Surgical ComplicationsNCT06968884
Application of a Comprehensive Protocol Aimed at Reducing the Risk of Complications After Surgery for Sarcoma. Interventions Before, During and After Surgery for Known and Presumed Risk Factors Compared to Standard of Care in a Total of 300 Patients.
A study testing Protocol based in people with Surgical Complications and Sarcoma, run by Region Stockholm at 1 site in Sweden.
Trial summary
Sarcoma is a rare malignancy made up by several sub types that can occur throughout the body. Roughly speaking, the division into soft tissue sarcoma (STS) and skeletal sarcoma (SS) can be made. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Surgical Complications, Sarcoma
- What is being tested?
- Protocol based
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 24 Sep 2024to Dec 2028
- Phase
- Interventional
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Sarcoma of the extremities or trunk
- Surgery for sarcoma at karolinska university Hospital in Sweden
- Age 15 years or older
Who cannot join
- Not meeting inclusion
- Patient declines
- Patient not a Swedish citizen
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Enhanced Recovery After Surgery for Patients With Sarcoma of the Extremities and Trunk.
Sarcoma is a rare malignancy made up by several sub types that can occur throughout the body. Roughly speaking, the division into soft tissue sarcoma (STS) and skeletal sarcoma (SS) can be made. STS of the limbs and trunk are primarily treated by surgical removal of the tumour and a margin of surrounding healthy tissue. Since size, depth and locale of tumours vary widely, surgery is seldom standardised.
Both STS and SS commonly result in large resections, leaving tissue defects that are prone to local complications such as seroma formation, wound dehiscence and infection. A wound complication following surgery can be considered minor if it does not call for additional surgery, i.e. seroma formation, a superficial infection or delayed wound closure that can be helped by oral antibiotics or wound care. A major wound complication is one that requires surgical treatment like debridement surgery, secondary suture of a ruptured wound or flap-reconstruction.
Read more
It is known that some tumour related factors increase the risk of wound complications, e.g. certain anatomical areas such as the inner thigh, large size and higher grade of the tumour. Other patient related factors known to influence the risk of complication are smoking, malnutrition and diabetes.
There is some research on orthopaedic patients looking at intraoperative factors that could affect risk of infection. Time in surgery, prophylactic antibiotics and bleeding have all been shown to influence outcome.
Enhanced Recovery After Surgery (ERAS) is a project implemented in other fields of surgery. It is a complete take on the risk factors for complications surrounding a patient and their surgery, as well as recovery afterwards. Some patient-related (intrinsic) risk factors associated with complications, such as obesity and alcohol abuse, take time to change. In other cases, even a short duration of for example smoke-cessation, correction of anaemia or better nutrition could have an effect on results. Intraoperative environmental (extrinsic) adjustments like surgical haemostasis and administration of Tranexamic acid are known to reduce risk of haematoma formation. This in turn reduces both the need for transfusion and the risk of infection.
In other areas, multimodal anaesthesia and analgesia have been shown to decrease use of opioids while still offering sufficient pain relief. This leads to reduced postoperative nausea and further promotes early postoperative mobilisation.
The thought behind a structured program addressing risk factors before, during and after surgery being that the collective risk reduction will big enough to be measurable where individual efforts might not be.
Since sarcoma surgery is burdened by postoperative complications, every possibility to affect this should be explored.
Read the detailed description
Prospective inclusion of patients 15 years or older, undergoing surgery for STS or SS. These include grade 1-3 sarcomas and all types of resection and reconstruction. The first 150 patients are the control group, treated according to standard procedure (best available care). The following 150 patients are the ERAS-interventions group.
This protocol with consecutive and not parallel arms is designed because of the difficulty to implement a new standard of care. To do so in only part of the population would increase the risk of contamination between groups and make evaluation harder.
Preoperative labs for anaemia and nutritional status are drawn at suspicion of sarcoma at the first visit to clinic. Patient reported information on smoking, alcohol use, weight and physical activity are registered. Preoperative interventions such as the administration of parenteral iron, enteral B1 or Folic acid, medication for smoking cessation or nutritional complements are prescribed.
The extra costs for nutritional supplements, iron injection and blood tests are minor. If number of days in hospital is shortened or any complication avoided these costs will be negligible.
Hypotheses A structured pre-, per- and postoperative effort on minimising known risk factors for complications are believed to reduce the rate of such complications by 40% compared to patients treated traditionally.
Primary outcome
- Early (<30 days) postoperative complications. Secondary outcomes
- Delayed complications (30d-1y), time to wound healing, time in hospital, death and patient reported outcome measures using EQ5d.
- Conditions
- Surgical Complications, Sarcoma
- Being tested
- Protocol based, Control (Standard treatment)
- Keywords
- risk reduction, eras
- Medical subject headings
- Sarcoma, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocol basedOther
Preoperative administration of iron, b12 and folate if criteria is met. Medication to aid in smoking cessation is offered if patient uses tobacco. Nutritional supplements offered pre-operative is patient malnurished and preoperative drink offered to all.
Anaesthetic method adapted with increased use of epidural, blocks and local anaesthesia.
Administration on TXA and fluids according to protocol. Postoperative nutritional drink to increase protein intake. Early mobilisation to reduce risk of VTE.
Control (Standard treatment)Procedure or surgery
Preoperative bloods including haemoglobin to establish that surgery is safe. Transfusions given if clinically necessary, no other protocol for anaemia treatment other then available clinical guidelines.
Peri- and postoperative treatment given in accordance with best clinical practice, no additional protocol.
| Study group | Role | What they receive |
|---|---|---|
| Control group - best available care | Active comparator | Patients receive best available care. Sarcoma surgery, transfusions and medication given is best known to medical professionals in care. Receives: Procedure: Control (Standard treatment) |
| ERAS intervention | Active comparator | The complete protocol including pre- per- and postop adjustments in addition to sarcoma surgery. Receives: Other: Protocol based |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complication
Defined as venous trombo-embolism (VTE) or a local wound complication at 30 days postoperative. Complication severity sub typed using the Clavien-Dindo classification.
Measured: 30 days postoperative
Secondary outcomes (1)
Delayed complications (30d-1y)
Complications that are not in the immediate postoperative period, byt appear 1-12 months after surgery. This will include surgical wound complications resulting in need for additional surgery, time in hospital and death. Clavien-Dindo classification is used to stratify severity.
Measured: 30 days to 1 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start24 Sep 2024
- Primary completionJul 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Surgical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Interventional prospective study. Control group included first and interventional group included thereafter.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Panagiotis Tsagkozis, Associate professor, MD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968884
- Sponsor's protocol ID
- 2024-00847-01
- Other IDs
- K2024-9009, RA 2024/98
- Status last verified
- Nov 2024
- First submitted
- 14 Apr 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Summarised data, text, tables and figures can be shares. Protocols and interventions as well. This data is available for up to 5 years after publication.
Publications
White JJ, Houghton-Clemmey R, Marval P. Enhanced recovery after surgery (ERAS): an orthopaedic perspective. J Perioper Pract. 2013 Oct;23(10):228-32. doi: 10.1177/175045891302301004.
PubMed 24279038Wischmeyer PE, Carli F, Evans DC, Guilbert S, Kozar R, Pryor A, Thiele RH, Everett S, Grocott M, Gan TJ, Shaw AD, Thacker JKM, Miller TE, Hedrick TL, McEvoy MD, Mythen MG, Bergamaschi R, Gupta R, Holubar SD, Senagore AJ, Abola RE, Bennett-Guerrero E, Kent ML, Feldman LS, Fiore JF Jr; Perioperative Quality Initiative (POQI) 2 Workgroup. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Nutrition Screening and Therapy Within a Surgical Enhanced Recovery Pathway. Anesth Analg. 2018 Jun;126(6):1883-1895. doi: 10.1213/ANE.0000000000002743.
PubMed 29369092Perrault DP, Lee GK, Yu RP, Carre AL, Chattha A, Johnson MB, Gardner DJ, Carey JN, Tseng WW, Menendez LR, Wong AK. Risk Factors for Wound Complications After Soft Tissue Sarcoma Resection. Ann Plast Surg. 2021 Mar 1;86(3S Suppl 2):S336-S341. doi: 10.1097/SAP.0000000000002592.
PubMed 33234885Moore J, Isler M, Barry J, Mottard S. Major wound complication risk factors following soft tissue sarcoma resection. Eur J Surg Oncol. 2014 Dec;40(12):1671-6. doi: 10.1016/j.ejso.2014.10.045. Epub 2014 Oct 18.
PubMed 25456440
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgery for Patients With Sarcoma of the Extremities and Trunk.
- ClinicalTrials.gov ID
- NCT06968884
- Acronym / sponsor ID
- 2024-00847-01
- Conditions
- Surgical Complications, Sarcoma
- Keywords
- risk reduction, eras
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 May 2025 (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.
Sarcoma is a rare malignancy made up by several sub types that can occur throughout the body. Roughly speaking, the division into soft tissue sarcoma (STS) and skeletal sarcoma (SS) can be made. STS of the limbs and trunk are primarily treated by surgical removal of the tumour and a margin of surrounding healthy tissue. Since size, depth and locale of tumours vary widely, surgery is seldom standardised.
Both STS and SS commonly result in large resections, leaving tissue defects that are prone to local complications such as seroma formation, wound dehiscence and infection. A wound complication following surgery can be considered minor if it does not call for additional surgery, i.e. seroma formation, a superficial infection or delayed wound closure that can be helped by oral antibiotics or wound care. A major wound complication is one that requires surgical treatment like debridement surgery, secondary suture of a ruptured wound or flap-reconstruction.
It is known that some tumour related factors increase the risk of wound complications, e.g. certain anatomical areas such as the inner thigh, large size and higher grade of the tumour. Other patient related factors known to influence the risk of complication are smoking, malnutrition and diabetes.
There is some research on orthopaedic patients looking at intraoperative factors that could affect risk of infection. Time in surgery, prophylactic antibiotics and bleeding have all been shown to influence outcome.
Enhanced Recovery After Surgery (ERAS) is a project implemented in other fields of surgery. It is a complete take on the risk factors for complications surrounding a patient and their surgery, as well as recovery afterwards. Some patient-related (intrinsic) risk factors associated with complications, such as obesity and alcohol abuse, take time to change. In other cases, even a short duration of for example smoke-cessation, correction of anaemia or better nutrition could have an effect on results. Intraoperative environmental (extrinsic) adjustments like surgical haemostasis and administration of Tranexamic acid are known to reduce risk of haematoma formation. This in turn reduces both the need for transfusion and the risk of infection.
In other areas, multimodal anaesthesia and analgesia have been shown to decrease use of opioids while still offering sufficient pain relief. This leads to reduced postoperative nausea and further promotes early postoperative mobilisation.
The thought behind a structured program addressing risk factors before, during and after surgery being that the collective risk reduction will big enough to be measurable where individual efforts might not be.
Since sarcoma surgery is burdened by postoperative complications, every possibility to affect this should be explored.
Detailed description
Prospective inclusion of patients 15 years or older, undergoing surgery for STS or SS. These include grade 1-3 sarcomas and all types of resection and reconstruction. The first 150 patients are the control group, treated according to standard procedure (best available care). The following 150 patients are the ERAS-interventions group.
This protocol with consecutive and not parallel arms is designed because of the difficulty to implement a new standard of care. To do so in only part of the population would increase the risk of contamination between groups and make evaluation harder.
Preoperative labs for anaemia and nutritional status are drawn at suspicion of sarcoma at the first visit to clinic. Patient reported information on smoking, alcohol use, weight and physical activity are registered. Preoperative interventions such as the administration of parenteral iron, enteral B1 or Folic acid, medication for smoking cessation or nutritional complements are prescribed.
The extra costs for nutritional supplements, iron injection and blood tests are minor. If number of days in hospital is shortened or any complication avoided these costs will be negligible.
Hypotheses A structured pre-, per- and postoperative effort on minimising known risk factors for complications are believed to reduce the rate of such complications by 40% compared to patients treated traditionally.
Primary outcome
- Early (<30 days) postoperative complications. Secondary outcomes
- Delayed complications (30d-1y), time to wound healing, time in hospital, death and patient reported outcome measures using EQ5d.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional prospective study. Control group included first and interventional group included thereafter.
| Arm | Type | Receives |
|---|---|---|
| Control group - best available care | Active comparator | Procedure: Control (Standard treatment)Patients receive best available care. Sarcoma surgery, transfusions and medication given is best known to medical professionals in care. |
| ERAS intervention | Active comparator | Other: Protocol basedThe complete protocol including pre- per- and postop adjustments in addition to sarcoma surgery. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Sarcoma of the extremities or trunk
- Surgery for sarcoma at karolinska university Hospital in Sweden
- Age 15 years or older
Key exclusion criteria (3 listed)
- Not meeting inclusion
- Patient declines
- Patient not a Swedish citizen
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 |
|---|---|---|
| Protocol basedPreoperative administration of iron, b12 and folate if criteria is met. Medication to aid in smoking cessation is offered if patient uses tobacco. Nutritional supplements offered pre-operative is patient malnurished and preoperative drink offered to all. Anaesthetic method adapted with increased use of epidural, blocks and local anaesthesia. Administration on TXA and fluids according to protocol. Postoperative nutritional drink to increase protein intake. Early mobilisation to reduce risk of VTE. | Other | ERAS intervention |
| Control (Standard treatment)Preoperative bloods including haemoglobin to establish that surgery is safe. Transfusions given if clinically necessary, no other protocol for anaemia treatment other then available clinical guidelines. Peri- and postoperative treatment given in accordance with best clinical practice, no additional protocol. | Procedure or surgery | Control group - best available care |
Primary outcome
Postoperative complication
Time frame: 30 days postoperative
Defined as venous trombo-embolism (VTE) or a local wound complication at 30 days postoperative. Complication severity sub typed using the Clavien-Dindo classification.
1 secondary outcome
Delayed complications (30d-1y)
Time frame: 30 days to 1 year postoperative
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 13 May 2025.
- Background: PubMed 24279038White JJ, Houghton-Clemmey R, Marval P. Enhanced recovery after surgery (ERAS): an orthopaedic perspective. J Perioper Pract. 2013 Oct;23(10):228-32. doi: 10.1177/175045891302301004.
- Background: PubMed 29369092Wischmeyer PE, Carli F, Evans DC, Guilbert S, Kozar R, Pryor A, Thiele RH, Everett S, Grocott M, Gan TJ, Shaw AD, Thacker JKM, Miller TE, Hedrick TL, McEvoy MD, Mythen MG, Bergamaschi R, Gupta R, Holubar SD, Senagore AJ, Abola RE, Bennett-Guerrero E, Kent ML, Feldman LS, Fiore JF Jr; Perioperative Quality Initiative (POQI) 2 Workgroup. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Nutrition Screening and Therapy Within a Surgical Enhanced Recovery Pathway. Anesth Analg. 2018 Jun;126(6):1883-1895. doi: 10.1213/ANE.0000000000002743.
- Background: PubMed 33234885Perrault DP, Lee GK, Yu RP, Carre AL, Chattha A, Johnson MB, Gardner DJ, Carey JN, Tseng WW, Menendez LR, Wong AK. Risk Factors for Wound Complications After Soft Tissue Sarcoma Resection. Ann Plast Surg. 2021 Mar 1;86(3S Suppl 2):S336-S341. doi: 10.1097/SAP.0000000000002592.
- Background: PubMed 25456440Moore J, Isler M, Barry J, Mottard S. Major wound complication risk factors following soft tissue sarcoma resection. Eur J Surg Oncol. 2014 Dec;40(12):1671-6. doi: 10.1016/j.ejso.2014.10.045. Epub 2014 Oct 18.
- Individual participant dataSharing planned: No. Summarised data, text, tables and figures can be shares. Protocols and interventions as well. This data is available for up to 5 years after publication.
Related trials for Surgical Complications
Recruiting
Supervised Endoscopic Tele-controlled Intelligent Lithotripsy
Renal Stone
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
Not yet recruitingObservational study
Hugo™ RAS Urology Post-Market Clinical Study
Prostatectomy, Cystectomy
Recruiting
Processed Electroencephalography-guided General Anesthesia and Outcomes in Major Abdominal Surgery
Postoperative Acute Kidney Injury
Not yet recruitingObservational study
Biomarkers of Postoperative Complications After Cardiac Surgery
Postoperative Complications
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.
Panagiotis Tsagkozis, Associate professor, MD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protocol based in people with Surgical Complications and Sarcoma, run by Region Stockholm at 1 site in Sweden.
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 3 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: enrolling by invitation, as of the sponsor's last update on 13 May 2025. 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 Sweden. 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?
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?
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?
Postoperative complication (time frame: 30 days postoperative). 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 NCT06968884, which also lists 4 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 13 May 2025.