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Salvage total laryngectomy (TL) and total pharyngolaryngectomy (TPL) are the gold standard for most recurrent laryngeal and hypopharyngeal tumors as well as in patients with contraindication for chemoradiotherapy (CRT). Free or pedicled flaps are the two mandatory options for pharyngeal reconstruction after TPL, while remain an optional indication to protect the neopharynx after TL. The most common complication after TL or TPL is pharyngocutaneous fistula (PCF), with an incidence ranging from 3% to 65%, according to the surgical defect and type of reconstruction. The etiology of PCF is multifactorial and the most important risk factors are a history of CRT, low hemoglobin levels (< 12.5 g/dl), and malnutrition. A growing concern is the role of nutritional status, with sarcopenia as an emergent risk factor for post-operative complications, because muscle wasting negatively influences wound healing and overall recovery. Salivary stent placement, 3-layers neopharyngeal sutures, cricopharyngeal myotomy and prophylactic use of vascularized flaps are possible protective factors to reduce the risk of PCF. Despite these evidences, it remains unclear which are the best candidates for flap reconstruction, as well as which preoperative risk factors influence the risk of PCF.
The rationale of this ambispective monocentric study is to identify the risk factors statistically significant associated with the development of PCF and the influence of preoperative sarcopenia on postoperative complications risks following TL and TPL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| reconstructive flap | patients affected by laryngeal and/or hypopharyngeal carcinoma who underwent/undergo total laryngectomy, total hemipharyngolaryngectomy, or circular pharyngolaryngectomy, with reconstructive flap, from January 2015 to December 2030 |
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| NO reconstructive flap | patients affected by laryngeal and/or hypopharyngeal carcinoma who underwent/undergo total laryngectomy, total hemipharyngolaryngectomy, or circular pharyngolaryngectomy,without reconstructive flap, from January 2015 to December 2030 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surgical flap | Procedure | Pedicled or free flap was harvested and placed over the pharyngeal suture (on-lay) following TL or tunnelled to reconstruct wide defects (in-lay) after TPL. |
| Measure | Description | Time Frame |
|---|---|---|
| The association between the use of a surgical flap and the incidence of post-operative fistulas during follow-up | Proportion of subjects who develop a post-operative fistula (blind or pharyngo-cutaneous fistula, PCF, with or without the use of a surgical flap, which develop within 30 days from surgery | within 30 days from surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The association between the use of a surgical flap and the incidence of mid to longterm post-operative fistulas | The rate of development of a mid to longterm post-operative fistula | 30 days and at mid to long term. |
| Potential correlates of fistulas development both within 30 days and at mid to long term |
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Inclusion Criteria:
Patients undergoing to TL with direct closure of the pharynx or TPL and reconstruction of the pharynx with a free or pedicled flap in cases of:
Exclusion Criteria:
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Patients affected by laryngeal and/or hypopharyngeal carcinoma who underwent/undergo total laryngectomy, total hemipharyngolaryngectomy, or circular pharyngolaryngectomy, with or without reconstructive flap, at Fondazione IRCCS Policlinico San Matteo from January 2015 to December 2030
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| Name | Affiliation | Role |
|---|---|---|
| Marco Benazzo, MD | Fondazione IRCCS Policlinico San Matteo di Pavia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SC Otorinolaringoiatria - Fondazione IRCCS Policlinico San Matteo, Pavia | Pavia | Pavia | 27100 | Italy |
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| ID | Term |
|---|---|
| D007818 | Laryngeal Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D013524 | Surgical Flaps |
| ID | Term |
|---|---|
| D019738 | Surgically-Created Structures |
| D004864 | Equipment and Supplies |
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|
| 30 days and 36 months |
| The incidence of any post-operative complications | Fistulas and any of the surgical and non surgical complications within 30 days. Surgical complications (require reintervention):
Non surgical Complications:
| 1-36 months follow-up |
| 36 months incidence of tumor related events | Potential correlates will be:
| 36 months after surgery |
| The prognostic role of both the use of a surgical flap and the development of post-operative fistulas | 36 months after surgery |