Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201712002851326 Date of Approval: 08/12/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Role of flexible nephroscope in conjuction with rigid nephroscope in standard percutaneous nephrolithotomy
Official scientific title Role of flexible nephroscope in conjuction with rigid nephroscope in standard percutaneous nephrolithotomy
Brief summary describing the background and objectives of the trial Percutaneous nephrolithotomy (PCNL) has become the gold standard treatment for large renal stones, as it has stone-free rate three times higher than extracorporeal shock wave lithotripsy (ESWL), along with lower morbidity, shorter length of hospital stay and operating time as well as faster return to work than open stone extraction surgery.The aim of this study is to evaluate the added benefits of using flexible in conjunction with rigid nephroscope in percutaneous nephrolithotomy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied renal stones,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 29/12/2017
Actual trial start date
Anticipated date of last follow up 28/12/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised patients will be randomly assigned to one of two treatment groups: group "A" (who will undergo nephrolithotomy by rigid nephroscope only) and group "B" (who will undergo nephrolithotomy by combined rigid and flexible nephroscopes) by simple randomisation using coin-tossing maneuver with the coin has letter "A" written on one side and letter "B" written on the other side allocation sequence will be concealed from the person allocating the participants to the intervention arms by using sealed opaque envelopes after ensuring that he/she doesnot know about group specifications associated with letter "A&B" on either side of the coin Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised patients will be randomly assigned to one of two treatment groups: group "A" (who will undergo nephrolithotomy by rigid nephroscope only) and group "B" (who will undergo nephrolithotomy by combined rigid and flexible nephroscopes) by simple randomisation using coin-tossing maneuver with the coin has letter "A" written on one side and letter "B" written on the other side allocation sequence will be concealed from the person allocating the participants to the intervention arms by using sealed opaque envelopes after ensuring that he/she doesnot know about group specifications associated with letter "A&B" on either side of the coin Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised patients will be randomly assigned to one of two treatment groups: group "A" (who will undergo nephrolithotomy by rigid nephroscope only) and group "B" (who will undergo nephrolithotomy by combined rigid and flexible nephroscopes) by simple randomisation using coin-tossing maneuver with the coin has letter "A" written on one side and letter "B" written on the other side allocation sequence will be concealed from the person allocating the participants to the intervention arms by using sealed opaque envelopes after ensuring that he/she doesnot know about group specifications associated with letter "A&B" on either side of the coin Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group rigid plus flexible nephroscopy adding flexible nephroscope to rigid nephroscop during PCNL 15
Control Group only rigid nephroscopy using only rigid nephroscope during PCNL 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All patients with renal stones eligible for percutaneous nephrolithotomy Conditions interfering with the results of parameters understudy: ¿ Skeletal deformity. ¿ Renal anomalies ¿ Coagulopathies 12 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/12/2017 ethics committee of assiut university hospital
Ethics Committee Address
Street address City Postal code Country
Assiut university hospital Assiut 7111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome ¿ Hematocrit value pre and postoperatively 24hrs pre-operative 24hrs postoperative
Secondary Outcome Intra and postoperative complications intraoperative for intraoperative complications at time of discharge for postoperative complications
Secondary Outcome Open conversion rate immediately post operative
Secondary Outcome Need for 2nd look PCNL at time of discharge from hospital
Secondary Outcome Hospital stay at time of discharge from hospital
Primary Outcome post operative Stone free rate 24hr postoperative
Secondary Outcome Operating time immediately post operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Assiut university hospital Assiut/ assiut university street Assiut 7111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mohammed baker gamal abdelnaser street egypt, minia, dermawas 20 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor mohammed baker gamal abdelnaser street egypt, minia, dermawas 20 Egypt Charities/Societies/Foundation
Primary Sponsor assiut university hospital Assiut/ assiut university street Assiut 7111 Egypt University
COLLABORATORS
Name Street address City Postal code Country
mohammed baker gamal abdelnaser street egypt, minia, dermawas 20 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed abdallah MoElgammal@gmail.com 01005212163 assiut
City Postal code Country Position/Affiliation
assiut 20 Egypt
Role Name Email Phone Street address
Public Enquiries fathy gaber fathy1058@yahoo.com 01005263708 assiut
City Postal code Country Position/Affiliation
assiut 20 Egypt
Role Name Email Phone Street address
Scientific Enquiries mahmoud mohammed shalabyjunior@gmail.com 01111222203 assiut
City Postal code Country Position/Affiliation
assiut 20 Egypt
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information