Comparison of laparoscopic and mini incision open donor nephrectomy: single blind, randomised controlled clinical trial
Abstract Objectives To determine the best approach for live donor nephrectomy to minimise discomfort to the donor and to provide good graft function. Design Single blind, randomised controlled trial. Setting Two university medical centres, the Netherlands. Participants 100 living kidney donors. Inte...
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Published in: | BMJ Vol. 333; no. 7561; pp. 221 - 224 |
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Main Authors: | , , , , , , , , , , , , , , |
Format: | Journal Article |
Language: | English |
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London
British Medical Journal Publishing Group
29-07-2006
British Medical Association BMJ Publishing Group LTD BMJ Publishing Group BMJ Publishing Group Ltd |
Edition: | International edition |
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Abstract | Abstract Objectives To determine the best approach for live donor nephrectomy to minimise discomfort to the donor and to provide good graft function. Design Single blind, randomised controlled trial. Setting Two university medical centres, the Netherlands. Participants 100 living kidney donors. Interventions Participants were randomly assigned to either laparoscopic donor nephrectomy or to mini incision muscle splitting open donor nephrectomy. Main outcome measures The primary outcome was physical fatigue using the multidimensional fatigue inventory 20 (MFI-20). Secondary outcomes were physical function using the SF-36, hospital stay after surgery, pain, operating times, recipient graft function, and graft survival. Results Conversions did not occur. Compared with mini incision open donor nephrectomy, laparoscopic donor nephrectomy resulted in longer skin to skin time (median 221 v 164 minutes, P < 0.001), longer warm ischaemia time (6 v 3 minutes, P < 0.001), less blood loss (100 v 240 ml, P < 0.001), and a similar number of complications (intraoperatively 12% v 6%, P = 0.49, postoperatively both 6%). After laparoscopic nephrectomy, donors required less morphine (16 v 25 mg, P = 0.005) and shorter hospital stay (3 v 4 days, P = 0.003). During one year's follow-up mean physical fatigue was less (difference - 1.3, 95% confidence interval - 2.4 to - 0.1) and physical function was better (difference 6.2, 2.0 to 10.3) after laparoscopic nephrectomy. Function of the graft and graft survival rate of the recipient at one year censored for death did not differ (100% after laparoscopic nephrectomy and 98% after open nephrectomy). Conclusions Laparoscopic donor nephrectomy results in a better quality of life compared with mini incision open donor nephrectomy but equal safety and graft function. |
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AbstractList | Objectives To determine the best approach for live donor nephrectomy to minimise discomfort to the donor and to provide good graft function. Design Single blind, randomised controlled trial. Setting Two university medical centres, the Netherlands. Participants 100 living kidney donors. Interventions Participants were randomly assigned to either laparoscopic donor nephrectomy or to mini incision muscle splitting open donor nephrectomy. Main outcome measures The primary outcome was physical fatigue using the multidimensional fatigue inventory 20 (MFI-20). Secondary outcomes were physical function using the SF-36, hospital stay after surgery, pain, operating times, recipient graft function, and graft survival. Results Compared with mini incision open donor nephrectomy, laparoscopic donor nephrectomy resulted in longer skin to skin time (median 221 v 164 minutes, P < 0.001), longer warm ischaemia time (6 v 3 minutes, P < 0.001 ), less blood loss (100 v 240 ml, P < 0.001), and a similar number of complications (intraoperatively 12% v 6%, P = 0.49, postoperatively both 6%). After laparoscopic nephrectomy, donors required less morphine (16 v 25 mg, P = 0.005) and shorter hospital stay (3 v 4 days, P = 0.003). During one year's follow-up mean physical fatigue was less (difference -1.3, 95% confidence interval -2.4 to -0.1) and physical function was better (difference 6.2, 2.0 to 10.3) after laparoscopic nephrectomy. Function of the graft and graft survival rate of the recipient at one year censored for death did not differ (100% after laparoscopic nephrectomy and 98% after open nephrectomy). Conclusions Laparoscopic donor nephrectomy results in a better quality of life compared with mini incision open donor nephrectomy but equal safety and graft function. Objectives To determine the best approach for live donor nephrectomy to minimise discomfort to the donor and to provide good graft function. Design Single blind, randomised controlled trial. Setting Two university medical centres, the Netherlands. Participants 100 living kidney donors. Interventions Participants were randomly assigned to either laparoscopic donor nephrectomy or to mini incision muscle splitting open donor nephrectomy. Main outcome measures The primary outcome was physical fatigue using the multidimensional fatigue inventory 20 (MFI-20). Secondary outcomes were physical function using the SF-36, hospital stay after surgery, pain, operating times, recipient graft function, and graft survival. Results Conversions did not occur. Compared with mini incision open donor nephrectomy, laparoscopic donor nephrectomy resulted in longer skin to skin time (median 221 v 164 minutes, P < 0.001), longer warm ischaemia time (6 v 3 minutes, P < 0.001), less blood loss (100 v 240 ml, P < 0.001), and a similar number of complications (intraoperatively 12% v 6%, P = 0.49, postoperatively both 6%). After laparoscopic nephrectomy, donors required less morphine (16 v 25 mg, P = 0.005) and shorter hospital stay (3 v 4 days, P = 0.003). During one year's follow-up mean physical fatigue was less (difference - 1.3, 95% confidence interval - 2.4 to - 0.1) and physical function was better (difference 6.2, 2.0 to 10.3) after laparoscopic nephrectomy. Function of the graft and graft survival rate of the recipient at one year censored for death did not differ (100% after laparoscopic nephrectomy and 98% after open nephrectomy). Conclusions Laparoscopic donor nephrectomy results in a better quality of life compared with mini incision open donor nephrectomy but equal safety and graft function. Abstract Objectives To determine the best approach for live donor nephrectomy to minimise discomfort to the donor and to provide good graft function. Design Single blind, randomised controlled trial. Setting Two university medical centres, the Netherlands. Participants 100 living kidney donors. Interventions Participants were randomly assigned to either laparoscopic donor nephrectomy or to mini incision muscle splitting open donor nephrectomy. Main outcome measures The primary outcome was physical fatigue using the multidimensional fatigue inventory 20 (MFI-20). Secondary outcomes were physical function using the SF-36, hospital stay after surgery, pain, operating times, recipient graft function, and graft survival. Results Conversions did not occur. Compared with mini incision open donor nephrectomy, laparoscopic donor nephrectomy resulted in longer skin to skin time (median 221 v 164 minutes, P < 0.001), longer warm ischaemia time (6 v 3 minutes, P < 0.001), less blood loss (100 v 240 ml, P < 0.001), and a similar number of complications (intraoperatively 12% v 6%, P = 0.49, postoperatively both 6%). After laparoscopic nephrectomy, donors required less morphine (16 v 25 mg, P = 0.005) and shorter hospital stay (3 v 4 days, P = 0.003). During one year's follow-up mean physical fatigue was less (difference - 1.3, 95% confidence interval - 2.4 to - 0.1) and physical function was better (difference 6.2, 2.0 to 10.3) after laparoscopic nephrectomy. Function of the graft and graft survival rate of the recipient at one year censored for death did not differ (100% after laparoscopic nephrectomy and 98% after open nephrectomy). Conclusions Laparoscopic donor nephrectomy results in a better quality of life compared with mini incision open donor nephrectomy but equal safety and graft function. OBJECTIVESTo determine the best approach for live donor nephrectomy to minimise discomfort to the donor and to provide good graft function.DESIGNSingle blind, randomised controlled trial.SETTINGTwo university medical centres, the Netherlands.PARTICIPANTS100 living kidney donors.INTERVENTIONSParticipants were randomly assigned to either laparoscopic donor nephrectomy or to mini incision muscle splitting open donor nephrectomy.MAIN OUTCOME MEASURESThe primary outcome was physical fatigue using the multidimensional fatigue inventory 20 (MFI-20). Secondary outcomes were physical function using the SF-36, hospital stay after surgery, pain, operating times, recipient graft function, and graft survival.RESULTSConversions did not occur. Compared with mini incision open donor nephrectomy, laparoscopic donor nephrectomy resulted in longer skin to skin time (median 221 v 164 minutes, P < 0.001), longer warm ischaemia time (6 v 3 minutes, P < 0.001), less blood loss (100 v 240 ml, P < 0.001), and a similar number of complications (intraoperatively 12% v 6%, P = 0.49, postoperatively both 6%). After laparoscopic nephrectomy, donors required less morphine (16 v 25 mg, P = 0.005) and shorter hospital stay (3 v 4 days, P = 0.003). During one year's follow-up mean physical fatigue was less (difference - 1.3, 95% confidence interval - 2.4 to - 0.1) and physical function was better (difference 6.2, 2.0 to 10.3) after laparoscopic nephrectomy. Function of the graft and graft survival rate of the recipient at one year censored for death did not differ (100% after laparoscopic nephrectomy and 98% after open nephrectomy).CONCLUSIONSLaparoscopic donor nephrectomy results in a better quality of life compared with mini incision open donor nephrectomy but equal safety and graft function. Objectives: To determine the best approach for live donor nephrectomy to minimise discomfort to the donor and to provide good graft function. Design: Single blind, randomised controlled trial. Setting: Two university medical centres, the Netherlands. Participants: 100 living kidney donors. Interventions: Participants were randomly assigned to either laparoscopic donor nephrectomy or to mini incision muscle splitting open donor nephrectomy. Main outcome measures: The primary outcome was physical fatigue using the multidimensional fatigue inventory 20 (MFI-20). Secondary outcomes were physical function using the SF-36, hospital stay after surgery, pain, operating times, recipient graft function, and graft survival. Results: Conversions did not occur. Compared with mini incision open donor nephrectomy, laparoscopic donor nephrectomy resulted in longer skin to skin time (median 221 v 164 minutes, P < 0.001), longer warm ischaemia time (6 v 3 minutes, P < 0.001), less blood loss (100 v 240 ml, P < 0.001), and a similar number of complications (intraoperatively 12% v 6%, P = 0.49, postoperatively both 6%). After laparoscopic nephrectomy, donors required less morphine (16 v 25 mg, P = 0.005) and shorter hospital stay (3 v 4 days, P = 0.003). During one year's follow-up mean physical fatigue was less (difference - 1.3, 95% confidence interval - 2.4 to - 0.1) and physical function was better (difference 6.2, 2.0 to 10.3) after laparoscopic nephrectomy. Function of the graft and graft survival rate of the recipient at one year censored for death did not differ (100% after laparoscopic nephrectomy and 98% after open nephrectomy). Conclusions: Laparoscopic donor nephrectomy results in a better quality of life compared with mini incision open donor nephrectomy but equal safety and graft function. [PUBLICATION ABSTRACT] To determine the best approach for live donor nephrectomy to minimise discomfort to the donor and to provide good graft function. Single blind, randomised controlled trial. Two university medical centres, the Netherlands. 100 living kidney donors. Participants were randomly assigned to either laparoscopic donor nephrectomy or to mini incision muscle splitting open donor nephrectomy. The primary outcome was physical fatigue using the multidimensional fatigue inventory 20 (MFI-20). Secondary outcomes were physical function using the SF-36, hospital stay after surgery, pain, operating times, recipient graft function, and graft survival. Conversions did not occur. Compared with mini incision open donor nephrectomy, laparoscopic donor nephrectomy resulted in longer skin to skin time (median 221 v 164 minutes, P < 0.001), longer warm ischaemia time (6 v 3 minutes, P < 0.001), less blood loss (100 v 240 ml, P < 0.001), and a similar number of complications (intraoperatively 12% v 6%, P = 0.49, postoperatively both 6%). After laparoscopic nephrectomy, donors required less morphine (16 v 25 mg, P = 0.005) and shorter hospital stay (3 v 4 days, P = 0.003). During one year's follow-up mean physical fatigue was less (difference - 1.3, 95% confidence interval - 2.4 to - 0.1) and physical function was better (difference 6.2, 2.0 to 10.3) after laparoscopic nephrectomy. Function of the graft and graft survival rate of the recipient at one year censored for death did not differ (100% after laparoscopic nephrectomy and 98% after open nephrectomy). Laparoscopic donor nephrectomy results in a better quality of life compared with mini incision open donor nephrectomy but equal safety and graft function. Objectives To determine the best approach for live donor nephrectomy to minimise discomfort to the donor and to provide good graft function. Design Single blind, randomised controlled trial. Setting Two university medical centres, the Netherlands. Participants 100 living kidney donors. Interventions Participants were randomly assigned to either laparoscopic donor nephrectomy or to mini incision muscle splitting open donor nephrectomy. Main outcome measures The primary outcome was physical fatigue using the multidimensional fatigue inventory 20 (MFI-20). Secondary outcomes were physical function using the SF-36, hospital stay after surgery, pain, operating times, recipient graft function, and graft survival. Results Conversions did not occur. Compared with mini incision open donor nephrectomy, laparoscopic donor nephrectomy resulted in longer skin to skin time (median 221 v 164 minutes, P < 0.001), longer warm ischaemia time (6 v 3 minutes, P < 0.001), less blood loss (100 v 240 ml, P < 0.001), and a similar number of complications (intraoperatively 12% v 6%, P = 0.49, postoperatively both 6%). After laparoscopic nephrectomy, donors required less morphine (16 v 25 mg, P = 0.005) and shorter hospital stay (3 v 4 days, P = 0.003). During one year's follow-up mean physical fatigue was less (difference - 1.3, 95% confidence interval - 2.4 to - 0.1) and physical function was better (difference 6.2, 2.0 to 10.3) after laparoscopic nephrectomy. Function of the graft and graft survival rate of the recipient at one year censored for death did not differ (100% after laparoscopic nephrectomy and 98% after open nephrectomy). Conclusions Laparoscopic donor nephrectomy results in a better quality of life compared with mini incision open donor nephrectomy but equal safety and graft function. |
Author | van der Wilt, Gert Jan Hansson, Birgitta M E Kok, Niels F M Hazebroek, Eric J Dooper, Ine M Mertens zur Borg, Ingrid R A M Lind, May Y Hop, Wim C J Bonjer, Hendrik J Pilzecker, Desiree Weimar, Willem van der Vliet, Jordanus A Knipscheer, Ben C Adang, Eddy M M IJzermans, Jan N M |
AuthorAffiliation | 3 Department of Nephrology, Radboud University Medical Centre 7 Department of Epidemiology and Biostatistics, Erasmus MC 6 Department of Nephrology, Erasmus MC 1 Department of Surgery, Erasmus MC, PO Box 2040, 3000 CA Rotterdam, Netherlands 2 Department of Surgery, Radboud University Medical Centre, Nijmegen, Netherlands 4 Department of Anaesthesiology, Erasmus MC 5 Department of Urology, Radboud University Medical Centre 8 Department of Medical Technology Assessment, Radboud University Medical Centre |
AuthorAffiliation_xml | – name: 5 Department of Urology, Radboud University Medical Centre – name: 6 Department of Nephrology, Erasmus MC – name: 3 Department of Nephrology, Radboud University Medical Centre – name: 4 Department of Anaesthesiology, Erasmus MC – name: 2 Department of Surgery, Radboud University Medical Centre, Nijmegen, Netherlands – name: 8 Department of Medical Technology Assessment, Radboud University Medical Centre – name: 7 Department of Epidemiology and Biostatistics, Erasmus MC – name: 1 Department of Surgery, Erasmus MC, PO Box 2040, 3000 CA Rotterdam, Netherlands |
Author_xml | – sequence: 1 givenname: Niels F M surname: Kok fullname: Kok, Niels F M organization: Department of Surgery, Erasmus MC, PO Box , CA Rotterdam, Netherlands – sequence: 2 givenname: May Y surname: Lind fullname: Lind, May Y organization: Department of Surgery, Erasmus MC, PO Box , CA Rotterdam, Netherlands – sequence: 3 givenname: Birgitta M E surname: Hansson fullname: Hansson, Birgitta M E organization: Department of Surgery, Radboud University Medical Centre, Nijmegen, Netherlands – sequence: 4 givenname: Desiree surname: Pilzecker fullname: Pilzecker, Desiree organization: Department of Nephrology, Radboud University Medical Centre – sequence: 5 givenname: Ingrid R A M surname: Mertens zur Borg fullname: Mertens zur Borg, Ingrid R A M organization: Department of Anaesthesiology, Erasmus MC – sequence: 6 givenname: Ben C surname: Knipscheer fullname: Knipscheer, Ben C organization: Department of Urology, Radboud University Medical Centre – sequence: 7 givenname: Eric J surname: Hazebroek fullname: Hazebroek, Eric J organization: Department of Surgery, Erasmus MC, PO Box , CA Rotterdam, Netherlands – sequence: 8 givenname: Ine M surname: Dooper fullname: Dooper, Ine M organization: Department of Nephrology, Radboud University Medical Centre – sequence: 9 givenname: Willem surname: Weimar fullname: Weimar, Willem organization: Department of Nephrology, Erasmus MC – sequence: 10 givenname: Wim C J surname: Hop fullname: Hop, Wim C J organization: Department of Epidemiology and Biostatistics, Erasmus MC – sequence: 11 givenname: Eddy M M surname: Adang fullname: Adang, Eddy M M organization: Department of Medical Technology Assessment, Radboud University Medical Centre – sequence: 12 givenname: Gert Jan surname: van der Wilt fullname: van der Wilt, Gert Jan organization: Department of Medical Technology Assessment, Radboud University Medical Centre – sequence: 13 givenname: Hendrik J surname: Bonjer fullname: Bonjer, Hendrik J organization: Department of Surgery, Erasmus MC, PO Box , CA Rotterdam, Netherlands – sequence: 14 givenname: Jordanus A surname: van der Vliet fullname: van der Vliet, Jordanus A organization: Department of Surgery, Radboud University Medical Centre, Nijmegen, Netherlands – sequence: 15 givenname: Jan N M surname: IJzermans fullname: IJzermans, Jan N M email: j.ijzermans@erasmusmc.nl organization: Department of Surgery, Erasmus MC, PO Box , CA Rotterdam, Netherlands |
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ContentType | Journal Article |
Copyright | 2006 BMJ Publishing Group Ltd. 2006 BMJ Publishing Group Ltd 2006 INIST-CNRS Copyright: 2006 (c) 2006 BMJ Publishing Group Ltd. Copyright BMJ Publishing Group Jul 29, 2006 Copyright © 2006, BMJ Publishing Group Ltd. 2006 |
Copyright_xml | – notice: 2006 BMJ Publishing Group Ltd. – notice: 2006 BMJ Publishing Group Ltd – notice: 2006 INIST-CNRS – notice: Copyright: 2006 (c) 2006 BMJ Publishing Group Ltd. – notice: Copyright BMJ Publishing Group Jul 29, 2006 – notice: Copyright © 2006, BMJ Publishing Group Ltd. 2006 |
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DOI | 10.1136/bmj.38886.618947.7C |
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Keywords | Human Incision Medicine Treatment Donor Nephrectomy Surgery Randomised controlled trial Clinical trial Laparoscopy Endoscopy Comparative study |
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Notes | local:bmj;333/7561/221 istex:E968BCC61CECDA0491EE53D6F8044C995A82887C ArticleID:bmj.38886.618947.7C href:bmj-333-221.pdf PMID:16847014 Correspondence to: J N M IJzermans ark:/67375/NVC-TC3GXDMX-R ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-News-2 ObjectType-Feature-3 content type line 23 Funding: This study was supported by unrestricted grants from the Society of American Gastrointestinal Endoscopic Surgeons and the Dutch Kidney Foundation. Competing interest: None declared. Table with data for additional dimensions is on bmj.com Contributors: WW, BMEH, GJvdW, EJH, IRAMMzB, HJB, JAvdV, and JNMI contributed to the design and initial planning of this study. BMEH, BCK, HJB, and JNMIJ attended all operations and controlled the carrying out of the surgical technique. NFMK, MYL, EJH, and DP collected the donors' data. WW and IMD collected the recipients' data. WCJH was the trial statistician. NFMK, EMMA, and GJvdW were responsible for collecting, analysing, interpreting, and writing up the quality of life data. IRAMMzB supervised and controlled the anaesthesiology protocol. NFMK, WW, JNMI, and EMMA coordinated the writing and drafting of the article. JNMI is guarantor. Ethical approval: This study was approved by the medical ethics committees of the university medical centres at Rotterdam and Nijmegen. Correspondence to: J N M IJzermans j.ijzermans@erasmusmc.nl We thank J G van Duuren-van Pelt, data manager, and I P J Alwayn, surgeon, for their contributions to this study. |
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Snippet | Abstract Objectives To determine the best approach for live donor nephrectomy to minimise discomfort to the donor and to provide good graft function. Design... Objectives To determine the best approach for live donor nephrectomy to minimise discomfort to the donor and to provide good graft function. Design Single... To determine the best approach for live donor nephrectomy to minimise discomfort to the donor and to provide good graft function. Single blind, randomised... Objectives: To determine the best approach for live donor nephrectomy to minimise discomfort to the donor and to provide good graft function. Design: Single... OBJECTIVESTo determine the best approach for live donor nephrectomy to minimise discomfort to the donor and to provide good graft function.DESIGNSingle blind,... Objectives To determine the best approach for live donor nephrectomy to minimise discomfort to the donor and to provide good graft function. Design Single... |
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SubjectTerms | Abdomen Adult Aged Biological and medical sciences Blood & organ donations Blood donation Cholecystectomy Clinical trials Digestive system. Abdomen Endoscopy Fatigue Fatigue - etiology Female General aspects Graft Survival Hospitals Humans Investigative techniques, diagnostic techniques (general aspects) Kidneys Laparoscopy Laparoscopy - methods Length of Stay Living Donors Male Medical imaging Medical sciences Middle Aged Nephrectomy Nephrectomy - methods Nephrology Organ donation Pain Patient safety Patients Postoperative complications Postoperative Complications - etiology Quality of Life Self image Single-Blind Method Skin Statistical median Surgery Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases Surgery of the urinary system Tissue grafting Transplants & implants Universities Veins & arteries |
Title | Comparison of laparoscopic and mini incision open donor nephrectomy: single blind, randomised controlled clinical trial |
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