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Title
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Utility of pectoralis major myofascial flap in reducing pharyngocutaneous fistula rates after salvage total laryngectomy (PMMF Study) Study design / Type :Prospective Phase III Randomized Controlled Trial |
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Investigators
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Dr. Devendra Chaukar |
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Participating Centres
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Number of participants
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160 |
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Status
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Ongoing |
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Synopsis
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In today’s era of organ preservation total laryngectomy is reserved for advanced cases with dysfunctioning larynx. An increasing number of cancers of the larynx and hypopharynx are treated by nonsurgical organ preservation protocols. This has resulted in an increase in the number of salvage laryngectomy over the last two decade. Prior radiation / chemoradiation has been known to be associated with significant postoperative morbidity namely pharyngocutaneous fistula. Pharyngocutaneous fistula is a troublesome complication following total laryngectomy prolonging hospital stay and sometimes requiring second surgery, thereby increasing cost of treatment significantly. Fistula rates in salvage settings are variable and reported between 14-61% in contrast to that of in primary setting which is reported to be in the range of 14-20 % in most series. In an effort to decrease the leak in salvage settings some authors have advocated reinforcing the suture line using onlaypectoralis major myofascial flap (PMMF). Rationale behind using onlay PMMF is providing the non-irradiated vascularized tissue over a suture line which is considered to be hypoxic and relatively sparse in micronutrients as a result of prior radiotherapy. However literature is divided as to whether a prophylactic flap to augment the suture line would help decrease the fistula rates. There is a paucity of adequate data in this regard. Though the recent meta-analysis published favors use of onlay PMMF, it has considerable heterogeneity and has included mainly retrospective series and observational studies with small number of patients. Thus there is a need to conduct a prospective study to answer this question. |
PMMF Study
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