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

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.

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 Overview

• Status: Unknown
• Conditions: Primary Hyperparathyroidism
• Intervention / Treatment: Procedure: outpatient management of parathyroidectomy; Procedure: conventional management of parathyroidectomy

• Study Type: Observational
• Enrollment (Anticipated): 140

Contacts and Locations

• Study Contact: Name: Pierre CATTAN, Pr; Phone Number: +33 0142499381; Email: pierre.cattan@aphp.fr
• Study Contact Backup: Name: Matthieu RESCHE-RIGON, Pr; Phone Number: +33 0142499742; Email: matthieu.resche-rigon@univ-paris-diderot.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Major patients with primary hyperparathyroidism

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
Proportion of patients with recurrent nerve paralysis	Clinical evaluation based on the occurrence of voice modification with swallowing disorder	at day 0 post operatively
Proportion of patients with recurrent nerve paralysis	Clinical evaluation based on the occurrence of voice modification with swallowing disorder	at day 1 post operatively
Proportion of patients with recurrent nerve paralysis	Clinical evaluation based on the occurrence of voice modification with swallowing disorder	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.	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.	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.	at 3 months post operatively
Total cost of mode of care	Total cost of hospital surgery stay and hospital readmission at 3 months	at 3 months post operatively

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2018
• Primary Completion (ANTICIPATED): July 1, 2019
• Study Completion (ANTICIPATED): July 1, 2019

Study Registration Dates

• First Submitted: September 18, 2018
• First Submitted That Met QC Criteria: November 2, 2018
• First Posted (ACTUAL): November 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 6, 2018
• Last Update Submitted That Met QC Criteria: November 2, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Primary Hyperparathyroidism; Parathyroidectomy; Outpatient management
• Additional Relevant MeSH Terms: Endocrine System Diseases; Parathyroid Diseases; Hyperparathyroidism; Hyperparathyroidism, Primary
• Other Study ID Numbers: K180301J

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No