African Surgical Outcomes Study (ASOS)

NCT03044899 | Completed

• 1 other identifier: ASOS
• Study Type: observational
• Target: 11,422
• Locations: 22 countries
• Sites: 22

Brief Summary

STUDY OBJECTIVE To confirm the incidence of in-hospital postoperative complications in adult surgical patients in Africa. STUDY DESIGN Seven day, African national multi-centre prospective observational cohort study of adult (≥18 years) patients undergoing surgery. Patients will be followed up for a maximum of 30 days. We will follow the original International Surgical Outcomes Study (ISOS) study design. The primary outcome is in-hospital postoperative complications in adult surgical patients in Africa. Secondary outcomes include in-hospital mortality and the relationship between postoperative complications and postoperative mortality. The intention is to present a representative sample of surgical outcomes across all African countries. This study will run between February and March 2016.

Conditions

Surgery; Surgery- Complications; Mortality

Keywords

Surgery; Complications; Mortality

Outcome Measures

Primary Outcomes (1)

• Incidence of in-hospital postoperative complications in adult surgical patients in Africa

  Postoperative complications

  In-hospital upto 30 days

Secondary Outcomes (2)

• Rate of mortality on the day of surgery for patients undergoing surgery in Africa

  1 day

• The in-hospital mortality rate for patients undergoing surgery in Africa

  In-hospital upto 30 days

Study Arms (1)

Adult surgical patients

All surgeries in adult patients

Procedure: All surgeries in adult patients

Interventions

All surgeries in adult patients PROCEDURE

All surgeries in adult patients

Adult surgical patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Seven day, African national multi-centre cohort study of adult (≥18 years) patients undergoing surgery.

You may qualify if:

• All consecutive patients admitted to participating centres undergoing elective and non-elective surgery commencing during a seven day study cohort period with a planned overnight hospital stay following surgery. The recruitment week will run between February and May 2016.

You may not qualify if:

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

Sponsors & Collaborators

• University of KwaZulu: lead
• Medical Research Council, South Africa: collaborator

Study Sites (25)

National Coordination Office

Algiers, Algiers Province, 16000, Algeria

Location

National Coordination Office

Cotonou, Cotonou, Benin

Location

National Coordination Office

Bujumbura, Bujumbura Mairie Province, Burundi

Location

National Coordination Office

Mutengene, Mutengene, Cameroon

Location

National Coordination Office

Kinshasa, Kinshasa City, Democratic Republic of the Congo

Location

National Coordination Office

Cairo, Cairo Governorate, Egypt

Location

National Coordination Office

Addis Ababa, Addis Ababa, Ethiopia

Location

National Coordination Office

Kumasi, Kumasi, Ghana

Location

National Coordination Office

Nairobi, Nairobi County, Kenya

Location

National Coordination Office

Tripoli, Tripoli, Libya

Location

National Coordination Office

Androhibe, Tana, Madagascar

Location

National Coordination Office

Bamako, Bamako, Mali

Location

National Coordination Office

Rose Belle, Rose Belle, Mauritius

Location

National Coordination Office

Windhoek, Khomas Region, Namibia

Location

National Coordination Office

Ibadan, Ibadan, Nigeria

Location

National Coordination Office

Niamey, Naimey, Niger

Location

National Coordination Office

Brazzaville, Brazzavile Department, Republic of the Congo

Location

National Coordination Office

Dakar, Dakar, Senegal

Location

University of Kwazulu-Natal

KwaKhangela, KwaZulu-Natal, 4013, South Africa

Location

National Coordination Office

Mwanza, Mwanza Region, Tanzania

Location

National Coordination Office

Banjul, City of Banjul, The Gambia

Location

National Coordination Office

Tokoin, Lomé, Togo

Location

National Coordination Office

Kampala, Kampala, Uganda

Location

National Coordination Office

Lusaka, Lusaka Province, Zambia

Location

National Coordination Office

Harare, Harare, Zimbabwe

Location

Related Publications (4)

• van der Merwe F, Vickery NJ, Kluyts HL, Yang D, Han Y, Munlemvo DM, Ashebir DZ, Mbwele B, Forget P, Basenero A, Youssouf C, Antwi-Kusi A, Ndonga AK, Ngumi ZWW, Elkhogia A, Omigbodun AO, Tumukunde J, Madzimbamuto FD, Gobin V, Mehyaoui R, Samateh AL, du Toit L, Madiba TE, Pearse RM, Biccard BM; African Surgical Outcomes Study (ASOS) investigators. Postoperative Outcomes Associated With Procedural Sedation Conducted by Physician and Nonphysician Anesthesia Providers: Findings From the Prospective, Observational African Surgical Outcomes Study. Anesth Analg. 2022 Aug 1;135(2):250-263. doi: 10.1213/ANE.0000000000005819. Epub 2021 Dec 28.

  PMID: 34962901 DERIVED

• Bishop D, Dyer RA, Maswime S, Rodseth RN, van Dyk D, Kluyts HL, Tumukunde JT, Madzimbamuto FD, Elkhogia AM, Ndonga AKN, Ngumi ZWW, Omigbodun AO, Amanor-Boadu SD, Zoumenou E, Basenero A, Munlemvo DM, Youssouf C, Ndayisaba G, Antwi-Kusi A, Gobin V, Forget P, Mbwele B, Ndasi H, Rakotoarison SR, Samateh AL, Mehyaoui R, Patel-Mujajati U, Sani CM, Esterhuizen TM, Madiba TE, Pearse RM, Biccard BM; ASOS investigators. Maternal and neonatal outcomes after caesarean delivery in the African Surgical Outcomes Study: a 7-day prospective observational cohort study. Lancet Glob Health. 2019 Apr;7(4):e513-e522. doi: 10.1016/S2214-109X(19)30036-1.

  PMID: 30879511 DERIVED

• Kluyts HL, le Manach Y, Munlemvo DM, Madzimbamuto F, Basenero A, Coulibaly Y, Rakotoarison S, Gobin V, Samateh AL, Chaibou MS, Omigbodun AO, Amanor-Boadu SD, Tumukunde J, Madiba TE, Pearse RM, Biccard BM; African Surgical Outcomes Study (ASOS) investigators. The ASOS Surgical Risk Calculator: development and validation of a tool for identifying African surgical patients at risk of severe postoperative complications. Br J Anaesth. 2018 Dec;121(6):1357-1363. doi: 10.1016/j.bja.2018.08.005. Epub 2018 Sep 17.

  PMID: 30442264 DERIVED

• Biccard BM, Madiba TE, Kluyts HL, Munlemvo DM, Madzimbamuto FD, Basenero A, Gordon CS, Youssouf C, Rakotoarison SR, Gobin V, Samateh AL, Sani CM, Omigbodun AO, Amanor-Boadu SD, Tumukunde JT, Esterhuizen TM, Manach YL, Forget P, Elkhogia AM, Mehyaoui RM, Zoumeno E, Ndayisaba G, Ndasi H, Ndonga AKN, Ngumi ZWW, Patel UP, Ashebir DZ, Antwi-Kusi AAK, Mbwele B, Sama HD, Elfiky M, Fawzy MA, Pearse RM; African Surgical Outcomes Study (ASOS) investigators. Perioperative patient outcomes in the African Surgical Outcomes Study: a 7-day prospective observational cohort study. Lancet. 2018 Apr 21;391(10130):1589-1598. doi: 10.1016/S0140-6736(18)30001-1. Epub 2018 Jan 3.

  PMID: 29306587 DERIVED

Related Links

• ASOS website

Study Officials

• Bruce Biccard, MD, PhD

  University of KwaZulu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 7, 2017
• Study Start: February 1, 2016
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2016
• Last Updated: February 7, 2017

Record last verified: 2017-02

Locations

TH (1); LI (1); BU (1); DE (1); MA (1); ZI (1); AL (1); CA (1); NI (1); RE (1); TO (1); NA (1); ET (1); EG (1); BE (1); TA (1); UG (1); GH (1); NG (1); KE (1); SE (1); ZA (1)