Pneumoperitoneum preconditioning for the prevention of renal function after laparoscopic partial nephrectomy: protocol for a double-blind randomised controlled trial. Issue 5 (26th May 2020)
- Record Type:
- Journal Article
- Title:
- Pneumoperitoneum preconditioning for the prevention of renal function after laparoscopic partial nephrectomy: protocol for a double-blind randomised controlled trial. Issue 5 (26th May 2020)
- Main Title:
- Pneumoperitoneum preconditioning for the prevention of renal function after laparoscopic partial nephrectomy: protocol for a double-blind randomised controlled trial
- Authors:
- Zhou, Changcheng
Xu, Luwei
Xu, Zheng
Ge, Yuzheng
Zhou, Liuhua
Wang, Feng
Liu, Jingyu
Pan, Gaojian
Yang, Tianli
Jia, Ruipeng - Abstract:
- Abstract : Introduction: Renal ischaemia reperfusion injury is an inevitable pathophysiology in different clinical situations including laparoscopic partial nephrectomy (LPN), which can obviously decrease the renal function after surgery. Pneumoperitoneum preconditioning (PP) is a promising approach that can yield a protective effect on kidney, which has already been demonstrated in some animal models. The present study is designed to assess whether the PP can yield a clinical renoprotective role after LPN. Methods and analysis: This study is a randomised, prospective, double-blind and parallel controlled clinical trial. Eligible participants will be patients with renal tumours and willing to choose elective LPN. Patients randomised to the treatment arm will receive PP consisted of three cycles of 5 min insufflation and 5 min desufflation before LPN, while the control arm will receive a sham operation. The primary endpoints are glomerular filtration rate and the level of serum cystatin C within 6 months after desufflation. The secondary endpoints are serum creatinine, estimated glomerular filtration rate, alanine transaminase, serum amylase, intestinal fatty acid binding protein, postoperative hospital stay, the incidence of adverse events and mortality in postoperative 6 months. Ethics and dissemination: This study has been approved by the institutional ethics committee of Nanjing First Hospital. The results of this study will be reported faithfully through scientificAbstract : Introduction: Renal ischaemia reperfusion injury is an inevitable pathophysiology in different clinical situations including laparoscopic partial nephrectomy (LPN), which can obviously decrease the renal function after surgery. Pneumoperitoneum preconditioning (PP) is a promising approach that can yield a protective effect on kidney, which has already been demonstrated in some animal models. The present study is designed to assess whether the PP can yield a clinical renoprotective role after LPN. Methods and analysis: This study is a randomised, prospective, double-blind and parallel controlled clinical trial. Eligible participants will be patients with renal tumours and willing to choose elective LPN. Patients randomised to the treatment arm will receive PP consisted of three cycles of 5 min insufflation and 5 min desufflation before LPN, while the control arm will receive a sham operation. The primary endpoints are glomerular filtration rate and the level of serum cystatin C within 6 months after desufflation. The secondary endpoints are serum creatinine, estimated glomerular filtration rate, alanine transaminase, serum amylase, intestinal fatty acid binding protein, postoperative hospital stay, the incidence of adverse events and mortality in postoperative 6 months. Ethics and dissemination: This study has been approved by the institutional ethics committee of Nanjing First Hospital. The results of this study will be reported faithfully through scientific conferences or published articles. Trial registration number: NCT03822338 . … (more)
- Is Part Of:
- BMJ open. Volume 10:Issue 5(2020)
- Journal:
- BMJ open
- Issue:
- Volume 10:Issue 5(2020)
- Issue Display:
- Volume 10, Issue 5 (2020)
- Year:
- 2020
- Volume:
- 10
- Issue:
- 5
- Issue Sort Value:
- 2020-0010-0005-0000
- Page Start:
- Page End:
- Publication Date:
- 2020-05-26
- Subjects:
- pneumoperitoneum preconditioning -- laparoscopic partial nephrectomy -- protocol -- randomised controlled trial
Medicine -- Research -- Periodicals
610.72 - Journal URLs:
- http://www.bmj.com/archive ↗
http://bmjopen.bmj.com/ ↗ - DOI:
- 10.1136/bmjopen-2019-032002 ↗
- Languages:
- English
- ISSNs:
- 2044-6055
- Deposit Type:
- Legaldeposit
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- British Library DSC - BLDSS-3PM
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