Postoperative ComplicationsNiSOSNCT03551912
The Nigerian Surgical Outcomes Study. This Study is Aimed at Observing for Complications Within 30 Days After Surgery
An observational study of Postoperative Complications, run by University of Ibadan at 1 site in Nigeria.
Trial summary
The Nigerian Surgical Outcome Study is a national 30-day observational cohort study of complications after surgery. Various institutions across Nigeria will be involved. The study aims at providing detailed data describing post-operative complications, requirement for intensive care and mortality. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 1 siteNigeria
- Study dates
- Jun 2018to 12 Aug 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults or Paediatrics coming for elective surgical procedures
Who may be able to join
- All consecutive patients admitted to participating centres undergoing elective surgery with a planned overnight hospital stay following surgery during a seven-day study period. The recruitment week will run between June and July 2018.
Who cannot join
- Patients undergoing planned day-case surgery or procedures outside the operating theatre.
Trial locations and contacts
1 site in 1 country.
Nigeria1 site
University College Hospital
Ibadan, Oyo State, 2340001
Babatunde Osinaike, MBChB, FMCA, +2348033303675, drosinaike@yahoo.co.uk
Olusola Idowu, MBChB,FWACS, +2348053136030, zolaspecky@yahoo.com
About this study
Official title: Nigerian Surgical Outcomes Study. A Nigerian, Multi-centre Seven-day Evaluation of Patient Care and Clinical Outcomes for Patients Undergoing Surgery
The Nigerian Surgical Outcome Study is a national 30-day observational cohort study of complications after surgery. Various institutions across Nigeria will be involved. The study aims at providing detailed data describing post-operative complications, requirement for intensive care and mortality. All patients undergoing either elective surgery during a 7-day study period with a planned overnight stay will be recruited.
Read the detailed description
It is widely known that complications after surgery are responsible for a good number of morbidity and mortality following surgery. This national cohort study will help contribute to, and allow a better computation of data on post-operative complications and mortality following elective surgery in Nigeria.
This study therefore has important public health implications for Nigeria. This study will also provide a baseline for other similar studies in future being the first of such in Nigeria.
Objectives are:
- To determine the mortality rate on the day of surgery for patients undergoing surgery in Nigeria.
- To determine the in-hospital mortality rate for patients undergoing surgery in Nigeria.
- To describe the relationship between anaesthetic complications and postoperative mortality.
- To describe the relationship between postoperative complications and postoperative mortality.
- To describe the proportional contribution of communicable, non-communicable diseases and traumatic injuries to critical care admissions and in-hospital mortality in Nigeria. We plan to recruit a minimum of 5 centres per state, made up of federal, state and private hospitals. The national coordinating centre shall be the University College Hospital, Ibadan. Regional coordinating centres shall be in Lagos, Kwara, Enugu, Kaduna, Port-Harcourt, Maiduguri and Abuja.The plan is to recruit all eligible patients during the recruitment week.
All recruited patients would have had the routine preoperative surgical and anaesthetic review. Since the study is purely observational, all basic intraoperative procedures as it relates to surgery and anaesthesia will not be altered. Following informed written consent by the patient, the following information will be obtained.
- Results of preoperative Haemoglobin, Total white cell count, and Creatinine.
- Patient's socio-demographics.
- Co-morbid conditions
- Type of anaesthesia and surgical procedure.
- Anaesthetic and Surgical details
- Critical care admission post-operatively, and
- Postoperative complications observed till discharge or up to 30 days if on admission.
- Conditions
- Postoperative Complications
- Being tested
- Surgery
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
All patients coming for elective surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative complications
In-hospital post-operative complications of any cause
Measured: At discharge or 30 days, whichever is earlier.
Secondary outcomes (4)
Mortality
Rate of mortality on the day of surgery
Measured: Within 24 hours
Mortality
In-hospital all-cause mortality
Measured: At 30 days after surgery
Critical care admission
Critical care admission after surgery
Measured: At 30 days after surgery
Duration of hospital stay
Duration of hospital stay after surgery
Measured: At discharge or 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study startJun 2018 (estimated)
- Primary completion14 Jun 2018 (estimated)
- Study completion12 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ibadan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Babatunde Osinaike, University of Ibadan
- Investigators
- Babatunde Babatunde, MBChB,FMCA, Principal investigator, University of Ibadan/University College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551912
- Sponsor's protocol ID
- NHREC/01/01/2007
- Acronym
- NiSOS
- Status last verified
- Jun 2018
- First submitted
- 26 May 2018
- Last updated
- 11 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be pseudo-anonymised by generation of a unique numeric code and transcribed by local investigators onto an internet based electronic CRF. Each patient will only be identified on the electronic CRF by their numeric code; thus the co- ordinating study team cannot trace data back to an individual patient without contact with the local team.
Publications
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.
PubMed 29306587International Surgical Outcomes Study group. Global patient outcomes after elective surgery: prospective cohort study in 27 low-, middle- and high-income countries. Br J Anaesth. 2016 Oct 31;117(5):601-609. doi: 10.1093/bja/aew316.
PubMed 27799174
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nigerian Surgical Outcomes Study. A Nigerian, Multi-centre Seven-day Evaluation of Patient Care and Clinical Outcomes for Patients Undergoing Surgery
- ClinicalTrials.gov ID
- NCT03551912
- Acronym / sponsor ID
- NiSOS / NHREC/01/01/2007
- Conditions
- Postoperative Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of IbadanUniversity, hospital or other
- Study start
- Jun 2018 (estimated)
- Primary completion
- 14 Jun 2018 (estimated)
- Study completion
- 12 Aug 2018 (estimated)
- First posted
- 11 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Nigerian Surgical Outcome Study is a national 30-day observational cohort study of complications after surgery. Various institutions across Nigeria will be involved. The study aims at providing detailed data describing post-operative complications, requirement for intensive care and mortality. All patients undergoing either elective surgery during a 7-day study period with a planned overnight stay will be recruited.
Detailed description
It is widely known that complications after surgery are responsible for a good number of morbidity and mortality following surgery. This national cohort study will help contribute to, and allow a better computation of data on post-operative complications and mortality following elective surgery in Nigeria.
This study therefore has important public health implications for Nigeria. This study will also provide a baseline for other similar studies in future being the first of such in Nigeria.
Objectives are:
- To determine the mortality rate on the day of surgery for patients undergoing surgery in Nigeria.
- To determine the in-hospital mortality rate for patients undergoing surgery in Nigeria.
- To describe the relationship between anaesthetic complications and postoperative mortality.
- To describe the relationship between postoperative complications and postoperative mortality.
- To describe the proportional contribution of communicable, non-communicable diseases and traumatic injuries to critical care admissions and in-hospital mortality in Nigeria. We plan to recruit a minimum of 5 centres per state, made up of federal, state and private hospitals. The national coordinating centre shall be the University College Hospital, Ibadan. Regional coordinating centres shall be in Lagos, Kwara, Enugu, Kaduna, Port-Harcourt, Maiduguri and Abuja.The plan is to recruit all eligible patients during the recruitment week.
All recruited patients would have had the routine preoperative surgical and anaesthetic review. Since the study is purely observational, all basic intraoperative procedures as it relates to surgery and anaesthesia will not be altered. Following informed written consent by the patient, the following information will be obtained.
- Results of preoperative Haemoglobin, Total white cell count, and Creatinine.
- Patient's socio-demographics.
- Co-morbid conditions
- Type of anaesthesia and surgical procedure.
- Anaesthetic and Surgical details
- Critical care admission post-operatively, and
- Postoperative complications observed till discharge or up to 30 days if on admission.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults or Paediatrics coming for elective surgical procedures
Key inclusion criteria (1 listed)
- All consecutive patients admitted to participating centres undergoing elective surgery with a planned overnight hospital stay following surgery during a seven-day study period. The recruitment week will run between June and July 2018.
Key exclusion criteria (1 listed)
- Patients undergoing planned day-case surgery or procedures outside the operating theatre.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryAll patients coming for elective surgery | Procedure or surgery | – |
Primary outcome
Post-operative complications
Time frame: At discharge or 30 days, whichever is earlier.
In-hospital post-operative complications of any cause
4 secondary outcomes
Mortality
Time frame: Within 24 hours
Mortality
Time frame: At 30 days after surgery
Critical care admission
Time frame: At 30 days after surgery
Duration of hospital stay
Time frame: At discharge or 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
- Results publication: PubMed 29306587Biccard 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.
- Results publication: PubMed 27799174International Surgical Outcomes Study group. Global patient outcomes after elective surgery: prospective cohort study in 27 low-, middle- and high-income countries. Br J Anaesth. 2016 Oct 31;117(5):601-609. doi: 10.1093/bja/aew316.
- Individual participant dataSharing planned: No. Data will be pseudo-anonymised by generation of a unique numeric code and transcribed by local investigators onto an internet based electronic CRF. Each patient will only be identified on the electronic CRF by their numeric code; thus the co- ordinating study team cannot trace data back to an individual patient without contact with the local team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Babatunde Babatunde, MBChB,FMCA principal investigator
University of Ibadan/University College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications, run by University of Ibadan at 1 site in Nigeria.
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 1 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: status not confirmed, as of the sponsor's last update on 11 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Babatunde Osinaike, MBChB,FMCA (+2348033303675, drosinaike@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative complications (time frame: At discharge or 30 days, whichever is earlier.). 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 NCT03551912, 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 11 Jun 2018.