Feasibility of Parathyroidectomy With Exploration of 4 Parathyroid Glands in Outpatients

NCT03732157 | Unknown DMC

• 1 other identifier: K180301J
• Study Type: observational
• Target: 140
• Locations: 0 countries
• Sites: N/A

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

Keywords

Primary Hyperparathyroidism; Parathyroidectomy; Outpatient management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Postoperative pain evaluated using visual analogue scale (VAS)

  at day 0 post operatively

• Postoperative pain evaluated using visual analogue scale (VAS)

  at day 1 post operatively

• Postoperative pain evaluated using visual analogue scale (VAS)

  at day 8 post operatively

• Proportion of patients with breathing difficulty.

  at day 1 post operatively

• Proportion of patients with breathing difficulty.

  at day 8 post operatively

Study Arms (2)

outpatient management of parathyroidectomy

Procedure: outpatient management of parathyroidectomy

conventional management of parathyroidectomy

Procedure: conventional management of parathyroidectomy

Interventions

outpatient management of parathyroidectomy PROCEDURE

The patient is discharged from hospital the same day of the parathyroidectomy intervention instead of conventional management (stay overnight in hospital)

outpatient management of parathyroidectomy

conventional management of parathyroidectomy PROCEDURE

The patient stays overnight in hospital after intervention

conventional management of parathyroidectomy

Eligibility Criteria

• Age: 19 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Major patients with primary hyperparathyroidism

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Central Study Contacts

Pierre CATTAN, Pr

CONTACT

0142499381; pierre.cattan@aphp.fr

Matthieu RESCHE-RIGON, Pr

CONTACT

0142499742; matthieu.resche-rigon@univ-paris-diderot.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: November 6, 2018
• Study Start: November 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: November 6, 2018

Record last verified: 2018-09