Primary HyperparathyroidismPARAMBUNCT03732157
Feasibility of Parathyroidectomy With Exploration of 4 Parathyroid Glands in Outpatients
An observational study of Primary Hyperparathyroidism, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
The development of outpatient surgery has become a national priority, with the objective of an ambulatory surgery rate of around 50% in 2016, whereas this rate reached only 37.7% in 2010. In the context of the management of primary hyperparathyroidism, there are two possible approaches. Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Primary Hyperparathyroidism
- What is being tested?
- outpatient management of parathyroidectomy and conventional management of parathyroidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to Jul 2019
- 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 19 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Major patients with primary hyperparathyroidism
Who may be able to join
- Patients > 18 years old
- Diagnosis of primary hyperparathyroidism (inappropriate parathyroid hormone secretion compared with calcemia)
- Surgical indication of parathyroidectomy with possible management outpatient or conventional hospitalization (choice of mode of care by the surgeon, after consultation with the patient)
Who cannot join
- Non-eligibility for outpatient surgery for general medical reasons (ASA score), determined during the consultation of preoperative anesthesia
- Preoperative hypercalcemia> 3 mmol / L (due to the high risk of postoperative hypocalcemia)
- History of cervicotomy for thyroidectomy or failure of parathyroid surgery
- Treatment of primary hyperparathyroidism with elective surgical approach
- Person under guardianship and curatorship
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Feasibility of Parathyroidectomy With Exploration of 4 Parathyroid Glands in Outpatients, for Treatment of Primary Hyperparathyroidism
The development of outpatient surgery has become a national priority, with the objective of an ambulatory surgery rate of around 50% in 2016, whereas this rate reached only 37.7% in 2010.
In the context of the management of primary hyperparathyroidism, there are two possible approaches. The first, which is commonly performed on an outpatient basis, consists in approaching only the pathological gland, if it was first identified by scintigraphy and ultrasound (which is the case in one patient in two), without exploring the others parathyroid glands.
Read more
The reference technique consists in exploring the 4 parathyroid sites by transverse cervicotomy. Although more invasive, it minimizes the risk of failure due to the lack of knowledge of multi-glandular forms of the disease (15 to 20%), whose preoperative diagnosis is difficult. This reference technique is poorly performed on an outpatient basis while it lends itself to this type of management because of the superficial character of the operative site, a short operating time, moderate postoperative pain, rapid return oral nutrition and exceptional and early serious complications (delay <24 h for cervical hematoma, <24 h for hypocalcemia and immediate diagnosis of recurrent palsy).
In this study, the investigators hypothesize that parathyroidectomy with 4-gland parathyroid exploration is feasible by ensuring patient safety. The investigators also believe that outpatient management will not lead to any difference after 3-month surgery, but will reduce hospitalization costs while increasing patient satisfaction with conventional care. To do so, the investigators carried out an observational cohort study of patients with an indication of parathyroidectomy wo will undergo outpatient management or conventional management (stay overnight in hospital) to inform all of these data.
- Conditions
- Primary Hyperparathyroidism
- Being tested
- outpatient management of parathyroidectomy, conventional management of parathyroidectomy
- Keywords
- Primary Hyperparathyroidism, Parathyroidectomy, Outpatient management
- Medical subject headings
- Hyperparathyroidism, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
outpatient management of parathyroidectomyProcedure or surgery
The patient is discharged from hospital the same day of the parathyroidectomy intervention instead of conventional management (stay overnight in hospital)
conventional management of parathyroidectomyProcedure or surgery
The patient stays overnight in hospital after intervention
| Study group | Role | What they receive |
|---|---|---|
| outpatient management of parathyroidectomy | Not described Receives: Procedure: outpatient management of parathyroidectomy | |
| conventional management of parathyroidectomy | Not described Receives: Procedure: conventional management of parathyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of conversion or readmission to conventional hospitalization
The primary endpoint will be assessed for patients receiving outpatient management. Proportion of patients who could not discharged from hospital the same day of surgery as originally scheduled or being readmitted to conventional hospitalization within 8 days post operatively.
Measured: within 8 days postoperatively
Secondary outcomes (17)
Postoperative pain evaluated using visual analogue scale (VAS)
Pain will be evaluated using visual analogue scale (VAS) . VAS score ranges from 0 to 10. A high VAS score represents a high level of pain while a low VAS score represents a low level of pain.
Measured: at day 0 post operatively
Postoperative pain evaluated using visual analogue scale (VAS)
Pain will be evaluated using visual analogue scale (VAS) . VAS score ranges from 0 to 10. A high VAS score represents a high level of pain while a low VAS score represents a low level of pain.
Measured: at day 1 post operatively
Postoperative pain evaluated using visual analogue scale (VAS)
Pain will be evaluated using visual analogue scale (VAS) . VAS score ranges from 0 to 10. A high VAS score represents a high level of pain while a low VAS score represents a low level of pain.
Measured: at day 8 post operatively
Proportion of patients with breathing difficulty.
Dyspnea will be evaluated using the New York Heart Association (NYHA) Functional Classification. The stage of dyspnea is classified in four categories based on how much patients are limited during physical activity. Breathing difficulty will be defined by a stage of 3 on the NYHA scale.
Measured: at day 1 post operatively
Proportion of patients with breathing difficulty.
Dyspnea will be evaluated using the New York Heart Association (NYHA) Functional Classification. The stage of dyspnea is classified in four categories based on how much patients are limited during physical activity. Breathing difficulty will be defined by a stage of 3 on the NYHA scale.
Measured: at day 8 post operatively
Proportion of patients with compressive cervical hematoma
clinical evaluation based on the occurrence of a cervical collection that can obstruct the upper aero-digestive tract (NYHA scale dyspnea)
Measured: at day 0 post operatively
Proportion of patients with compressive cervical hematoma
clinical evaluation based on the occurrence of a cervical collection that can obstruct the upper aero-digestive tract (NYHA scale dyspnea)
Measured: at day 1 post operatively
Proportion of patients with compressive cervical hematoma
clinical evaluation based on the occurrence of a cervical collection that can obstruct the upper aero-digestive tract (NYHA scale dyspnea)
Measured: at day 8 post operatively
Proportion of patients with hypocalcemia
Hypocalcemia will be defined as calcemia lower than 2 mmol/L or 80 mg/L
Measured: at day 1 post operatively
Proportion of patients with hypocalcemia
Hypocalcemia will be defined as calcemia lower than 2 mmol/L or 80 mg/L
Measured: at 3 months post operatively
Proportion of patients with recurrent nerve paralysis
Clinical evaluation based on the occurrence of voice modification with swallowing disorder
Measured: at day 0 post operatively
Proportion of patients with recurrent nerve paralysis
Clinical evaluation based on the occurrence of voice modification with swallowing disorder
Measured: at day 1 post operatively
Proportion of patients with recurrent nerve paralysis
Clinical evaluation based on the occurrence of voice modification with swallowing disorder
Measured: at day 8 post operatively
Patients' satisfaction regarding his/her care evaluated using visual analogue scale (VAS)
Patients' satisfaction evaluated using visual analogue scale (VAS). VAS score ranges from 0 to 10. A high VAS score represents a high level of satisfaction while a low VAS score represents a low level of satisfaction.
Measured: at day 0 post operatively
Patients' satisfaction regarding his/her care evaluated using visual analogue scale (VAS)
Patients' satisfaction evaluated using visual analogue scale (VAS). VAS score ranges from 0 to 10. A high VAS score represents a high level of satisfaction while a low VAS score represents a low level of satisfaction.
Measured: at day 1 post operatively
Patients' satisfaction regarding his/her care evaluated using visual analogue scale (VAS)
Patients' satisfaction evaluated using visual analogue scale (VAS). VAS score ranges from 0 to 10. A high VAS score represents a high level of satisfaction while a low VAS score represents a low level of satisfaction.
Measured: at 3 months post operatively
Total cost of mode of care
Total cost of hospital surgery stay and hospital readmission at 3 months
Measured: at 3 months post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study startNov 2018 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732157
- Sponsor's protocol ID
- K180301J
- Acronym
- PARAMBU
- Status last verified
- Sep 2018
- First submitted
- 18 Sep 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Parathyroidectomy With Exploration of 4 Parathyroid Glands in Outpatients, for Treatment of Primary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT03732157
- Acronym / sponsor ID
- PARAMBU / K180301J
- Conditions
- Primary Hyperparathyroidism
- Keywords
- Primary Hyperparathyroidism, Parathyroidectomy, Outpatient management
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 6 Nov 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 development of outpatient surgery has become a national priority, with the objective of an ambulatory surgery rate of around 50% in 2016, whereas this rate reached only 37.7% in 2010.
In the context of the management of primary hyperparathyroidism, there are two possible approaches. The first, which is commonly performed on an outpatient basis, consists in approaching only the pathological gland, if it was first identified by scintigraphy and ultrasound (which is the case in one patient in two), without exploring the others parathyroid glands.
The reference technique consists in exploring the 4 parathyroid sites by transverse cervicotomy. Although more invasive, it minimizes the risk of failure due to the lack of knowledge of multi-glandular forms of the disease (15 to 20%), whose preoperative diagnosis is difficult. This reference technique is poorly performed on an outpatient basis while it lends itself to this type of management because of the superficial character of the operative site, a short operating time, moderate postoperative pain, rapid return oral nutrition and exceptional and early serious complications (delay <24 h for cervical hematoma, <24 h for hypocalcemia and immediate diagnosis of recurrent palsy).
In this study, the investigators hypothesize that parathyroidectomy with 4-gland parathyroid exploration is feasible by ensuring patient safety. The investigators also believe that outpatient management will not lead to any difference after 3-month surgery, but will reduce hospitalization costs while increasing patient satisfaction with conventional care. To do so, the investigators carried out an observational cohort study of patients with an indication of parathyroidectomy wo will undergo outpatient management or conventional management (stay overnight in hospital) to inform all of these data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| outpatient management of parathyroidectomy | – | Procedure: outpatient management of parathyroidectomy |
| conventional management of parathyroidectomy | – | Procedure: conventional management of parathyroidectomy |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major patients with primary hyperparathyroidism
Key inclusion criteria (3 listed)
- Patients > 18 years old
- Diagnosis of primary hyperparathyroidism (inappropriate parathyroid hormone secretion compared with calcemia)
- Surgical indication of parathyroidectomy with possible management outpatient or conventional hospitalization (choice of mode of care by the surgeon, after consultation with the patient)
Key exclusion criteria (5 listed)
- Non-eligibility for outpatient surgery for general medical reasons (ASA score), determined during the consultation of preoperative anesthesia
- Preoperative hypercalcemia> 3 mmol / L (due to the high risk of postoperative hypocalcemia)
- History of cervicotomy for thyroidectomy or failure of parathyroid surgery
- Treatment of primary hyperparathyroidism with elective surgical approach
- Person under guardianship and curatorship
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 |
|---|---|---|
| outpatient management of parathyroidectomyThe patient is discharged from hospital the same day of the parathyroidectomy intervention instead of conventional management (stay overnight in hospital) | Procedure or surgery | outpatient management of parathyroidectomy |
| conventional management of parathyroidectomyThe patient stays overnight in hospital after intervention | Procedure or surgery | conventional management of parathyroidectomy |
Primary outcome
Proportion of conversion or readmission to conventional hospitalization
Time frame: within 8 days postoperatively
The primary endpoint will be assessed for patients receiving outpatient management. Proportion of patients who could not discharged from hospital the same day of surgery as originally scheduled or being readmitted to conventional hospitalization within 8 days post operatively.
17 secondary outcomes
Postoperative pain evaluated using visual analogue scale (VAS)
Time frame: at day 0 post operatively
Postoperative pain evaluated using visual analogue scale (VAS)
Time frame: at day 1 post operatively
Postoperative pain evaluated using visual analogue scale (VAS)
Time frame: at day 8 post operatively
Proportion of patients with breathing difficulty.
Time frame: at day 1 post operatively
Proportion of patients with breathing difficulty.
Time frame: at day 8 post operatively
Proportion of patients with compressive cervical hematoma
Time frame: at day 0 post operatively
Proportion of patients with compressive cervical hematoma
Time frame: at day 1 post operatively
Proportion of patients with compressive cervical hematoma
Time frame: at day 8 post operatively
Proportion of patients with hypocalcemia
Time frame: at day 1 post operatively
Proportion of patients with hypocalcemia
Time frame: at 3 months post operatively
Proportion of patients with recurrent nerve paralysis
Time frame: at day 0 post operatively
Proportion of patients with recurrent nerve paralysis
Time frame: at day 1 post operatively
Proportion of patients with recurrent nerve paralysis
Time frame: at day 8 post operatively
Patients' satisfaction regarding his/her care evaluated using visual analogue scale (VAS)
Time frame: at day 0 post operatively
Patients' satisfaction regarding his/her care evaluated using visual analogue scale (VAS)
Time frame: at day 1 post operatively
Patients' satisfaction regarding his/her care evaluated using visual analogue scale (VAS)
Time frame: at 3 months post operatively
Total cost of mode of care
Time frame: at 3 months post operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Hyperparathyroidism, run by Assistance Publique - Hôpitaux de Paris.
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 5 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 6 Nov 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre CATTAN, Pr (0142499381 ext. +33, pierre.cattan@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of conversion or readmission to conventional hospitalization (time frame: within 8 days postoperatively). 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 6 Nov 2018.