Clinical trial NCT03732157: Feasibility of Parathyroidectomy With Exploration of 4 Parathyroid Glands in Outpatients
Official title: Feasibility of Parathyroidectomy With Exploration of 4 Parathyroid Glands in Outpatients, for Treatment of Primary Hyperparathyroidism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Hyperparathyroidism
Keywords: Primary Hyperparathyroidism
Parathyroidectomy
Outpatient management
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 140
Sex: ALL
Minimum age (years): 19
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major patients with primary hyperparathyroidism

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.


Eligibility 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

Primary outcomes:
measure: Proportion of conversion or readmission to conventional hospitalization
timeFrame: within 8 days postoperatively
Secondary outcomes:
measure: Postoperative pain evaluated using visual analogue scale (VAS)
timeFrame: at day 0 post operatively
measure: Postoperative pain evaluated using visual analogue scale (VAS)
timeFrame: at day 1 post operatively
measure: Postoperative pain evaluated using visual analogue scale (VAS)
timeFrame: at day 8 post operatively
measure: Proportion of patients with breathing difficulty.
timeFrame: at day 1 post operatively
measure: Proportion of patients with breathing difficulty.
timeFrame: at day 8 post operatively
measure: Proportion of patients with compressive cervical hematoma
timeFrame: at day 0 post operatively
measure: Proportion of patients with compressive cervical hematoma
timeFrame: at day 1 post operatively
measure: Proportion of patients with compressive cervical hematoma
timeFrame: at day 8 post operatively
measure: Proportion of patients with hypocalcemia
timeFrame: at day 1 post operatively
measure: Proportion of patients with hypocalcemia
timeFrame: at 3 months post operatively
measure: Proportion of patients with recurrent nerve paralysis
timeFrame: at day 0 post operatively
measure: Proportion of patients with recurrent nerve paralysis
timeFrame: at day 1 post operatively
measure: Proportion of patients with recurrent nerve paralysis
timeFrame: at day 8 post operatively
measure: Patients' satisfaction regarding his/her care evaluated using visual analogue scale (VAS)
timeFrame: at day 0 post operatively
measure: Patients' satisfaction regarding his/her care evaluated using visual analogue scale (VAS)
timeFrame: at day 1 post operatively
measure: Patients' satisfaction regarding his/her care evaluated using visual analogue scale (VAS)
timeFrame: at 3 months post operatively
measure: Total cost of mode of care
timeFrame: at 3 months post operatively
Other outcomes:
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