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.

Region Stockholm

Status: Invitation-only

Conditions: Sarcoma; Surgical Complications

Treatments: Procedure: Control (Standard treatment); Other: Protocol based

Study type: Interventional

Funder types: Other

Identifiers

NCT06968884

2024-00847-01

K2024-9009 (Other Identifier)

RA 2024/98 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Control group - best available care

Active Comparator group

Description:

Patients receive best available care. Sarcoma surgery, transfusions and medication given is best known to medical professionals in care.

Treatment:

Procedure: Control (Standard treatment)

ERAS intervention

Active Comparator group

Description:

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

Treatment:

Other: Protocol based