This study is evaluating the feasibility and safety of radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma, as well as the clinical value of the radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma as a new minimally invasive operation for esophageal carcinoma.
This is a prospective, multicenter, open clinical study in which 155 patients (including 5% shedding rate) who require surgical treatment are scheduled to be included in the study. Prior to any screening process, each subject / legal guardian should sign the informed consent form. Screening tests are used to determine whether each subject is eligible for the study. Eligible subjects who meet the standard will be treated with radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma and followed up until 3 years postoperatively. Primary study outcome are the prioperative complication rate and the number of intraoperative lymph node dissection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
155
The radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma is new minimally invasive operation for esophageal carcinoma. All enrolled subjects will receive this operation for their ESCC.
Beijing Chao-yang Hospital
Beijing, Beijing Municipality, China
Perioperative complication rate
Perioperative complications include: pulmonary infection, respiratory failure, managed pleural effusion, heart failure, myocardial infarction, managed arrhythmia, anastomotic fistula or gastric fistula, recurrent laryngeal nerve injury, chylothorax, unscheduled reoperation
Time frame: Through operation completion, an average of 12 days
Number of lymph nodes dissected
number of lymph nodes dissected during operation
Time frame: During the operation
Intraoperative bleeding volume
Calculation of intraoperative bleeding with ml/kg
Time frame: During the operation
Operative time
Calculate the operating time in minutes
Time frame: During the operation
Proportion of patients undergoing thoracotomy or laparotomy
The ratio of the number of patients converted to thoracotomy or laparotomy to the total number of patients undergoing surgery
Time frame: During the operation
Intraoperative mortality
The ratio of the number of patients who died during the operation to the number of patients who underwent the operation
Time frame: During the operation
Postoperative hospital stay
The days of postoperative hospitalization
Time frame: Up to 2 weeks after the operation
Postoperative pain score
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Affiliated Daping Hospital
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
NOT_YET_RECRUITINGSun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGShantou Central Hospital
Shantou, Guangdong, China
NOT_YET_RECRUITINGAffiliated Hospital of Zunyi Medical College
Zunyi, Guizhou, China
RECRUITINGThe Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
NOT_YET_RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGAnyang Cancer Hospital
Anyang, Henan, China
RECRUITINGXiangyang No.1 People's Hospital
Xiangyang, Hubei, China
RECRUITING...and 11 more locations
Daily pain scores were recorded by VAS (Visual Analogue Scale/Score) 1-3 days after operation
Time frame: 1-3 days after the operation
Postoperative icu monitoring time
If the patient needs to be transferred to ICU after operation, stay in icu monitoring time should be observed
Time frame: 0-12 days after the operation
Incidence of adverse events during and after operation
Special attention is paid to observing whether arrhythmias need to be dealt with during the operation (record the types of arrhythmias, treatment methods, medication, time of occurrence, possible causes)
Time frame: 3 years
Postoperative drainage
Total postoperative thoracic or mediastinal drainage (ml/kg)
Time frame: 0-12 days after the operation
Postoperative drainage tube indwelling time
The retention time of different types of drainage tube
Time frame: 0-12 days after the operation