Analytical Approach to the Selection of Research Topics for Gallstone Disease and Acute Cholecystitis (an Overview of Cochrane Reviews)

Aim: description of modern methods of statistical evaluation of the world evidence base to determine the direction of promising scientific research in diagnosis and treatment of cholelithiasis and cholecystitis.

Materials and methods. The umbrella review of systematic reviews and meta-analyses of the Cochrane Library has been conducted, identifying topics for which further evidence-based research is needed. The information obtained by the Cochrane expert panels through Trial Sequential Analysis (TSA), Diversity-Adjusted Required Information Size (DARIS) calculations, and Z-curve monitoring on benefit, harm, or futility boundary plots is systematized.

Results. There were established multidirectional trends and significantly different levels of achievement of evidence-based results. These should be taken into account when determining the prospect of further evidence-based studies. In the context of bile duct injury between early and delayed laparoscopic cholecystectomy, number of complications between early and delayed laparoscopic cholecystectomy, small-incision cholecystectomy and laparoscopic cholecystectomy, single-port and standard four-ports cholecystectomy and low-pressure laparoscopy the required size of meta-analysis information is unlikely to be achieved — in current versions of Cochrane library DARIS is less than 1 % of required. The same applies to mortality, the probability of developing serious complications and the conversion rate of various minimally invasive procedures, as the required sample sizes (hundreds of thousands of observations) are difficult to achieve — currently range is from 0.03 to 21.9 %. On the contrary, the achieved values from the estimated DARIS in establishing the differences in the duration between minimally invasive surgery options (21.2 to 76 %), in some issues of pain management in the immediate postoperative period (43.6 to 92.6 %) and additional intraoperative anesthesia (13.7 to 14.9 %) and Z-curve monitoring give hope for their achievement in the foreseeable future. There is little prospect of continuing evidence-based studies to determine the need for intraperitoneal anesthetic instillation, differences in the duration of hospitalization after various minimally invasive surgeries, since new information is unlikely to change the conclusions of meta-analyses (the required information size has been achieved by 100 %).

Conclusion. It is necessary to take into account the results of a TSA analysis of Cochrane expert groups, when choosing research topics in patients with gallstone disease and acute cholecystitis.

1. Revishvili A.Sh., Olovyanny V.E., Sazhin V.P., Kuznetsov A.V., Shelina N.V., Ovecnkin A.I. Surgical care in the Russian Federation. Information and analytical collection for 2021. Moscow, 2022. (In Russ.).

2. Nechay T., Titkova S., Tyagunov A., Anurov M., Sazhin A. Modified enhanced recovery after surgery protocol in patients with acute cholecystitis: Efficacy, safety and feasibility. Multicenter randomized control study. Updates Surg. 2021;73(4):1407–17. DOI: 10.1007/s13304-021-01031-5

3. Омельяновский В.В. Методические рекомендации по проведению метаанализа. М., 2017. [Omel'yanovskii V.V. Guidelines for conducting meta-analysis. Moscow, 2017. (In Russ.).

4. Belov Yu.V., Salagaev G.I., Lysenko A.V., Lednev P.V. Meta-analysis in medical practice. Pirogov Russian Journal of Surgery = Khirurgiya. Zurnal im. N.I. Pirogova. 2018;3:4–15. (In Russ.). DOI: 10.17116/hirurgia201834-15

5. Rebrova O.Yu., Fediaeva V.K. The questionnaire to assess the risk of systematic bias in non-randomized comparative studies: The Russian-language version of the Newcastle-Ottawa Scale. Meditsinskie tekhnologii. Otsenka i vybor. 2016;3(25):14–9. (In Russ.).

6. Grant M.J., Booth A.A. Typology of reviews: An analysis of 14 review types and associated methodologies. Health Info Libr J. 2009;26(2):91–108. DOI: 10.1111/j.14711842.2009.00848.x

7. Raitskaya L.K., Tikhonova E.V. Review as a promising type of scholarly publication, its types and characteristics. Nauchnyi Redaktor i Izdatel’ = Science Editor and Publisher. 2019;4(3–4):131–9. (In Russ.).

8. Order of the Ministry of Health of the Russian Federation dated February 28, 2019, №. 103н “On approval of the procedure and timing for the development of clinical recommendations, their revision, the standard form of clinical recommendations and the requirements for their structure, composition and scientific validity of information included in clinical recommendations”. (In Russ.). URL: http://base.garant.ru/72240714/#ixzz68LOaBXde

9. Brok J., Thorlund K., Wetterslev J., Gluud C. Apparently conclusive meta-analyses may be inconclusive — Trial sequential analysis adjustment of random error risk due to repetitive testing of accumulating data in apparently conclusive neonatal meta-analyses. Int J Epidemiol. 2009;38(1):287–98. DOI: 10.1093/ije/dyn188

10. Varganova D.L., Pavlov C.S., Svistunov A.A. Cochrane method for evaluating the efficacy of drugs, national contribution to international Cochrane collaboration. Sechenov Medical Journal. 2019;10(4):31–9. (In Russ.). DOI: 10.26442/22187332.2019.4.31-39

11. Gurusamy K.S., Giljaca V., Takwoingi Y., Higgie D., Poropat G., Štimac D., et al. Endoscopic retrograde cholangiopancreatography versus intraoperative cholangiography for diagnosis of common bile duct stones. Cochrane Database Syst Rev. 2015;2015(2):CD010339. DOI: 10.1002/14651858.CD010339.pub2

12. Gurusamy K.S., Vaughan J., Toon C.D., Davidson B.R. Pharmacological interventions for prevention or treatment of postoperative pain in people undergoing laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014;(3):CD008261. DOI: 10.1002/14651858.CD008261.pub2

13. Gurusamy K.S., Nagendran M., Toon C.D., Guerrini G.P., Zinnuroglu M., Davidson B.R. Methods of intraperitoneal local anaesthetic instillation for laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014;(3):CD009060. DOI: 10.1002/14651858.CD009060.pub2

14. Gurusamy K.S., Vaughan J., Davidson B.R. Low pressure versus standard pressure pneumoperitoneum in laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014;(3):CD006930. DOI: 10.1002/14651858.CD006930.pub3

15. Rutherford D., Massie E.M., Worsley C., Wilson M.S.J. Intraperitoneal local anaesthetic instillation versus no intraperitoneal local anaesthetic instillation for laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2021;10(10):CD007337. DOI: 10.1002/14651858.CD007337.pub4

16. Loizides S., Gurusamy K.S., Nagendran M., Rossi M., Guerrini G.P., Davidson B.R. Wound infiltration with local anaesthetic agents for laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014;(3):CD007049. DOI: 10.1002/14651858.CD007049.pub2

17. Gurusamy K.S., Vaughan J., Rossi M., Davidson B.R. Fewer-than-four ports versus four ports for laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014;(2):CD007109. DOI: 10.1002/14651858.CD007109.pub2

18. Vaughan J., Nagendran M., Cooper J., Davidson B.R., Gurusamy K.S. Anaesthetic regimens for day-procedure laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014;2014(1):CD009784. DOI: 10.1002/14651858.CD009784.pub2

19. Dasari B.V.M., Tan C.J., Gurusamy K.S., Martin D.J., Kirk G., McKie L., et al. Surgical versus endoscopic treatment of bile duct stones. Cochrane Database Syst. Rev. 2013;2013(12):CD003327. DOI: 10.1002/14651858.CD003327.pub4

20. Gurusamy K.S., Koti R., Davidson B.R. Routine abdominal drainage versus no abdominal drainage for uncomplicated laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2013;(9):CD006004. DOI: 10.1002/14651858.CD006004.pub4

21. Gurusamy K.S., Koti R., Davidson B.R. Abdominal lift for laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2013;(8):CD006574. DOI: 10.1002/14651858.CD006574.pub4

22. Gurusamy K.S., Rossi M., Davidson B.R. Percutaneous cholecystostomy for high‐risk surgical patients with acute calculous cholecystitis. Cochrane Database Syst Rev. 2013;(8):CD007088. DOI: 10.1002/14651858.CD007088.pub2

23. Gurusamy K.S., Vaughan J., Ramamoorthy R., Fusai G., Davidson B.R. Miniports versus standard ports for laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2013;(8):CD006804. DOI: 10.1002/14651858.CD006804.pub3

24. Vaughan J., Gurusamy K.S., Davidson B.R. Day-surgery versus overnight stay surgery for laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2013;(7):CD006798. DOI: 10.1002/14651858.CD006798.pub4

25. Gurusamy K.S., Koti R., Fusai G., Davidson B.R. Early versus delayed laparoscopic cholecystectomy for uncomplicated biliary colic. Cochrane Database Syst Rev. 2013;(6):CD007196. DOI: 10.1002/14651858.CD007196.pub3

26. Gurusamy K.S., Davidson C., Gluud C., Davidson B.R. Early versus delayed laparoscopic cholecystectomy for people with acute cholecystitis. Cochrane Database Syst Rev. 2013;(6):CD005440. DOI: 10.1002/14651858.CD005440.pub3

27. Gurusamy K.S., Koti R., Davidson B.R. T-tube drainage versus primary closure after laparoscopic common bile duct exploration. Cochrane Database Syst Rev. 2013;(6):CD005641. DOI: 10.1002/14651858.CD005641.pub3

28. Gurusamy K.S., Koti R., Davidson B.R. T-tube drainage versus primary closure after open common bile duct exploration. Cochrane Database Syst Rev. 2013;(6):CD005640. DOI: 10.1002/14651858.CD005640.pub3

29. Fang Y., Gurusamy K.S., Wang Q., Davidson B.R., Lin H., Xie X., et al. Pre-operative biliary drainage for obstructive jaundice. Cochrane Database Syst Rev. 2012;9(9):CD005444. DOI: 10.1002/14651858.CD005444.pub3

30. Gurusamy K.S., Samraj K., Fusai G., Davidson B.R. Robot assistant versus human or another robot assistant in patients undergoing laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2012;9(9):CD006578. DOI: 10.1002/14651858.CD006578.pub3

31. Tse F., Yuan Y. Early routine endoscopic retrograde cholangiopancreatography strategy versus early conservative management strategy in acute gallstone pancreatitis. Cochrane Database Syst Rev. 2012;(5):CD009779. DOI: 10.1002/14651858.CD009779.pub2

32. Gurusamy K.S., Sahay S., Davidson B.R. Three dimensional versus two dimensional imaging for laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2011;(1):CD006882. DOI: 10.1002/14651858.CD006882.pub2

33. Sanabria A., Dominguez L.C., Valdivieso E., Gomez G. Antibiotic prophylaxis for patients undergoing elective laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2010;(12):CD005265. DOI: 10.1002/14651858.CD005265.pub2

34. Gurusamy K.S., Bong J.J., Fusai G., Davidson B.R. Methods of cystic duct occlusion during laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2010;(10):CD006807. DOI: 10.1002/14651858.CD006807.pub2

35. Brand M., Bizos D., O'Farrell P.J.R. Antibiotic prophylaxis for patients undergoing elective endoscopic retrograde cholangiopancreatography. Cochrane Database Syst Rev. 2010;(10):CD007345. DOI: 10.1002/14651858.CD007345.pub2

36. Gurusamy K.S., Junnarkar S., Farouk M., Davidson B.R. Cholecystectomy for suspected gallbladder dyskinesia. Cochrane Database Syst Rev. 2009;(1):CD007086. DOI: 10.1002/14651858.CD007086.pub2

37. Gurusamy K.S., Abu-Amara M., Farouk M., Davidson B.R. Cholecystectomy for gallbladder polyp. Cochrane Database of Syst Rev. 2009;2009(1):CD007052. DOI: 10.1002/14651858.CD007052.pub2

38. McAlister V., Davenport E., Renouf E. Cholecystectomy deferral in patients with endoscopic sphincterotomy. Cochrane Database Syst Rev. 2007;2007(4):CD006233. DOI: 10.1002/14651858.CD006233.pub2

39. Gurusamy K.S., Samraj K. Routine abdominal drainage for uncomplicated open cholecystectomy. Cochrane Database Syst Rev. 2007;2007(2):CD006003. DOI: 10.1002/14651858.CD006003.pub2

40. Gurusamy K.S., Samraj K. Cholecystectomy for patients with silent gallstones. Cochrane Database Syst Rev. 2007;2007(1):CD006230. DOI: 10.1002/14651858.CD006230.pub2

41. Keus F., de Jong J., Gooszen H.G., Laarho- ven C.J.H.M. Small-incision versus open cholecystectomy for patients with symptomatic cholecystolithiasis. Cochrane Database of Syst Rev. 2006;2006(4):CD004788. DOI: 10.1002/14651858.CD004788.pub2

42. Weinberg B., Shindy W., Lo S. Endoscopic balloon sphincter dilation (sphincteroplasty) versus sphincterotomy for common bile duct stones. Cochrane Database Syst Rev. 2006;2006(4):CD004890. DOI: 10.1002/14651858.CD004890.pub2

43. Keus F., de Jong J., Gooszen H.G., van Laarhoven C.H.J.M. Laparoscopic versus small-incision cholecystectomy for patients with symptomatic cholecystolithiasis. Cochrane Database Syst Rev. 2006;2006(4):CD006229. DOI: 10.1002/14651858.CD006229

44. Keus F., de Jong J., Gooszen H.G., van Laarhoven C.J.H.M. Laparoscopic versus open cholecystectomy for patients with symptomatic cholecystolithiasis. Cochrane Database Syst Rev. 2006;2006(4):CD006231. DOI: 10.1002/14651858.CD006231

45. Vettoretto N., Arezzo A., Famiglietti F., Cirocchi R., Moja L., Morino M. Laparoscopic-endoscopic rendezvous versus preoperative endoscopic sphincterotomy in people undergoing laparoscopic cholecystectomy for stones in the gallbladder and bile duct. Cochrane Database Syst Rev. 2018;4(4):CD010507. DOI: 10.1002/14651858.CD010507.pub2

46. Panin S.I., Nechay T.V., Sazhin A.V., Puzikova A.V., Linchenko D.V., Chechin E.R. Evidence-based medicine of gallstone disease regarding development of national clinical guidelines. Pirogov Russian Journal of Surgery = Khirurgiya. Zurnal im. N.I. Pirogova. 2022;(7):85–93. (In Russ.). DOI: 10.17116/hirurgia202207185

47. Keus F., Wetterslev J., Gluud C., Gooszen H.G., van Laarhoven C.J. Trial sequential analyses of meta-analyses of complications in laparoscopic vs. small-incision cholecystectomy: more randomized patients are needed. J Clin Epidemiol. 2010;63(3):246–56. DOI: 10.1016/j.jclinepi.2009.08.023

48. Gurusamy K.S., Nagendran M., Guerrini G.P., Toon C.D., Zinnuroglu M., Davidson B.R. Intraperitoneal local anaesthetic instillation versus no intraperitoneal local anaesthetic instillation for laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014;(3):CD007337. DOI: 10.1002/14651858.CD007337.pub3

49. Murphy M.M., Ng S.C., Simons J.P., Csikesz N.G., Shah S.A., Tseng J.F. Predictors of major complications after laparoscopic cholecystectomy: Surgeon, hospital, or patient? J Am Coll Surg. 2010;211(1):73–80. DOI: 10.1016/j.jamcollsurg.2010.02.050