Outcome of Plastibell Circumcision Versus Open Method Circumcision

NCT06366984 | Completed

• 1 other identifier: Adeel4
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the outcomes of plastibell circumcision method with open surgical technique in infants presenting at tertiary care hospital. Methods This randomized controlled trial (NCT??) was conducted at Pediatric surgery department, the Children's hospital and the University of Child health, Lahore. Study was carried out over a period of six months from 11-01-2022 to 11-07-2022. Non probability, purposive sampling was used. 174 infants presenting for circumcision were admitted and assigned a method of circumcision randomly. They were randomly divided in to 2 groups by using opaque sealed envelope technique. Infants in group A were underwent plastibell circumcision while infants in group B were underwent open technique circumcision. 87 circumcisions were performed by each method. The informed consent was taken from parents for inclusion into the study. All infants were underwent circumcision under local anesthesia as per assigned method. Same preoperative, per-operative, and postoperative care was given to each regardless of the technique. These patients were followed for 3 hours to assess bleeding as per operational definition. Then followed on an outpatient basis every 6th day until complete healing is achieved (30 days).The data regarding age, weight, duration of procedure, wound infection and post circumcision bleeding was recorded in a predesigned performa. (As per operational definition).

Conditions

Bleeding; Site Infection

Keywords

Circumcision,; Infection; Bleeding,; Plastibell,

Outcome Measures

Primary Outcomes (1)

• infection

  incidence of surgical site infection according to southampton score

  30 days

Study Arms (2)

Plastibell group

EXPERIMENTAL

plastibell method applied for circumcision

Other: plastibell

open method circumcision

EXPERIMENTAL

open method of circumcision applied

Other: open method

Interventions

plastibell OTHER

plastibell used for circumcision

Plastibell group

open method OTHER

open method used for circumcision

open method circumcision

Eligibility Criteria

• Age: 1 Day - 12 Months
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• all uncircumcised male

You may not qualify if:

• hypospadias, syndromic children

Sponsors & Collaborators

• Children Hospital and Institute of Child Health, Lahore: lead

Study Sites (1)

The Children Hospital

Lahore, Punjab Province, 42000, Pakistan

Location

MeSH Terms

Conditions

Hemorrhage; Infections

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Muhammad A Ashiq, M.S

  The Children hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: outcome assessor is unaware of group allocated
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controll trial

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 16, 2024
• Study Start: January 11, 2022
• Primary Completion: July 11, 2022
• Study Completion: August 11, 2022
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)