3.1. Background Characteristics of Patients
The results of comparisons of the patients’ background characteristics between the free jejunal flap and cutaneous free tissue flap groups are shown in
Table 1. Reconstruction in the 223 patients with hypopharyngeal cancer consisted of free jejunal flap reconstruction (
n = 188) and cutaneous free tissue flap reconstruction (
n = 35). Furthermore, cutaneous free tissue flap reconstruction comprised both anterolateral thigh flap reconstruction (
n = 24) and forearm flap reconstruction (
n = 11). Regarding the sex proportion, the free jejunal flap group consisted of 162 males and 26 females, whereas the cutaneous free tissue flap group comprised 31 males and four females. The mean ages of the free jejunal and cutaneous free tissue flap groups were 68 years (range, 45–84 years) and 71 years (range, 52–80 years), respectively. The pyriform sinus consisted of 133 free jejunal flaps and 25 cutaneous free tissue flaps, whereas the postcricoid region consisted of 26 free jejunal flaps and eight cutaneous free tissue flaps. Finally, the posterior wall comprised 29 free jejunal flaps and two cutaneous free tissue flaps. Regarding T classification, there were 43 T1/2 patients in the free jejunal flap group and seven T1/2 patients in the cutaneous free tissue flap group. Moreover, there were 145 T3/4 patients in the free jejunal flap group and 28 T3/4 patients in the cutaneous free tissue flap group. Regarding N classification, there were 51 N0 patients, 27 N1 patients, 92 N2 patients, and 18 N3 patients in the free jejunal flap group and eight N0 patients, six N1 patients, 18 N2 patients, and three N3 patients in the cutaneous free tissue flap group. Regarding preoperative treatment history, 26 patients in the free jejunal flap group and four in the cutaneous free tissue flap group had a history of chemotherapy. Nine patients in the free jejunal flap group and two in the cutaneous free tissue flap group had a history of chemoradiotherapy. Twenty-five patients in the free jejunal flap group and three in the cutaneous free tissue flap group had a history of radiotherapy. Regarding the purpose of surgery, patients who underwent definitive surgery consisted of 156 patients with free jejunal flap reconstruction and 31 patients with cutaneous free tissue flap reconstruction, respectively. The patients who underwent salvage surgery consisted of 32 patients who underwent free jejunal flap reconstruction and four who underwent cutaneous free tissue flap reconstruction. Age, sex, medical history, subsite, T classification, preoperative treatment history, and purpose of surgery were compared between the free jejunal flap and cutaneous free tissue flap groups. There were no significant differences in any variables between the two groups, including the patients’ background characteristics.
3.2. Complications
The assessment of the primary endpoint, swallowing function, is shown in
Table 2.
Regarding the diet form at discharge, 132 patients had FOIS scores of 1–6 (70%), and 56 patients had a FOIS score of 7 (30%) in the free jejunal flap group, whereas 18 patients had FOIS scores of 1–6 (51%), and 17 patients had a FOIS score of 7 (49%) in the cutaneous free tissue flap group. The normal diet rate was significantly higher in the cutaneous free tissue flap group than in the free jejunal flap group (
p = 0.04).
Table 3 reports the ORs and 95% CIs from logistic regressions of diet at discharge, adjusted for the patient and setting characteristics described above.
The cutaneous free tissue flap group had a higher regular dietary intake rate than the free jejunal flap group with an adjusted OR of 0.35 (95% CI, 0.16–0.78; p = 0.01). Other factors, such as age, sex, medical history, T classification, preoperative therapy (neo-adjuvant chemotherapy and radiotherapy), and objective (definitive or salvage surgery) were not associated with diet at discharge.
Eleven patients in the free jejunal flap group (6%) and two patients in the cutaneous free tissue flap group (6%) had nasopharyngeal reflux. Twenty-one patients in the free jejunal flap group (11%) and three patients in the cutaneous free tissue flap group (9%) had anastomotic strictures. However, there were no significant differences between the two groups.
The assessment of the primary endpoint, swallowing function excluding radiotherapy, is shown in
Table 4.
Regarding the diet form at discharge, 106 patients had FOIS scores of 1–6 (69%) and 48 patients had a FOIS score of 7 (31%) in the free jejunal flap group, whereas 13 patients had FOIS scores of 1–6 (43%) and 17 patients had a FOIS score of 7 (57%) in the cutaneous free tissue flap group. The normal diet rate was significantly higher in the cutaneous free tissue flap group than in the free jejunal flap group (
p = 0.01).
Table 5 reports the ORs and 95% CIs from logistic regressions of diet at discharge excluding radiotherapy, adjusted for the patient and setting characteristics described above.
The cutaneous free tissue flap group had a higher regular dietary intake rate than the free jejunal flap group with an adjusted OR of 0.31 (95% CI, 0.14–0.72; p = 0.01) Other factors, such as age, sex, medical history, T classification, and preoperative therapy were not associated with diet at discharge.
Ten patients in the free jejunal flap group (6%) and one patient in the cutaneous free tissue flap group (3%) had nasopharyngeal reflux. Twenty-nine patients in the free jejunal flap group (12%) and two patients in the cutaneous free tissue flap group (7%) had anastomotic strictures. However, there were no significant differences between the two groups.
The incidence of pharyngocutaneous fistula as the secondary endpoint is shown in
Table 6.
Pharyngocutaneous fistula was observed in 21 (9%) of 223 patients. Pharyngocutaneous involvement was observed in 18 patients (10%) requiring free jejunal flap reconstruction and in three patients requiring reoperation (2%). Furthermore, it was observed in three patients requiring cutaneous free tissue flap reconstruction (9%) and in one patient requiring reoperation (3%). However, there was no significant difference between the two groups (
p = 0.99). The data regarding perioperative complications are shown in
Table 7.
Regarding donor site complications in the free jejunal flap group, 16 patients (8%) had intestinal obstruction, and six (3%) had infection. No hemorrhage or neuropathy was observed. None of the patients in the cutaneous free tissue flap group experienced donor site complications. There was no significant difference between the two groups; however, the total incidence of donor site complications was significantly higher in the free jejunal flap group than in the cutaneous free tissue flap group (p = 0.03). Regarding systemic complications in the free jejunal flap group, respiratory disorders were observed in five patients (3%) whereas cardiovascular disorders were observed in two patients (1%). In the cutaneous free tissue flap group, respiratory disorders were observed in two patients (6%) and cardiovascular disorders were observed in one patient (3%). However, there were no significant differences in any of the variables between the two groups. In total, 68 patients (40%) in the free jejunal flap group had cervical complications, including fistula in 24 patients (13%), flap necrosis in nine patients (5%), lymph fistula in 26 patients (14%), hemorrhage in five patients (3%), and infection in 26 patients (14%). Ten patients (31%) in the cutaneous free tissue flap group had cervical complications, including fistula in six patients (17%), flap necrosis in one patient (3%), lymph fistula in three patients (9%), and infection in three patients (9%). However, there were no significant differences in any of the variables between the two groups.