Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06366984
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2024-04-08
Brief Title:
Outcome of Plastibell Circumcision Versus Open Method Circumcision
Sponsor:
Children Hospital and Institute of Child Health Lahore
Organization:
Children Hospital and Institute of Child Health Lahore
Study Overview
Official Title:
Comparison of Outcome of Plastibell Circumcision Method With Open Surgical Technique in Infants Presenting at Tertiary Care Hospital
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Childrens 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 daysThe data regarding age weight duration of procedure wound infection and post circumcision bleeding was recorded in a predesigned performa As per operational definition
Methods This randomized controlled trial NCT was conducted at Pediatric surgery department the Childrens 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 daysThe 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 Childrens 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 daysThe 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 ie bleeding and wound infection were compared between both groups by using Chi-square test P-value 005 was considered significant
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 Childrens 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 daysThe 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 ie bleeding and wound infection were compared between both groups by using Chi-square test P-value 005 was considered significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None