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Feasibility of Parathyroidectomy With Exploration of 4 Parathyroid Glands in Outpatients (PARAMBU)

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ClinicalTrials.gov Identifier: NCT03732157
Recruitment Status : Not yet recruiting
First Posted : November 6, 2018
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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. 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.


Condition or disease Intervention/treatment
Primary Hyperparathyroidism Procedure: outpatient management of parathyroidectomy Procedure: conventional management of parathyroidectomy

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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Feasibility of Parathyroidectomy With Exploration of 4 Parathyroid Glands in Outpatients, for Treatment of Primary Hyperparathyroidism
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019


Group/Cohort Intervention/treatment
outpatient management of parathyroidectomy Procedure: outpatient management of parathyroidectomy
The patient is discharged from hospital the same day of the parathyroidectomy intervention instead of conventional management (stay overnight in hospital)

conventional management of parathyroidectomy Procedure: conventional management of parathyroidectomy
The patient stays overnight in hospital after intervention




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Postoperative pain evaluated using visual analogue scale (VAS) [ Time Frame: at day 0 post operatively ]
    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.

  2. Postoperative pain evaluated using visual analogue scale (VAS) [ Time Frame: at day 1 post operatively ]
    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.

  3. Postoperative pain evaluated using visual analogue scale (VAS) [ Time Frame: at day 8 post operatively ]
    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.

  4. Proportion of patients with breathing difficulty. [ Time Frame: at day 1 post operatively ]
    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.

  5. Proportion of patients with breathing difficulty. [ Time Frame: at day 8 post operatively ]
    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.

  6. Proportion of patients with compressive cervical hematoma [ Time Frame: at day 0 post operatively ]
    clinical evaluation based on the occurrence of a cervical collection that can obstruct the upper aero-digestive tract (NYHA scale dyspnea)

  7. Proportion of patients with compressive cervical hematoma [ Time Frame: at day 1 post operatively ]
    clinical evaluation based on the occurrence of a cervical collection that can obstruct the upper aero-digestive tract (NYHA scale dyspnea)

  8. Proportion of patients with compressive cervical hematoma [ Time Frame: at day 8 post operatively ]
    clinical evaluation based on the occurrence of a cervical collection that can obstruct the upper aero-digestive tract (NYHA scale dyspnea)

  9. Proportion of patients with hypocalcemia [ Time Frame: at day 1 post operatively ]
    Hypocalcemia will be defined as calcemia lower than 2 mmol/L or 80 mg/L

  10. Proportion of patients with hypocalcemia [ Time Frame: at 3 months post operatively ]
    Hypocalcemia will be defined as calcemia lower than 2 mmol/L or 80 mg/L

  11. Proportion of patients with recurrent nerve paralysis [ Time Frame: at day 0 post operatively ]
    Clinical evaluation based on the occurrence of voice modification with swallowing disorder

  12. Proportion of patients with recurrent nerve paralysis [ Time Frame: at day 1 post operatively ]
    Clinical evaluation based on the occurrence of voice modification with swallowing disorder

  13. Proportion of patients with recurrent nerve paralysis [ Time Frame: at day 8 post operatively ]
    Clinical evaluation based on the occurrence of voice modification with swallowing disorder

  14. Patients' satisfaction regarding his/her care evaluated using visual analogue scale (VAS) [ Time Frame: at day 0 post operatively ]
    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.

  15. Patients' satisfaction regarding his/her care evaluated using visual analogue scale (VAS) [ Time Frame: at day 1 post operatively ]
    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.

  16. Patients' satisfaction regarding his/her care evaluated using visual analogue scale (VAS) [ Time Frame: at 3 months post operatively ]
    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.

  17. Total cost of mode of care [ Time Frame: at 3 months post operatively ]
    Total cost of hospital surgery stay and hospital readmission at 3 months



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Ages Eligible for Study:   19 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Major patients with primary hyperparathyroidism
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03732157


Contacts
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Contact: Pierre CATTAN, Pr 0142499381 ext +33 pierre.cattan@aphp.fr
Contact: Matthieu RESCHE-RIGON, Pr 0142499742 ext +33 matthieu.resche-rigon@univ-paris-diderot.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03732157     History of Changes
Other Study ID Numbers: K180301J
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Primary Hyperparathyroidism
Parathyroidectomy
Outpatient management

Additional relevant MeSH terms:
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Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases
Parathyroid Hormone
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs