OBJECTIVE: To assess if the bilateral mediastinal lymphadenectomy results in lymphatic congestion in the lungs producing clinically significant impairment of respiratory function. METHODS: In the prospective, randomized, double-blind clinical study, non-small cell lung carcinoma patients underwentpreoperatively mediastinoscopy or the transcervical extended mediastinal lymphadenectomy (TEMLA). In both groups, the blood gas analysis and spirometry were measured preoperatively and on the 1st, 3rd, and 5th postoperative day, and the carbon monoxide diffusing capacity of the lung (DLCO) and lung compliance were measured preoperatively and on the 3-5 postoperative day. Any respiratory complications were also recorded. RESULTS: Forty-one patients were randomized: 21 to the TEMLA group and 20 to the mediastinoscopy group. There was no significant difference of the baseline and the 1st, 3rd, and 5th day measurements of vital capacity and forced expiratory volume (FEV1) (p>0.98), pH, pO(2), pCO(2), standard bicarbonates and base excess (p>0.31), nor significant difference of baseline and 3-5 day measurements for DLCO (p=0.91) and lung compliance (p=0.38). The incidence of respiratory insufficiency was not significantly different (p=0.51). CONCLUSIONS: (1) Complete excision of mediastinal lymph nodes stations 1, 2R, 2L, 3A, 4R, 4L, 5, 6, 7, and 8 (TEMLA) is not associated with greater incidence of respiratory insufficiency comparing with standard mediastinoscopy. (2) The TEMLA procedure does not produce greater alterations in spirometry, blood gas analysis, DLCO and lung compliance comparing with standard mediastinoscopy.
RCT Entities:
OBJECTIVE: To assess if the bilateral mediastinal lymphadenectomy results in lymphatic congestion in the lungs producing clinically significant impairment of respiratory function. METHODS: In the prospective, randomized, double-blind clinical study, non-small cell lung carcinomapatients underwent preoperatively mediastinoscopy or the transcervical extended mediastinal lymphadenectomy (TEMLA). In both groups, the blood gas analysis and spirometry were measured preoperatively and on the 1st, 3rd, and 5th postoperative day, and the carbon monoxide diffusing capacity of the lung (DLCO) and lung compliance were measured preoperatively and on the 3-5 postoperative day. Any respiratory complications were also recorded. RESULTS: Forty-one patients were randomized: 21 to the TEMLA group and 20 to the mediastinoscopy group. There was no significant difference of the baseline and the 1st, 3rd, and 5th day measurements of vital capacity and forced expiratory volume (FEV1) (p>0.98), pH, pO(2), pCO(2), standard bicarbonates and base excess (p>0.31), nor significant difference of baseline and 3-5 day measurements for DLCO (p=0.91) and lung compliance (p=0.38). The incidence of respiratory insufficiency was not significantly different (p=0.51). CONCLUSIONS: (1) Complete excision of mediastinal lymph nodes stations 1, 2R, 2L, 3A, 4R, 4L, 5, 6, 7, and 8 (TEMLA) is not associated with greater incidence of respiratory insufficiency comparing with standard mediastinoscopy. (2) The TEMLA procedure does not produce greater alterations in spirometry, blood gas analysis, DLCO and lung compliance comparing with standard mediastinoscopy.