دورية أكاديمية
The Influence of Surgical Complexity and Center Experience on Postoperative Morbidity After Minimally Invasive Surgery in Gynecologic Oncology: Lessons Learned from the ROBOGYN-1004 Trial.
| العنوان: | The Influence of Surgical Complexity and Center Experience on Postoperative Morbidity After Minimally Invasive Surgery in Gynecologic Oncology: Lessons Learned from the ROBOGYN-1004 Trial. |
|---|---|
| المؤلفون: | Lambaudie E; Paoli Calmettes Institute, Marseille, France., Bogart E; Oscar Lambret Cancer Center, Lille, France., Le Deley MC; Oscar Lambret Cancer Center, Lille, France.; Université Paris-Sud, UVSQ, CESP, INSERM, Université Paris-Saclay, Villejuif, France., El Hajj H; Paoli Calmettes Institute, Marseille, France. Houssein-elhajj@outlook.com.; Oscar Lambret Cancer Center, Lille, France. Houssein-elhajj@outlook.com., Gauthier T; University Hospital-Limoges, Limoges, France., Hebert T; University Hospital-Tours, Tours, France., Collinet P; University Hospital-Lille, Lille, France., Classe JM; Institut de Cancérologie de l'Ouest-Nantes, Nantes, France., Lecuru F; Curie Institute, Paris, France., Motton S; University Hospital-Toulouse, Toulouse, France., Conri V; University Hospital-Bordeaux, Bordeaux, France., Ferrer C; University Hospital-Nîmes, Nîmes, France., Marchal F; CRAN, UMR 7039, CNRS Institut de Cancérologie de Lorraine Vandoeuvre les-Nancy, Université de Lorraine, Nancy, France., Ferron G; Institut Claudius Regaud Cancer Center-Toulouse, Toulouse, France., Probst A; Oscar Lambret Cancer Center, Lille, France., Jauffret C; Paoli Calmettes Institute, Marseille, France., Narducci F; Oscar Lambret Cancer Center, Lille, France. |
| المصدر: | Annals of surgical oncology [Ann Surg Oncol] 2024 Jul; Vol. 31 (7), pp. 4566-4575. Date of Electronic Publication: 2024 Apr 15. |
| نوع المنشور: | Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial |
| اللغة: | English |
| بيانات الدورية: | Publisher: Springer Country of Publication: United States NLM ID: 9420840 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1534-4681 (Electronic) Linking ISSN: 10689265 NLM ISO Abbreviation: Ann Surg Oncol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2005- : New York, NY : Springer Original Publication: New York, NY : Raven Press, c1994- |
| مواضيع طبية MeSH: | Genital Neoplasms, Female*/surgery , Laparoscopy*/adverse effects , Laparoscopy*/methods , Postoperative Complications*/etiology , Robotic Surgical Procedures*/adverse effects , Robotic Surgical Procedures*/methods, Adult ; Aged ; Female ; Humans ; Middle Aged ; Follow-Up Studies ; Gynecologic Surgical Procedures/methods ; Gynecologic Surgical Procedures/adverse effects ; Minimally Invasive Surgical Procedures/adverse effects ; Minimally Invasive Surgical Procedures/methods ; Morbidity ; Prognosis |
| مستخلص: | Background: This study was a secondary analysis of the ROBOGYN-1004 trial conducted between 2010 and 2015. The study aimed to identify factors that affect postoperative morbidity after either robot-assisted laparoscopy (RL) or conventional laparoscopy (CL) in gynecologic oncology. Methods: The study used two-level logistic regression analyses to evaluate the prognostic and predictive value of patient, surgery, and center characteristics in predicting severe postoperative morbidity 6 months after surgery. Results: This analysis included 368 patients. Severe morbidity occurred in 49 (28 %) of 176 patients who underwent RL versus 41 (21 %) of 192 patients who underwent CL (p = 0.15). In the multivariate analysis, after adjustment for the treatment group (RL vs CL), the risk of severe morbidity increased significantly for patients who had poorer performance status, with an odds ratio (OR) of 1.62 for the 1-point difference in the WHO performance score (95 % CI 1.06-2.47; p = 0.027) and according to the type of surgery (p < 0.001). A focus on complex surgical acts showed significant more morbidity in the RL group than in the CL group at the less experienced centers (OR, 3.31; 95 % CI 1.0-11; p = 0.05) compared with no impact at the experienced centers (OR, 0.87; 95 % CI 0.38-1.99; p = 0.75). Conclusion: The findings suggest that the center's experience may have an impact on the risk of morbidity for patients undergoing complex robot-assisted surgical procedures. (© 2024. The Author(s).) |
| References: | Ramirez PT, Adams S, Boggess JF, Burke WM, Frumovitz MM, Gardner GJ, et al. Robotic-assisted surgery in gynecologic oncology: a Society of Gynecologic Oncology consensus statement. Gynecol Oncol. 2012;124:180–4. (PMID: 10.1016/j.ygyno.2011.11.00622079679) Wang LL, Yan PJ, Yao L, Liu R, Hou F, Chen XH, et al. Evaluation of intra- and postoperative outcomes to compare robot-assisted surgery and conventional laparoscopy for gynecologic oncology. Asian J Surg. 2020;43:347–53. (PMID: 10.1016/j.asjsur.2019.05.00331229360) Zanagnolo V, Garbi A, Achilarre MT, Minig L. Robot-assisted surgery in gynecologic cancers. J Minim Invasive Gynecol. 2017;24:379–96. (PMID: 10.1016/j.jmig.2017.01.00628104497) Ngô C, Cornou C, Rossi L, Bats AS, Bensaid C, Frati A, et al. Evidence for the use of robotically assisted surgery in gynecologic cancers. Curr Opin Oncol. 2016;28:398–403. (PMID: 10.1097/CCO.000000000000031527434623) Narducci F, Bogart E, Hebert T, Gauthier T, Collinet P, Classe JM, et al. Severe perioperative morbidity after robot-assisted versus conventional laparoscopy in gynecologic oncology: results of the randomized ROBOGYN-1004 trial. Gynecol Oncol. 2020;158:382–9. (PMID: 10.1016/j.ygyno.2020.05.01032467054) Lawrie TA, Liu H, Lu D, Dowswell T, Song H, Wang L, et al. Robot-assisted surgery in gynaecology. Cochrane Gynaecological, Neuro-oncology and Orphan Cancer Group, editor. Cochrane Database Syst Rev. 2022. https://doi.org/10.1002/14651858.CD011422.pub2 . (PMID: 10.1002/14651858.CD011422.pub2) Bouquet de Joliniere J, Librino A, Dubuisson JB, Khomsi F, Ben Ali N, Fadhlaoui A, et al. Robotic surgery in gynecology. Front Surg. 2016. https://doi.org/10.3389/fsurg.2016.00026/abstract . (PMID: 10.3389/fsurg.2016.00026/abstract272003584852174) Jauffret C, Lambaudie E, Esterni B, Bannier M, Buttarelli M, Houvenaeghe G. Learning curve of robot-assisted laparoscopy in gynecologic oncology surgery: team training and impact on morbidity. Clin Surg. 2016;1:1112. Ramirez PT, Frumovitz M, Pareja R, Lopez A, Vieira M, Ribeiro R, et al. Minimally invasive versus abdominal radical hysterectomy for cervical cancer. N Engl J Med. 2018;379:1895–904. (PMID: 10.1056/NEJMoa180639530380365) Kazaryan AM, Røsok BI, Edwin B. Morbidity assessment in surgery: refinement proposal based on a concept of perioperative adverse events. ISRN Surg. 2013;2013:1–7. (PMID: 10.1155/2013/625093) Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, et al. The Clavien–Dindo classification of surgical complications: five-year experience. Ann Surg. 2009;250:187–96. (PMID: 10.1097/SLA.0b013e3181b13ca219638912) Trotti A, Colevas A, Setser A, Rusch V, Jaques D, Budach V, et al. CTCAE v3.0: development of a comprehensive grading system for the adverse effects of cancer treatment. Semin Radiat Oncol. 2003;13:176–81. (PMID: 10.1016/S1053-4296(03)00031-612903007) Gelman A, Hill J. Data analysis using regression and multilevel/hierarchical models. 1st edn. Cambridge: Cambridge University Press; 2006. (PMID: 10.1017/CBO9780511790942) Walker JL, Piedmonte MR, Spirtos NM, Eisenkop SM, Schlaerth JB, Mannel RS, et al. Recurrence and survival after random assignment to laparoscopy versus laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group LAP2 study. JCO. 2012;30:695–700. (PMID: 10.1200/JCO.2011.38.8645) Shi G, Lu D, Liu Z, Liu D, Zhou X, The Cochrane Collaboration. Robotic-assisted surgery for gynaecological cancer. In: Cochrane database of systematic reviews. Chichester: Wiley; 2012. p. CD008640. https://doi.org/10.1002/14651858.CD008640 . Marino P, Houvenaeghel G, Narducci F, Boyer-Chammard A, Ferron G, Uzan C, et al. Cost-effectiveness of conventional vs robotic-assisted laparoscopy in gynecologic oncologic indications. Int J Gynecol Cancer. 2015;25:1102–8. (PMID: 10.1097/IGC.000000000000045826098092) Lacorre A, Merlot B, Garabedian C, Narducci F, Chereau E, Resbeut M, et al. Early-stage cervical cancer: brachytherapy followed by type a hysterectomy versus type B radical hysterectomy alone, a retrospective evaluation. EJSO Eur J Surg Oncol. 2016;42:376–82. (PMID: 10.1016/j.ejso.2015.12.00326725307) Aloisi A, Tseng J, Kuhn T, Feinberg J, Chi DS, Brown CL, et al. Robotic surgery in the frail elderly: analysis of perioperative outcomes. Ann Surg Oncol. 2020;27:3772–80. (PMID: 10.1245/s10434-020-08475-w323289838366272) Aletti GD, Dowdy SC, Gostout BS, Jones MB, Stanhope RC, Wilson TO, et al. Quality improvement in the surgical approach to advanced ovarian cancer: the Mayo Clinic experience. J Am Coll Surg. 2009;208:614–20. (PMID: 10.1016/j.jamcollsurg.2009.01.00619476798) Aletti G, Santillan A, Eisenhauer E, Hu J, Aletti G, Podratz K, et al. A new frontier for quality of care in gynecologic oncology surgery: multi-institutional assessment of short-term outcomes for ovarian cancer using a risk-adjusted model. Gynecol Oncol. 2007;107:99–106. (PMID: 10.1016/j.ygyno.2007.05.03217602726) Aletti GD, Dowdy SC, Gostout BS, Jones MB, Stanhope CR, Wilson TO, et al. Aggressive surgical effort and improved survival in advanced-stage ovarian cancer. Obstet Gynecol. 2006;107:77–85. (PMID: 10.1097/01.AOG.0000192407.04428.bb16394043) Fagotti A, Ferrandina MG, Vizzielli G, Pasciuto T, Fanfani F, Gallotta V, et al. Randomized trial of primary debulking surgery versus neoadjuvant chemotherapy for advanced epithelial ovarian cancer (SCORPION-NCT01461850). Int J Gynecol Cancer. 2020;30. Retrieved 25 April 2021 at https://ijgc.bmj.com/content/30/11/1657. Fagotti A, Vizzielli G, Ferrandina G, Fanfani F, Gallotta V, Chiantera V, et al. Survival analyses from a randomized trial of primary debulking surgery versus neoadjuvant chemotherapy for advanced epithelial ovarian cancer with high tumor load (SCORPION trial). JCO. 2018;36(15 Suppl):5516–5516. (PMID: 10.1200/JCO.2018.36.15_suppl.5516) Bixel KL, Leitao MM, Chase DM, Quick A, Lim PC, Eskander RN, et al. ROCC/GOG-3043: a randomized non-inferiority trial of robotic versus open radical hysterectomy for early-stage cervical cancer. JCO. 2022;40(16 Suppl):TPS5605–TPS5605. (PMID: 10.1200/JCO.2022.40.16_suppl.TPS5605) Ismail A, Wood M, Ind T, Gul N, Moss E. The development of a robotic gynaecological surgery training curriculum and results of a delphi study. BMC Med Educ. 2020;20:66. (PMID: 10.1186/s12909-020-1979-y321318127057472) Rusch P, Ind T, Kimmig R, Maggioni A, Ponce J, Zanagnolo V, et al. Recommendations for a standardised educational program in robot assisted gynaecological surgery: consensus from the Society of European Robotic Gynaecological Surgery (SERGS). Facts Views Vis Obgyn. 2019;11:29–41. (PMID: 316958556822956) |
| معلومات مُعتمدة: | INCa-PHRC-2010 Institut National Du Cancer |
| فهرسة مساهمة: | Keywords: Conventional laparoscopy; Gynecologic oncology; Morbidity; Prognostics factors; Randomized phase III trial; Robotic-assisted laparoscopy |
| تواريخ الأحداث: | Date Created: 20240414 Date Completed: 20240613 Latest Revision: 20240710 |
| رمز التحديث: | 20240710 |
| مُعرف محوري في PubMed: | PMC11164758 |
| DOI: | 10.1245/s10434-024-15265-1 |
| PMID: | 38616209 |
| قاعدة البيانات: | MEDLINE |
Find this article in full text from Springer Verlag. 
Full Text Finder | تدمد: | 1534-4681 |
|---|---|
| DOI: | 10.1245/s10434-024-15265-1 |