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.: PACTR201809543305111 Date of Approval: 27/09/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title One key to fit all locks: routine internal drainage during thigh lift surgeries to minimize seroma
Official scientific title Fascial excision to reduce seroma during thigh lift surgery
Brief summary describing the background and objectives of the trial Body contouring surgeries are followed by seromas in 15%-40% of cases. Exact mechanism of formation is not well understood, and attempts at reducing their rates have been successful. We thought of extending the Thomson principle that treats lymphedema by excising deep fascia to seromas. This way we would allow the deep lymphatics and muscles to absorb seromas after body contouring surgeries. Objectives : Compare incidence of seromas in limbs with fascial excision and those without fascia! excision. Twenty patients undergoing thigh lift after massive weight loss will have fascial excision on one side , and the other will be left as a control. Rates of seroma formation will be compared
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 06/09/2016
Actual trial start date 24/09/2016
Anticipated date of last follow up 23/12/2018
Actual Last follow-up date 30/12/2018
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 20
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table from a statistics book Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Fascial excision During surgery Once Excision of deep fascia 20
Control Group No fascial Excision Once During surgery Classic thigh lift without fascial excision 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Massive Weight Loss Patients Previous Bariatric Surgery Previous body contouring surgery Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 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 13/07/2016 Cairo University Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Manial Cairo 11211 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Seroma formation 1 week, and every week for 3 month after the surgery
Secondary Outcome Volume of Seroma and Time needed to resolve totally Every week for 3 months after the surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Hospitals Manial Cairo 11211 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Prof Adel Wilson 42 Dokki Street Cairo 11211 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Manial Cairo 11211 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adel Shatby dr_adel_wilson@yahoo.com +201222144209 42 Dokki St
City Postal code Country Position/Affiliation
Cairo 12311 Egypt Professor of Plastic Surgery Cairo University
Role Name Email Phone Street address
Scientific Enquiries Sarah Raafat sarahraafat@yahoo.com +201221575511 23 Nile Street
City Postal code Country Position/Affiliation
Cairo Egypt Clinical Fellow cairo University
Role Name Email Phone Street address
Public Enquiries Aya Ismail ayaismail1982@gmail.com +201211157225 42 Dokki St
City Postal code Country Position/Affiliation
Cairo 12311 Egypt Secretary Cairo Plastic Clinic
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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