NCT04504656

Brief Summary

a comparative prospective study of postoperative between minimally invasive and open surgery complications for esophageal replacement in 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 Mar 2020

Typical duration 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

March 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

August 7, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

August 1, 2020

Last Update Submit

August 5, 2020

Conditions

Post-Op ComplicationAnastomosis; Complications

Outcome Measures

Primary Outcomes (1)

  • Anastamotic leaks

    Incidence of anastamotic leak which is identified clinically in both groups

    2 years

Secondary Outcomes (2)

  • Anastamotic stricture

    2 years

  • Mortality

    2 years

Study Arms (2)

1

open surgery

Other: observation of postoperative leak, stenosis, mortality

2

minimally invasive surgery

Other: observation of postoperative leak, stenosis, mortality

Interventions

observation of postoperative leak, stenosis, mortalityOTHER

detect complications in both groups

12

Eligibility Criteria

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

children up to 18 years

You may qualify if:

  • All children undergoing oesophageal replacement aged one to 18 years. Due to
  • long gap esophageal atresia
  • caustic ingestion
  • congenital esophageal stenosis or strictures

You may not qualify if:

  • patient who underwent previous esophageal replacement operations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Children Hospitals

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Postoperative Complications

Interventions

ConstrictionMortality

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative TechniquesVital StatisticsData CollectionEpidemiologic MethodsDemographyPopulation CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Ahmed Eltayeb, MD

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Ahmed Maher, Msc.

CONTACT

01026338229ahmedmaherali31@gmail.com

Mahmoud Mohamed Mostafa, MD

CONTACT

01005010897mmostafa@aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of surgery

Study Record Dates

First Submitted

August 1, 2020

First Posted

August 7, 2020

Study Start

March 1, 2020

Primary Completion

March 1, 2022

Study Completion

October 1, 2022

Last Updated

August 7, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

EG(1)