LymphoceleNCT05398458
Management of a Giant Lymphocele Following Varicose Vein Surgery - A Case Report
An observational study of Lymphocele and Varicose Veins, run by Bahria International Hospital at 1 site in Pakistan.
Trial summary
A 48-year-old female presented to the plastic surgery outpatient department (OPD) with a history of painful, progressive swelling of the right groin and medial aspect of the right thigh for 4 months. After investigation, it was diagnosed as a giant lymphocele. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lymphocele, Varicose Veins
- What is being tested?
- Lymphocele excision and space obliterated by pedicle Gracilis muscle only flap
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2019to 21 Apr 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: post varicose vein surgery ,patient developed lymphocele in right thigh
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
A 48-year-old female presented to the plastic surgery outpatient department (OPD) with a history of painful, progressive swelling of the right groin and medial aspect of the right thigh for 4 months. After investigation, it was diagnosed as a giant lymphocele. A pedicled gracilis muscle flap was used to reconstruct and obliterate the cavity. There was no recurrence of the swelling. : Lymphocele is a common complication after extensive vascular surgeries. In the unfortunately case of its development, prompt intervention must be done to prevent its growth and ensuing complications.
- Conditions
- Lymphocele, Varicose Veins
- Being tested
- Lymphocele excision and space obliterated by pedicle Gracilis muscle only flap
- Keywords
- Lymphocele, Varicose Vein, Gracilis Muscle, Sclerotherapy.
- Medical subject headings
- Lymphocele, Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymphocele excision and space obliterated by pedicle Gracilis muscle only flapProcedure or surgery
By this procedure it has helped in reduction and complete resolution of the lymphocele with no recurrence in the past 2 years
What is being measured
The primary outcome is the main question the study is designed to answer.
Management of a Giant Lymphocele Following Varicose Vein Surgery - A Case Report
Complete resolution of lymphocele
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 Jan 2019
- Primary completion1 Mar 2021
- Study completion21 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphoceleStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahria International Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Noshi Bibi, Bahria International Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398458
- Sponsor's protocol ID
- BIH
- Status last verified
- May 2022
- First submitted
- 26 May 2022
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of a Giant Lymphocele Following Varicose Vein Surgery - A Case Report
- ClinicalTrials.gov ID
- NCT05398458
- Acronym / sponsor ID
- BIH
- Conditions
- Lymphocele, Varicose Veins
- Keywords
- Lymphocele, Varicose Vein, Gracilis Muscle, Sclerotherapy.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Bahria International HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 21 Apr 2022 (actual)
- First posted
- 1 Jun 2022 (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 48-year-old female presented to the plastic surgery outpatient department (OPD) with a history of painful, progressive swelling of the right groin and medial aspect of the right thigh for 4 months. After investigation, it was diagnosed as a giant lymphocele. A pedicled gracilis muscle flap was used to reconstruct and obliterate the cavity. There was no recurrence of the swelling. : Lymphocele is a common complication after extensive vascular surgeries. In the unfortunately case of its development, prompt intervention must be done to prevent its growth and ensuing complications.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- post varicose vein surgery ,patient developed lymphocele in right thigh
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Lymphocele excision and space obliterated by pedicle Gracilis muscle only flapBy this procedure it has helped in reduction and complete resolution of the lymphocele with no recurrence in the past 2 years | Procedure or surgery | – |
Primary outcome
Management of a Giant Lymphocele Following Varicose Vein Surgery - A Case Report
Time frame: 2 year
Complete resolution of lymphocele
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 1 Jun 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Lymphocele
Recruiting
Use of Compression Bandages in the Prevention of Post-mastectomy Lymphoceles
Lymphocele
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lymphocele and Varicose Veins, run by Bahria International Hospital at 1 site in Pakistan.
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 0 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: finished, as of the sponsor's last update on 1 Jun 2022. 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 Pakistan. 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?
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?
Management of a Giant Lymphocele Following Varicose Vein Surgery - A Case Report (time frame: 2 year). 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 1 Jun 2022.