Esophageal Neoplasms, Surgical Stomas
Conditions
Keywords
Esophagogastrostomy, Circular everted anastomosis, Side-side anastomosis, Randomized clinical trial
Brief summary
The investigators improved the hybrid everted esophagogastrostomy and expected to prevent the incidence of anastomotic stricture. The purpose of this study is to determine the clinical value of this kind of operation type, and analyzes the clinicopathological factors causing the postoperative complications.
Detailed description
This randomized clinical trial compared a hybrid everted esophagogastric anastomosis with conventional hand-sewn or stapled esophagogastrostomy for prevention of anastomotic stricture. The patients were completely randomized to receive either a hybrid everted esophagogastric anastomosis (HE group), or the conventional hand-sewn (HS group), or a stapled (SA group) anastomosis, after the removal of esophageal tumor. The primary outcome measured the incidence of anastomotic stricture at 3 months after the operation (defined as the diameter of the anastomotic orifice \<= 0.8 cm on esophagogram), analyzed by intention-to-treat.
Interventions
OTHERhybrid everted esophagogastric anastomosis
OTHERthe conventional hand-sewn anastomosis
OTHERa stapled anastomosis
Sponsors
Sichuan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* pathologically diagnosed esophageal neoplasms * undergoing the Esophagogastrostomy
Exclusion criteria
* the patients with previous the upper gastrointestinal tract surgery * the esophageal carcinoma patients with previous neoadjuvant chemotherapy * the esophageal carcinoma complicated other esophagogastric diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the incidence of anastomotic stricture | three months | the anastomotic stricture is defined as the diameter of the anastomotic orifice \<= 0.8 cm on esophagogram |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The grades of dysphagia | three months | 0:No dysphagia on solid diet 1. dysphagia on solid diet 2. dyspahgia on semi-solid diet 3. dysphagia on fluid diet 4. dysphagia with water swallowing |
| the grades of acid regurgitation | three months | 0:no reflux on semi-supine position 1. postprandial reflux on semi-supine position 2. reflux with empty stomatch on semi-supine position 3. postprandial reflux on upright position 4. reflux with empty stomach on upright positino |
| the clinicopathological parameters in relation to postoperative complications | three months | — |
Outcome results
None listed