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Published in: Trials 1/2013

Open Access 01-12-2013 | Research

Postoperative pain and perioperative outcomes after laparoscopic radical hysterectomy and abdominal radical hysterectomy in patients with early cervical cancer: a randomised controlled trial

Authors: Luciana Silveira Campos, Leo Francisco Limberger, Airton Tetelbom Stein, Antonio Nocchi Kalil

Published in: Trials | Issue 1/2013

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Abstract

Background

Non-randomised studies have suggested that the postoperative complications of (Campos LS, Limberger LF, Stein AT, Kalil AN) laparoscopic radical hysterectomy are similar to those in abdominal radical hysterectomy. However, no study evaluating postoperative pain comparing both techniques has been published thus far. Our objective was to compare pain intensity and other perioperative outcomes between laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH) in early cervical cancer.

Methods

This single centre, randomised, controlled trial enrolled 30 cervical cancer patients who were clinically staged IA2 with lymph vascular invasion and IB according to the FIGO (International Federation of Gynaecology and Obstetrics) classification, and underwent LRH or ARH between late 1999 and early 2004. Postoperative pain, as measured by a 10-point numerical rate scale, was considered the primary endpoint. Postoperative pain was assessed every six hours during a patient’s usual postoperative care. Perioperative outcomes were also registered. Both surgical techniques were executed by the same surgical team. Secondary outcomes included intraoperative and other postoperative surgicopathological factors and 5-year survival rates.

Results

IA2 patients with lymphatic vascular space invasion and IB cervical cancer patients were randomised to either the LRH group (16 patients) or the ARH group (14 patients). Four patients (25%) in the LRH group and 5 patients (36%) in the ARH group presented with transoperative or serious postoperative complications. All of the transoperative complications occurred in the LRH group. The relative risk of presenting with complications was 0.70; CI 95% (0.23–2.11); P = 0.694. LRH group mean pain score was significantly lower than ARH after 36 h of observation (P = 0.044; mean difference score: 1.42; 95% CI: 0.04–2.80). The survival results will be published elsewhere.

Conclusions

LRH provided lower pain scores after 36 h of observation in this series. The perioperative and serious postoperative complications ratios were comparable between the groups.

Trial Registration

Appendix
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Literature
1.
go back to reference Parkin D, Bray F, Ferlay J, Pisani P: Global cancer statistics. CA Cancer J Clin. 2005, 55: 74-108. 10.3322/canjclin.55.2.74.CrossRefPubMed Parkin D, Bray F, Ferlay J, Pisani P: Global cancer statistics. CA Cancer J Clin. 2005, 55: 74-108. 10.3322/canjclin.55.2.74.CrossRefPubMed
2.
go back to reference Instituto Nacional do Câncer: Estimativas da Incidência e Mortalidade por Câncer. 2006, Rio de Janeiro, Brazil: INCA, National Institute of Cancer Instituto Nacional do Câncer: Estimativas da Incidência e Mortalidade por Câncer. 2006, Rio de Janeiro, Brazil: INCA, National Institute of Cancer
3.
go back to reference Benedet JL, Ngam HYS, Hacker NF: FIGO Committee on Gynecologic Oncology: Staging Classifications and Clinical Practice Guidelines of Gynaecologic Cancer. 2010, [http://www.figo.org] Benedet JL, Ngam HYS, Hacker NF: FIGO Committee on Gynecologic Oncology: Staging Classifications and Clinical Practice Guidelines of Gynaecologic Cancer. 2010, [http://​www.​figo.​org]
4.
go back to reference Ramirez PT, Soliman PT, Schmeler KM, dos Reis R, Frumovitz M: Laparoscopic and robotic techniques for radical hysterectomy in patients with early-stage cervical cancer. Gynecol Oncol. 2008, 110 (Suppl 2): 21-24.CrossRef Ramirez PT, Soliman PT, Schmeler KM, dos Reis R, Frumovitz M: Laparoscopic and robotic techniques for radical hysterectomy in patients with early-stage cervical cancer. Gynecol Oncol. 2008, 110 (Suppl 2): 21-24.CrossRef
5.
go back to reference Medeiros LR, Stein AT, Fachel J, Garry R, Furness S: Laparoscopy versus laparotomy for benign ovarian tumor: a systematic review and meta-analysis. Int J Gynecol Cancer. 2008, 18: 387-399. 10.1111/j.1525-1438.2007.01045.x.CrossRefPubMed Medeiros LR, Stein AT, Fachel J, Garry R, Furness S: Laparoscopy versus laparotomy for benign ovarian tumor: a systematic review and meta-analysis. Int J Gynecol Cancer. 2008, 18: 387-399. 10.1111/j.1525-1438.2007.01045.x.CrossRefPubMed
6.
go back to reference Kluivers KB, Hendriks JC, Mol BW, Bongers MY, Bremer GL, de Vet HC, Vierhout ME, Brolmann HA: Quality of life and surgical outcome after total laparoscopic hysterectomy versus total abdominal hysterectomy for benign disease: a randomized, controlled trial. J Minim Invasive Gynecol. 2007, 14: 145-152. 10.1016/j.jmig.2006.08.009.CrossRefPubMed Kluivers KB, Hendriks JC, Mol BW, Bongers MY, Bremer GL, de Vet HC, Vierhout ME, Brolmann HA: Quality of life and surgical outcome after total laparoscopic hysterectomy versus total abdominal hysterectomy for benign disease: a randomized, controlled trial. J Minim Invasive Gynecol. 2007, 14: 145-152. 10.1016/j.jmig.2006.08.009.CrossRefPubMed
7.
go back to reference Holzer A, Jirecek ST, Illievich M, Huber J, Wenzl RJ: Laparoscopic versus open myomectomy: a double-blind study to evaluate postoperative pain. Anesth Analg. 2006, 102: 1480-1484. 10.1213/01.ane.0000204321.85599.0d.CrossRefPubMed Holzer A, Jirecek ST, Illievich M, Huber J, Wenzl RJ: Laparoscopic versus open myomectomy: a double-blind study to evaluate postoperative pain. Anesth Analg. 2006, 102: 1480-1484. 10.1213/01.ane.0000204321.85599.0d.CrossRefPubMed
8.
go back to reference Spirtos NM, Einsekop SM, Schalerth JB, Ballon SC: Laparoscopic radical hysterectomy (type III) with aortic and pelvic lymphadenectomy in patients with stage I cervical cancer: surgical morbidity and intermediate follow-up. Am J Obstet Gynecol. 2002, 187: 340-348. 10.1067/mob.2002.123035.CrossRefPubMed Spirtos NM, Einsekop SM, Schalerth JB, Ballon SC: Laparoscopic radical hysterectomy (type III) with aortic and pelvic lymphadenectomy in patients with stage I cervical cancer: surgical morbidity and intermediate follow-up. Am J Obstet Gynecol. 2002, 187: 340-348. 10.1067/mob.2002.123035.CrossRefPubMed
9.
go back to reference Ramirez PT, Slomovitz BM, Soliman PT, Coleman RL, Levenback C: Total laparoscopic radical hysterectomy and lymphadenectomy: the M.D. Anderson Cancer Center experience. Gynecol Oncol. 2006, 102: 252-255. 10.1016/j.ygyno.2005.12.013.CrossRefPubMed Ramirez PT, Slomovitz BM, Soliman PT, Coleman RL, Levenback C: Total laparoscopic radical hysterectomy and lymphadenectomy: the M.D. Anderson Cancer Center experience. Gynecol Oncol. 2006, 102: 252-255. 10.1016/j.ygyno.2005.12.013.CrossRefPubMed
10.
go back to reference Obermair A, Ginbey P, McCartney AJ: Feasibility and safety of total laparoscopic radical hysterectomy. J Am Assoc Gynecol Laparosc. 2003, 10: 345-349. 10.1016/S1074-3804(05)60259-9.CrossRefPubMed Obermair A, Ginbey P, McCartney AJ: Feasibility and safety of total laparoscopic radical hysterectomy. J Am Assoc Gynecol Laparosc. 2003, 10: 345-349. 10.1016/S1074-3804(05)60259-9.CrossRefPubMed
11.
go back to reference Zakashansky K, Chuang L, Gretz H, Nagarsheth NP, Rahaman J, Nezhat FR: A case-controlled study of total laparoscopic radical hysterectomy with pelvic lymphadenectomy versus radical abdominal hysterectomy in a fellowship training program. Int J Gynecol Cancer. 2007, 17: 1075-1082. 10.1111/j.1525-1438.2007.00921.x.CrossRefPubMed Zakashansky K, Chuang L, Gretz H, Nagarsheth NP, Rahaman J, Nezhat FR: A case-controlled study of total laparoscopic radical hysterectomy with pelvic lymphadenectomy versus radical abdominal hysterectomy in a fellowship training program. Int J Gynecol Cancer. 2007, 17: 1075-1082. 10.1111/j.1525-1438.2007.00921.x.CrossRefPubMed
12.
go back to reference Frumovitz M, dos Reis R, Sun CC, Bevers MW, Brown J, Slomowitz M, Ramirez PT: Comparison of total laparoscopic and abdominal radical hysterectomy for patients with early-stage cervical cancer. Obstet Gynecol. 2007, 110: 96-102. 10.1097/01.AOG.0000268798.75353.04.CrossRefPubMed Frumovitz M, dos Reis R, Sun CC, Bevers MW, Brown J, Slomowitz M, Ramirez PT: Comparison of total laparoscopic and abdominal radical hysterectomy for patients with early-stage cervical cancer. Obstet Gynecol. 2007, 110: 96-102. 10.1097/01.AOG.0000268798.75353.04.CrossRefPubMed
13.
go back to reference Li G, Yan X, Shang H, Wang G, Chen L, Yan Y: A comparison of laparoscopic radical hysterectomy and pelvic lymphadenectomy and laparotomy in the treatment of Ib-IIa cervical cancer. Gynecol Oncol. 2007, 105: 176-80. 10.1016/j.ygyno.2006.11.011.CrossRefPubMed Li G, Yan X, Shang H, Wang G, Chen L, Yan Y: A comparison of laparoscopic radical hysterectomy and pelvic lymphadenectomy and laparotomy in the treatment of Ib-IIa cervical cancer. Gynecol Oncol. 2007, 105: 176-80. 10.1016/j.ygyno.2006.11.011.CrossRefPubMed
14.
go back to reference Ghezzi F, Cromi A, Ciravolo G, Volpi E, Ucella S, Rampinelli F, Bergamini V: Surgicopathologic outcome of laparoscopic versus open radical hysterectomy. Gynecol Oncol. 2007, 106: 502-506. 10.1016/j.ygyno.2007.04.027.CrossRefPubMed Ghezzi F, Cromi A, Ciravolo G, Volpi E, Ucella S, Rampinelli F, Bergamini V: Surgicopathologic outcome of laparoscopic versus open radical hysterectomy. Gynecol Oncol. 2007, 106: 502-506. 10.1016/j.ygyno.2007.04.027.CrossRefPubMed
15.
go back to reference Diaz-Feijoo B, Gil-Moreno A, Perez-Benavente MA, Morchon S, Martinez-Palones JM: Sentinel lymph node identification and radical hysterectomy with lymphadenectomy in early stage cervical cancer: laparoscopy versus laparotomy. J Minim Invasive Gynecol. 2008, 15: 531-537. 10.1016/j.jmig.2008.04.015.CrossRefPubMed Diaz-Feijoo B, Gil-Moreno A, Perez-Benavente MA, Morchon S, Martinez-Palones JM: Sentinel lymph node identification and radical hysterectomy with lymphadenectomy in early stage cervical cancer: laparoscopy versus laparotomy. J Minim Invasive Gynecol. 2008, 15: 531-537. 10.1016/j.jmig.2008.04.015.CrossRefPubMed
16.
go back to reference Obermair A, Gebski V, Frumovitz M, Soliman PT, Schmeler KM, Levenback C, Ramirez PT: A phase III randomized clinical trial comparing laparoscopic or robotic radical hysterectomy with abdominal radical hysterectomy in patients with early stage cervical cancer. J Minim Invasive Gynecol. 2008, 15: 584-588. 10.1016/j.jmig.2008.06.013.CrossRefPubMed Obermair A, Gebski V, Frumovitz M, Soliman PT, Schmeler KM, Levenback C, Ramirez PT: A phase III randomized clinical trial comparing laparoscopic or robotic radical hysterectomy with abdominal radical hysterectomy in patients with early stage cervical cancer. J Minim Invasive Gynecol. 2008, 15: 584-588. 10.1016/j.jmig.2008.06.013.CrossRefPubMed
17.
go back to reference Campos LS, Limberger LF, Koch MD, Kalil AN, Stein AT: Laparoscopic versus abdominal radical hysterectomy with pelvic lymphadenectomy in patients with early cervical cancer: a randomized clinical trial. Braz J Videoendosc Surg. 2011, 4: 143-148. Campos LS, Limberger LF, Koch MD, Kalil AN, Stein AT: Laparoscopic versus abdominal radical hysterectomy with pelvic lymphadenectomy in patients with early cervical cancer: a randomized clinical trial. Braz J Videoendosc Surg. 2011, 4: 143-148.
18.
go back to reference Spirtos N, Schalerth J, Kimball R, Leiphar VM, Ballon SC: Laparoscopic radical hysterectomy (type III) with aortic and pelvic lymphadenectomy. Am J Obstet Gynecol. 1996, 174: 1763-1768. 10.1016/S0002-9378(96)70208-9.CrossRefPubMed Spirtos N, Schalerth J, Kimball R, Leiphar VM, Ballon SC: Laparoscopic radical hysterectomy (type III) with aortic and pelvic lymphadenectomy. Am J Obstet Gynecol. 1996, 174: 1763-1768. 10.1016/S0002-9378(96)70208-9.CrossRefPubMed
19.
go back to reference Campos LS, Limberger LF, Kalil AN, de Vargas GS, Damiani PA: Videolaparoscopic radical hysterectomy approach: a ten-year experience. JSLS. 2009, 13: 504-508. 10.4293/108680809X12589998404083.CrossRefPubMedPubMedCentral Campos LS, Limberger LF, Kalil AN, de Vargas GS, Damiani PA: Videolaparoscopic radical hysterectomy approach: a ten-year experience. JSLS. 2009, 13: 504-508. 10.4293/108680809X12589998404083.CrossRefPubMedPubMedCentral
20.
go back to reference Piver MS, Rutledge F, Smith JP: Five classes of extended hysterectomy for women with cervical cancer. Obstet Gynecol. 1974, 44: 265-272.PubMed Piver MS, Rutledge F, Smith JP: Five classes of extended hysterectomy for women with cervical cancer. Obstet Gynecol. 1974, 44: 265-272.PubMed
21.
go back to reference Ghezzi F, Ucella S, Cromi A, Siesto G, Serati M, Bogani G, Bolis P: Postoperative pain after laparoscopic and vaginal hysterectomy for benign gynecologic disease: a randomized trial. Am J Obstet Gynecol. 2010, 118: 1-8. Ghezzi F, Ucella S, Cromi A, Siesto G, Serati M, Bogani G, Bolis P: Postoperative pain after laparoscopic and vaginal hysterectomy for benign gynecologic disease: a randomized trial. Am J Obstet Gynecol. 2010, 118: 1-8.
22.
go back to reference Breivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad A, Hals EK, Kvastein G, Stubhaug A: Assessment of pain. Br J Anaesth. 2008, 101: 17-24. 10.1093/bja/aen103.CrossRefPubMed Breivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad A, Hals EK, Kvastein G, Stubhaug A: Assessment of pain. Br J Anaesth. 2008, 101: 17-24. 10.1093/bja/aen103.CrossRefPubMed
23.
go back to reference Veenhof AA FA, Sietses C, von Blomberg BME, van Hoogstraten IMW, Vd Pas MHGM, Meijerink WJHJ, Peet DL, Vd Tol MP, Bonjer HJ, Cuesta MA: The surgical stress response and postoperative immune function after laparoscopic or conventional total mesorectal excision in rectal cancer: a randomized trial. Int J Colorectal Dis. 2011, 26: 53-59. 10.1007/s00384-010-1056-9.CrossRefPubMed Veenhof AA FA, Sietses C, von Blomberg BME, van Hoogstraten IMW, Vd Pas MHGM, Meijerink WJHJ, Peet DL, Vd Tol MP, Bonjer HJ, Cuesta MA: The surgical stress response and postoperative immune function after laparoscopic or conventional total mesorectal excision in rectal cancer: a randomized trial. Int J Colorectal Dis. 2011, 26: 53-59. 10.1007/s00384-010-1056-9.CrossRefPubMed
24.
go back to reference Carvalho GL, Cavazzola LT: Can mathematic formulas help us with our patients?. Surg Endosc. 2011, 25: 336-337. 10.1007/s00464-010-1065-3.CrossRefPubMed Carvalho GL, Cavazzola LT: Can mathematic formulas help us with our patients?. Surg Endosc. 2011, 25: 336-337. 10.1007/s00464-010-1065-3.CrossRefPubMed
25.
go back to reference Nieboer TE, Johnson N, Lethaby A, Tavender E, Curr E, Garry R, van Voorst S, Mol BW, Kluivers KB: Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009, 3: CD003677-PubMed Nieboer TE, Johnson N, Lethaby A, Tavender E, Curr E, Garry R, van Voorst S, Mol BW, Kluivers KB: Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009, 3: CD003677-PubMed
26.
go back to reference Hong JA, Choi JS, Lee JH, Eom JM, Ko JH, Bae JW, Park SH, Hong JA: Can laparoscopic radical hysterectomy be a standard surgical modality in stage IA2–IIA cervical cancer?. Gynecol Oncol. 2012, 127: 102-106. 10.1016/j.ygyno.2012.06.003.CrossRefPubMed Hong JA, Choi JS, Lee JH, Eom JM, Ko JH, Bae JW, Park SH, Hong JA: Can laparoscopic radical hysterectomy be a standard surgical modality in stage IA2–IIA cervical cancer?. Gynecol Oncol. 2012, 127: 102-106. 10.1016/j.ygyno.2012.06.003.CrossRefPubMed
27.
go back to reference Yan X, Li G, Shang H, Wang F, Han Y, Lin T, Zheng F: Twelve-year experience with laparoscopic radical hysterectomy and pelvic lymphadenectomy in cervical cancer. Gynecol Oncol. 2011, 120: 362-367. 10.1016/j.ygyno.2010.11.033.CrossRefPubMed Yan X, Li G, Shang H, Wang F, Han Y, Lin T, Zheng F: Twelve-year experience with laparoscopic radical hysterectomy and pelvic lymphadenectomy in cervical cancer. Gynecol Oncol. 2011, 120: 362-367. 10.1016/j.ygyno.2010.11.033.CrossRefPubMed
28.
go back to reference Naik R, Jackson KS, Lopes A, Cross P, Henry JA: Laparoscopic assisted radical vaginal hysterectomy versus radical abdominal hysterectomy—a randomised phase II trial: perioperative outcomes and surgicopathological measurements. BJOG. 2010, 117: 746-751. 10.1111/j.1471-0528.2010.02479.x.CrossRefPubMed Naik R, Jackson KS, Lopes A, Cross P, Henry JA: Laparoscopic assisted radical vaginal hysterectomy versus radical abdominal hysterectomy—a randomised phase II trial: perioperative outcomes and surgicopathological measurements. BJOG. 2010, 117: 746-751. 10.1111/j.1471-0528.2010.02479.x.CrossRefPubMed
29.
go back to reference DeLoach LJ, Higgins MS, Caplan MB, Stiff JF: The visual analog scale in the immediate postoperative period: lntrasubject variability and correlation with a numeric scale. Anesth Analg. 1998, 86: 102-106.PubMed DeLoach LJ, Higgins MS, Caplan MB, Stiff JF: The visual analog scale in the immediate postoperative period: lntrasubject variability and correlation with a numeric scale. Anesth Analg. 1998, 86: 102-106.PubMed
30.
go back to reference Uccella S, Laterza R, Ciravolo G, Volpi E, Franchi M, Zefiro F, Donadello N, Ghezzi F: A comparison of urinary complications following total laparoscopic radical hysterectomy and laparoscopic pelvic lymphadenectomy to open abdominal surgery. Gynecol Oncol. 2007, 107 (Suppl 1): 147-149.CrossRef Uccella S, Laterza R, Ciravolo G, Volpi E, Franchi M, Zefiro F, Donadello N, Ghezzi F: A comparison of urinary complications following total laparoscopic radical hysterectomy and laparoscopic pelvic lymphadenectomy to open abdominal surgery. Gynecol Oncol. 2007, 107 (Suppl 1): 147-149.CrossRef
31.
go back to reference Devereaux PJ, Bhandari M, Clarke M, Montoni VM, Cook DJ, Yusuf S, Sackett DL, Cinà CS, Walter SD, Haynes B, Schünemann HJ, Norman GR, Guyatt GH: Need for expertise based randomised controlled trials. BMJ. 2005, 330: 88-92. 10.1136/bmj.330.7482.88.CrossRefPubMedPubMedCentral Devereaux PJ, Bhandari M, Clarke M, Montoni VM, Cook DJ, Yusuf S, Sackett DL, Cinà CS, Walter SD, Haynes B, Schünemann HJ, Norman GR, Guyatt GH: Need for expertise based randomised controlled trials. BMJ. 2005, 330: 88-92. 10.1136/bmj.330.7482.88.CrossRefPubMedPubMedCentral
32.
go back to reference Brummer TH, Seppälä TT, Härkki PS: National learning curve for laparoscopic hysterectomy and trends in hysterectomy in Finland 2000–2005. Hum Reprod. 2008, 23: 840-845. 10.1093/humrep/den006.CrossRefPubMed Brummer TH, Seppälä TT, Härkki PS: National learning curve for laparoscopic hysterectomy and trends in hysterectomy in Finland 2000–2005. Hum Reprod. 2008, 23: 840-845. 10.1093/humrep/den006.CrossRefPubMed
Metadata
Title
Postoperative pain and perioperative outcomes after laparoscopic radical hysterectomy and abdominal radical hysterectomy in patients with early cervical cancer: a randomised controlled trial
Authors
Luciana Silveira Campos
Leo Francisco Limberger
Airton Tetelbom Stein
Antonio Nocchi Kalil
Publication date
01-12-2013
Publisher
BioMed Central
Published in
Trials / Issue 1/2013
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-14-293

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