Mismatch of populations between randomised controlled trials of perioperative interventions in major abdominal surgery and current clinical practice

Alleway R, Butt A, Ellis D, Freeth H, Kelly K, Jarman D, et al. Knowing the risk a review of the peri-operative care of surgical patients A report by the National Confidential Enquiry into Patient Outcome and Death (2011).

Andaker L, Burman LG, Eklund A, Graffner H, Hansson J, Hellberg R, et al. Fosfomycin/metronidazole compared with doxycycline/metronidazole for the prophylaxis of infection after elective colorectal surgery. A randomised double-blind multicentre trial in 517 patients. Eur J Surg. 1992;158(3):181–5.

CAS  PubMed  Google Scholar 

Aoyama T, Yoshikawa T, Ida S, Cho H, Sakamaki K, Ito Y, et al. Effects of perioperative eicosapentaenoic acid-enriched oral nutritional supplement on the long-term oncological outcomes after total gastrectomy for gastric cancer. Oncol Lett. 2022;23(5):1–6.

Article  Google Scholar 

Aqua K, Gimbel JS, Singla N, Ma T, Ahdieh H, Kerwin R. Efficacy and tolerability of oxymorphone immediate release for acute postoperative pain after abdominal surgery: a randomized, double-blind, active- and placebo-controlled, parallel-group trial. Clin Ther. 2007;29(6):1000–12.

Article  CAS  PubMed  Google Scholar 

Arnaud JP, Bellissant E, Boissel P, Carlet J, Chastang C, Lafaix C, et al. Single-dose amoxycillin-clavulanic acid vs. cefotetan for prophylaxis in elective colorectal surgery: a multicentre, prospective, randomized study. The PRODIGE Group. J Hosp Infect. 1992;22:23–32.

Article  PubMed  Google Scholar 

Atkinson C, Penfold CM, Ness AR, Longman RJ, Thomas SJ, Hollingworth W, et al. Randomized clinical trial of postoperative chewing gum versus standard care after colorectal resection. Br J Surg. 2016;103(8):962–70.

Article  CAS  PubMed  Google Scholar 

Auer RC, Ott M, Karanicolas P, Brackstone MR, Ashamalla S, Weaver J, et al. Efficacy and safety of extended duration to perioperative thromboprophylaxis with low molecular weight heparin on disease-free survival after surgical resection of colorectal cancer (PERIOP-01): multicentre, open label, randomised controlled trial. BMJ. 2022;378(8900488): e071375.

Article  PubMed Central  PubMed  Google Scholar 

Baker M, Penny D. Is there a reproducibility crisis? Nature. 2016;533:452–4 Nature Publishing Group.

Article  CAS  PubMed  Google Scholar 

Barlow R, Price P, Reid TD, Hunt S, Clark GW, Havard TJH, et al. Prospective multicentre randomised controlled trial of early enteral nutrition for patients undergoing major upper gastrointestinal surgical resection. Clin Nutr. 2011;30(5):560–6.

Article  PubMed  Google Scholar 

Bedford J, Martin P, Crowe S, Wagstaff D, Santos C, Singleton G, et al. Development and internal validation of a model for postoperative morbidity in adults undergoing major elective colorectal surgery: the peri-operative quality improvement programme (PQIP) colorectal risk model. Anaesthesia. 2022;2022:1356–67. https://doi.org/10.1111/anae.15858. Cited 25 Jul 2023.

Boden I, Skinner EH, Browning L, Reeve J, Anderson L, Hill C, et al. Preoperative physiotherapy for the prevention of respiratory complications after upper abdominal surgery: pragmatic, double blinded, multicentre randomised controlled trial. BMJ. 2018;360(8900488): j5916.

Article  PubMed Central  PubMed  Google Scholar 

Boet S, Burns JK, Cheng-Boivin O, Khan H, Derry K, Diep D, et al. Mapping multicenter randomized controlled trials in anesthesiology: a scoping review. Syst Rev. 2021;10(1):276. https://doi.org/10.1186/s13643-021-01776-5. Cited 28 Sep 2022.

Boggett S, Chahal R, Griffiths J, Lin J, Wang D, Williams Z, et al. A randomised controlled trial comparing deep neuromuscular blockade reversed with sugammadex with moderate neuromuscular block reversed with neostigmine. Anaesthesia. 2020;75(9):1153–63.

Article  CAS  PubMed  Google Scholar 

Bohlin KS, Löfgren M, Lindkvist H, Milsom I. Smoking cessation prior to gynecological surgery-a registry-based randomized trial. Acta Obstet Gynecol Scand. 2020;99(9):1230–7. https://doi.org/10.1111/(ISSN)1600-0412/https://orcid. org/000.-0002-9064-8454.

Boyd O. The fragility of evidence in critical care research: is it just a house of cards?. Critical Care Medicine. Lippincott Williams and Wilkins; 2016 44;1423–4. Available from: https://pubmed.ncbi.nlm.nih.gov/27309159/. Cited 30 Apr 2023.

Bretagnol F, Panis Y, Rullier E, Rouanet P, Berdah S, Dousset B, et al. Rectal cancer surgery with or without bowel preparation: the French GRECCAR III multicenter single-blinded randomized trial. Ann Surg. 2010;252(5):863–8.

Article  PubMed  Google Scholar 

Bruintjes MH, Krijtenburg P, Martini CH, Poyck PP, d’Ancona FC, Huurman VA, et al. Efficacy of profound versus moderate neuromuscular blockade in enhancing postoperative recovery after laparoscopic donor nephrectomy: a randomised controlled trial. Eur J Anaesthesiol. 2019;36(7):494–501. Available from: https://journals.lww.com/ejanaesthesiology/pages/default.aspx.

Bucher P, Gervaz P, Soravia C, Mermillod B, Erne M, Morel P. Randomized clinical trial of mechanical bowel preparation versus no preparation before elective left-sided colorectal surgery. Br J Surg. 2005;92(4):409–14.

Article  CAS  PubMed  Google Scholar 

Buppasiri P, Chongsomchai C, Wongproamas N, Ounchai J, Suwannachat B, Lumbiganon P. Effectiveness of vaginal douching on febrile and infectious morbidities after total abdominal hysterectomy: a multicenter randomized controlled trial. J Med Assoc Thail. 2004;87(1):16–23.

Google Scholar 

Burden ST, Gibson DJ, Lal S, Hill J, Pilling M, Soop M, et al. Pre-operative oral nutritional supplementation with dietary advice versus dietary advice alone in weight-losing patients with colorectal cancer: single-blind randomized controlled trial. J Cachexia Sarcopenia Muscle. 2017;8(3):437–46.

Article  PubMed Central  PubMed  Google Scholar 

Cao Z, Qiu J, Guo J, Xiong G, Jiang K, Zheng S, et al. A randomised, multicentre trial of somatostatin to prevent clinically relevant postoperative pancreatic fistula in intermediate-risk patients after pancreaticoduodenectomy. J Gastroenterol. 2021;56(10):938–48. https://doi.org/10.1007/s00535-021-01818-8. Available from.

Article  CAS  PubMed  Google Scholar 

Chanques G, Conseil M, Roger C, Constantin JM, Prades A, Carr J, et al. Immediate interruption of sedation compared with usual sedation care in critically ill postoperative patients (SOS-ventilation): a randomised, parallel-group clinical trial. Lancet Respir Med. 2017;5(10):795–805.

Article  PubMed  Google Scholar 

Chermesh I, Tamir A, Reshef R, Chowers Y, Suissa A, Katz D, Gelber M, Halpern Z, Bengmark S, Eliakim R, et al. Failure of synbiotic 2000 to prevent postoperative recurrence of Crohn’s disease. Dig Dis Sci. 2007;52(2):385–9.

Article  PubMed  Google Scholar 

Chongsomchai C, Lumbiganon P, Thinkhamrop J, Ounchai J, Vudhikamraksa N. Placebo-controlled, double-blind, randomized study of prophylactic antibiotics in elective abdominal hysterectomy. J Hosp Infect. 2002;52(4):302–6.

Article  CAS  PubMed  Google Scholar 

Contant CME, Hop WCJ, van’t Sant HP, Oostvogel HJM, Smeets HJ, Stassen LPS, et al. Mechanical bowel preparation for elective colorectal surgery: a multicentre randomised trial. Lancet (London, England). 2007;370(9605):2112–7.

Article  PubMed  Google Scholar 

Cutillo G, Maneschi F, Franchi M, Giannice R, Scambia G, Benedetti-Panici P. Early feeding compared with nasogastric decompression after major oncologic gynecologic surgery: a randomized study. Obstet Gynecol. 1999;93(1):41–5.

CAS  PubMed  Google Scholar 

de Leede EM, van Leersum NJ, Kroon HM, van Weel V, van der Sijp JRM, Bonsing BA, et al. Multicentre randomized clinical trial of the effect of chewing gum after abdominal surgery. Br J Surg. 2018;105(7):820–8.

Article  PubMed  Google Scholar 

de Milliano I, Huirne JAF, Thurkow AL, Radder C, Bongers MY, van Vliet H, et al. Ulipristal acetate vs gonadotropin-releasing hormone agonists prior to laparoscopic myomectomy (MYOMEX trial): short-term results of a double-blind randomized controlled trial. Acta Obstet Gynecol Scand. 2020;99(1):89–98.

Article  PubMed  Google Scholar 

Del Rio P, Vellone M, Fragapane P, Di Millo M, Mazzitelli R, Allegri C, et al. Cefepime for prophylaxis of infections in the surgery of cholelithiasis. Results of a multicentric comparative trial. Acta Biomed l’Ateneo Parm. 2008;79(1):23–7.

Google Scholar 

Deng C, Bellomo R, Myles P. Systematic review and meta-analysis of the perioperative use of vasoactive drugs on postoperative outcomes after major abdominal surgery. Bri J Anaesth. 2020;124:513–24.

Article  CAS  Google Scholar 

DiPiro JT, Welage LS, Levine BA, Wing PE, Stanfield JA, Gaskill HV, et al. Single-dose cefmetazole versus multiple dose cefoxitin for prophylaxis in abdominal surgery. J Antimicrob Chemother. 1989;23:71–7.

Article  PubMed  Google Scholar 

Ellison LM, Nguyen M, Fabrizio MD, Soh A, Permpongkosol S, Kavoussi LR. Postoperative robotic telerounding: a multicenter randomized assessment of patient outcomes and satisfaction. Arch Surg. 2007;142(12):1177–81.

Article  PubMed  Google Scholar 

Espin Basany E, Solis-Pena A, Pellino G, Kreisler E, Fraccalvieri D, Muinelo-Lorenzo M, et al. Preoperative oral antibiotics and surgical-site infections in colon surgery a multicentre, single-blind, pragmatic, randomised controlled trial. Lancet Gastroenterol Hepatol. 2020;5(8):729–38.

Article  PubMed  Google Scholar 

Fafaj A, Lo Menzo E, Alaedeen D, Petro CC, Rosenblatt S, Szomstein S, et al. Effect of intraoperative urinary catheter use on postoperative urinary retention after laparoscopic inguinal hernia repair: a randomized clinical trial. JAMA Surg. 2022;157(8):667–74.

Article  PubMed Central  PubMed  Google Scholar 

Fa-Si-Oen P, Roumen R, Buitenweg J, van de Velde C, van Geldere D, Putter H, et al. Mechanical bowel preparation or not? Outcome of a multicenter, randomized trial in elective open colon surgery. Dis Colon Rectum. 2005;48(8):1509–16.

Article  PubMed  Google Scholar 

Fiess H, Klempa I, Hermanek P, Sulkowski U, Uhl W, Beger HG, Büchler MW, et al. Prophylaxis of complications after pancreatic surgery: results of a multicenter trial in Germany. Digestion. 1994;55:35–40.

Article  PubMed  Google Scholar 

Fogel DB. Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: a review. Contemp Clin Trials Commun. 2018;11:156–64 Elsevier Inc.

Article  PubMed Central  PubMed  Google Scholar 

Fowler AJ, Abbott TEF, Prowle J, Pearse RM. Age of patients undergoing surgery. Br J Surg. 2019;106(8):1012–8.

Article  CAS  PubMed  Google Scholar 

Frauenknecht J, Kirkham KR, Jacot‐Guillarmod A, Albrecht E. Analgesic impact of intra‐operative opioids vs. opioid‐free anaesthesia: a systematic review and meta‐analysis. Anaesthesia. 2019;74(5):651–62. https://doi.org/10.1111/anae.14582. Cited 30 Apr 2023.

Fushida S, Oyama K, Kaji M, Hirono Y, Kinoshita J, Tsukada T, et al. A randomized multicenter phase II study of perioperative tiotropium intervention in gastric cancer patients with chronic obstructive pulmonary disease. Int J COPD. 2015;10(1):2177–83. Available from: https://www.dovepress.com/getfile.php?fileID=27483.

Futier E, Garot M, Godet T, Biais M, Verzilli D, Ouattara A, et al. Effect of hydroxyethyl starch vs saline for volume replacement therapy on death or postoperative complications among high-risk patients undergoing major abdominal surgery: the FLASH randomized clinical trial. JAMA. 2020;323(3):225–36.

Article  CAS  PubMed Central  PubMed  Google Scholar 

Gadsden J. A tale of two studies: is there a reproducibility problem in the anaesthetic literature? Anaesthesia. 2023; https://doi.org/10.1111/anae.16056. Cited 7 Jun 2023.

Gao X, Liu Y, Zhang L, Zhou D, Tian F, Gao T, et al. Effect of early vs late supplemental parenteral nutrition in patients undergoing abdominal surgery: a randomized clinical trial. JAMA Surg. 2022;157(5):384–93.

Article  PubMed Central 

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