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.: PACTR202604804181360 Date of Registration: 24/04/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Avoidance of short-term lymphatic complications in extraperitoneal radical cystectomy, prospective randomized study
Official scientific title prospective randomized study between different methods of lymphatics ligation during extraperitoneal radical cystectomy
Brief summary describing the background and objectives of the trial Radical cystectomy with pelvic lymphadenectomy and urinary diversion is considered to be the gold standard for treatment of non-metastatic muscle-invasive and high-risk non-muscle-invasive bladder cancer. We adopt open extraperitoneal approach. However, it led to the emergence of lymphatic complications. There is so little in the literature about the most favorable method for lymphatics ligation that’s why we decided to design this study. this study compares between monopolar, bipolar and clips in lymphatics ligation during extraperitoneal radical cystectomy . the objective of our study is to find the most effective method of lymphatic ligation with the least complications
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/06/2022
Actual trial start date 01/06/2022
Anticipated date of last follow up 30/06/2024
Actual Last follow-up date 30/06/2024
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
Recruitment status Completed
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group monopolar at time of operation using monopolar energy only to do lymphadenectomy 30 Active-Treatment of Control Group
Experimental Group bipolar at time of operation using bipolar energy / ligasure to do lymphadenectomy 45
Experimental Group clips at time of operation using only clips for lymphatics ligation during lymphadenectomy 45
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult male patients with bladder tumor eligible for radical cystectomy with pelvic lymph node according to EAU 2022 bladder cancer guidelines Female patients patients undergoing salvage cystectomy Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 75 Year(s) Male
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 17/11/2022 ETHICS COMMITTEE FACULTY OF MEDICINE ALEXANDRIA UNIVERSITY
Ethics Committee Address
Street address City Postal code Country
Alexandria Faculty of Medicine alex 21517 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ● The Time required for the pelvic lymph node dissection during surgery
Primary Outcome ● Any intraoperative events especially blood vessel, nerve or ureteric injuries during surgery
Primary Outcome ● Drain output and duration 5 days after surgery
Primary Outcome ● Lower limb status to record any incidence of vascular compromise or lymphedema early post operative days
Secondary Outcome pelvic fluid collection and lymphocele formation. 4-8 weeks post operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria university faculty of medicine 01 champlion street Alexandria 21617 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alexandria university faculty of medicine 01 champlion st alexandria 21517 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria university 01 champlion st Alexandria 21517 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud ElSabbagh mahmoudelsabagh93@gmail.com 00201116177511 01 champlion St
City Postal code Country Position/Affiliation
Alexandria Egypt university teaching Staff member
Role Name Email Phone Street address
Public Enquiries Mahmoud Elsabbagh mahmoudelsabagh93@gmail.com 00201116177511 01 champlion st
City Postal code Country Position/Affiliation
Alexandia Egypt university teaching Staff member
Role Name Email Phone Street address
Scientific Enquiries Mahmoud Elsabbagh mahmoudelsabagh93@gmail.com 00201116177511 01 champlion St
City Postal code Country Position/Affiliation
Alexandria Egypt university teaching staff member
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data that underlie the results reported are available after deidentification Clinical Study Report,Study Protocol starting 3 months after publication until 36 months after data can be shared to researchers who provide a methodologically sound proposal, all analysis can be done as long to aims to achieve the approved proposal, all inquiries can be sent to m_elsabbagh12@alexmed.edu.eg
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 02/04/2026
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 02/04/2026
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 24/04/2026 adding objective of the study Radical cystectomy with pelvic lymphadenectomy and urinary diversion is considered to be the gold standard for treatment of non-metastatic muscle-invasive and high-risk non-muscle-invasive bladder cancer. We adopt open extraperitoneal approach. However, it led to the emergence of lymphatic complications. There is so little in the literature about the most favorable method for lymphatics ligation that’s why we decided to design this study. this study compares between monopolar, bipolar and clips in lymphatics ligation during extraperitoneal radical cystectomy Radical cystectomy with pelvic lymphadenectomy and urinary diversion is considered to be the gold standard for treatment of non-metastatic muscle-invasive and high-risk non-muscle-invasive bladder cancer. We adopt open extraperitoneal approach. However, it led to the emergence of lymphatic complications. There is so little in the literature about the most favorable method for lymphatics ligation that’s why we decided to design this study. this study compares between monopolar, bipolar and clips in lymphatics ligation during extraperitoneal radical cystectomy . the objective of our study is to find the most effective method of lymphatic ligation with the least complications
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 14/04/2026 PACTR Admin 01 Jun 2022
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 14/04/2026 PACTR Admin 30 Jun 2024