The use of clips to completely clip mucosal defects after ESD/EMR can reduce postoperative adverse events, but the rate of incomplete mucosal defects closure is high. The continuous suture technique can completely close the mucosal defects by using surgical sutures and clips to suture the mucosal defects after ESD/EMR. In this study, a clinical randomized controlled study was conducted in our hospital. A total of 62 enrolled patients were divided into two groups, 31 patients were set as a treatment group using continuous suture technique to close post-EMR/ESD mucosal/submucosal defects, the rest patients were set as a control group using clips. The safety and effectiveness of continuous sutures and clips to clamp the post-EMR/ESD mucosal/submucosal defect were compared in the two groups. The complete mucosal/submucosa defects closure rates were the primary outcome.
Endoscopic submucosal resection (EMR) or submucosal dissection (ESD) for gastrointestinal lesions were used to treat early gastrointestinal cancer or large benign polyps, and their complete resection rates were high, which greatly reduce unnecessary surgical operations. However, after endoscopic resection of mucosal/submucosal lesions, large mucosal/submucosal defects may be created. These defects may cause more delayed postoperative adverse events (bleeding, perforation). The use of clips to completely seal the mucosal defect after gastrointestinal mucosal/submucosal lesion resection can significantly reduce postoperative adverse events, but the rate of incomplete mucosal defects closure is high. The surgical sutures combined with clips to close the mucosal defect after surgery significantly increased the complete closure rates of the post-EMR/ESD mucosal/submucosal defect. This study intends to further determine its safety and effectiveness through a clinical randomized controlled study, and standardize indications and contraindications. A total of 62 enrolled patients were allocated into two groups, 31 patients were set as a treatment group using continuous suture technique to close post-EMR/ESD mucosal/submucosal defects, the rest patients were set as a control group using clips. The safety and effectiveness of continuous sutures and clips to clamp the post-EMR/ESD mucosal/submucosal defect were compared in the two groups. The primary outcome was complete mucosal/submucosa defects closure rates. The secondary outcomes were the closure time, closure speed, and immediate bleeding during the operation as well as delayed bleeding, delayed perforation, and polyps syndrome after resection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
62
Cotinuous suture using surgery thread
Hemostatic clips
The Fifth Medical Center of Chinese PLA General Hosptial
Beijing, Beijing Municipality, China
The rates of complete closure of mucosal/submucosal defects
When the clips were applied next to each other and there were no substantial submucosal areas in the closure line
Time frame: 1day
The duration time of closure
The duration of closure was defined as the interval from insertion of the first clip until complete or incomplete closure
Time frame: 1 day
The closure speed
The closure speed was defined as the resection area divided by 10x the duration of the ligation procedure (cm2 /10 minutes).
Time frame: 1day
Immediate bleeding
Immediate bleeding refers to those episodes of hemorrhage that occurred during the procedure and lasted more than 30 seconds or required endoscopic treatment.
Time frame: 1 day
Delayed bleeding
Delayed bleeding was defined as bleeding requiring emergency endoscopic hemostasis or transfusion or the presence of hemoglobin loss≥2 g/dL after EMR/ESD
Time frame: 14 days
Delayed perforation
Delayed perforation was defined as the presence of free air on abdominal CT or radiography after completion of the procedure in patients without perforation during EMR/ESD and no symptoms of peritoneal irritation after EMR/ESD
Time frame: 14 days
Post polypectomy syndrome
Post polypectomy syndrome was defined by symptoms of pain, fever, leukocytosis, peritoneal tenderness, and guarding.
Time frame: 14 days
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