Minimally invasive esophagectomy (MIE) has been gradually adopted as a feasible and effective treatment option for esophageal cancer. Previously the investigators have published the adoption of single-incision approach both in the thoracoscopic and laparoscopic phases in MIE (SIMIE).The preliminary clinical results showed that SIMIE can provide an equivalent perioperative outcome whereas reduced the wound pain on the days 7 after surgery as compared to MIE performed with multi-incision (MIMIE). The goal of the current study was to conduct a prospective randomized trial to compare the perioperative outcome and survival of SIMIE and MIMIE.
Surgery remains the main stay of treating esophageal cancer. However, esophagectomy is a complex and technical demanding surgical procedure harboring substantial morbidity and mortality. Minimally invasive esophagectomy (MIE) has been gradually adopted as a feasible and effective treatment option for esophageal cancer. The standardized procedure including lymph node dissection, esophageal mobilization and reconstruction can be effectively performed under minimized wound incision whereas rendering the patients a possibility of faster postoperative recovery and reduced risk of perioperative postoperative pulmonary complication. The procedure of MIE including the thoracoscopic and laparoscopic phases which are usually performed multiple incisional wounds. Previously the investigators have published the adoption of single-incision approach both in the thoracoscopic and laparoscopic phases in MIE (SIMIE). The preliminary clinical results showed that SIMIE can provide an equivalent perioperative outcome whereas reduced the wound pain on the days 7 after surgery as compared to MIE performed with multi-incision (MIMIE). The goal of the current study was to conduct a prospective randomized trial to compare the perioperative outcome and survival of SIMIE and MIMIE.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Minimally invasive esophagectomy is a surgical procedure for esophageal resection
Jang-Ming Lee
Taipei, Zhongzheng Dist., Taiwan
RECRUITINGOverall survival rate
Overall survival rate of the participants after surgery
Time frame: 60 months
Pain score as assessed by the face rating scale
The scale range of face rating scale is ranging from 0 (happy face) to 10 (crying face). Higher values represent a worse outcome.
Time frame: 1,7,14,28 days
Ratio of ambulation
30-minute walk test
Time frame: post-operative day 2 (POD2)
Postoperative force vital capacity
Force vital capacity (FVC) is one of the most common parameters for pulmonary function measured in spirometry
Time frame: 1 and 3 months
Post operative forced expiratory volume in one second
Forced expiratory volume in one second (FEV1) is one of the most common parameters for pulmonary function measured in spirometry
Time frame: 1 and 3 months
Postoperative pulmonary complication
pulmonary complication after esophagectomy
Time frame: 1 month
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