An interventional study of Modified Nesbit's procedure and dorsal dartos flap in Congenital Anomaly, Chordee and Curvature of Penis, sponsored by dr. Muhammad Abdelhafez Mahmoud, MD. Completed at 1 site in Egypt. Open to male participants aged 2 Years to 10 Years. Per ClinicalTrials.gov, last updated 2020-11-19.
Sponsored by dr. Muhammad Abdelhafez Mahmoud, MD · Not applicable, Interventional, and Treatment
To present update \& experience in management of congenital penile curvature complex.
Type of study: prospective study
Review of literature:
This is a prospective study conducted at pediatric surgery department, New Damietta \& Alhoussain Al-Azhar University Hospitals, from January 2015 to May 2020, on 56 male patients with isolated CPCC. All of them will undergo one-stage correction corporoplasty using modified Nesbit technique accompanied by dorsal dartos flap.
Institutes of the study:
A multicenter study at Pediatric Surgery Departments, Al-Azhar University hospitals at New Damietta \& Cairo. Number of cases: Fifty-six male patients. Time frame: period of 5.6 years.
Ethical Consideration:
The protocol will be discussed and approved for clinical study by the Ethical Research Committee at the principal investigator's hospital. The study protocol was approved by local research and ethics committee of Al-Azhar Faculty of Medicine; the study protocol was explained to all guardians and their informed consents were obtained for involvement in the study. Confidentiality and the right to withdraw from the study at any time were guaranteed.
Preoperative preparation:
Children with CPCC those fulfill inclusion criteria will undergo a nursing evaluation of functional health status and a preoperative evaluation by an anesthesiologist \& pediatrician. The angle of penile rotation will be measured on the photograph, using Millen Med DICOM viewer program for image analysis, based on the orientation of the urethral meatus relative to the vertical position.
Follow-up:
Patients will be followed-up at OPD.
Statistical Analysis:
Data will be summarized into continuous variables expressed as mean ± standard deviation and categorical variables expressed as frequency count and percentage (%), using appropriate software computer package. Fisher's exact test is used for comparison of frequency counts/percentage. A two-sided p-value \< 0.05 is considered statistically significant.
Discussion:
It will focus on one-stage correction of congenital penile curvature complex (CPCC) using modified Nesbit's procedure (to correct curvature) and dorsal dartos flap (to correct torsion). The results obtained from this study will be compared between both group and with those reported in the literature. Also, it will focus on results, complications, their management, and clinical evaluation by noticing urine stream direction. At the end, the investigators will conclude that this technique ensures correction of the complex penile anomaly with satisfactory results and nice cosmetic outcome.
781 studies on the registry are indexed under Congenital Abnormalities; 77 are open to participants now.
This study's enrollment of 56 is above the median of 40 across 466 interventional studies indexed under Congenital Abnormalities.
Browse Congenital Abnormalities studies →dr. Muhammad Abdelhafez Mahmoud, MD is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Modified Nesbit technique to correct penile curvature followed by dorsal dartos flap to correct penile torsion
Procedure: Modified Nesbit's procedure and dorsal dartos flap
Modified Nesbit's procedure to correct the penile curvature and dorsal dartos flap to correct the associated penile torsion
Clockwise rotation
Clockwise rotation of the penis (number \& percent)
Time frame: 5 years
Counterlockwise rotation
Counterlockwise rotation of the penis (number \& percent)
Time frame: 5 years
Ventral Curvature
Ventral Curvature of the penis (number \& percent)
Time frame: 5 years
Dorsal Curvature
Dorsal Curvature of the penis (number \& percent)
Time frame: 5 years
Lateral Curvature
Lateral Curvature of the penis (number \& percent)
Time frame: 5 years
Age
Age of the patients (years)
Time frame: 5 years
Operative time
Operative time (minutes)
Time frame: 1 day (day of surgery)
Post-operative hospital stay
Hospital stay period (days)
Time frame: 1 week
Post-operative follow-up period
Follow-up period (months)
Time frame: 5 years
Functional impairment
Functional impairment (number \& percent)
Time frame: 5 years
Aesthetic impairment
Aesthetic impairment (number \& percent)
Time frame: 5 years
Residual curvature > 10°
Residual curvature \> 10° (number \& percent)
Time frame: 5 years
Residual rotation > 10°
Residual rotation \> 10° (number \& percent)
Time frame: 5 years
Post-operative paresthesia
Post-operative paresthesia (number \& percent)
Time frame: 5 years
Skin ischemia
Skin ischemia (number \& percent)
Time frame: 5 years
Hematoma
Hematoma (number \& percent)
Time frame: 5 years
Dressing soaked with blood
Dressing soaked with blood (number \& percent)
Time frame: 5 years
Plan to share: Yes — Data will be available for other researchers including methodology, figures, tables, results, and philosophy of discussion and the value this study will add to the literature
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: from now indefinitely
Access criteria: after the article became accepted and available online.
No publications or documents are linked to this record.
Ran from Jan 2015 to primary completion in Nov 2019, 58 months.
Of 71 non-industry interventional studies with no phase under Congenital Abnormalities, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 71. This study's 58 months is above that.
Counting every sponsor, half of 76 studies reached it within 37 months; a quarter within 14 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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dr. Muhammad Abdelhafez Mahmoud, MD