To compare the complications and outcomes of primary definitive surgery versus definitive surgery after a diverting colostomy for management of anorectal malformations in females

Primary definitive procedure versus conventional three-staged procedure for management of low anorectal malformations in females : A randomized controlled trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/04/003552

Enrollment

Registered

2013-04-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- LOW ANORECTAL MALFORMATIONS

Interventions

Intervention1: PRIMARY DEFINITIVE SURGERY: SINGLE STAGE PRIMARY SURGERY FOR THE ANORECTAL MALFORMATION WITHOUT A DIVERTING COLOSTOMY Control Intervention1: THREE-STAGED PROCEDURE: DIVERTING COLOSTOMY

Eligibility

Inclusion criteria

Inclusion criteria: Female patients with LARM in which the LARM could be in the form of Rectovestibular fistula(RVF)/ Anovestibular fistula (AVF)/ Vestibular anus (VA) / Anterior ectopic anus (AEA)

Exclusion criteria

Exclusion criteria: 1.Any previous attempted definitive surgery for the LARM. 2.Any local perineal abnormality like absent vagina,perineal mass,Currarino triad which precludes the performance of primary definitive procedure 3.Refused parental consent to participate in the study.

Design outcomes

Primary

Measure	Time frame
incidence of wound dehiscenceTimepoint: 0-7 days	—

Secondary

Measure	Time frame
1.no.of days of patient kept nil per orally after the definitive procedure 2.incidence of immediate post operative complications like fever/bleeding/wound erythema/pus discharge 3.incidence of early post operative complications like mucosal prolapse/stenosis/ recurrence/retraction 4.incidence of various complications in relation to the age of the child at the time of definitive surgery and the type of anomaly of LARM.Timepoint: 0-3 months	—

Measure

Time frame

1.no.of days of patient kept nil per orally after the definitive procedure 2.incidence of immediate post operative complications like fever/bleeding/wound erythema/pus discharge 3.incidence of early post operative complications like mucosal prolapse/stenosis/ recurrence/retraction 4.incidence of various complications in relation to the age of the child at the time of definitive surgery and the type of anomaly of LARM.Timepoint: 0-3 months

—

Countries

India

Contacts

Public ContactDr Sandeep Agarwala

AIIMS

sandpagr@hotmail.com01126593309

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026