This study will compare the gastric pull up (GPU) with the free flap \[(specifically, anterolateral thigh (ALT) and radial forearm free flap (RFFF)\] techniques used in the reconstruction of alimentary tracts in patients who require laryngectomy and circumferential pharyngectomy for carcinoma resection. These two interventions will be compared by block randomizing 20 patients based on history of failed chemoradiation to undergo either ALT or RFFF. The primary outcome will be the type and number of postoperative complications. The secondary outcomes will include swallowing function, speech, and quality of life measures along with cancer specific endpoints.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Using gastric tissue to reconstruct the esophagus and pharynx after pharyngo-esophagectomy.
Using radial forearm free flap or anterolateral thigh free flap to reconstruct the cervical esophagus and pharynx after pharyngectomy and cervical esophagectomy.
Vancouver General Hospital
Vancouver, British Columbia, Canada
RECRUITINGType and number of postoperative complications
Complications will be divided by: (1) in-hospital mortality (2) reconstruction related complications (anastomotic leak, fistula formation, flap necrosis, flap stenosis or stricture, requirement for surgical revision), and (3) addition in-hospital complications ( bleeding, pulmonary, cardiac, infectious, abdominal, wound concern)
Time frame: Within 90 days of surgery occurring on the same or separate admission.
Surgical Time
Time from first incision to the end of surgical closure as documented on the nursing record.
Time frame: Initial Surgery
Operative blood loss
Total volume of blood lost and accounted for in suction canisters as documented in nursing charts. (this excludes blood not accounted for in the suction containers)
Time frame: Initial surgery
Operative Parameters
Requirement for transfusion, measured in units of blood.
Time frame: During initial surgery and within the first 72 hours.
Flap Donor Site Morbidity (RFFF) )
Donor site associated quality of life (Toronto Extremity Salvage Score - Upper Extremity)
Time frame: Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (8 visits total)
Flap Donor Site Morbidity (ALT)
Donor site associated quality of life (Toronto Extremity Salvage Score - Lower Extremity)
Time frame: Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (8 visits total)
Time to return to swallowing
Time from surgery to swallowing liquids.
Time frame: If occurs in hospital will be documented by the treating team. Otherwise will be documented based on patient or speech language pathology reporting at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (9 visits total)
Time to return of FULL oral diet
Time from surgery to return of diet that is sufficient for patient to maintain nutrition without requiring G-tube or NG feeding. Patient or Speech Language Pathology reported.
Time frame: Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (9 visits total)
Requirement for feeding tube at 1 year after surgery.
Whether patients are still feeding tube dependent for nutrition at 1 year follow up.
Time frame: Documented at 1 year follow up visit.
Voice Function
Measured by Voice Handicap Index -10
Time frame: Measure documented at time of surgical booking and at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (9 visits total)
Dysphagia
M.D. Anderson Dysphagia Inventory for assessment of dysphagia
Time frame: Measure documented at time of surgical booking and at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (9 visits total)
Dumping Symptoms
Assessed with the dumping symptom rating scale
Time frame: Measure documented at time of surgical booking and at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (9 visits total)
Quality of Life
Measure with combined scores of two questionnaires: European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ) - C30 and EORTC QLQ - H\&N35
Time frame: Measure documented at 1, 3, 6 and 12 months post-surgery, thereafter yearly for 5 years. (8 visits total)
Margin status of the resected specimen as reported by pathology
Will be classified as positive and negative based on what is reported at Vancouver General Hospital Pathology reports generated at the time of surgery. A measure of clearance in millimeters will also be provided.
Time frame: At the time of surgery
Time to progression
time from the date of the surgery until local, regional, or metastatic disease is detected
Time frame: Patients will be monitored for 5 years post-operatively
Disease Free Survival
Time from the date of the surgery until a patient experiences a recurrence, a new primary cancer or death
Time frame: Patients will be monitored for 5 years post-operatively
Progression-free survival
Time from the date of the surgery until a patient shows sign of disease progression
Time frame: Patients will be monitored for 5 years post-operatively
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