Clinical trial · Interventional
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.
Enhanced Recovery After Surgery for Patients With Sarcoma of the Extremities and Trunk.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Surgical Complications | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control (Standard treatment) | Procedure | — | UNRESOLVED |
| Protocol based | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control group - best available care
- description
- Patients receive best available care. Sarcoma surgery, transfusions and medication given is best known to medical professionals in care.
- interventionNames
- Procedure: Control (Standard treatment)
- type
- ACTIVE_COMPARATOR
- label
- ERAS intervention
- description
- The complete protocol including pre- per- and postop adjustments in addition to sarcoma surgery.
- interventionNames
- Other: Protocol based
Primary outcomes (1)
- measure
- Postoperative complication
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: * Sarcoma of the extremities or trunk * Surgery for sarcoma at karolinska university Hospital in Sweden * Age 15 years or older Exclusion Criteria: * Not meeting inclusion * Patient declines * Patient not a Swedish citizen
References
Publications (4)
- BACKGROUNDWhite 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. PMID 24279038
- BACKGROUNDWischmeyer 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. PMID 29369092
- BACKGROUNDPerrault 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. PMID 33234885
- BACKGROUNDMoore 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. PMID 25456440