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.: PACTR202508509050861 Date of Registration: 04/08/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Can Specialized Nutrition management Reduce Complications After Gastrointestinal Cancer Surgery? A Study in Hospital Patients
Official scientific title Effect of Immunonutrition on Postoperative Complications in Patients Undergoing Gastrointestinal Cancer Surgery: A randomized controlled trial
Brief summary describing the background and objectives of the trial The impact of immunonutrition on survival and the overall importance of nutritional support in cancer patients undergoing surgery remain subjects of debate. This study is the first one in Tunisia aimed to investigate how preoperative and postoperative immunonutrition influence the morbidity ,the mortality and the incidence of postoperative complications in patients undergoing cancer surgery
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 30/04/2023
Actual trial start date 30/04/2023
Anticipated date of last follow up 31/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 35
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 Non-randomised Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group supplemented group 7 days before surgery and 7 days after surgery The supplemented group received one sachet of Argi+ and three tablets of Omévie Omega-3 daily, administered 5 to 7 days before and 5 to 7 days after surgery. 18
Control Group control they undergo surgery without any supplementation there is no intervention for this group 17 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Eligible participants included adults aged 19 to 65 years who were in generally good health and scheduled for elective GI cancer resections Patients were excluded if they had a history of GI surgery or conditions affecting nutrient absorption; hepatic failure reflected by abnormal prothrombin time; renal impairment with creatinine clearance below 60 mL/min; thyroid disorders; ongoing use of omega-3 supplements or other oral nutritional products; cognitive deficits interfering with adherence; severe systemic infection; emergency surgical procedures; inability to tolerate oral intake after surgery; or if they discontinued the study supplements Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 65 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 04/04/2023 national intitute of nutrition
Ethics Committee Address
Street address City Postal code Country
11 rue jbal lakhdhar tunis 1007 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative complications were classified according to the Clavien-Dindo grading system immediatly after surgery and at 30 days after surgery post intervention
Secondary Outcome body weight measurements post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
the Salah Azaiez Institute in Tunisia 11 boulevard 9 avril tunis 1006 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
rym ben othman 11 rue jbal lakhdhar tunis Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor none none tunis Tunisia none
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator rym ben othman benothmanr@gmail.com +21699907402 11 rue jbal lakhdhar
City Postal code Country Position/Affiliation
tunis Tunisia institut national de nutrition et de technologie alimentaire de tunis
Role Name Email Phone Street address
Scientific Enquiries saida sakhri saida.sakhri@fmt.utm.tn 0021694119862 13 boulevard 9 avril
City Postal code Country Position/Affiliation
tunis Tunisia institut salah azaiez de tunis
Role Name Email Phone Street address
Public Enquiries henda jamoussi hendajamoussi@gmail.com +21652262806 11 rue jbal lakhdhar
City Postal code Country Position/Affiliation
tunis Tunisia institut national de nutrition et de technologie alimentaire de tunis
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participant data (IPD) that will be shared include anonymized data collected during the trial, such as demographic information, baseline characteristics, intervention details, and primary and secondary outcome measures. Informed Consent Form 2 years the access will be controlled by principal investigator upon resonnable request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
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 Actual trial start date 04/08/2025 PACTR Admin 30 Apr 2023
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 01/08/2025 we thicked 65 case Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s) Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 01/08/2025 sorry for the mistake Primary Outcome, postoperative complications were classified according to the Clavien-Dindo grading system immediatly after surgery and at 30 days after surgery , 1 month Primary Outcome, postoperative complications were classified according to the Clavien-Dindo grading system immediatly after surgery and at 30 days after surgery , post intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 01/08/2025 outcomes will be seen after the intervention Secondary Outcome, body weight measurements, 1 month Secondary Outcome, body weight measurements, post intervention
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 01/08/2025 the study is self funded none, none, none, , Tunisia, , principal investigator rym ben othman, 11 rue jbal lakhdhar, tunis, , Tunisia, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 04/08/2025 PACTR Admin principal investigator rym ben othman, 11 rue jbal lakhdhar, tunis, , Tunisia, Self Funded, rym ben othman, 11 rue jbal lakhdhar, tunis, , Tunisia, Self Funded,