Dataset Information

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.

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.

SUBMITTER: Kok NF

PROVIDER: S-EPMC1523437 | biostudies-literature | 2006 Jul

REPOSITORIES: biostudies-literature

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Publications

Comparison of laparoscopic and mini incision open donor nephrectomy: single blind, randomised controlled clinical trial.

Kok Niels F M NF Lind May Y MY Hansson Birgitta M E BM Pilzecker Desiree D Mertens zur Borg Ingrid R A M IR Knipscheer Ben C BC Hazebroek Eric J EJ Dooper Ine M IM Weimar Willem W Hop Wim C J WC Adang Eddy M M EM van der Wilt Gert Jan GJ Bonjer Hendrik J HJ van der Vliet Jordanus A JA IJzermans Jan N M JN

BMJ (Clinical research ed.) 20060717 7561

<h4>Objectives</h4>To determine the best approach for live donor nephrectomy to minimise discomfort to the donor and to provide good graft function.<h4>Design</h4>Single blind, randomised controlled trial.<h4>Setting</h4>Two university medical centres, the Netherlands.<h4>Participants</h4>100 living kidney donors.<h4>Interventions</h4>Participants were randomly assigned to either laparoscopic donor nephrectomy or to mini incision muscle splitting open donor nephrectomy.<h4>Main outcome measures< ...[more]

PMID: 16847014

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Project description:BACKGROUND:Hand-assisted laparoscopic living donor nephrectomy (HALDN) using a periumbilical or Pfannenstiel incision was developed to improve donor outcome after a kidney transplant. The aim of this study was to investigate two methods of hand assistance and kidney removal during HALDN and their effect on the time it takes for the donor to return to normal physical activity. METHODS/DESIGN:This study was initiated in November 2017 and is expected to last for 2 years. To be eligible for the study, donors must be more than 20 years of age and must not be receiving permanent pain therapy. Only donors with a single artery and vein in the graft are being enrolled in this trial. Donors with infections or scars in the periumbilical or hypogastric area, bleeding disorders, chronic use of immunosuppressive agents, or active infection will be excluded. Donors will be randomly allocated to either a control arm (periumbilical incision) or an intervention arm (Pfannenstiel incision). The sample size was calculated as 26 organ donors in each group. The primary endpoint is the number of days it takes the donor to return to normal physical activity (up to 4 weeks after the operation). Secondary endpoints are intraoperative outcomes, including estimated blood loss, warm ischemia time, and duration of the operation. Postoperative pain will be assessed using the visual analog scale, rescue analgesic use, and peak expiratory flow rate. Length of hospital stay, physical activity score, time to return to work, donor satisfaction, cosmetic score, postoperative complications, and all-cause mortality in living donors will also be reported. Delayed graft function, primary non-function, serum creatinine levels, and glomerular filtration rate will also be assessed in the recipients after transplantation. DISCUSSION:This is the first randomized controlled trial to compare the time it takes the living donor to return to normal physical activity after HALDN using two different types of incision. The comprehensive findings of this study will help decide which nephrectomy procedure is best for living donors with regard to patient comfort and satisfaction as well as graft function in the recipient after transplantation. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03317184 . Registered on 23 October 2017.

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Dataset Information

Comparison of laparoscopic and mini incision open donor nephrectomy: single blind, randomised controlled clinical trial.

Objectives

Design

Setting

Participants

Interventions

Main outcome measures

Results

Conclusions

Publications

Comparison of laparoscopic and mini incision open donor nephrectomy: single blind, randomised controlled clinical trial.

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