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SurgeryNCT04961489

Impact of Measures Taken to Contain COVID-19 on Hospital Surgical Care Services and Clinical Outcomes

An observational study of Surgery, run by National Cancer Centre, Singapore at 2 sites in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to look at the impact on patient outcomes arising from measures implemented during the COVID-19 pandemic. The information and knowledge from this study will be useful for the management and allocation of hospital resources and patients in tne event of a disease outbreak. Read more about this study

Who is it for?
Ages 21 to 100 years
Conditions the study is for
Surgery
How many people
11,000 participants
Where
2 sitesSingapore
Study dates
1 Aug 2020to 31 Mar 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This study seeks to assess the effect of the measures taken to contain COVID 19 on patients who need surgical services measured by patient outcomes, such as, length of hospital stay (LOS), ICU stay, APACHE score, and stage of cancer at surgery.

Who may be able to join

  • This study involves the extraction of patient records from the enterprise dataware house. As such, we do not stipulate the age limits.
  • Patients who had the following surgeries during over the period of 1 Jan 2017 to 31 December 2020
  • From the identified surgical procedure type or the following cancer-related procedures:
  • Breast
  • Colon
  • Liver
Show all 12Show fewer
  • Rectum
  • Selected non-cancer surgeries:
  • Abdominal Wall
  • Gallbladder
  • Patients from SGH and its related institute NCC
  • Only local Singapore Citizens

Who cannot join

  • No exclusion criteria

Trial locations and contacts

2 sites in 1 country.

Singapore2 sites

  • Singapore General Hospital

    Singapore, 169608

  • National Cancer Center Singapore

    Singapore, 169690

Other trials in Singapore

About this study

This study aims to look at the impact on patient outcomes arising from measures implemented during the COVID-19 pandemic. The information and knowledge from this study will be useful for the management and allocation of hospital resources and patients in tne event of a disease outbreak.

Conditions
Surgery
Keywords
Covid-19 pandemic, emergency, cancer, elective surgery, postponement
Medical subject headings
COVID-19, Emergencies, Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Analysis of patients according to type of surgical procedures, medical condition and dates of surgical treatment retrospectively.

    These patients are classified according to the institution, type of surgical procedures, the medical condition and the dates of surgical treatment. The study will be compared across four time periods.

    Measured: 1 Jan - 31 Dec 2017, 1 Jan - 31 Dec 2018, 1 Jan - 31 Dec 2019, 1 Jan - 31 Dec 2020

  2. Comparing surgical indices for high volume cancer and non-cancer diagnoses

    The study focus on surgical indices for selected high-volume cancer and non-cancer diagnoses over the period 1st January2020 to 31 December 2020 and compare them with similar indices across the same period of time in the preceding 3 years in particular, for the following surgical procedures:

    1. Surgeries for the following cancer diagnoses:
    2. breast cancer, [XIV- N60, no malignancy], [Malignant, IINeoplasms- C50], colorectal cancer, [C18, 19, 20],
    3. hepatocellular carcinoma, [C22]
    4. Selected non-cancer surgeries:
    5. Cholecystectomy
    6. Abdominal hernia repair

    Measured: 1 Jan 2020 - 31 Dec 2020

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2021
  2. Study start1 Aug 2020
  3. Primary completion31 Mar 2021
  4. Study completion31 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
11,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04961489
Sponsor's protocol ID
2020/2706
Status last verified
Jul 2021
First submitted
12 Jul 2021
Last updated
14 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mazingi D, Navarro S, Bobel MC, Dube A, Mbanje C, Lavy C. Exploring the Impact of COVID-19 on Progress Towards Achieving Global Surgery Goals. World J Surg. 2020 Aug;44(8):2451-2457. doi: 10.1007/s00268-020-05627-7.

    PubMed 32488665

  • Al-Jabir A, Kerwan A, Nicola M, Alsafi Z, Khan M, Sohrabi C, O'Neill N, Iosifidis C, Griffin M, Mathew G, Agha R. Impact of the Coronavirus (COVID-19) pandemic on surgical practice - Part 2 (surgical prioritisation). Int J Surg. 2020 Jul;79:233-248. doi: 10.1016/j.ijsu.2020.05.002. Epub 2020 May 12.

    PubMed 32413502

Questions about this trial

What is this clinical trial studying?

An observational study of Surgery, run by National Cancer Centre, Singapore at 2 sites in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Analysis of patients according to type of surgical procedures, medical condition and dates of surgical treatment retrospectively. (time frame: 1 Jan - 31 Dec 2017, 1 Jan - 31 Dec 2018, 1 Jan - 31 Dec 2019, 1 Jan - 31 Dec 2020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04961489, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.

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