Prophylactic pectoralis major flap to compensate for increased risk of pharyngocutaneous fistula in laryngectomy patients with low skeletal muscle mass (PECTORALIS): study protocol for a randomized controlled trial

• Published in: BMC cancer Vol. 24; no. 1; p. 76
• Main Authors: van Beers, Maartje A, Speksnijder, Caroline M, van Gils, Carla H, Frederix, Geert W J, Dankbaar, Jan Willem, de Bree, Remco
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 15-01-2024; BioMed Central; BMC
• Subjects: Care and treatment; Chemoradiotherapy; Clinical trials; Complications; Complications and side effects; Cutaneous Fistula - etiology; Cutaneous Fistula - prevention & control; Cutaneous Fistula - surgery; Diagnosis; Fistula; Fistulae; Flaps (Surgery); Head & neck cancer; Head and Neck cancer; Health aspects; Humans; Laryngeal carcinoma; Laryngeal Neoplasms - pathology; Laryngectomy; Laryngectomy - adverse effects; Low skeletal muscle mass; Multicenter Studies as Topic; Musculoskeletal system; Myofascial pectoral major flap; Neck; Ostomy; Patients; Pectoralis Muscles; Pharyngeal Diseases - etiology; Pharyngeal Diseases - prevention & control; Pharyngocutaneous fistula; Pharynx; Postoperative; Postoperative Complications - etiology; Postoperative Complications - prevention & control; Quality of life; Radiation therapy; Randomized Controlled Trials as Topic; Retrospective Studies; Risk factors; Risk groups; Sarcopenia; Shoulder; Skeletal muscle; Skin; Study Protocol; Swallowing; Throat cancer; Total laryngectomy; Vertebrae; Netherlands; Sarcopenia; Total laryngectomy; Head and Neck cancer; Low skeletal muscle mass; Myofascial pectoral major flap; Pharyngocutaneous fistula
• ISSN: 1471-2407; 1471-2407
• DOI: 10.1186/s12885-023-11773-7

Total laryngectomy (TL) is a surgical procedure commonly performed on patients with advanced laryngeal or hypopharyngeal carcinoma. One of the most common postoperative complications following TL is the development of a pharyngocutaneous fistula (PCF), characterized by a communication between the neopharynx and the skin. PCF can lead to extended hospital stays, delayed oral feeding, and compromised quality of life. The use of a myofascial pectoralis major flap (PMMF) as an onlay technique during pharyngeal closure has shown potential in reducing PCF rates in high risk patients for development of PCF such as patients undergoing TL after chemoradiation and low skeletal muscle mass (SMM). Its impact on various functional outcomes, such as shoulder and neck function, swallowing function, and voice quality, remains less explored. This study aims to investigate the effectiveness of PMMF in reducing PCF rates in patients with low SMM and its potential consequences on patient well-being.
This multicenter study adopts a randomized clinical trial (RCT) design and is funded by the Dutch Cancer Society. Eligible patients for TL, aged ≥ 18 years, mentally competent, and proficient in Dutch, will be enrolled. One hundred and twenty eight patients with low SMM will be centrally randomized to receive TL with or without PMMF, while those without low SMM will undergo standard TL. Primary outcome measurement involves assessing PCF rates within 30 days post-TL. Secondary objectives include evaluating quality of life, shoulder and neck function, swallowing function, and voice quality using standardized questionnaires and functional tests. Data will be collected through electronic patient records.
This study's significance lies in its exploration of the potential benefits of using PMMF as an onlay technique during pharyngeal closure to reduce PCF rates in TL patients with low SMM. By assessing various functional outcomes, the study aims to provide a comprehensive understanding of the impact of PMMF deployment. The anticipated results will contribute valuable insights into optimizing surgical techniques to enhance patient outcomes and inform future treatment strategies for TL patients.
NL8605, registered on 11-05-2020; International Clinical Trials Registry Platform (ICTRP).