Outcome reporting in randomised controlled trials and meta-analyses of appendicitis treatments in children: A systematic review

Trials

Volumn 16, Issue 1, 2015, Pages

  Hall, Nigel J ^a,b   Kapadia, Mufiza Z ^c   Eaton, Simon ^d   Chan, Winnie W Y ^c   Nickel, Cheri ^e   Pierro, Agostino ^e   Offringa, Martin ^c  

^a UNIVERSITY OF SOUTHAMPTON   (United Kingdom)

^b SOUTHAMPTON GENERAL HOSPITAL   (United Kingdom)

^c HOSPITAL FOR SICK CHILDREN RESEARCH INSTITUTE   (Canada)

^d UNIVERSITY COLLEGE LONDON   (United Kingdom)

^e HOSPITAL FOR SICK CHILDREN   (Canada)

Author keywords

appendicitis; children; core outcome set; outcome measures; patient reported outcome measures; surgery; systematic review

Indexed keywords

ABDOMINAL ABSCESS; ADOLESCENT; APPENDECTOMY; APPENDICITIS; ARTICLE; CHILD; CHILD CARE; CLINICAL FEATURE; DATA ANALYSIS; HEALTH CARE UTILIZATION; HUMAN; INFORMATION PROCESSING; LENGTH OF STAY; META ANALYSIS (TOPIC); MORTALITY; OUTCOME ASSESSMENT; PATHOPHYSIOLOGY; RANDOMIZED CONTROLLED TRIAL (TOPIC); SYSTEMATIC REVIEW; SYSTEMATIC REVIEW (TOPIC); TREATMENT OUTCOME; WOUND INFECTION; ACUTE DISEASE; META ANALYSIS;

ACUTE DISEASE; APPENDICITIS; CHILD; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME;

EID: 84936940239     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-015-0783-1     Document Type: Article

References (86)

1. St Peter SD, Tsao K, Spilde TL, Holcomb III GW, Sharp SW, Murphy JP, et al. Single daily dosing ceftriaxone and metronidazole versus standard triple antibiotic regimen for perforated appendicitis in children: a prospective randomized trial. J Pediatr Surg. 2008;43:981-5.
2. Blomqvist PG, Andersson RE, Granath F, Lambe MP, Ekbom AR. Mortality after appendectomy in Sweden, 1987-1996. Ann Surg. 2001;233:455-60.
3. Styrud J, Eriksson S, Nilsson I, Ahlberg G, Haapaniemi S, Neovius G, et al. Appendectomy versus antibiotic treatment in acute appendicitis. a prospective multicenter randomized controlled trial. World J Surg. 2006;30:1033-7.
4. Hansson J, Korner U, Khorram-Manesh A, Solberg A, Lundholm K. Randomized clinical trial of antibiotic therapy versus appendicectomy as primary treatment of acute appendicitis in unselected patients. Br J Surg. 2009;96:473-81.
5. Vons C, Barry C, Maitre S, Pautrat K, Leconte M, Costaglioli B, et al. Amoxicillin plus clavulanic acid versus appendicectomy for treatment of acute uncomplicated appendicitis: an open-label, non-inferiority, randomised controlled trial. Lancet. 2011;377:1573-9.
6. Svensson JF, Patkova B, Almstrom M, Naji H, Hall NJ, Eaton S, et al. Nonoperative treatment with antibiotics versus surgery for acute nonperforated appendicitis in children: a pilot randomized controlled trial. Ann Surg. 2014;261:67-71.
7. Minneci PC, Sulkowski JP, Nacion KM, Mahida JB, Cooper JN, Moss RL, et al. Feasibility of a nonoperative management strategy for uncomplicated acute appendicitis in children. J Am Coll Surg. 2014;219:272-9.
8. Sinha IP, Altman DG, Beresford MW, Boers M, Clarke M, Craig J, et al. Standard 5: selection, measurement, and reporting of outcomes in clinical trials in children. Pediatrics. 2012;129 Suppl 3:S146-52.
9. Williamson P, Altman D, Blazeby J, Clarke M, Gargon E. Driving up the quality and relevance of research through the use of agreed core outcomes. J Health Serv Res Policy. 2012;17:1-2.
10. Gargon E, Gurung B, Medley N, Altman DG, Blazeby JM, Clarke M, et al. Choosing important health outcomes for comparative effectiveness research: a systematic review. PLoS One. 2014;9:e99111.
11. Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ. 2009;339:b2535.
12. Boers M, Kirwan JR, Gossec L, Conaghan PG, D'Agostino MA, Bingham III CO, et al. How to choose core outcome measurement sets for clinical trials: OMERACT 11 approves filter 2.0. J Rheumatol. 2014;41:1025-30.
13. Foster MC, Kapila L, Morris DL, Slack RC. A randomized comparative study of sulbactam plus ampicillin vs metronidazole plus cefotaxime in children. REV INFECT DIS. 1986;8 Suppl 5:S634-8.
14. Foster MC, Morris DL, Legan C, Kapila L, Slack RCB. Perioperative prophylaxis with sulbactam and ampicillin compared with metronidazole and cefotaxime in the prevention of wound infection in children undergoing appendectomy. J Pediatr Surg. 1987;22:869-72.
15. Sauerland S, Lefering R, Neugebauer EA. Laparoscopic versus open surgery for suspected appendicitis. Cochrane Database Syst Rev. 2004;4:CD001546.
16. Andersen BR, Kallehave FL, Andersen HK. Antibiotics versus placebo for prevention of postoperative infection after appendicectomy. Cochrane Database Syst Rev. 2001;2:CD001439.
17. Andersen BR, Kallehave FL, Andersen HK. Antibiotics versus placebo for prevention of postoperative infection after appendicectomy. Cochrane Database Syst Rev. 2003;2:CD001439.
18. Sauerland S, Lefering R, Neugebauer EA. Laparoscopic versus open surgery for suspected appendicitis. Cochrane Database Syst Rev. 2002;1:CD001546.
19. Andersen BR, Kallehave FL, Andersen HK. Antibiotics versus placebo for prevention of postoperative infection after appendicectomy. Cochrane Database Syst Rev. 2005;3:CD001439.
20. Sauerland S, Jaschinski T, Neugebauer EA. Laparoscopic versus open surgery for suspected appendicitis. Cochrane Database Syst Rev. 2010;10:CD001546.
21. Myers AL, Williams RF, Giles K, Waters TM, Eubanks III JW, Hixson SD, et al. Hospital cost analysis of a prospective, randomized trial of early vs interval appendectomy for perforated appendicitis in children. J Am Coll Surg. 2012;214:427-34.
22. Blakely ML, Williams R, Dassinger MS, Eubanks III JW, Fischer P, Huang EY, et al. Early vs interval appendectomy for children with perforated appendicitis. Arch Surg. 2011;146:660-5.
23. Schurman JV, Cushing CC, Garey CL, Laituri CA, St. Peter SD. Quality of life assessment between laparoscopic appendectomy at presentation and interval appendectomy for perforated appendicitis with abscess: Analysis of a prospective randomized trial. J Pediatr Surg. 2011;46:1121-4.
24. St Peter SD, Aguayo P, Fraser JD, Keckler SJ, Sharp SW, Leys CM, et al. Initial laparoscopic appendectomy versus initial nonoperative management and interval appendectomy for perforated appendicitis with abscess: a prospective, randomized trial. J Pediatr Surg. 2010;45:236-40.
25. Gasior AC, Knott EM, Holcomb III GW, Ostlie DJ, Peter SD. S. Patient and parental scar assessment after single incision versus standard 3-port laparoscopic appendectomy: Long-term follow-up from a prospective randomized trial. J Pediatr Surg. 2014;49:120-2.
26. St Peter SD, Adibe OO, Juang D, Sharp SW, Garey CL, Laituri CA, et al. Single incision versus standard 3-port laparoscopic appendectomy: a prospective randomized trial. Ann Surg. 2011;254:586-90.
27. Lejus C, Delile L, Plattner V, Baron M, Guillou S, Heloury Y, et al. Randomized, single-blinded trial of laparoscopic versus open appendectomy in children: Effects on postoperative analgesia. Anesthesiology. 1996;84:801-6.
28. Blencowe NS, Strong S, McNair AG, Brookes ST, Crosby T, Griffin SM, et al. Reporting of short-term clinical outcomes after esophagectomy: a systematic review. Ann Surg. 2012;255:658-66.
29. Bhangu A, Singh P, Pinkney T, Blazeby JM. Hernia: A detailed analysis of outcome reporting from randomised controlled trials and meta-analyses of inguinal hernia repair. Hernia. 2015;19:65-75.
30. Johnston BC, Shamseer L, da Costa BR, Tsuyuki RT, Vohra S. Measurement issues in trials of pediatric acute diarrheal diseases: a systematic review. Pediatrics. 2010;126:e222-31.
31. Bruce J, Krukowski ZH, Al-Khairy G, Russell EM, Park KG. Systematic review of the definition and measurement of anastomotic leak after gastrointestinal surgery. Br J Surg. 2001;88:1157-68.
32. Gargon E, Williamson PR, Altman DG, Blazeby JM, Clarke M. The COMET Initiative database: progress and activities from 2011 to 2013. Trials. 2014;15:279.
33. Boers M, Kirwan JR, Wells G, Beaton D, Gossec L, D'Agostino MA, et al. Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0. J Clin Epidemiol. 2014;67:745-53.
34. Malik AH, Wani RA, Saima BD, Wani MY. Small lateral access-an alternative approach to appendicitis in paediatric patients: A randomised controlled trial. Int J Surg. 2007;5:234-8.
35. Romero P, Frongia G, Wingerter S, Holland-Cunz S. Prospective, randomized, controlled trial comparing a tissue adhesive (Dermabond) with adhesive strips (Steri-Strips) for the closure of laparoscopic trocar wounds in children. Eur J Pediatr Surg. 2011;21:159-62.
36. Saini P, Loke YK, Gamble C, Altman DG, Williamson PR, Kirkham JJ. Selective reporting bias of harm outcomes within studies: findings from a cohort of systematic reviews. BMJ. 2014;349:g6501.
37. Haller J, Shaker IJ, Donahoo JS. Peritoneal drainage versus non drainage for generalized peritonitis from ruptured appendicitis in children: A prospective study. Ann Surg. 1973;177:595-600.
38. Bates T, Down RH, Houghton MC, Lloyd GJ. Topical ampicillin in the prevention of wound infection after appendicectomy. Br J Surg. 1974;61:489-92.
39. Fowler R. A controlled trial of intraperitoneal cephaloridine administration in peritonitis. J Pediatr Surg. 1975;P10:43-50.
40. Sherman JO, Luck SR, Borger JA. Irrigation of the peritoneal cavity for appendicitis in children: a double blind study. J Pediatr Surg. 1976;11:371-4.
41. Giacomantonio M, Bortolussi R, Gillis DA. Should prophylactic antibiotics be given perioperatively in acute appendicitis without perforation? Can J Surg. 1982;25:555-6.
42. Hutchinson GH, Patel BG, Doig CM. A double-blind controlled trial of metronidazole suppositories in children undergoing appendicectomy. Curr Med Res Opin. 1983;8:441-5.
43. King DR, Browne AF, Birken GA. Antibiotic management of complicated appendicitis. J Pediatr Surg. 1983;18:945-50.
44. Gutierrez C, Vila J, Garcia-Sala C, Velazques J, Otero M, Santos M, et al. Study of appendicitis in children treated with four different antibiotic regimens. J Pediatr Surg. 1987;22:865-8.
45. Thomson SR, Carle G, Reid TM, Davidson AI, Miller SS. Antibiotic prophylaxis in non-perforated appendicitis of childhood: tetracycline lavage compared with peroperative intravenous cefuroxime and metronidazole. J Hosp Infect. 1987;9:158-61.
46. McAllister TA, Fyfe AHB, Young DG, Raine PAM. Cefotaxime lavage in children undergoing appendicectomy. Drugs. 1988;35 Suppl 2:127-32.
47. Schmitt M, Bondonny JM, Delmas P, Galifer RB, Revillon Y, Robert M, et al. Antibiotic therapy of perforated appendicitis in children: a comparison of amoxycillin/clavulanate with a combination of benzylpenicillin, netilmicin and metronidazole. J Antimicrob Chemother. 1989;24(Suppl B):157-63.
48. Kooi GH, Pit S. Ceftazidime/metronidazole versus netilmicin/metronidazole in the treatment of perforated appendicitis in children. Clin Ther. 1990;12:54-60.
49. Meller JL, Reyes HM, Loeff DS, Federer L, Hall JR. One-drug versus two-drug antibiotic therapy in pediatric perforated appendicitis: A prospective randomized study. Surgery (USA). 1991;110:764-8.
50. Pokorny WJ, Kaplan SL, Mason EOJ. A preliminary report of ticarcillin and clavulanate versus triple antibiotic therapy in children with ruptured appendicitis. Surg Gynecol Obstet. 1991;172(Suppl):54-6.
51. Schropp KP, Kaplan S, Golladay ES, King DR, Pokorny W, Mollitt DL, et al. A randomized clinical trial of ampicillin, gentamicin and clindamycin versus cefotaxime and clindamycin in children with ruptured appendicitis. Surg Gynecol Obstet. 1991;172:351-6.
52. Kizilcan F, Tanyel FC, Buyukpamukcu N, Hicsonmez A. The necessity of prophylactic antibiotics in uncomplicated appendicitis during childhood. J Pediatr Surg. 1992;27:586-8.
53. Tsang TM, Tam PK, Saing H. Delayed primary wound closure using skin tapes for advanced appendicitis in children. A prospective, controlled study. Arch Surg. 1992;127:451-3.
54. Uhari M, Seppanen J, Heikkinen E. Imipenem-cilastatin vs. tobramycin and metronidazole for appendicitis-related infections. Pediatr Infect Dis J. 1992;11:445-50.
55. Banani SA, Amirghofran AA. The role and value of oral metronidazole in acute appendicitis. Pediatr Surg Int. 1995;10:101-4.
56. Soderquist-Elinder C, Hirsch K, Bergdahl S, Rutqvist J, Frenckner B. Prophylactic antibiotics in uncomplicated appendicitis during childhood-a prospective randomised study. Eur J Pediatr Surg. 1995;5:282-5.
57. Toki A, Ogura K, Horimi T, Tokuoka H, Todani T, Watanabe Y, et al. Peritoneal lavage versus drainage for perforated appendicitis in children. Surg Today. 1995;25:207-10.
58. Ciftci AO, Tanyel FC, Buyukpamukcu N, Hicsonmez A. Comparative trial of four antibiotic combinations for perforated appendicitis in children. Eur J Surg. 1997;163:591-6.
59. Banani SA, Talei A. Can oral metronidazole substitute parenteral drug therapy in acute appendicitis? A new policy in the management of simple or complicated appendicitis with localized peritonitis: a randomized controlled clinical trial. Am Surg. 1999;65:411-6.
60. Gorecki WJ, Grochowski JA. Are antibiotics necessary in nonperforated appendicitis in children? A double blind randomized controlled trial. Med Sci Monit. 2001;7:289-92.
61. Lavonius MI, Liesjarvi S, Ovaska J, Pajulo O, Ristkari S, Alanen M. Laparoscopic versus open appendectomy in children: a prospective randomised study. Eur J Pediatr Surg. 2001;11:235-8.
62. Lintula H, Kokki H, Vanamo K. Single-blind randomized clinical trial of laparoscopic versus open appendicectomy in children. Br J Surg. 2001;88:510-4.
63. Rice HE, Brown RL, Gollin G, Caty MG, Gilbert J, Skinner MA, et al. Results of a pilot trial comparing prolonged intravenous antibiotics with sequential intravenous/oral antibiotics for children with perforated appendicitis. Arch Surg. 2001;136:1391-5.
64. Shalaby R, Arnos A, Desoky A, Samaha AH. Laparoscopic appendectomy in children: evaluation of different techniques. Surg Laparosc Endosc Percutan Tech. 2001;11:22-7.
65. Lintula H, Kokki H, Vanamo K, Antila P, Eskelinen M. Laparoscopy in children with complicated appendicitis. J Pediatr Surg. 2002;37:1317-20.
66. Little DC, Custer MD, May BH, Blalock SE, Cooney DR. Laparoscopic appendectomy: An unnecessary and expensive procedure in children? J Pediatr Surg. 2002;37:310-7.
67. Tander B, Pektas O, Bulut M. The utility of peritoneal drains in children with uncomplicated perforated appendicitis. Pediatr Surg Int. 2003;19:548-50.
68. Lintula H, Kokki H, Vanamo K, Valtonen H, Mattila M, Eskelinen M. The costs and effects of laparoscopic appendectomy in children. Arch Pediatr Adolesc Med. 2004;158:34-7.
69. Oka T, Kurkchubasche AG, Bussey JG, Wesselhoeft CWJ, Tracy TFJ, Luks FI. Open and laparoscopic appendectomy are equally safe and acceptable in children. Surg Endosc. 2004;18:242-5.
70. Snelling CM, Poenaru D, Drover JW. Minimum postoperative antibiotic duration in advanced appendicitis in children: a review. Pediatr Surg Int. 2004;20:838-45.
71. Henry MCW, Moss RL. Primary versus delayed wound closure in complicated appendicitis: an international systematic review and meta-analysis. Pediatr Surg Int. 2005;21:625-30.
72. Schneider A, Sack U, Rothe K, Bennek J. Peritoneal taurolidine lavage in children with localised peritonitis due to appendicitis. Pediatr Surg Int. 2005;21:445-8.
73. Aziz O, Athanasiou T, Tekkis PP, Purkayastha S, Haddow J, Malinovski V, et al. Laparoscopic versus open appendectomy in children: a meta-analysis. Ann Surg. 2006;243:17-27.
74. Padankatti LR, Pramod RK, Gupta A, Ramachandran P. Laparoscopic versus open appendicectomy for complicated appendicitis: A prospective study. J Indian Assoc Pediatr Surg. 2008;13:104-6.
75. Fraser JD, Aguayo P, Leys CM, Keckler SJ, Newland JG, Sharp SW, et al. A complete course of intravenous antibiotics vs a combination of intravenous and oral antibiotics for perforated appendicitis in children: a prospective, randomized trial. J Pediatr Surg. 2010;45:1198-202.
76. Pauniaho SL, Lahdes-Vasama T, Helminen MT, Iber T, Makela E, Pajulo O. Non-absorbable interrupted versus absorbable continuous skin closure in pediatric appendectomies. Scand J Surg. 2010;99:142-6.
77. Saha N, Saha DK, Rahman MA, Islam MK, Aziz MA. Comparison of post operative morbidity between laparoscopic and open appendectomy in children. Mymensingh Med J. 2010;19:348-52.
78. Perez V, Saenz D, Madriz J, Harhay M, Feoli J, Castro M, et al. A double-blind study of the efficacy and safety of multiple daily doses of amikacin versus one daily dose for children with perforated appendicitis in Costa Rica. Int J Infect Dis. 2011;15:e569-75.
79. Esposito C, Calvo AI, Castagnetti M, Alicchio F, Suarez C, Giurin I, et al. Open versus laparoscopic appendectomy in the pediatric population: a literature review and analysis of complications. J Laparoendosc Adv Surg Tech A. 2012;22:834-9.
80. Markar SR, Blackburn S, Cobb R, Karthikesalingam A, Evans J, Kinross J, et al. Laparoscopic versus open appendectomy for complicated and uncomplicated appendicitis in children. J Gastrointest Surg. 2012;16:1993-2004.
81. St Peter SD, Adibe OO, Iqbal CW, Fike FB, Sharp SW, Juang D, et al. Irrigation versus suction alone during laparoscopic appendectomy for perforated appendicitis: a prospective randomized trial. Ann Surg. 2012;256:581-5.
82. Yu TC, Hamill JK, Liley A, Hill AG. Warm, humidified carbon dioxide gas insufflation for laparoscopic appendicectomy in children: a double-blinded randomized controlled trial. Ann Surg. 2013;257:44-53.
83. Dalgic N, Karadag CA, Bayraktar B, Sancar M, Kara O, Pelit S, et al. Ertapenem versus standard triple antibiotic therapy for the treatment of perforated appendicitis in pediatric patients: a prospective randomized trial. Eur J Pediatr Surg. 2014;24:410-8.
84. Li P, Chen ZH, Li QG, Qiao T, Tian YY, Wang DR. Safety and efficacy of single-incision laparoscopic surgery for appendectomies: a meta-analysis. World J Gastroenterol. 2013;19:4072-82.
85. Nataraja RM, Loukogeorgakis SP, Sherwood WJ, Clarke SA, Haddad MJ. The incidence of intraabdominal abscess formation following laparoscopic appendicectomy in children: a systematic review and meta-analysis. J Laparoendosc Adv Surg Tech A. 2013;23:795-802.
86. Perez EA, Piper H, Burkhalter LS, Fischer AC. Single-incision laparoscopic surgery in children: a randomized control trial of acute appendicitis. Surg Endosc. 2013;27:1367-71.