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Comparison of anterior and posterior approach for correction of abnormal anal opening in vestibule

COMPARISON OF OUTCOME OF ASARP VERSUS PSARP IN REPAIR OF RECTOVESTIBULAR FISTULA; A RANDOMISED CONTROL TRIAL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250313005
Enrollment
60
Registered
2025-03-13
Start date
2023-01-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorectal malformations are birth deformities in which the anus is absent or deformed. It affects both males and females and has a prevalence of one in 5000 live births. ARM is a combination of disorders, including simple issues like anal stenosis and fistulas in the perineum, which are grouped as low variety malformations, to very complex anomalies, which include persistent cloaca and recto-vesical fistulas, which require multistage procedures for correction. Recto vestibular fistula is the mos

Interventions

To keep the intestine as empty as possible, the patient is kept on a liquid or low-residue diet for one week prior to surgery. The lithotomy position of the patient is made before the operation begins
s reaction, indicating the direction in which muscle fibers flow. The superficial external sphincter muscle first becomes visible. Then a deep portion of the external sphincter showed up. This deep sp
Active Comparator Procedure/Surgery,Active Comparator Procedure/Surgery
Anterior sagittal anorectoplasty,Posterior sagittal anorectoplasty

Sponsors

Self
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
6 Months to 14 Years

Inclusion criteria

Inclusion criteria: 1. All-female patients with rectovestibular fistula, aged between 6 months and 14 years 2. Weight 5 kg and above 3. Confirmed diagnosis of rectovestibular fistula 4. All patients with rectovestibular fistula having colostomy formed previously for staged repair.

Exclusion criteria

Exclusion criteria: 1. Anovestibular fistulas will be excluded 2. Associated major congenital anomalies, including Impeforate anus without fistula, absent vaginal opening, urogenital sinus (common cloaca) 3. Poor general conditions, like malnutrition and anemia 4. A previous trial of repair elsewere 5. Lost to follow up 6. Change in the treatment plan 7. Expiry before surgery due to some other disease

Design outcomes

Primary

MeasureTime frame
Procedural injuries including vaginal wall tear and rectal wall injury At the time of operation Injury of any size,Anal Stenosis 2 weeks after operation Dilator size,Mucosal Prolapse After operation Visual assessment,Sphincter contractions all around After Operation TENS- visual method

Secondary

MeasureTime frame
Operative time From start of 1st incision Analogue timer,Wound Infection After operation SSI

Countries

Pakistan

Contacts

Public ContactHassan Mahmud

University of Child Health Sciences, Lahore

drhassanmahmudpsurgeon@gmail.com00923338415699

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026