Pre- and Postoperative Apnea-Hypopnea Index After Same-Day Discharge Bariatric Surgery

NCT ID: NCT06452784

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 103 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2025-07-05

Brief Summary

A recent development is same-day discharge in bariatric surgery, this seems to be safe if proper discharge criteria are used. However, yet there is no guideline for these discharge criteria, including for patients with (potential) Obstructive Sleep Apnea (OSA). To establish proper discharge criteria concerning OSA more information about (changes in) OSA during the first days after bariatric surgery is required.

The aim of this study is to assess postoperative Apnea-Hypopnea Index (AHI) changes during the first and third night after Same-Day Discharge bariatric surgery in patients with potentially untreated OSA.

Methods: Patients (n=60) will undergo a Home Sleep Apnea test , pre-operatively and during the first en third postoperative night after bariatric surgery to asses the AHI and sleep architecture.

Detailed Description

Rationale:

Bariatric surgery is a highly effective and sustainable treatment against obesity. Recently there has been a trend towards Same-Day Discharge (SDD) bariatric surgery. SDD bariatric surgery has proven to be safe, when proper discharge criteria are used. However, there is no consensus or guideline for discharge criteria for SDD bariatric surgery. In particular, discharge criteria for patients with obstructive sleep apnea (OSA) diverge between hospitals. In some, but not all hospitals, having (untreated) OSA is a contra-indication for SDD bariatric surgery.

In Rijnstate hospital, bariatric patients are not routinely tested for OSA preoperatively, meaning that they potentially have undiagnosed OSA. Having potentially undiagnosed OSA, is not a contra-indication for SDD bariatric surgery in Rijnstate hospital. Hospitals could be hesitant for SDD bariatric surgery in patients with OSA, because it is known that the apnea hypopnea index (AHI) increases postoperatively. In a population without obesity, the highest postoperative AHI was found during the third postoperative night. During this third postoperative night, patients with a normal postoperative course will already sleep at home, both after inpatient and SDD bariatric surgery. This raises the question whether having (untreated) OSA should be a contra-indication for SDD bariatric surgery. However, it is unknown if the same postoperative changes in AHI and sleep architecture occur in patients undergoing bariatric surgery. Objective: The primary objective of this study is to assess postoperative Apnea-Hypopnea Index (AHI) changes during the first and third night after Same-Day Discharge bariatric surgery in patients with potentially untreated OSA. The secondary objective of this study is to compare postoperative AHI changes between patients with a pre-operative AHI of 0-14 or ≥15. The tertiary objective of this study is to describe and compare pre- and postoperative sleep architecture.

Study design:

This is a prospective observational study. AHI and sleep architecture will be assessed and compared before and after Same-Day discharge (SDD) bariatric surgery during the first and third postoperative night with Home Sleep Apnea Tests.

Study population: Patients scheduled for primary SDD bariatric surgery without treated OSA

Main study parameters/endpoints: Primary endpoint is AHI. Secondary and tertiary endpoints are 30 days complications rate, and parameters for sleep architecture and sleep related breathing.

Conditions

Obstructive Sleep Apnea; Bariatric Surgery Candidate; Same-day Discharge

Study Design

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

Study Groups

All study participants

Alle study participants will receive standard of care. For this study participants will complete two short questionnaires (the STOPBANG and ESS) and will undergo three home sleep apnea tests with the WatchPat one. These will be performed during the night seven days prior to surgery and during night one and three after surgery.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Undergo primary bariatric surgery (Roux and y gastric bypass or sleeve gastrectomy)
• Eligible for same-day discharge
• In possession and able to use a smartphone

Exclusion Criteria

• Revisional bariatric surgery (e.g. sleeve conversion, RYGB after gastric banding)
• Not eligible for same-day discharge
• Diagnosed OSA with treatment (CPAP, oral appliances)
• Professional drivers
• Use of alpha blockers
• Unable to speak or read the Dutch language
• Not in possession or not able to use a smartphone

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rijnstate Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Hazebroek, Professor

Role: PRINCIPAL_INVESTIGATOR

Vitalys part of Rijnstate

Locations

Vitalys

Elst, , Netherlands

Countries

Netherlands

Other Identifiers

2024-2418

Identifier Type: -

Identifier Source: org_study_id