| CTRI Number |
CTRI/2024/12/077693 [Registered on: 05/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of new and old technique of circumcision |
|
Scientific Title of Study
|
Comparison between outcomes of the conventional dorsal slit technique vs the sleeve technique for circumcision-A Randomised Control Trial. |
| 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 Prashant Taneja |
| Designation |
Post graduate Student |
| Affiliation |
Datta Meghe Institue of Higher Education and Reseach |
| Address |
Department of Surgery 4th Floor SMSC Building AVBRH Campus Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9461986290 |
| Fax |
|
| Email |
tanejaprashant60@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Darshana totte |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institue of Higher Education and Reseach |
| Address |
Department of Surgery 4th Floor SMSC Building AVBRH Campus Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9923129974 |
| Fax |
|
| Email |
drtotedarshana@gmai.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Darshana totte |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institue of Higher Education and Reseach |
| Address |
Department of Surgery 4th Floor SMSC Building AVBRH Campus Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9923129974 |
| Fax |
|
| Email |
drtotedarshana@gmai.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institue of Higher Education and Research Wardha India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institue of Higher Education and Research |
| Address |
Sawangi Meghe Wardha 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Prashant Taneja |
Datta Meghe Institue of Higher Education and Research |
Department of Surgery 4th Floor SMSC Building AVBRH Campus Sawangi Meghe Wardha 442001
Wardha
MAHARASHTRA |
9461986290
tanejaprashant60@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institue of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dorsal Slit Technique |
Patient Wil be Treated by Dorsal Slit Technique |
| Intervention |
Sleeve Technique |
Cases of Phimosis will be treated Sleeve Technique |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
1.All patient posted for circumcision for various medical indication.
2.Patient undergoing circumcisionfor religious purpose by this technique.
|
|
| ExclusionCriteria |
| Details |
1.Carcinoma penis.
2.hypospadiasis
3.Bleeding disorders.
4.Patient not willing to participate in study
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| outcomes of both techniques will be compared for operative time, introperative bleeding ,post operative pain ,requirement of analgesia ,post operative infection. |
assessment will be done at 1 week , 2 weeks and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2025 |
| Date of Study Completion (India) |
03/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
03/03/2026 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Circumcision is a widely performed surgical procedure with significant cultural, religious, and medical implications. This study aims to compare the effectiveness of two common circumcision techniques: the conventional dorsal slit technique and the sleeve technique, in terms of operative time, intraoperative bleeding, postoperative pain, requirement of analgesia, and postoperative infection. This prospective randomized interventional study will be conducted at JN Medical College, Datta Meghe Institute of Medical Sciences, from October 2023 to August 2025. Fifty-two patients scheduled for circumcision for various medical or religious reasons will be randomly assigned into two groups using sealed envelopes. The outcomes will be evaluated at 1, 2, and 6 weeks postoperatively. The study will provide a comprehensive assessment of the relative merits and drawbacks of each technique by systematically evaluating various parameters such as operative time, postoperative pain, and postoperative infection. The findings of this study will help in guiding surgeons to select the most appropriate circumcision technique based on patient outcomes, potentially influencing clinical practice and patient care standards.
|