Prepuce; AccessoryNCT06766838
Outcomes Of The Different Techniques Of Male Circumcision
A study testing 1. Conventional dissection technique (group A) :, 2. Bone cutting forceps technique (Group B) and 3. Electro-cauterization (bipolar) assisted circumcision (Group C) in people with Prepuce; Accessory, run by Sohag University at 1 site in Egypt.
Trial summary
Aim of work: The aim of study is to comprehensively evaluate and compare the efficacy, safety, clinical outcomes, cosmetic appearance and complication rates associated with different technique of circumcisions. Read more about this study
- Who is it for?
- Ages Up to 5 years, men only
- Conditions the study is for
- Prepuce; Accessory
- What is being tested?
- 1. Conventional dissection technique (group A) :, 2. Bone cutting forceps technique (Group B) and 3. Electro-cauterization (bipolar) assisted circumcision (Group C)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- All uncircumcised boys with intact prepuce
- Age below 5 years presented at our department for routine circumcision or for medical indications.
Who cannot join
- Age above 5 years
- Ambiguous genitalia
- Congenital penile anomalies
- Redo-circumcision
- Balanitis or inflammatory process around the penis.
- Bleeding disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag
Mahmoud Bakr Ahmed, 021153259080, mbakr7725@gmail.com
About this study
Aim of work:
The aim of study is to comprehensively evaluate and compare the efficacy, safety, clinical outcomes, cosmetic appearance and complication rates associated with different technique of circumcisions.
Read the detailed description
The aim of study is to comprehensively evaluate and compare the efficacy, safety, clinical outcomes, cosmetic appearance and complication rates associated with different technique of circumcisions.
Patients and methods:
According to the method of circumcision used; infants were divided into 5 groups :
- Group A: Conventional dissection technique;
- Group B: Bone cutting ;
- Group C: Electro-cauterization (bipolar) assisted circumcision;
- Group D: Thermal cauterization assisted circumcision;
- Group E: Gomco clamp technique;
- Group F: Plastibell device technique. Place of the study: The study will be held in the department of Pediatric surgery at Sohag University Hospital.
Type of the study: Prospective comparative Cohort study. Duration of the study: The study lasts for 6 months from the acceptance of the protocol (december 2024) to (Jone 2025).
Inclusion criteria:
All uncircumcised boys with intact prepuce aged below 15 years presented at our department for routine circumcision or for medical indications.
Exclusion criteria:
- Age above 15 years
- Ambiguous genitalia
- Congenital penile anomalies e.g. hypospadias, epispadias, buried penis, webbed penis, micropenis, congenital chordee, incomplete prepuce and mega-urethra.
- Redo-circumcision
- Balanitis or inflammatory process around the penis.
- Bleeding disorders; hemophilia or thrombocytopenia
- Conditions
- Prepuce; Accessory
- Being tested
- 1. Conventional dissection technique (group A) :, 2. Bone cutting forceps technique (Group B), 3. Electro-cauterization (bipolar) assisted circumcision (Group C), 4. Thermal cauterization assisted circumcision (Group D), 5. Gomco clamp technique (Group E):
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1. Conventional dissection technique (group A) :Procedure or surgery
In this group, circumcision is performed by the dorsal slit technique. A slit is made dorsally to the level of about 5 mm from the coronal sulcus, and the redundant foreskin and mucosa were excised circumferentially. Hemostasis is secured with ligation , and the cut edges are sutured with absorbable suture. Then, dressing is applied.
2. Bone cutting forceps technique (Group B)Procedure or surgery
Two mosquito forceps are used to grasp the foreskin. The glans penis is squeezed back to avoid its injury. After that, bone cutting forceps is applied to the foreskin for 3 minutes, at the level of the mark, then the foreskin is excised by scalpel at the same level. Bleeding points are ligated and the cut edges are sutured with absorbable suture. Then, a dressing is applied
3. Electro-cauterization (bipolar) assisted circumcision (Group C)Procedure or surgery
The skin is held by two hemostats to elevate the foreskin, and then the kocher clamp applied at the level of the skin to be removed for circumcision. Excess foreskin will be cut by scissor with hemostasis by bipolar cauterization.
The skin retracted proximally after that to expose the glans. Sutures are made if there is separation between the skin and the mucous membrane.
4. Thermal cauterization assisted circumcision (Group D)Procedure or surgery
The skin is held by two hemostats to elevate the foreskin, and then the kocher clamp applied at the level of the skin to be removed for circumcision. Excess foreskin will be cut by thermal cauterization. The skin retracted proximally after that to expose the glans. Sutures are made if there is separation between the skin and the mucous membrane.
5. Gomco clamp technique (Group E):Procedure or surgery
The prepuce is grasped using two hemostats applied at 2 and 10 o'clock. A dorsal slit at 12 o'clock is made, appropriate-sized bell is placed over the glans, and the foreskin is brought over its top. The string is placed around the foreskin and the Plastibell device at the level of the mark in a groove that acted as the string placement guide. The string is then tightened and tied in a simple square knot. The excess foreskin is trimmed from around the bell using iris scissors. The handle is then broken off the device
6. Plastibell device technique (Group F):Procedure or surgery
The prepuce is grasped using two hemostats applied at 2 and 10 o'clock. A dorsal slit at 12 o'clock is made, appropriate-sized bell is placed over the glans, and the foreskin is brought over its top. The string is placed around the foreskin and the Plastibell device at the level of the mark in a groove that acted as the string placement guide. The string is then tightened and tied in a simple square knot. The excess foreskin is trimmed from around the bell using iris scissors. The handle is then broken off the device
| Study group | Role | What they receive |
|---|---|---|
| 1. Group A: Conventional dissection technique; | Active comparator | In this group, circumcision is performed by the dorsal slit technique. A slit is made dorsally to the level of about 5 mm from the coronal sulcus, and the redundant foreskin and mucosa were excised circumferentially. Hemostasis is secured with ligation , and the cut edges are sutured Receives: Procedure: 1. Conventional dissection technique (group A) : |
| 2. Group B: Bone cutting ; | Active comparator | Two mosquito forceps are used to grasp the foreskin. The glans penis is squeezed back to avoid its injury. After that, bone cutting forceps is applied to the foreskin for 3 minutes, at the level of the mark, then the foreskin is excised by scalpel at the same level. Bleeding points are ligated and the cut edges are sutured with absorbable suture Receives: Procedure: 2. Bone cutting forceps technique (Group B) |
| 3. Group C: Electro-cauterization (bipolar) assisted circumcision; | Active comparator | The skin is held by two hemostats to elevate the foreskin, and then the kocher clamp applied at the level of the skin to be removed for circumcision. Excess foreskin will be cut by scissor with hemostasis by bipolar cauterization. Receives: Procedure: 3. Electro-cauterization (bipolar) assisted circumcision (Group C) |
| 4. Group D: Thermal cauterization assisted circumcision; | Active comparator | The skin is held by two hemostats to elevate the foreskin, and then the kocher clamp applied at the level of the skin to be removed for circumcision. Excess foreskin will be cut by thermal cauterization. Receives: Procedure: 4. Thermal cauterization assisted circumcision (Group D) |
| 5. Group E: Gomco clamp technique; | Active comparator | The prepuce is grasped using two hemostats applied at 2 and 10 o'clock. A dorsal slit at 12 o'clock is made, and then the bell is applied gently to the glans. The base plate is placed over the metal bell. The foreskin then is protracted back over the bell with the clamps still attached. The foreskin is drawn evenly through the hole bilaterally using the ink mark as a guide. The clamp then is tightened and left in place for 5 minutes to squeeze the prepuce between the bell and the clamp to make it blood free before a circumferential incision is made. Receives: Procedure: 5. Gomco clamp technique (Group E): |
| 6. Group F: Plastibell device technique. | Active comparator | The prepuce is grasped using two hemostats applied at 2 and 10 o'clock. A dorsal slit at 12 o'clock is made, appropriate-sized bell is placed over the glans, and the foreskin is brought over its top. The string is placed around the foreskin and the Plastibell device at the level of the mark in a groove that acted as the string placement guide. The string is then tightened and tied in a simple square knot. The excess foreskin is trimmed from around the bell using iris scissors. Receives: Procedure: 6. Plastibell device technique (Group F): |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding
combine the number of dressing, Significant bleeding is considered if the dressing is completely soaked
Measured: 1 day
Secondary outcomes (1)
Cosmetic appearance
Score for parent and physician
- Excellent 3
- Good 2
- Poor 1
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start1 Dec 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prepuce; AccessoryStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Bakr Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766838
- Sponsor's protocol ID
- Soh-Med--24-12-02MS
- Status last verified
- Jan 2025
- First submitted
- 29 Dec 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
[1] Myers A, Earp B. What Is the Best Age to Circumcise? A Medical and Ethical Analysis. Bioethics. 2020;34:645-663. [2] Schneider, T., 2013. Ancient Egypt investigated: 101 important questions and intriguing answers. Bloomsbury Publishing. [3] Alanis MC, Lucidi RS. Neonatal circumcision: a review of the world's oldest and most controversial operation. Obstet Gynecol Surv 2004;59(5):379e95. [4] Abdulwahab-Ahmed, A. and Mungadi, I.A., 2013. Techniques of male circumcision. Journal of surgical technique and case report, 5(1), pp.1-7. [5] Deacon, M. and Muir, G., 2023. What is the medical evidence on non-therapeutic child circumcision?. International journal of impotence research, 35(3), pp.256-263. [6] Iacob, S.I., Feinn, R.S. and Sardi, L., 2022. Systematic review of complications arising from male circumcision. BJUI compass, 3(2), pp.99-123. [7] Prakash, K.P., 2019. Comparative Study of Frenulum Sparing Circumcision with Dorsal Slit-Sleeve Technique of Circumcision for Phimosis (Master's thesis, Rajiv Gandhi University of Health Sciences (India). [8] Prabhakaran S, Ljuhar D, Coleman R, Nataraja RM. Circumcision in the paediatric patient: a review of indications, technique and complications. J Paediatr Child Health. 2018;54(12):1299-307. [9] Zafar, G.M., Sajjad, M.N., Zaheer, M., Yousaf, M.H. and Javeed, M.N., 2024. Split Glans & Advancement Flap To Repair Penile Hair Tourniquet Injury In Children: A Challenging Problem Of Unknown Etiology. Pakistan Journal of Urology (PJU), 2(01), pp.82-87. [10] Wang X, Dong C, Beekoo D et al. (2019): Dorsal penile nerve block via perineal approach, an alternative to a caudal block for pediatric circumcision: a randomized controlled trial. BioMed Research International, 19:6875756. doi: 10.1155/2019/6875756. [11] Kamil M (2012): Bone cutter circumcision in neonates. AL-Kindy College Medical Journal, 8(1): 119-121. [12] Wan J (2002): Gomco circumcision clamp: an enduring and unexpected success. Urology, 59(5): 790- 794. [13] Morris B, Eley C (2011): Male circumcision: An appraisal of current instrumentation. Biomedical Engineering, University of Rijeka, Rijeka, Pp. 315-354. DOI: 10.5772/18543
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes Of The Different Techniques Of Male Circumcision
- ClinicalTrials.gov ID
- NCT06766838
- Acronym / sponsor ID
- Soh-Med--24-12-02MS
- Conditions
- Prepuce; Accessory
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of work:
The aim of study is to comprehensively evaluate and compare the efficacy, safety, clinical outcomes, cosmetic appearance and complication rates associated with different technique of circumcisions.
Detailed description
The aim of study is to comprehensively evaluate and compare the efficacy, safety, clinical outcomes, cosmetic appearance and complication rates associated with different technique of circumcisions.
Patients and methods:
According to the method of circumcision used; infants were divided into 5 groups :
- Group A: Conventional dissection technique;
- Group B: Bone cutting ;
- Group C: Electro-cauterization (bipolar) assisted circumcision;
- Group D: Thermal cauterization assisted circumcision;
- Group E: Gomco clamp technique;
- Group F: Plastibell device technique. Place of the study: The study will be held in the department of Pediatric surgery at Sohag University Hospital.
Type of the study: Prospective comparative Cohort study. Duration of the study: The study lasts for 6 months from the acceptance of the protocol (december 2024) to (Jone 2025).
Inclusion criteria:
All uncircumcised boys with intact prepuce aged below 15 years presented at our department for routine circumcision or for medical indications.
Exclusion criteria:
- Age above 15 years
- Ambiguous genitalia
- Congenital penile anomalies e.g. hypospadias, epispadias, buried penis, webbed penis, micropenis, congenital chordee, incomplete prepuce and mega-urethra.
- Redo-circumcision
- Balanitis or inflammatory process around the penis.
- Bleeding disorders; hemophilia or thrombocytopenia
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1. Group A: Conventional dissection technique; | Active comparator | Procedure: 1. Conventional dissection technique (group A) :In this group, circumcision is performed by the dorsal slit technique. A slit is made dorsally to the level of about 5 mm from the coronal sulcus, and the redundant foreskin and mucosa were excised circumferentially. Hemostasis is secured with ligation , and the cut edges are sutured |
| 2. Group B: Bone cutting ; | Active comparator | Procedure: 2. Bone cutting forceps technique (Group B)Two mosquito forceps are used to grasp the foreskin. The glans penis is squeezed back to avoid its injury. After that, bone cutting forceps is applied to the foreskin for 3 minutes, at the level of the mark, then the foreskin is excised by scalpel at the same level. Bleeding points are ligated and the cut edges are sutured with absorbable suture |
| 3. Group C: Electro-cauterization (bipolar) assisted circumcision; | Active comparator | Procedure: 3. Electro-cauterization (bipolar) assisted circumcision (Group C)The skin is held by two hemostats to elevate the foreskin, and then the kocher clamp applied at the level of the skin to be removed for circumcision. Excess foreskin will be cut by scissor with hemostasis by bipolar cauterization. |
| 4. Group D: Thermal cauterization assisted circumcision; | Active comparator | Procedure: 4. Thermal cauterization assisted circumcision (Group D)The skin is held by two hemostats to elevate the foreskin, and then the kocher clamp applied at the level of the skin to be removed for circumcision. Excess foreskin will be cut by thermal cauterization. |
| 5. Group E: Gomco clamp technique; | Active comparator | Procedure: 5. Gomco clamp technique (Group E):The prepuce is grasped using two hemostats applied at 2 and 10 o'clock. A dorsal slit at 12 o'clock is made, and then the bell is applied gently to the glans. The base plate is placed over the metal bell. The foreskin then is protracted back over the bell with the clamps still attached. The foreskin is drawn evenly through the hole bilaterally using the ink mark as a guide. The clamp then is tightened and left in place for 5 minutes to squeeze the prepuce between the bell and the clamp to make it blood free before a circumferential incision is made. |
| 6. Group F: Plastibell device technique. | Active comparator | Procedure: 6. Plastibell device technique (Group F):The prepuce is grasped using two hemostats applied at 2 and 10 o'clock. A dorsal slit at 12 o'clock is made, appropriate-sized bell is placed over the glans, and the foreskin is brought over its top. The string is placed around the foreskin and the Plastibell device at the level of the mark in a groove that acted as the string placement guide. The string is then tightened and tied in a simple square knot. The excess foreskin is trimmed from around the bell using iris scissors. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All uncircumcised boys with intact prepuce
- Age below 5 years presented at our department for routine circumcision or for medical indications.
Key exclusion criteria (6 listed)
- Age above 5 years
- Ambiguous genitalia
- Congenital penile anomalies
- Redo-circumcision
- Balanitis or inflammatory process around the penis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1. Conventional dissection technique (group A) :In this group, circumcision is performed by the dorsal slit technique. A slit is made dorsally to the level of about 5 mm from the coronal sulcus, and the redundant foreskin and mucosa were excised circumferentially. Hemostasis is secured with ligation , and the cut edges are sutured with absorbable suture. Then, dressing is applied. | Procedure or surgery | 1. Group A: Conventional dissection technique; |
| 2. Bone cutting forceps technique (Group B)Two mosquito forceps are used to grasp the foreskin. The glans penis is squeezed back to avoid its injury. After that, bone cutting forceps is applied to the foreskin for 3 minutes, at the level of the mark, then the foreskin is excised by scalpel at the same level. Bleeding points are ligated and the cut edges are sutured with absorbable suture. Then, a dressing is applied | Procedure or surgery | 2. Group B: Bone cutting ; |
| 3. Electro-cauterization (bipolar) assisted circumcision (Group C)The skin is held by two hemostats to elevate the foreskin, and then the kocher clamp applied at the level of the skin to be removed for circumcision. Excess foreskin will be cut by scissor with hemostasis by bipolar cauterization. The skin retracted proximally after that to expose the glans. Sutures are made if there is separation between the skin and the mucous membrane. | Procedure or surgery | 3. Group C: Electro-cauterization (bipolar) assisted circumcision; |
| 4. Thermal cauterization assisted circumcision (Group D)The skin is held by two hemostats to elevate the foreskin, and then the kocher clamp applied at the level of the skin to be removed for circumcision. Excess foreskin will be cut by thermal cauterization. The skin retracted proximally after that to expose the glans. Sutures are made if there is separation between the skin and the mucous membrane. | Procedure or surgery | 4. Group D: Thermal cauterization assisted circumcision; |
| 5. Gomco clamp technique (Group E):The prepuce is grasped using two hemostats applied at 2 and 10 o'clock. A dorsal slit at 12 o'clock is made, appropriate-sized bell is placed over the glans, and the foreskin is brought over its top. The string is placed around the foreskin and the Plastibell device at the level of the mark in a groove that acted as the string placement guide. The string is then tightened and tied in a simple square knot. The excess foreskin is trimmed from around the bell using iris scissors. The handle is then broken off the device | Procedure or surgery | 5. Group E: Gomco clamp technique; |
| 6. Plastibell device technique (Group F):The prepuce is grasped using two hemostats applied at 2 and 10 o'clock. A dorsal slit at 12 o'clock is made, appropriate-sized bell is placed over the glans, and the foreskin is brought over its top. The string is placed around the foreskin and the Plastibell device at the level of the mark in a groove that acted as the string placement guide. The string is then tightened and tied in a simple square knot. The excess foreskin is trimmed from around the bell using iris scissors. The handle is then broken off the device | Procedure or surgery | 6. Group F: Plastibell device technique. |
Primary outcome
Bleeding
Time frame: 1 day
combine the number of dressing, Significant bleeding is considered if the dressing is completely soaked
1 secondary outcome
Cosmetic appearance
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Background[1] Myers A, Earp B. What Is the Best Age to Circumcise? A Medical and Ethical Analysis. Bioethics. 2020;34:645-663. [2] Schneider, T., 2013. Ancient Egypt investigated: 101 important questions and intriguing answers. Bloomsbury Publishing. [3] Alanis MC, Lucidi RS. Neonatal circumcision: a review of the world's oldest and most controversial operation. Obstet Gynecol Surv 2004;59(5):379e95. [4] Abdulwahab-Ahmed, A. and Mungadi, I.A., 2013. Techniques of male circumcision. Journal of surgical technique and case report, 5(1), pp.1-7. [5] Deacon, M. and Muir, G., 2023. What is the medical evidence on non-therapeutic child circumcision?. International journal of impotence research, 35(3), pp.256-263. [6] Iacob, S.I., Feinn, R.S. and Sardi, L., 2022. Systematic review of complications arising from male circumcision. BJUI compass, 3(2), pp.99-123. [7] Prakash, K.P., 2019. Comparative Study of Frenulum Sparing Circumcision with Dorsal Slit-Sleeve Technique of Circumcision for Phimosis (Master's thesis, Rajiv Gandhi University of Health Sciences (India). [8] Prabhakaran S, Ljuhar D, Coleman R, Nataraja RM. Circumcision in the paediatric patient: a review of indications, technique and complications. J Paediatr Child Health. 2018;54(12):1299-307. [9] Zafar, G.M., Sajjad, M.N., Zaheer, M., Yousaf, M.H. and Javeed, M.N., 2024. Split Glans & Advancement Flap To Repair Penile Hair Tourniquet Injury In Children: A Challenging Problem Of Unknown Etiology. Pakistan Journal of Urology (PJU), 2(01), pp.82-87. [10] Wang X, Dong C, Beekoo D et al. (2019): Dorsal penile nerve block via perineal approach, an alternative to a caudal block for pediatric circumcision: a randomized controlled trial. BioMed Research International, 19:6875756. doi: 10.1155/2019/6875756. [11] Kamil M (2012): Bone cutter circumcision in neonates. AL-Kindy College Medical Journal, 8(1): 119-121. [12] Wan J (2002): Gomco circumcision clamp: an enduring and unexpected success. Urology, 59(5): 790- 794. [13] Morris B, Eley C (2011): Male circumcision: An appraisal of current instrumentation. Biomedical Engineering, University of Rijeka, Rijeka, Pp. 315-354. DOI: 10.5772/18543
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1. Conventional dissection technique (group A) :, 2. Bone cutting forceps technique (Group B) and 3. Electro-cauterization (bipolar) assisted circumcision (Group C) in people with Prepuce; Accessory, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Bakr Ahmed (021153259080, mbakr7725@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06766838, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.