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Fecal Continence Outcomes and Quality of Life After Excision of Sacrococcygeal Teratoma (Retrospective Study)

Sponsor
Sohag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06133036
Collaborator
(none)
20
Enrollment
1
Location
6
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Fecal Continence Outcomes and Quality of Life After Excision of Sacrococcygeal Teratma (Retrospective Study)
    Anticipated Study Start Date :
    Nov 1, 2023
    Anticipated Primary Completion Date :
    Feb 1, 2024
    Anticipated Study Completion Date :
    May 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Fecal continence [6 months]

      Measured by Rintala continence score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sohag University Hospitals Sohag Egypt 82511

    Sponsors and Collaborators

    • Sohag University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mohamed Kamal Mohamed Sayed Khalil, resident-pediatric surgery department, Sohag University
    ClinicalTrials.gov Identifier:
    NCT06133036
    Other Study ID Numbers:
    • Soh-Med-23-10-10MS
    First Posted:
    Nov 15, 2023
    Last Update Posted:
    Nov 15, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Teratoma

    Study Results

    No Results Posted as of Nov 15, 2023