Post-Op ComplicationNCT04504656
Comparison of Early Outcomes of Minimally Invasive Surgery for Oesophageal Replacement Versus Open Surgery in Children
An observational study of Post-Op Complication and Anastomosis; Complications, run by Assiut University at 1 site in Egypt.
Trial summary
a comparative prospective study of postoperative between minimally invasive and open surgery complications for esophageal replacement in children Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Post-Op Complication, Anastomosis; Complications
- What is being tested?
- observation of postoperative leak, stenosis, mortality
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2020to 1 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children up to 18 years
Who may be able to join
- All children undergoing oesophageal replacement aged one to 18 years. Due to
- long gap esophageal atresia
- caustic ingestion
- congenital esophageal stenosis or strictures
Who cannot join
- patient who underwent previous esophageal replacement operations.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Children Hospitals
Asyut
Mohamed Abdel-Kadir Othman Ahmed, MD, 01062226639, osman@med.aun.edu.eg
About this study
a comparative prospective study of postoperative between minimally invasive and open surgery complications for esophageal replacement in children
Read the detailed description
Esophageal replacement in childhood is indicated in esophageal atresia patients with long-gap defects or following complications of primary esophageal anastomosis, as well as in patients with trauma and scarring to the esophagus following caustic ingestion. It is widely accepted that the ideal esophageal replacement is one that resembles the function of the native esophagus with minimal deterioration over time. Several techniques of esophageal replacement have been developed. These have focused mainly on the use of native tissues (including the stomach, jejunum, and colon) as conduits (1), attempts to use a synthetic prosthesis have been largely unsuccessful. In an attempt to reduce the trauma and morbidity associated with laparotomy and thoracotomy incisions, minimally invasive techniques are increasingly used. (2-4). Meta-analyses of adult esophagectomy for the treatment of esophageal cancer support the use of minimally invasive surgery (5) however, equivalent comparative studies in the pediatric population are lacking. As such, it is unclear whether minimally esophageal replacement is as safe as the open procedure in children. The present study aims to address this question by comparing the postoperative outcomes of children who underwent minimally invasive versus open esophageal replacement procedures at single-center and multicenter levels.
- Conditions
- Post-Op Complication, Anastomosis; Complications
- Being tested
- observation of postoperative leak, stenosis, mortality
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observation of postoperative leak, stenosis, mortalityOther
detect complications in both groups
| Study group | Role | What they receive |
|---|---|---|
| 1 | open surgery Receives: Other: observation of postoperative leak, stenosis, mortality | |
| 2 | minimally invasive surgery Receives: Other: observation of postoperative leak, stenosis, mortality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastamotic leaks
Incidence of anastamotic leak which is identified clinically in both groups
Measured: 2 years
Secondary outcomes (2)
Anastamotic stricture
Incidence of symptomstic strictures which is identified by upper barium studies
Measured: 2 years
Mortality
Number of patient who die intraoperative and post operative in both groups
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start1 Mar 2020
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Op ComplicationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A maher, Assiut University
- Investigators
- Ahmed Eltayeb, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504656
- Sponsor's protocol ID
- Esophageal replacement
- Status last verified
- Aug 2020
- First submitted
- 1 Aug 2020
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Early Outcomes of Minimally Invasive Surgery for Oesophageal Replacement Versus Open Surgery in Children
- ClinicalTrials.gov ID
- NCT04504656
- Acronym / sponsor ID
- Esophageal replacement
- Conditions
- Post-Op Complication, Anastomosis; Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
a comparative prospective study of postoperative between minimally invasive and open surgery complications for esophageal replacement in children
Detailed description
Esophageal replacement in childhood is indicated in esophageal atresia patients with long-gap defects or following complications of primary esophageal anastomosis, as well as in patients with trauma and scarring to the esophagus following caustic ingestion. It is widely accepted that the ideal esophageal replacement is one that resembles the function of the native esophagus with minimal deterioration over time. Several techniques of esophageal replacement have been developed. These have focused mainly on the use of native tissues (including the stomach, jejunum, and colon) as conduits (1), attempts to use a synthetic prosthesis have been largely unsuccessful. In an attempt to reduce the trauma and morbidity associated with laparotomy and thoracotomy incisions, minimally invasive techniques are increasingly used. (2-4). Meta-analyses of adult esophagectomy for the treatment of esophageal cancer support the use of minimally invasive surgery (5) however, equivalent comparative studies in the pediatric population are lacking. As such, it is unclear whether minimally esophageal replacement is as safe as the open procedure in children. The present study aims to address this question by comparing the postoperative outcomes of children who underwent minimally invasive versus open esophageal replacement procedures at single-center and multicenter levels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: observation of postoperative leak, stenosis, mortalityopen surgery |
| 2 | – | Other: observation of postoperative leak, stenosis, mortalityminimally invasive surgery |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children up to 18 years
Key inclusion criteria (4 listed)
- All children undergoing oesophageal replacement aged one to 18 years. Due to
- long gap esophageal atresia
- caustic ingestion
- congenital esophageal stenosis or strictures
Key exclusion criteria (1 listed)
- patient who underwent previous esophageal replacement operations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observation of postoperative leak, stenosis, mortalitydetect complications in both groups | Other | 1, 2 |
Primary outcome
Anastamotic leaks
Time frame: 2 years
Incidence of anastamotic leak which is identified clinically in both groups
2 secondary outcomes
Anastamotic stricture
Time frame: 2 years
Mortality
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Eltayeb, MD study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Op Complication and Anastomosis; Complications, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Maher, Msc. (01026338229, ahmedmaherali31@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastamotic leaks (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2020.