Optimising Microsurgical Reconstruction After Advanced Head and Neck Cancers

• Conditions: Head and Neck Cancer
• Interventions: Behavioral: Early ambulation; Other: Standard/historical postoperative regimen; Behavioral: Early oral feeding; Other: Multimodal opioid-sparing analgesia; Procedure: Goal-directed fluid therapy; Procedure: CAD/CAM system for reconstructive plates; Other: Functional discharge criteria

• Registration Number: NCT04308525
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

This study aims to improve the peri- and postoperative care regimen for patients undergoing microvascular reconstruction after head and neck cancer by introducing an enhanced recovery after surgery (ERAS) programme.

Detailed Description

Advanced stage head and neck cancers have a poor prognosis and a 5-year survival rate of as low as 35-37%. The treatment is complex and often requires a multidisciplinary approach including surgery. The goal besides removal of the cancer is to restore function and appearance. If possible, both resection as well as immediate reconstruction will be performed during the same surgical procedure. Due to the large bone- and soft tissue loss following the ablative procedure, local solutions are often inadequate for reconstruction. In addition, many patients require post-operative radiotherapy, which may result in tightness of scar tissue and impaired function. In these cases it is necessary to perform the reconstruction using a free flap.

Free flap reconstruction involves tissue taken from other parts of the body, that is transplanted along with the associated blood vessels to the reconstruction site. The vessels of the flap are usually anastomosed to the vessels of the neck (microvascular reconstruction) and the transplanted tissue thereby obtains a blood supply at its new location. Head and neck cancer patients are usually reconstructed using the free fibular flap, the latissimus dorsi flap, the radial forearm flap or the anterolateral thigh flap.

The combination of complicated surgery and often malnourished patients with a low body mass index (BMI), that typically suffer from tobacco and alcohol abuse, commonly lead to postoperative ICU treatment and complications. The most common are infections, re-operations, delayed wound healing and refeeding syndrome, which is reported in up to 35% of patients undergoing major surgery for head and neck cancer.

Even with successful reconstruction, many patients suffer from drooling, lack of adequate clenching, permanent gastric tube feeding, insufficient wound healing and a high recurrence rate. Enhanced recovery after surgery (ERAS) is a peri- and postoperative care concept designed to accelerate recovery and improve convalescence. It has previously been established as superior to conventional care for a wide variety of procedures. As one of the first departments in the world our department has successfully implemented an ERAS program for microsurgical patients that undergo breast reconstruction using autologous tissue. By utilizing our experience with ERAS and combining it with a review of our own patient data we have developed an ERAS protocol for microvascular reconstruction after ablative surgery for head and neck cancer.

Study Timeline

• Study Start: 2019-06-01
• Status Verified: 2020-03
• Study First Submitted: 2020-03-11
• Study First Submitted QC: 2020-03-11
• Study First Posted: 2020-03-16
• Last Update Submitted: 2020-03-21
• Last Update Posted: 2020-03-24
• Primary Completion: 2021-01-31
• Study Completion: 2021-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Patients eligible for ablative surgery for head and neck cancer with primary microvascular reconstruction.

Exclusion Criteria

• Patients with conditions leading to increased risk of thromboembolic events
• Patients pre-operatively admitted to the ICU

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ERAS Group	Multimodal opioid-sparing analgesia	Prospectively included patients after introduction of an ERAS programme
ERAS Group	Functional discharge criteria	Prospectively included patients after introduction of an ERAS programme
ERAS Group	Early ambulation	Prospectively included patients after introduction of an ERAS programme
Control group	Standard/historical postoperative regimen	We retrospectively evaluated our procedures for the period 2014-2016
ERAS Group	CAD/CAM system for reconstructive plates	Prospectively included patients after introduction of an ERAS programme
ERAS Group	Early oral feeding	Prospectively included patients after introduction of an ERAS programme
ERAS Group	Goal-directed fluid therapy	Prospectively included patients after introduction of an ERAS programme

Primary Outcome Measures

Name	Time	Method
Length of stay (LOS)	1 to 4 weeks	Time from surgery to discharge

Secondary Outcome Measures

Name	Time	Method
Time to ambulation	1-7 days	Days from surgery until full ambulation (walking)
Complication-rate	30 days	Number of surgical related complications
ICU LOS	1-2 days	Time spent in the ICU (intensive care unit) post-operatively
Incidence of re-operations	30 days	Number of return-to-theatre events
Incidence of infections	30 days	Number of postoperative infections

Trial Locations

Locations (1)

Copenhagen University Hospital, Rigshospitalet; 🇩🇰 Copenhagen, København Ø, Denmark