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.: PACTR202312729770861 Date of Approval: 22/12/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Conservative surgery of liver hydatid cysts using a standardized technique
Official scientific title Standardization of the conservative surgery of hepatic cystic echinococcosis: A prospective study
Brief summary describing the background and objectives of the trial The conservative treatment of hepatic hydatid cysts carries a non-negligible risk of recurrence and significant morbidity, dominated by Deep Surgical Site Infections (DSSI). Through this study, we aim to improve the surgical technique through a standardization of the technique, in order to reduce complications and achieve better postoperative outcomes.
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Infections and Infestations,Surgery
Sub-Disease(s) or condition(s) being studied Cystic echinococcosis of the liver
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/07/2017
Actual trial start date 01/07/2017
Anticipated date of last follow up 30/11/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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
Single Group Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Standardized technique from 2017 to 2024 In addition to deroofing of the liver cyst, participants included will undergo a cholecystectomy with methylene blue test to look for cystobiliary fistulas. Liver mobilization for cysts of the dome, omentoplasty and intraoperative ultrasound are techniques already used in conventional surgery. 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
all patients who were operated for liver hydatid cysts in an emergent or elective setting. Patients who had cysts complicated with a large cystobiliary fistula revealed by acute cholangitis or acute pancreatitis Presence of cystic debris in the common bile duct on preoperative imaging Patients operated with the radical method such as liver resections. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 16 Year(s) 99 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 06/05/2017 Committee for the Protection of Persons C.P.P.SUD
Ethics Committee Address
Street address City Postal code Country
Rue Firdaous Sfax 3029 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Deep Surgical Site Infections (DSSI) At the end of the study
Secondary Outcome overall morbidity, mortality, and disease recurrence at the end of the study and during follow-up to detect disease recurrence
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Habib Bourguiba University Hospital Sfax Tunisia Rue Firdaous, 3029 Sfax, Tunisia Sfax 3029 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
None Rue Firdaous, Sfax Sfax Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Aymen Trigui Department of General Surgery, Habib Bourguiba University Hospital, Sfax Sfax 3029 Tunisia Individual
Secondary Sponsor Salah Boujelben Rue Firdaous Sfax 3029 Tunisia Individual
COLLABORATORS
Name Street address City Postal code Country
Saumtally Mohammad Saad Department of General Surgery, Habib Bourguiba University Hospital, Sfax Sfax Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aymen Trigui ayman.trigui@gmail.com +21650435438 Rue Firdaous
City Postal code Country Position/Affiliation
Sfax 3029 Tunisia Associate Professor in Digestive and General Surgery Habib Bourguiba Hospital University of Sfax
Role Name Email Phone Street address
Public Enquiries Amira Akrout amiraak659@gmail.com +21624574825 Rue Firdaous, 3029 Sfax
City Postal code Country Position/Affiliation
Sfax 3029 Tunisia Senior Registrar at Habib Bourguiba University Hospital
Role Name Email Phone Street address
Scientific Enquiries Mohammad Saad Saumtally saad09@live.com +21652229879 Rue Firdaous
City Postal code Country Position/Affiliation
Sfax 3029 Tunisia Doctor at Habib Bourguiba University Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data will be made available Individual participant data that underlie the results reported in this article, after deidentification, Beginning 9 months and ending 36 months following article publication. Data will be provided to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. Proposals should be directed to ayman.trigui@gmail.com. Informed Consent Form for 36 months after article publication The accessed to the data is controlled and requests should be directed to ayman.trigui@gmail.com.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 20/09/2024 26/06/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 20/09/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information