Feasibility of Parathyroidectomy With Exploration of 4 Parathyroid Glands in Outpatients

NCT ID: NCT03732157

Last Updated: 2018-11-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-30
• Study Completion Date: 2019-07-31

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.

Conditions

Primary Hyperparathyroidism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

outpatient management of parathyroidectomy

outpatient management of parathyroidectomy

Intervention Type: PROCEDURE

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

conventional management of parathyroidectomy

Intervention Type: PROCEDURE

The patient stays overnight in hospital after intervention

Interventions

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)

Intervention Type: PROCEDURE

conventional management of parathyroidectomy

The patient stays overnight in hospital after intervention

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Pierre CATTAN, Pr

Role: CONTACT

pierre.cattan@aphp.fr

0142499381 ext. +33

Matthieu RESCHE-RIGON, Pr

Role: CONTACT

matthieu.resche-rigon@univ-paris-diderot.fr

0142499742 ext. +33

Other Identifiers

K180301J

Identifier Type: -

Identifier Source: org_study_id