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.

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

Interventions

OTHER

Protocol based

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.

PROCEDURE

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.

Sponsors & Collaborators

• Karolinska Institutet

  collaborator OTHER

• Region Stockholm

  lead OTHER_GOV

Principal Investigators

• Panagiotis Tsagkozis, Associate professor, MD · Karolinska University Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-24

Primary Completion

2027-07-31

Completion

2028-12-31

Countries

• Sweden

Study Locations