Surgery ComplicationsSurgWeek-2NCT07785076
SurgWeek-2: Identifying the Global Burden of Post Operative Complications: an International Prospective Cohort Study Protocol
An observational study of Surgery Complications and Surgery, run by University of Birmingham.
Trial summary
This study aims to assess and improve the global outcomes following surgery. Every year approximately 313 million operations are performed, with 50 million people experiencing a complication and unfortunately 3.5 million people will die following these operations. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Surgery Complications, Surgery, Global Surgery
- How many people
- 100,000 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2026to Mar 2027
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All consecutive patients undergoing surgery
Who may be able to join
- Any operation (elective or emergency) performed in an operating theatre is eligible for inclusion, except for minor procedures specified in Appendix A.
- All surgical specialties can participate including acute care surgery, breast surgery, cardiac surgery, colorectal surgery, general surgery, gynaecology, hepatobiliary surgery, neurosurgery, obstetrics, oesophagogastric surgery, ophthalmology, oral and maxillofacial surgery, orthopaedics, otolaryngology, paediatric surgery, plastic surgery, thoracic surgery, transplant surgery, trauma surgery, urology and vascular surgery.
- Patients undergoing both day case surgery and inpatient surgery should be included.
Who cannot join
- Patients who do not undergo an operation (e.g. planned operations that are cancelled).
- Patients undergoing angiography or minor procedures.
- Procedures performed outside of an operating theatre
- Individual participating centres can choose to include children only, adults only, or both children and adults. If including children or adults only, an age cut off should be selected that is appropriate to the local context.
- Each individual patient should only be included in the study once, based on the first operation they undergo within the data capture window. Therefore, patients who are re-operated within 30-days should only be entered once.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Rachel Lillywhite contact
About this study
This study aims to assess and improve the global outcomes following surgery. Every year approximately 313 million operations are performed, with 50 million people experiencing a complication and unfortunately 3.5 million people will die following these operations. This study will assess how outcomes vary following surgery throughout the world and explore system access, quality and efficiency.
The secondary aims of this study are to (1) assess the use of antibiotics and the impact of resistant organisms globally, (2) assess who dies after an operation and whether there are factors that were identified that could have prevented the death, (3) assess the assess and outcomes to minimally invasive and robotic surgery, (4) assess the outcomes of the Bellwether procedures (laparotomy, caesarean delivery, open fracture management) as these are conditions used to assess the functioning of a health system.
Read more
The study will take place for six week in May-June 2026 and will aim to collect data from 100,000 patients across 1000 hospitals in 100 countries to give a global perspective on the above outcome measures. The data will be analysed by hospital income group to understand how resources impact on outcomes.
By combining global data on clinical outcomes with information on hospital resources, this study hopes to provide valuable insights into how to improve surgical care across diverse settings, making recommendations that lead to better access to safe, timely and affordable care for surgical problems worldwide.
Read the detailed description
Background:
Surgery is a fundamental and core component of global healthcare. Without it we are unable to deliver safe maternity, trauma and cancer care. Access and treatment options vary globally. Approximately 313 million operations are performed globally every year, however high-quality outcome data is available for only a fraction of these. (1) There are estimated to be 50 million adults experiencing at least one post operative complication per year, of whom 3.5 million will die within 30 days of surgery. (1) Evidence suggests around half of complications are avoidable. (2, 3) Complications after surgery prolong inpatient admissions, increase care costs and can lead to death and disability. Global data on post-operative outcomes is lacking. We propose an International, prospective, multicentre cohort study to assess the global burden of post operative complications, its variation and sequalae.
Methodology:
This International, prospective, multicentre, global cohort study will include consecutive patients undergoing surgery within an overall six-week window between 4th May 2026 and 14th June 2026. The primary outcome will be complications measured by Clavien-Dindo grade at 30-days following surgery. Any hospital delivering surgery are eligible to participate. All patients undergoing elective or emergency operations will be included. Hospitals can have a team of up to three collaborators for each surgical speciality per week. Teams can choose to collect data for one or multiple specialities and one or multiple week periods. Hospitals can have multiple teams to allow all specialities to submit data. Data will be collected on consecutive patients from their chosen surgical specialities for one or multiple 7-day periods, with a subsequent 30-day follow-up over the six-week window. There will be no changes made to routine patient care pathways/management or follow-up as this will be an observational study. No identifiable data will be collected. There will be a mandatory site survey for all centres participating.
Appropriate registration and study approval as per local regulations is mandatory for participation. All data will be captured with REDCap - a secure online data management system.
Discussion: This study will generate data on the global variability in post operative complications for a range of common operations. This will offer insights to the global burden of disease, access to emergency and elective care, imaging and 'rescue' from complications. This data will aid in the creation of guidelines to improve care across the world and informing trial design to target areas of preventable morbidity and mortality.
- Conditions
- Surgery Complications, Surgery, Global Surgery, Robotic, Laparotomy, Caesarean Section
- Keywords
- Complications, mortality, Laparotomy, Caesarean Delivery/Section, Open fracture, Antimicrobial use, Robotic surgery, Minimally invasive surgery
- Medical subject headings
- Fractures, Open
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing surgery | Patients undergoing surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global variation in post operative complications.
The primary aim of SurgWeek-2 is to assess the global burden and variation of postoperative complications. We will determine the frequency of postoperative complications across low-, middle- and high-income countries, further stratifying by age, sex, and surgical speciality.
Measured: 30 days
Secondary outcomes (5)
Global variation in postoperative infective complication and antimicrobial resistance rates.
We will determine the variation of postoperative infective complications across low-, middle- and high-income countries, further stratifying by age, sex, and surgical speciality. This will include, surgical site infection, deep organ space infection, postoperative pneumonia and anastomotic leak. We will assess patterns in antimicrobial resistances in wound swabs.
Measured: 30 days
Global variation in postoperative mortality rates and underlying reasons for postoperative mortality.
We will determine the variation of postoperative mortality across low-, middle- and high-income countries, further stratifying by age, sex, and surgical speciality. We will assess causes and patterns of postoperative mortality across countries.
Measured: 30 days
Global variation in access to and outcomes associated with minimally invasive and robotic surgery.
We will determine the variation and outcomes of minimally invasive and robotic surgery across low-, middle- and high-income countries, further stratifying by age, sex, and surgical speciality.
Measured: 30 days
Global variation in the outcomes of the Bellwether procedures (laparotomy, caesarean delivery and open fracture management)
We will determine the variation and outcomes of the Bellwether procedures (laparotomy, caesarean delivery and open fracture management) across low-, middle- and high-income countries, further stratifying by age, sex, and surgical speciality.
Measured: 30 days
30-day Clavien-Dindo complication grade.
We will determine the grade of postoperative complications according to the Clavien-Dindo classification and compare outcomes across low-, middle- and high-income countries, further stratifying by age, sex, and surgical speciality. Complication is defined as: Any deviation from the normal post-operative course that has an adverse effect on the patient and is not either a treatment failure or sequel.
Specific complications that will be assessed include:
- 30 day acute respiratory distress syndrome
- 30 day unexpected ventilation
- 30 day pulmonary embolism
- 30 day deep vein thrombosis
- 30 day cardiac complications
- Hospital length of stay within 30 days of surgery
- Days alive out of hospital at postoperative day 30
- 30 day reoperation
- 30 day readmission
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start31 Aug 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery 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
- 100,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785076
- Sponsor's protocol ID
- 156087
- Acronym
- SurgWeek-2
- Status last verified
- Jul 2026
- First submitted
- 20 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: SurgWeek-2 is collecting only routinely collected hospital data, seeking to measure current clinical practice.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SurgWeek-2: Identifying the Global Burden of Post Operative Complications: an International Prospective Cohort Study Protocol
- ClinicalTrials.gov ID
- NCT07785076
- Acronym / sponsor ID
- SurgWeek-2 / 156087
- Conditions
- Surgery Complications, Surgery, Global Surgery, Robotic, Laparotomy, Caesarean Section
- Keywords
- Complications, mortality, Laparotomy, Caesarean Delivery/Section, Open fracture, Antimicrobial use, Robotic surgery, Minimally invasive surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 25 Aug 2026 (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.
This study aims to assess and improve the global outcomes following surgery. Every year approximately 313 million operations are performed, with 50 million people experiencing a complication and unfortunately 3.5 million people will die following these operations. This study will assess how outcomes vary following surgery throughout the world and explore system access, quality and efficiency.
The secondary aims of this study are to (1) assess the use of antibiotics and the impact of resistant organisms globally, (2) assess who dies after an operation and whether there are factors that were identified that could have prevented the death, (3) assess the assess and outcomes to minimally invasive and robotic surgery, (4) assess the outcomes of the Bellwether procedures (laparotomy, caesarean delivery, open fracture management) as these are conditions used to assess the functioning of a health system.
The study will take place for six week in May-June 2026 and will aim to collect data from 100,000 patients across 1000 hospitals in 100 countries to give a global perspective on the above outcome measures. The data will be analysed by hospital income group to understand how resources impact on outcomes.
By combining global data on clinical outcomes with information on hospital resources, this study hopes to provide valuable insights into how to improve surgical care across diverse settings, making recommendations that lead to better access to safe, timely and affordable care for surgical problems worldwide.
Detailed description
Background:
Surgery is a fundamental and core component of global healthcare. Without it we are unable to deliver safe maternity, trauma and cancer care. Access and treatment options vary globally. Approximately 313 million operations are performed globally every year, however high-quality outcome data is available for only a fraction of these. (1) There are estimated to be 50 million adults experiencing at least one post operative complication per year, of whom 3.5 million will die within 30 days of surgery. (1) Evidence suggests around half of complications are avoidable. (2, 3) Complications after surgery prolong inpatient admissions, increase care costs and can lead to death and disability. Global data on post-operative outcomes is lacking. We propose an International, prospective, multicentre cohort study to assess the global burden of post operative complications, its variation and sequalae.
Methodology:
This International, prospective, multicentre, global cohort study will include consecutive patients undergoing surgery within an overall six-week window between 4th May 2026 and 14th June 2026. The primary outcome will be complications measured by Clavien-Dindo grade at 30-days following surgery. Any hospital delivering surgery are eligible to participate. All patients undergoing elective or emergency operations will be included. Hospitals can have a team of up to three collaborators for each surgical speciality per week. Teams can choose to collect data for one or multiple specialities and one or multiple week periods. Hospitals can have multiple teams to allow all specialities to submit data. Data will be collected on consecutive patients from their chosen surgical specialities for one or multiple 7-day periods, with a subsequent 30-day follow-up over the six-week window. There will be no changes made to routine patient care pathways/management or follow-up as this will be an observational study. No identifiable data will be collected. There will be a mandatory site survey for all centres participating.
Appropriate registration and study approval as per local regulations is mandatory for participation. All data will be captured with REDCap - a secure online data management system.
Discussion: This study will generate data on the global variability in post operative complications for a range of common operations. This will offer insights to the global burden of disease, access to emergency and elective care, imaging and 'rescue' from complications. This data will aid in the creation of guidelines to improve care across the world and informing trial design to target areas of preventable morbidity and mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing surgery | – | –Patients undergoing surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive patients undergoing surgery
Key inclusion criteria (3 listed)
- Any operation (elective or emergency) performed in an operating theatre is eligible for inclusion, except for minor procedures specified in Appendix A.
- All surgical specialties can participate including acute care surgery, breast surgery, cardiac surgery, colorectal surgery, general surgery, gynaecology, hepatobiliary surgery, neurosurgery, obstetrics, oesophagogastric surgery, ophthalmology, oral and maxillofacial surgery, orthopaedics, otolaryngology, paediatric surgery, plastic surgery, thoracic surgery, transplant surgery, trauma surgery, urology and vascular surgery.
- Patients undergoing both day case surgery and inpatient surgery should be included.
Key exclusion criteria (5 listed)
- Patients who do not undergo an operation (e.g. planned operations that are cancelled).
- Patients undergoing angiography or minor procedures.
- Procedures performed outside of an operating theatre
- Individual participating centres can choose to include children only, adults only, or both children and adults. If including children or adults only, an age cut off should be selected that is appropriate to the local context.
- Each individual patient should only be included in the study once, based on the first operation they undergo within the data capture window. Therefore, patients who are re-operated within 30-days should only be entered once.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Global variation in post operative complications.
Time frame: 30 days
The primary aim of SurgWeek-2 is to assess the global burden and variation of postoperative complications. We will determine the frequency of postoperative complications across low-, middle- and high-income countries, further stratifying by age, sex, and surgical speciality.
5 secondary outcomes
Global variation in postoperative infective complication and antimicrobial resistance rates.
Time frame: 30 days
Global variation in postoperative mortality rates and underlying reasons for postoperative mortality.
Time frame: 30 days
Global variation in access to and outcomes associated with minimally invasive and robotic surgery.
Time frame: 30 days
Global variation in the outcomes of the Bellwether procedures (laparotomy, caesarean delivery and open fracture management)
Time frame: 30 days
30-day Clavien-Dindo complication grade.
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No. SurgWeek-2 is collecting only routinely collected hospital data, seeking to measure current clinical practice.
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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.
Rachel Lillywhite contact
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery Complications and Surgery, run by University of Birmingham.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liam N Phelan (00447816774368, lxp417@student.bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global variation in post operative complications. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2026.