Hsao-Hsun Hsu1, Yun-Hen Liu2, Hsuan-Yu Chen3, Pei-Hsing Chen4, Ke-Cheng Chen1, Ming-Ju Hsieh2, Mong-Wei Lin1, Shuenn-Wen Kuo1, Pei-Ming Huang1, Yin-Kai Chao2, Ching-Feng Wu2, Ching-Yang Wu2, Chien-Hung Chiu2, Wei-Hsun Chen2, Chih-Tsung Wen2, Chao-Yu Liu5, Yi-Cheng Wu6, Jin-Shing Chen7. 1. Division of Thoracic Surgery, Department of Surgery, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan. 2. Division of Thoracic Surgery, Department of Surgery, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan. 3. Institute of Statistical Science, Academia Sinica, Taipei, Taiwan. 4. Division of Thoracic Surgery, Department of Surgery, National Taiwan University Hospital Yun-Lin Branch, Yun-Lin, Taiwan. 5. Division of Thoracic Surgery, Department of Surgery, Far-Eastern Memorial Hospital, New Taipei City, and Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan. 6. Division of Thoracic Surgery, Department of Surgery, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan. Electronic address: expert96@cgmh.org.tw. 7. Division of Thoracic Surgery, Department of Surgical Oncology, National Taiwan University Cancer Center and National Taiwan University College of Medicine, Taipei, Taiwan.
Abstract
BACKGROUND: Although thoracoscopic stapled bullectomy is a standard procedure for primary spontaneous pneumothorax (PSP), the postoperative recurrence rate is high. We investigated whether using a Vicryl (Ethicon, Somerville, NJ) mesh to cover the staple line after bullectomy reduces the postoperative recurrence rate. METHODS: Our single-blind, parallel-group, prospective, randomized controlled trial at 2 medical centers in Taiwan studied patients with PSP who were aged 15 to 50 years and required thoracoscopic bullectomy. On the day of operation, patients were randomly assigned (1:1) to receive Vicryl mesh (mesh group) or not (control group) after thoracoscopic bullectomy with linear stapling and mechanical apical pleural abrasion. Randomization was achieved using computer-generated random numbers in sealed envelopes. Our primary end point was the pneumothorax recurrence rate within 1 year after the operation (clinicaltrials.gov number, NCT01848860.) RESULTS:Between June 2013 and March 2016, 102 patients were assigned to the mesh group and 102 to the control group. Within 1 year after operation, recurrent pneumothorax was diagnosed in 3 patients (2.9%) in the mesh group compared with 16 (15.7%) in the control group (P = .005). The short-term postoperative results and hospitalization duration were comparable between the groups. CONCLUSIONS: For thoracoscopic bullectomy with linear stapling and mechanical apical pleural abrasion, the use of a Vicryl mesh to cover the staple line is effective for reducing the postoperative recurrence of pneumothorax. Vicryl mesh coverage can be considered an optimal adjunct to the standard surgical procedure for PSP.
RCT Entities:
BACKGROUND: Although thoracoscopic stapled bullectomy is a standard procedure for primary spontaneous pneumothorax (PSP), the postoperative recurrence rate is high. We investigated whether using a Vicryl (Ethicon, Somerville, NJ) mesh to cover the staple line after bullectomy reduces the postoperative recurrence rate. METHODS: Our single-blind, parallel-group, prospective, randomized controlled trial at 2 medical centers in Taiwan studied patients with PSP who were aged 15 to 50 years and required thoracoscopic bullectomy. On the day of operation, patients were randomly assigned (1:1) to receive Vicryl mesh (mesh group) or not (control group) after thoracoscopic bullectomy with linear stapling and mechanical apical pleural abrasion. Randomization was achieved using computer-generated random numbers in sealed envelopes. Our primary end point was the pneumothorax recurrence rate within 1 year after the operation (clinicaltrials.gov number, NCT01848860.) RESULTS: Between June 2013 and March 2016, 102 patients were assigned to the mesh group and 102 to the control group. Within 1 year after operation, recurrent pneumothorax was diagnosed in 3 patients (2.9%) in the mesh group compared with 16 (15.7%) in the control group (P = .005). The short-term postoperative results and hospitalization duration were comparable between the groups. CONCLUSIONS: For thoracoscopic bullectomy with linear stapling and mechanical apical pleural abrasion, the use of a Vicryl mesh to cover the staple line is effective for reducing the postoperative recurrence of pneumothorax. Vicryl mesh coverage can be considered an optimal adjunct to the standard surgical procedure for PSP.