Outcome of Plastibell Circumcision Versus Open Method Circumcision

NCT ID: NCT06366984

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-11
• Study Completion Date: 2022-08-11

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).

Detailed Description

Circumcision is a surgical method in which surgical removal of the prepuce (foreskin) is done. Religious, cultural, medical, and common public health reasons are known to be the major indications for this procedure. It is usually done in neonatal age but can also be performed at any age. The WHO has begun to recommend circumcision on the basis of studies indicating its positive effects on human health and especially its role in protection from AIDS. As with adult circumcision, neonatal circumcision may be helpful to reduce the risk of acquiring HIV infection, phimosis and paraphimosis in future adult life. Though Circumcision is one of the commonest procedures in the surgery, still a gold standard approach is not defined. In Pakistan most circumcisions are done in neonatal or infant life, or circumcised in the adult age group. It is a relatively simple procedure with healing time up to 2 weeks.

There are many advantages of male circumcision at younger age than older, which include lower risk of complications, lower cost, and faster healing. Different techniques are being in practice like Plastibell method, Mogen Clamp, bone cutter technique and Free-hand open surgical method.

This randomized control trial was conducted at Pediatric Surgery Department, The Children's Hospital and University of Child Health Sciences, Lahore from 11-01-2022 to 11-07-2022. After approval from the ethical review committee of the hospital, all infants came for circumcision were included except those who need redo circumcision or have Inadequate clinical record or have hypospadias or who are syndromic children.

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).

The data was entered in SPSS version 23 and analyzed through it. Means and SD was calculated for quantitative variables like age, weight and operation time. Frequency and percentage was calculated for qualitative variables like bleeding and wound infection. Outcomes i.e bleeding and wound infection were compared between both groups by using Chi-square test. P-value ≤ 0.05 was considered significant.

Conditions

Bleeding; Site Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Plastibell group

plastibell method applied for circumcision

Group Type: EXPERIMENTAL

plastibell

Intervention Type: OTHER

plastibell used for circumcision

open method circumcision

open method of circumcision applied

Group Type: EXPERIMENTAL

open method

Intervention Type: OTHER

open method used for circumcision

Interventions

plastibell

plastibell used for circumcision

Intervention Type: OTHER

open method

open method used for circumcision

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• all uncircumcised male

Exclusion Criteria

• hypospadias, syndromic children

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 12 Months
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Children Hospital and Institute of Child Health, Lahore

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Adeel Ashiq

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muhammad A Ashiq, M.S

Role: PRINCIPAL_INVESTIGATOR

The Children hospital

Locations

The Children Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

Adeel4

Identifier Type: -

Identifier Source: org_study_id