| CTRI Number |
CTRI/2023/07/055905 [Registered on: 31/07/2023] Trial Registered Prospectively |
| Last Modified On: |
28/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A scientific study comparing the outcomes of circumcision (surgery to remove foreskin) done using stitches with circumcision done with stapler in patients with tight foreskin |
|
Scientific Title of Study
|
A prospective randomized study comparing the outcomes of stapler circumcision with conventional circumcision in adults with phimosis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Karthik Subramanian |
| Designation |
Urology Resident |
| Affiliation |
ASIAN INSTITUTE OF NEPHROLOGY AND UROLOGY |
| Address |
Room number 4,
Department of urology,
Asian Institute Of Nephrology and urology,
No.6-3-562/A,
Behind More Megastore,
Erramanzil Colony , Somajiguda,
Hyderabad
TELANGANA
500082
India |
| Phone |
9003333060 |
| Fax |
|
| Email |
karthik1989s@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Bhavatej Enganti |
| Designation |
Consultant Urologist |
| Affiliation |
ASIAN INSTITUTE OF NEPHROLOGY AND UROLOGY |
| Address |
Room number 4,
Department of urology,
Asian Institute Of Nephrology and Urology,
No.6-3-562/A,
Behind More Megastore,
Erramanzil Colony , Somajiguda,
Hyderabad
TELANGANA
500082
India |
| Phone |
9652342642 |
| Fax |
|
| Email |
bhavatej@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Karthik Subramanian |
| Designation |
Urology Resident |
| Affiliation |
ASIAN INSTITUTE OF NEPHROLOGY AND UROLOGY |
| Address |
Room number 4,
Department of urology,
Asian Institute of Nephrology and Urology,
No.6-3-562/A,
Behind More Megastore,
Erramanzil Colony,
Somajiguda,
Hyderabad
TELANGANA
500082
India |
| Phone |
9003333060 |
| Fax |
|
| Email |
karthik1989s@gmail.com |
|
|
Source of Monetary or Material Support
|
| Asian Institute of nephrology and urology,
No.6-3-562/A,
Behind More Megastore,
Erramanzil Colony,
Somajiguda,
Hyderabad,
Telangana 500082 |
|
|
Primary Sponsor
|
| Name |
Asian Institute of nephrology and urology |
| Address |
6-3-562/A, Behind More Megastore,
Erramanzil Colony , Somajiguda, Hyderabad, Telangana 500082 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Karthik |
ASIAN INSTITUTE OF NEPHROLOGY AND UROLOGY |
Room no.4,
Department of urology
No.6-3-562/A, Behind More Megastore,
Erramanzil Colony , Somajiguda,
Hyderabad
TELANGANA |
9003333060
karthik1989s@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AINU ( ASIAN INSTITUTE OF NEPHROLOGY AND UROLOGY) ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N476||Balanoposthitis, (2) ICD-10 Condition: N471||Phimosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONVENTIONAL CIRCUMCISION |
Parts will be painted and draped. Anaesthesia will be given. Sleeve resection technique will be used. Inner and outer circum-coronal incision will be given. Excision of skin by sleeve resection. Hemostasis will be achieved. Re-approximation with absorbable sutures. Sterile compressive dressing will be applied.
|
| Intervention |
Stapler circumcision |
Measurement will be done preoperatively and appropriate size of stapler will be taken. Following anesthesia small dorsal slit will be given if needed. Frenuloplasty will be done if needed. Glans Bell will be applied and then stapling device will be attached. Staplers will be fired and held for 3 minutes and then stapling device will be removed along with the foreskin. Sterile compressive dressing will be applied. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
All patients with phimosis,
Balanophosthitis,
Acrophosthion
|
|
| ExclusionCriteria |
| Details |
Hypospadias,
Balanophosthitis with dense preputial adhesions,
Paraphimosis,
Circumcision done along with any other surgery,
Balanitis xerotica obliterans,
Carcinoma penis,
Previous penile surgery. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the safety and efficacy of the two techniques of circumcision |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cosmetic outcome |
3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Phimosis is a condition in
which patient cannot retract the foreskin of penis. Circumcision is a surgery in which foreskin is removed. Circumcision is the
treatment of choice for phimosis. We are going to conduct study comparing the outcomes of
stapler circumcision with conventional circumcision. We are going to evaluate safety,
efficacy and cosmetic outcomes. |