Adrenal MyelolipomaNCT06480357
A Giant Myelolipoma.
An observational study of Adrenal Myelolipoma, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
48-year-old woman who presented with intermittent left flank pain with incidental findings of adrenal tumor on computed tomography (CT). She underwent laparoscopic tumor resection due to a large tumor of 12 cm in size. Read more about this study
- Who is it for?
- Ages 48 years and older, women only
- Conditions the study is for
- Adrenal Myelolipoma
- What is being tested?
- laparoscopic adrenalectomy
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteMexico
- Study dates
- 24 Jun 2024to 24 Jun 2024
- 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 48 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 48 Year old Female
Who may be able to join
- Patient with myelolipoma
Who cannot join
- Patient without myelolipoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Giant Myelolipoma, Management by Laparoscopy.
48-year-old woman who presented with intermittent left flank pain with incidental findings of adrenal tumor on computed tomography (CT). She underwent laparoscopic tumor resection due to a large tumor of 12 cm in size.
Read the detailed description
A 48-year-old female presented to our hospital with the following medical conditions: She denies smoking and drug addiction. Type 2 diabetes mellitus under treatment with metfomin, surgical history of abdominal hysterectomy and open cholecystectomy.
The patient started experiencing pain located in the left flank for 2 months, which was intermittent, yielded to the administration of analgesics, she denied hematuria and weight loss.
On physical examination, the abdomen was distended due to adipose tissue, normal bowel sounds were auscultated, and abdominal masses are not palpable.
She underwent a computed tomography (CT) scan. CT features in the anatomical site of the left adrenal gland, a well-defined ovoid tumor is observed, with heterogeneous content with areas of hypodense (5 HU), fat and calcification. It measures 90 x 69 x 92 mm. Upon application of contrast medium, the hypodense parts present enhancement up to 44 HU. (Fig. 1, 2). She was decided for surgical resection of the tumor via laparoscopic transabdominal approach. The surgery went well without any intraoperative and postoperative complications. She was discharged after day 3.
- Conditions
- Adrenal Myelolipoma
- Being tested
- laparoscopic adrenalectomy
- Keywords
- Benign, neoplasms, adrenal myelolipoma
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic adrenalectomyProcedure or surgery
laparoscopic transabdominal approach.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure of the disease
Complete myelolipoma resection
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start24 Jun 2024
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal MyelolipomaStudies 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
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Huber Díaz Fuentes, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480357
- Sponsor's protocol ID
- 98337029
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: manuscript publication
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Giant Myelolipoma, Management by Laparoscopy.
- ClinicalTrials.gov ID
- NCT06480357
- Acronym / sponsor ID
- 98337029
- Conditions
- Adrenal Myelolipoma
- Keywords
- Benign, neoplasms, adrenal myelolipoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 28 Jun 2024 (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.
48-year-old woman who presented with intermittent left flank pain with incidental findings of adrenal tumor on computed tomography (CT). She underwent laparoscopic tumor resection due to a large tumor of 12 cm in size.
Detailed description
A 48-year-old female presented to our hospital with the following medical conditions: She denies smoking and drug addiction. Type 2 diabetes mellitus under treatment with metfomin, surgical history of abdominal hysterectomy and open cholecystectomy.
The patient started experiencing pain located in the left flank for 2 months, which was intermittent, yielded to the administration of analgesics, she denied hematuria and weight loss.
On physical examination, the abdomen was distended due to adipose tissue, normal bowel sounds were auscultated, and abdominal masses are not palpable.
She underwent a computed tomography (CT) scan. CT features in the anatomical site of the left adrenal gland, a well-defined ovoid tumor is observed, with heterogeneous content with areas of hypodense (5 HU), fat and calcification. It measures 90 x 69 x 92 mm. Upon application of contrast medium, the hypodense parts present enhancement up to 44 HU. (Fig. 1, 2). She was decided for surgical resection of the tumor via laparoscopic transabdominal approach. The surgery went well without any intraoperative and postoperative complications. She was discharged after day 3.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 48 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 48 Year old Female
Key inclusion criteria (1 listed)
- Patient with myelolipoma
Key exclusion criteria (1 listed)
- Patient without myelolipoma
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 |
|---|---|---|
| laparoscopic adrenalectomylaparoscopic transabdominal approach. | Procedure or surgery | – |
Primary outcome
Cure of the disease
Time frame: 3 days
Complete myelolipoma resection
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 28 Jun 2024.
- Individual participant dataSharing planned: Yes. manuscript publication
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 Adrenal Myelolipoma, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
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 1 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 28 Jun 2024. 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 Mexico. 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?
Cure of the disease (time frame: 3 days). 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 28 Jun 2024.