NCT06133036

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

November 15, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

November 10, 2023

Last Update Submit

November 10, 2023

Conditions

Sacrococcygeal Teratoma

Outcome Measures

Primary Outcomes (1)

  • Fecal continence

    Measured by Rintala continence score

    6 months

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients operated in Sohag university hospital after july 2010 for sacrococcygeal teratoma.

You may qualify if:

  • all patients with sacrococcygeal teratoma operated after july 2010 and older than 3 years old.

You may not qualify if:

  • Patients lost to follow up before 6 months after surgery.
  • Patients with Currarino triad.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospitals

Sohag, 82511, Egypt

RECRUITING

Central Study Contacts

Mohamed K Khalil

CONTACT

01028900808mohamedkamal@med.sohag.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident-pediatric surgery department

Study Record Dates

First Submitted

November 10, 2023

First Posted

November 15, 2023

Study Start

November 1, 2023

Primary Completion

February 1, 2024

Study Completion

May 1, 2024

Last Updated

November 15, 2023

Record last verified: 2023-11

Locations

EG(1)