Conjoined TwinCTNCT03388684
Conjoined Twins: a Report of Four Cases.
An observational study of Conjoined Twin, run by Assiut University.
Trial summary
The present study aims to report our experience in conjoined twin separation surgery in Assuit university and pediatric hospital, Assiut university, Assiut, Egypt over a period of 20 years. Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Conjoined Twin
- What is being tested?
- Conjoined twin separation surgery
- Type of treatment
- Surgery or procedure
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Feb 2000to Oct 2017
- 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 1 day to 30 days
- All sexes
- No healthy volunteers
- Child
Study population: conjoined twins whether symmetrical or asymmetrical.
Who may be able to join
- conjoined twins
- symmetrical or
- asymmetrical.
Who cannot join
- conjoined twins incompatible with life
- conjoined twins with decapitating medical illness.
About this study
The present study aims to report our experience in conjoined twin separation surgery in Assuit university and pediatric hospital, Assiut university, Assiut, Egypt over a period of 20 years.
Read the detailed description
A conjoined twin is a subset of monozygotic twin gestation. It's a rare phenomenon with an incidence of 1 in 50,000 to 1:100,000 births with the higher incidence in Africa and Southwest Asia. Based on the terminology proposed by Spencer and colleagues, conjoined twins are classified according to the most prominent site of conjunction into three major groups; First, twins with a ventral union; [cephalopagus (head), thoracopagus (Thorax), omphalopagus (Abdomen) and ischiopagus (pelvis)]. Second; twins with a dorsal union; [pygopagus (sacrum), rachipagus (spine, back) and craniopagus (cranium)] and lastly; twins with a lateral union that is referred to as parapagus (side). Depending on the aspect of the embryonic disc, the most common types are thoracopagus (19%).
Surgical separation of conjoined twins is extremely challenging taking in consideration the high perioperative risk. The low incidence of such surgeries and anatomical variations in each type of conjoined twins makes each separation surgery a unique experience.
- Conditions
- Conjoined Twin
- Being tested
- Conjoined twin separation surgery
- Medical subject headings
- Twins, Conjoined
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conjoined twin separation surgeryProcedure or surgery
Also called CT Separation
This study included 4 case reports on conjoined twins (CT), 2 male and three female patients; 3 of them were parasitic and one was conjoined. We operated upon 2 parasitic and one conjoined. The 1st case died preoperatively.
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of the conjoined twin separation surgery
The operative details of the separation surgery were written in details and the separation process was showen in pictures.
Measured: For each case was the 1 week survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study startFeb 2000
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Conjoined TwinStudies 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
- Retrospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Saad Abdel-Ghaffar, Assiut University
- Investigators
- Hala S Abdelghaffar, MD, Principal investigator, Professor in anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388684
- Sponsor's protocol ID
- 17300170
- Acronym
- CT
- Status last verified
- Jun 2024
- First submitted
- 25 Dec 2017
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Takrouney MH, Ibrahim IA, Abdel-Ghaffar HS, Abdel-Wahhab AI, Mostafa MM, Ali WN, Abd-Elaal MS. Conjoined twins: A report of four cases. Int J Surg Case Rep. 2020;73:289-293. doi: 10.1016/j.ijscr.2020.06.072. Epub 2020 Jun 20.
PubMed 32721891
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conjoined Twins: a Report of Four Cases.
- ClinicalTrials.gov ID
- NCT03388684
- Acronym / sponsor ID
- CT / 17300170
- Conditions
- Conjoined Twin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2000 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 3 Jan 2018 (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.
The present study aims to report our experience in conjoined twin separation surgery in Assuit university and pediatric hospital, Assiut university, Assiut, Egypt over a period of 20 years.
Detailed description
A conjoined twin is a subset of monozygotic twin gestation. It's a rare phenomenon with an incidence of 1 in 50,000 to 1:100,000 births with the higher incidence in Africa and Southwest Asia. Based on the terminology proposed by Spencer and colleagues, conjoined twins are classified according to the most prominent site of conjunction into three major groups; First, twins with a ventral union; [cephalopagus (head), thoracopagus (Thorax), omphalopagus (Abdomen) and ischiopagus (pelvis)]. Second; twins with a dorsal union; [pygopagus (sacrum), rachipagus (spine, back) and craniopagus (cranium)] and lastly; twins with a lateral union that is referred to as parapagus (side). Depending on the aspect of the embryonic disc, the most common types are thoracopagus (19%).
Surgical separation of conjoined twins is extremely challenging taking in consideration the high perioperative risk. The low incidence of such surgeries and anatomical variations in each type of conjoined twins makes each separation surgery a unique experience.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- conjoined twins whether symmetrical or asymmetrical.
Key inclusion criteria (3 listed)
- conjoined twins
- symmetrical or
- asymmetrical.
Key exclusion criteria (2 listed)
- conjoined twins incompatible with life
- conjoined twins with decapitating medical illness.
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 |
|---|---|---|
| Conjoined twin separation surgeryAlso: CT SeparationThis study included 4 case reports on conjoined twins (CT), 2 male and three female patients; 3 of them were parasitic and one was conjoined. We operated upon 2 parasitic and one conjoined. The 1st case died preoperatively. | Procedure or surgery | – |
Primary outcome
Success of the conjoined twin separation surgery
Time frame: For each case was the 1 week survival
The operative details of the separation surgery were written in details and the separation process was showen in pictures.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Derived from this study: PubMed 32721891Takrouney MH, Ibrahim IA, Abdel-Ghaffar HS, Abdel-Wahhab AI, Mostafa MM, Ali WN, Abd-Elaal MS. Conjoined twins: A report of four cases. Int J Surg Case Rep. 2020;73:289-293. doi: 10.1016/j.ijscr.2020.06.072. Epub 2020 Jun 20.
- Individual participant dataSharing planned: No
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.
Hala S Abdelghaffar, MD principal investigator
Professor in anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt.
Questions about this trial
What is this clinical trial studying?
An observational study of Conjoined Twin, run by Assiut University.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of the conjoined twin separation surgery (time frame: For each case was the 1 week survival). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03388684, which also lists 1 linked publication.
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 25 Jun 2024.