South African Surgical Outcomes Study

NCT02141867 | Completed Results

• 1 other identifier: SASOS
• Study Type: observational
• Target: 3,927
• Locations: 1 country
• Sites: 1

Brief Summary

We will conduct a 7 day cohort study of consecutive patients aged 16 years and older undergoing inpatient noncardiac surgery. Patients will be followed up for a maximum of 30 days. We will follow the original European Surgical Outcomes Study (EuSOS) study design. The primary outcome is in-hospital mortality. Secondary outcomes include length of stay and admission to intensive care. Centres across South Africa representing the public service will recruit patients. This study will run from 19 May 2014 to 26 May 2014.

Conditions

Mortality Following Noncardiac Surgery

Keywords

Surgery; Mortality

Outcome Measures

Primary Outcomes (1)

• Mortality

  In hospital mortality

  Upto 30 days

Secondary Outcomes (3)

• Duration of Hospital Stay

  Upto 30 days

• Admission to Critical Care After Surgery

  Upto 30 days

• Duration of Critical Care Stay

  Upto 30 days

Study Arms (1)

Noncardiac surgical patients

Noncardiac surgery patients 16 years or older undergoing inpatient surgery

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Seven day, South African national multi-centre cohort study of adult (≥16 years) patients undergoing in-patient non-cardiac surgery.

You may qualify if:

• All consecutive patients admitted to participating centres undergoing elective and non-elective non-cardiac surgery commencing during the seven day study cohort period with a planned overnight stay. The recruitment week will run from 07h00 on 19 May 2014 to 06h59 on 26 May 2014.

You may not qualify if:

• Patients undergoing planned day-case surgery, cardiac surgery or radiological procedures not requiring anaesthesia.

Sponsors & Collaborators

• University of KwaZulu: lead
• South African Society of Anaesthesiologists (SASA): collaborator
• South African Vascular Society (VASSA): collaborator

Study Sites (1)

University of Kwazulu-Natal

KwaKhangela, KwaZulu-Natal, 4013, South Africa

Location

Related Publications (2)

• Skinner DL, De Vasconcellos K, Wise R, Esterhuizen TM, Fourie C, Goolam Mahomed A, Gopalan PD, Joubert I, Kluyts HL, Mathivha LR, Mrara B, Pretorius JP, Richards G, Smith O, Spruyt MGL, Pearse RM, Madiba TE, Biccard BM, The South African Surgical Outcomes Study Sasos Investigators OBO. Critical care admission of South African (SA) surgical patients: Results of the SA Surgical Outcomes Study. S Afr Med J. 2017 Apr 25;107(5):411-419. doi: 10.7196/SAMJ.2017.v107i5.11455.

  PMID: 28492122 DERIVED

• Biccard BM, Madiba TE; South African Surgical Outcomes Study Investigators. The South African Surgical Outcomes Study: A 7-day prospective observational cohort study. S Afr Med J. 2015 Jun;105(6):465-75. doi: 10.7196/samj.9435.

  PMID: 26716164 DERIVED

Results Point of Contact

• Title: Prof Bruce Biccard
• Organization: South African Surgical Outcomes Study

biccardb@ukzn.ac.za

+27312604328

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 20, 2014
• Study Start: May 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 9, 2016
• Results First Posted: February 9, 2016

Record last verified: 2016-01

Locations

ZA (1)