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

November 10, 2023 updated by: Mohamed Kamal Mohamed Sayed Khalil, Sohag University

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fecal continence
Time Frame: 6 months
Measured by Rintala continence score
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

November 10, 2023

First Submitted That Met QC Criteria

November 10, 2023

First Posted (Actual)

November 15, 2023

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-23-10-10MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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