Feasibility of Parathyroidectomy With Exploration of 4 Parathyroid Glands in Outpatients

Primary Hyperparathyroidism Clinical Trial

— PARAMBU  

Official title:

Feasibility of Parathyroidectomy With Exploration of 4 Parathyroid Glands in Outpatients, for Treatment of Primary Hyperparathyroidism

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03732157
• Other study ID #: K180301J
• Status: Not yet recruiting
• Start date: November 2018
• Est. completion date: July 2019

Study information

• Verified date: September 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Pierre CATTAN, Pr
• Phone: 0142499381
• Email: pierre.cattan[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Primary Hyperparathyroidism

Intervention

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
The patient stays overnight in hospital after intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within 8 days postoperatively
Secondary	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.	at day 0 post operatively
Secondary	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.	at day 1 post operatively
Secondary	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.	at day 8 post operatively
Secondary	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.	at day 1 post operatively
Secondary	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.	at day 8 post operatively
Secondary	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)	at day 0 post operatively
Secondary	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)	at day 1 post operatively
Secondary	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)	at day 8 post operatively
Secondary	Proportion of patients with hypocalcemia	Hypocalcemia will be defined as calcemia lower than 2 mmol/L or 80 mg/L	at day 1 post operatively
Secondary	Proportion of patients with hypocalcemia	Hypocalcemia will be defined as calcemia lower than 2 mmol/L or 80 mg/L	at 3 months post operatively
Secondary	Proportion of patients with recurrent nerve paralysis	Clinical evaluation based on the occurrence of voice modification with swallowing disorder	at day 0 post operatively
Secondary	Proportion of patients with recurrent nerve paralysis	Clinical evaluation based on the occurrence of voice modification with swallowing disorder	at day 1 post operatively
Secondary	Proportion of patients with recurrent nerve paralysis	Clinical evaluation based on the occurrence of voice modification with swallowing disorder	at day 8 post operatively
Secondary	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.	at day 0 post operatively
Secondary	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.	at day 1 post operatively
Secondary	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.	at 3 months post operatively
Secondary	Total cost of mode of care	Total cost of hospital surgery stay and hospital readmission at 3 months	at 3 months post operatively