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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06133036
Other study ID # Soh-Med-23-10-10MS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2023
Est. completion date May 2024

Study information

Verified date November 2023
Source Sohag University
Contact Mohamed K Khalil
Phone 01028900808
Email mohamedkamal@med.sohag.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Sacrococcygeal teratoma is one of the most common tumors that occur in the neonatal period. It presents either as a mass protruding from the sacrococcygeal region or as a pelviabdominal mass according to the type. Surgical excision is the main treatment, most masses are benign, however some are malignant and require radiotherapy or chemotherapy. Complications may occur due to pressure resulting from the tumor growth in the fetal period, or due to damage to important near tissues during surgical excision. Postoperative complications may be urinary as neurogenic bladder, Lower gastrointestinal as constipation, soiling or incontinence. In this work we study the outcomes of fecal continence through a questionnaire and its effect on the quality of life of the affected children.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date May 2024
Est. primary completion date February 2024
Accepts healthy volunteers No
Gender All
Age group 3 Years to 18 Years
Eligibility Inclusion Criteria: - all patients with sacrococcygeal teratoma operated after july 2010 and older than 3 years old. Exclusion Criteria: - Patients lost to follow up before 6 months after surgery. - Patients with Currarino triad.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Sohag University Hospitals Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fecal continence Measured by Rintala continence score 6 months
See also
  Status Clinical Trial Phase
Completed NCT04623658 - Improving Prenatal Parental Counseling in Cases of Sacrococcygeal Teratoma
Completed NCT00780117 - Characterization of At-risk Population for Pre-sacral Tumor in CURRARINO Syndrome N/A
Completed NCT05182853 - Voiding Disorders in Children After Sacrococcygeal Teratoma Resection