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.: PACTR202407845732769 Date of Approval: 29/07/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Intact Perineal Body Technique, A Modification of the Posterior Sagittal Anorectoplasty for Anorectal Malformations with Rectovestibular Fistulae In Female children: A Prospective Clinical Trial
Official scientific title Intact Perineal Body Technique, A Modification of the Posterior Sagittal Anorectoplasty for Anorectal Malformations with Rectovestibular Fistulae In Female children
Brief summary describing the background and objectives of the trial The most common technique for the surgical correction of imperforate anus with vestibular fistula is the posterior sagittal anorectoplasty (PSARP) approach. However, perineal body dehiscence is the most common complication associated with this procedure which can have significant implications for long-term functional outcomes. Our study aims to evaluate a modification in the PSARP technique by limiting the incision to the anoplasty area and leaving the perineal body intact.
Type of trial Non-Randomised
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 01/01/2023
Actual trial start date 01/03/2023
Anticipated date of last follow up 29/02/2024
Actual Last follow-up date 31/03/2024
Anticipated target sample size (number of participants) 12
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
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 Intact Perineal Body Technique The duration of the operation Modifying the traditional posterior sagittal anorectoplasty technique by limiting the incision to the anoplasty area during the surgical correction of imperforate anus with vestibular fistula n female patients. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1 - Female patients referred to our department and diagnosed with imperforate anus with rectovestibular fistula. 2- Age from one day to 14 years old. 1 - Patients with major cardiac, neurological, syndromatic, or skeletal anomalies. 2- Patients with other types of anorectal malformations. 3- Patients with a history of other anorectal surgeries. 4- Patients with recurrent rectovestibular fistula. 5- Patients age > 14 years old. 6- Immunocompromised patients. Child: 6 Year-12 Year,Infant: 0 Month-23 Month,Infant: 1 Month-23 Month,New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 1 Day(s) 14 Year(s) Female
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 02/03/2023 Faculty of Medicine Minia University
Ethics Committee Address
Street address City Postal code Country
Minia University Egypt Minia 61519 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Operative time (mins) intraoperative
Primary Outcome Intraoperative complications (Blood loss, Urethral injury, Vaginal injury, and Difficulty in identifying and separating the vagina from the rectum). Intraoperative
Primary Outcome The number of cases converted to traditional PSARP. Intraoperative
Primary Outcome Mean follow up time (months) Postoperative
Primary Outcome Postoperative complications (Wound infection, Wound Dehiscence, Anal stenosis, Anal stricture, Rectal mucosal prolapse, Mislocated anus, Constipation, Remnant of the original fistula, and Recurrent fistula) Postoperative
Primary Outcome Duration of hospital stay (days) Postoperative
Secondary Outcome Cosmosis Score: According to The scar cosmosis assessment and rating scale Postoperative at the end of follow-up
Secondary Outcome Continence score for patients > 3 years old: According to "The international Kickenbeck continence classification Postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Pediatric Surgery Department Minia University Hospital Minia Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
No Funding Not applicable Not applicable Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Minia University Hospital Agricultural road, Minia University Minia Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Kamal Sayed A.Kamal@s-mu.edu.eg +201025979232 6 mahmoud khalefa Street, Mallawi city, Minia
City Postal code Country Position/Affiliation
Minia Egypt Assistant lecturer of Pediatric Surgery Minia University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Fathy Mohamed.fathy@minia.edu.eg +201006350884 Taha hussin Street
City Postal code Country Position/Affiliation
Minia Egypt Head of Pediatric Surgery Department Minia University
Role Name Email Phone Street address
Public Enquiries Ahmed Hossney Ahmed Lmasmaasr2017@gmail.com +201001378209 Abufleo region
City Postal code Country Position/Affiliation
Minia Egypt Lecturer of Pediatric Surgery Minia University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available (including data dictionaries). Individual participant data underlying the results reported in this article after deidentification (text, tables, figures, and appendices) will be available. Study Protocol will be available. Data will be available beginning 3 months and ending 5 years following article publication. Data will be available for researchers who provide a methodologically sound proposal to achieve the aims in the approved proposal. Data will be made available by a Proposal directed to A.Kamal@s-mu.edu.eg to gain access. Statistical Analysis Plan,Study Protocol Data will be available beginning 3 months and ending 5 years following article publication. The study protocol is available. Data will be available for researchers who provide a methodologically sound proposal to achieve the aims in the approved proposal. Data will be made available by a Proposal directed to A.Kamal@s-mu.edu.eg to gain access.
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