Outcome of Plastibell Circumcision Versus Open Method Circumcision

Bleeding Clinical Trial

Official title:

Comparison of Outcome of Plastibell Circumcision Method With Open Surgical Technique in Infants Presenting at Tertiary Care Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06366984
• Other study ID #: Adeel4
• Status: Completed
• Phase: N/A
• Start date: January 11, 2022
• Est. completion date: August 11, 2022

Study information

• Verified date: April 2024
• Source: Children Hospital and Institute of Child Health, Lahore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: August 11, 2022
• Est. primary completion date: July 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 1 Day to 12 Months

Eligibility

Inclusion Criteria:

• all uncircumcised male

Exclusion Criteria:

• hypospadias, syndromic children

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage
• Site Infection

Intervention

Other:
• plastibell
plastibell used for circumcision
• open method
open method used for circumcision

Locations

Country	Name	City	State
Pakistan	The Children Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Children Hospital and Institute of Child Health, Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	infection	incidence of surgical site infection according to southampton score	30 days