Shunting outcomes in communicating hydrocephalus: protocol for a multicentre, open-label, randomised controlled trial
Introduction Ventriculoperitoneal shunt (VPS) remains the most widely used methods to treat communicating hydrocephalus. More recently, lumboperitoneal shunt (LPS) has been suggested as a reasonable option in some studies. However, there is lack of high-quality studies comparing these two techniques...
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BMJ Publishing Group
2021-08-01
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| author | Chao You Jingguo Yang Tong Sun Yikai Yuan Xuepei Li Hang Yu Junwen Guan Wenyao Cui Yicheng Zhou |
| author_facet | Chao You Jingguo Yang Tong Sun Yikai Yuan Xuepei Li Hang Yu Junwen Guan Wenyao Cui Yicheng Zhou |
| author_sort | Chao You |
| collection | DOAJ |
| description | Introduction Ventriculoperitoneal shunt (VPS) remains the most widely used methods to treat communicating hydrocephalus. More recently, lumboperitoneal shunt (LPS) has been suggested as a reasonable option in some studies. However, there is lack of high-quality studies comparing these two techniques in order to certain the benefits and harms to use one of these two methods. The purpose of the current study is to determine the effectiveness and safety of the LPS versus the VPS in patients with communicating hydrocephalus.Methods and analysis All eligible patients aged 18–90 years with communicating hydrocephalus will be recruited and then randomly allocated into LPS or VPS group in a ratio of 1:1. All patients will be analysed before shunt insertion, at the time of discharge, 1 month, 6 months, 12 months and 24 months postoperatively. The primary outcome measure is the rate of shunt failure at a 2-year follow-up term. The secondary outcomes include Keifer’s Hydrocephalus Scale, National Institute of Health Stroke Scale, Glasgow Outcome Scale Extended, Evans index, safety endpoints and cost-effectiveness of hospital stay.Ethics and dissemination The study will be performed in compliance with the Declaration of Helsinki (2002) of the World Medical Association. The study was approved by Institutional Review Board of West China Hospital. All patients will be fully informed the potential benefits, potential risks and responsibilities, those who will sign the informed consents once they are included. Preliminary and final results will be published in peer-reviewed journals and presented at national and international congresses.Trial registration number ChiCTR2100043839. |
| format | Article |
| id | doaj-art-6ba3e44ab1f84a27994ffbf3c659f1f8 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-6ba3e44ab1f84a27994ffbf3c659f1f82024-12-08T18:35:10ZengBMJ Publishing GroupBMJ Open2044-60552021-08-0111810.1136/bmjopen-2021-051127Shunting outcomes in communicating hydrocephalus: protocol for a multicentre, open-label, randomised controlled trialChao You0Jingguo Yang1Tong Sun2Yikai Yuan3Xuepei Li4Hang Yu5Junwen Guan6Wenyao Cui7Yicheng Zhou81 Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, Sichuan, ChinaDepartment of Neurosurgery, Sichuan University West China Hospital, Chengdu, Sichuan, ChinaDepartment of Neurosurgery, Sichuan University West China Hospital, Chengdu, Sichuan, ChinaDepartment of Neurosurgery, Sichuan University West China Hospital, Chengdu, Sichuan, ChinaMedical Simulation Center, Chengdu First People’s Hospital, Chengdu, Sichuan, ChinaDepartment of Neurology, Sichuan Provincial People’s Hospital, Chengdu, Sichuan, ChinaDepartment of Neurosurgery, Sichuan University West China Hospital, Chengdu, Sichuan, China1 Department of Neurosurgery, Sichuan University West China Hospital, Chengdu, Sichuan, ChinaDepartment of Neurosurgery, Sichuan University West China Hospital, Chengdu, Sichuan, ChinaIntroduction Ventriculoperitoneal shunt (VPS) remains the most widely used methods to treat communicating hydrocephalus. More recently, lumboperitoneal shunt (LPS) has been suggested as a reasonable option in some studies. However, there is lack of high-quality studies comparing these two techniques in order to certain the benefits and harms to use one of these two methods. The purpose of the current study is to determine the effectiveness and safety of the LPS versus the VPS in patients with communicating hydrocephalus.Methods and analysis All eligible patients aged 18–90 years with communicating hydrocephalus will be recruited and then randomly allocated into LPS or VPS group in a ratio of 1:1. All patients will be analysed before shunt insertion, at the time of discharge, 1 month, 6 months, 12 months and 24 months postoperatively. The primary outcome measure is the rate of shunt failure at a 2-year follow-up term. The secondary outcomes include Keifer’s Hydrocephalus Scale, National Institute of Health Stroke Scale, Glasgow Outcome Scale Extended, Evans index, safety endpoints and cost-effectiveness of hospital stay.Ethics and dissemination The study will be performed in compliance with the Declaration of Helsinki (2002) of the World Medical Association. The study was approved by Institutional Review Board of West China Hospital. All patients will be fully informed the potential benefits, potential risks and responsibilities, those who will sign the informed consents once they are included. Preliminary and final results will be published in peer-reviewed journals and presented at national and international congresses.Trial registration number ChiCTR2100043839.https://bmjopen.bmj.com/content/11/8/e051127.full |
| spellingShingle | Chao You Jingguo Yang Tong Sun Yikai Yuan Xuepei Li Hang Yu Junwen Guan Wenyao Cui Yicheng Zhou Shunting outcomes in communicating hydrocephalus: protocol for a multicentre, open-label, randomised controlled trial BMJ Open |
| title | Shunting outcomes in communicating hydrocephalus: protocol for a multicentre, open-label, randomised controlled trial |
| title_full | Shunting outcomes in communicating hydrocephalus: protocol for a multicentre, open-label, randomised controlled trial |
| title_fullStr | Shunting outcomes in communicating hydrocephalus: protocol for a multicentre, open-label, randomised controlled trial |
| title_full_unstemmed | Shunting outcomes in communicating hydrocephalus: protocol for a multicentre, open-label, randomised controlled trial |
| title_short | Shunting outcomes in communicating hydrocephalus: protocol for a multicentre, open-label, randomised controlled trial |
| title_sort | shunting outcomes in communicating hydrocephalus protocol for a multicentre open label randomised controlled trial |
| url | https://bmjopen.bmj.com/content/11/8/e051127.full |
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