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.

NCT06968884 | Enrolling By Invitation

• 3 other identifiers: 2024-00847-01K2024-9009RA 2024/98
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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

Surgical Complications; Sarcoma

Keywords

risk reduction; eras

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days postoperative

Secondary Outcomes (1)

• Delayed complications (30d-1y)

  30 days to 1 year postoperative

Other Outcomes (1)

• Patient reported outcome measures (PROMS)

  1 year postoperative

Study Arms (2)

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.

Procedure: Control (Standard treatment)

ERAS intervention

ACTIVE COMPARATOR

The complete protocol including pre- per- and postop adjustments in addition to sarcoma surgery.

Other: Protocol based

Interventions

Protocol based OTHER

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.

ERAS intervention

Control (Standard treatment) PROCEDURE

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.

Control group - best available care

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Sarcoma of the extremities or trunk
• Surgery for sarcoma at karolinska university Hospital in Sweden
• Age 15 years or older

You may not qualify if:

• Patient declines
• Patient not a Swedish citizen

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, Stockholm County, 17176, Sweden

Location

Related Publications (4)

• 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.

  PMID: 24279038 BACKGROUND

• Wischmeyer 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 BACKGROUND

• Perrault 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 BACKGROUND

• Moore 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 BACKGROUND

MeSH Terms

Conditions

Sarcoma; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Behavior

Study Officials

• Panagiotis Tsagkozis, Associate professor, MD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Interventional prospective study. Control group included first and interventional group included thereafter.

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: May 13, 2025
• Study Start: September 24, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 13, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)