NCT06738004

Brief Summary

The goal of this observational study is to investigate the incidence, management, and outcomes of complications following bariatric surgery in patients in the United Kingdom. The main questions it aims to answer are:

  • What is the prevalence of unplanned interventions due to complications following bariatric surgery in the UK?
  • What are the current practices for managing these complications, and how do they impact patient outcomes? Participants will: Be identified from hospitals treating patients presenting with complications following bariatric surgery. Have their data collected regarding demographics, surgical history, complications, treatments, and outcomes. Researchers will compare different management strategies and their impact on patient outcomes, with the aim of identifying best practices to improve emergency bariatric care and factors leading to patients attending as an emergency.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2025

Completed
Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

2.1 years

First QC Date

December 12, 2024

Last Update Submit

December 12, 2024

Conditions

Bariatric SurgeryPostoperative ComplicationsEmergenciesSurgical Procedures, OperativeOutcome Assessment (Health Care)Quality ImprovementMorbidityMortality

Keywords

Bariatric surgeryEmergency complicationsNational auditSurgical outcomesManagement strategiesUnited KingdomPatient safetyQuality improvementMorbidity and mortalityPostoperative complications

Outcome Measures

Primary Outcomes (3)

  • 30-day mortality

    Time in days

    up to 30 days from procedure or admission

  • Inpatient length of stay

    Time in days

    Up to 100 weeks from admission

  • Clavien-Dindo Classification of Complications

    Severity of complication

    through study completion, an average of 1 year

Secondary Outcomes (6)

  • Frequency and rate of nutritional support

    through study completion, an average of 1 year

  • Frequency and type of interventional radiology

    through study completion, an average of 1 year

  • Frequency and type of surgery, diagnostic or therapeutic procedures

    through study completion, an average of 15 years post-op from index surgery

  • Frequency of admission to critical care units

    through study completion, an average of 1 year

  • Engagement with NHS specialised weight management services

    through study completion, an average of 10 years prior to admission

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients admitted from these locations i) the emergency department, clinic, urgent care or primary care to the bariatric surgical team as an emergency; ii) from an inpatient team as an urgent referral; iii) a return to theatre following an elective bariatric procedure; iv) another hospital via patient transfer to a specialised unit,with the intent to treat or diagnose complications of bariatric surgery

You may qualify if:

  • Admissions from i) the emergency department, clinic, urgent care or primary care to the bariatric surgical team as an emergency; ii) from an inpatient team as an urgent referral; iii) a return to theatre following an elective bariatric procedure; iv) another hospital via patient transfer to a specialised unit.
  • Participants undergoing any intervention or procedure to treat or diagnose bariatric complications, (e.g., OGDs, interventional radiology, surgery, supplemental enteral or parenteral nutrition).

You may not qualify if:

  • age \<18 years old
  • have a length of stay \<24 hrs.
  • initial diagnosis of BSE is changed or if their readmission is found to be unrelated to previous bariatric surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luton and Dunstable Hospital

Luton, United Kingdom

RECRUITING

MeSH Terms

Conditions

Postoperative ComplicationsEmergencies

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • Mohamed Aly, FRCS

    The Hillingdon Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Aly, FRCS

CONTACT

01895 279994m.aly@nhs.net

Alan Askari, FRCS

CONTACT

alan.askari@nhs.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Upper GI and General Surgeon

Study Record Dates

First Submitted

December 12, 2024

First Posted

December 17, 2024

Study Start

November 9, 2023

Primary Completion

December 9, 2025

Study Completion

December 9, 2025

Last Updated

December 17, 2024

Record last verified: 2024-12

Locations

GB(1)