of 100 was more than the calculated sample size of 78 using operative time as the primary parameter (power 80%, α 0.05, σ 20, sampling ratio 1). [4, Ge B] . A non-inferiority margin of 1% (+ 6 min, assuming average operative time as 60 minutes) was chosen. The primary outcome was to compare operative times for GAL and COL. The secondary outcomes of interest were: intraoperative vital signs, postoperative pain and surgeon satisfaction for cholecystectomy, diagnostic laparoscopy and appendectomy. The patients were randomly allocated using computer generated random numbers and sealed envelopes to conventional laparoscopy (COL) or gasless laparoscopy (GAL). Cases were grouped according to diagnosis to avoid unequal distribution in the two groups. The surgeries were performed by two proficient laparoscopic surgeons (authors) with more than five years of experience. Surgeons underwent one month of training and familiarization of the technique and equipment. General anaesthesia was used for all cases as the standard operating technique practised in the institute. The only variation was the creation of intraperitoneal space. Standard 4-port technique was used for COL group [5, Olsen] . For GAL the peritoneal cavity was accessed through a two-centimetre infra-umbilical midline incision. After entering the peritoneal cavity, a finger sweep was done to rule out any adhesions to the anterior abdominal wall and creating safe space for the ring of SLP device [6, WHO compendium]. In a paper form, data was recorded on demographics, clinical profile, operative times, vital signs, use of analgesia, efficiency, procedure safety, patient and surgeon satisfaction. For GAL group, the operating surgeon was asked to rate their satisfaction score on a Likert scale of 1 to 10, 10 being satisfied. All recorded data was transferred to Microsoft excel file and was analyzed using Descriptive statistics. Chi-square test and Student's t-test was used in IBM SPSS version 25. Strict safety monitoring framework was adopted to ensure no harm is done to participating patients. Critical red flag events were identified at the beginning of and were adhered to during the whole period of study. Out of 133 patients screened, 29 were excluded due to the exclusion criteria, and 4 did not consent. Those who met inclusion criteria were randomized into two groups. (see Figure 2 ). The groups matched in terms of their demographic and base surgical characteristics, as shown in Table 1 . The mean time for setting up GAL was 11.8 minutes (5-25, 5.3) which was statistically similar to that of the conventional procedure with a mean of 12.4 (5-25, 5.6) minutes. The mean operating time from incision to closure was less in the GAL group (52.9) compared to the COL group (55 minutes), but this was not statistically significant [p=0.3] ( Table 2) . Conversion: In GAL group, three cases of cholecystectomy were converted to standard [COL] due to inadequate operative space in one case and complicated anatomy in the other two cases. One of the latter cases were subsequently converted to an open procedure. There were no cases of conversion in appendectomy or diagnostic laparoscopy cases. In COL group, the three cases were converted to an open procedure due to technical difficulties. The Vital Signs were comparatively more stable in the GAL group. The average maximum heart rates recorded were 94.7 beats/minute in the GAL group and 97.9 beats/minute in the COL group. The range between the highest and lowest recorded heart rates was better in the GAL group [15.9 vs 18.8] (P 0.049) ( Figure 3 ). (Table 2) The GAL group had a lower variation in Blood pressures [ Table 2 . Overall, in either group, the pain was not severe (>5) at any time. The average pain recorded six hours after surgery was around the umbilicus -3.34 on the VAS pain scale (range 1-8, SD J o u r n a l P r e -p r o o f 1.5). The VAS pain scores were recorded below 1 by the second day. The pain at 24 hrs and 48 hrs was found to be higher in the GAL group. A mild shoulder tip pain which was found to be higher in the COL group. (Figure 4 ) Seventy-three of total patients did not require additional analgesia after the first dose as per protocol (Table 3) . During the entire hospital stay, a similar analgesic was required -103.5 mg and 99 mg in GAL and COL groups, respectively (p 0.31). No significant difference was noted for postoperative recovery and hospital stay ( Table 4 ). No intraoperative complications or mortality was experienced in either group during the study and follow up period of 7 days. The overall incidence of SSI and delayed wound healing was 10 and 11 per cent, respectively, with no difference between the two groups. Most of these complications were mild, and it healed without any interventions. Average Surgeon satisfaction score with GAL was found to be 6.4. The score gradually improved as the number of cases increased, forming a linear relation (Fig 5) . The score for 1st 25 case and 2nd 25 cases was 5.56 and 7.24, respectively. Adverse effects of MAS are known and related to the use of carbon dioxide gas under pressure causing increased intraabdominal pressure and hypercarbia and subsequent acidosis. Other risks include gas embolism, hypothermia if the gas is not pre-conditioned and by convection effects, oliguria, decrease in gut perfusion, subcutaneous emphysema, pneumothorax, pneumomediastinum, fogging issues, desiccation of peritoneum by dry gas, loss of space issues, and increased likelihood of DVT due to pooling of blood. [8 Whelan, 9 Gutt.] In low resource setting in LMICs, there is a lack of trained Anaesthesiologists, logistics of a constant supply of gases and lack of sophisticated monitoring equipment. [20, Ren] In another meta-analysis on gasless laparoscopic cholecystectomy, Liu et al. concluded that surgeries using abdominal wall lifts appear to decrease respiratory and cardiovascular complications of laparoscopy as compared to conventional. [21, Liu] Yet another study by Ge B et al. found that Gasless and conventional approaches are comparable in terms of operative duration, complications, and total hospital stay for J o u r n a l P r e -p r o o f laparoscopic appendectomy and the former may have an advantage due to reduced hospital cost and reduced need for analgesia. [Ge B et al. 4] Despite the many advantages GAL did not become popular due to the suboptimal exposure due to tenting and difficulty in handling the instruments and longer operating time [20, Ren] . Our study found that the operating time is similar to GAL and COL, the time lost with setting up is recovered with maintained operating space as there is no gas loss and quick specimen extraction We found that the GAL group experienced marginally higher pain score. However, it did not require additional analgesics. Anaesthesiologists preferred the lesser fluctuations in the vital signs like including heart rate, blood pressure and eTCO2. The haemodynamic stability observed during GAL could encourage more surgeons to take up laparoscopic surgeries in low resource settings. The urban centres can also consider using the technique for patients with ASA III-IV. However, further studies are required to understand safety in this patient group. As there is no issue around the gas leak and loss of operative space in GAL, the procedure can be easily performed without sophisticated ports. One can introduce camera and instruments without need of any port, still to avoid repeated injury and soiling of the laparoscope on entry. We recommend the use of valve-less sleeve made of abdominal drains/ reusable metal sleeve as the port. They are readily available and a cost-effective alternative to commercially available ports. It makes it extremely convenient for a surgeon who is providing services in a resource-constrained area. Also, because there is no gas insufflation, Cost-effectiveness is another added benefit while using the gasless technique. Though it was not evaluated in this study, it was highly indicative that we did not require new and costly access ports. We could work with cheaper alternatives like a basic sleeve and cut drain pieces. The cost of saved gas and monitoring equipment makes a strong case to promote gasless surgeries. During this COVID-19 pandemic, various guidelines are issuing caution for the use of highpressure gas in laparoscopic surgeries as it may increase chances of cross-infection due to aerosol formation. Use of gasless has the potential to decrease the viral spread as it prevents the use of gas under pressure. This role can be a topic for further research. The study was not blinded, so subjective outcomes such as pain may have reporting bias. Operating surgeons are co-authors of the study, which introduces bias. Our hospital is a tertiary teaching hospital in the metropolis and does not simulate a rural resource-limited setting. Results may not be directly applicable to this setting. Still, it may offer insights into the potential benefits for use in limited resource settings. The current study included patients with a maximum of BMI 28kg/m2. Further study with higher BMI patients is needed to evaluate the safety and advocate its wider use. 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