A Phase 3 interventional study of Discharge the NG tube during the surgery in Esophageal Cancer, sponsored by Fudan University. Status unknown. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-06.
Sponsored by Fudan University · Phase 3, Interventional, and Treatment
Nasogastric decompression is standard practice after esophageal resection in most centers because it is expected to reduce the incidence of esophagogastric anastomotic leakage by preventing overdistension of the gastric conduit. Most esophageal surgeons have been reluctant to move away from this tradition because of the considerable morbidity of anastomotic leaks after esophagectomy. However, a contrarian view is that the use of prolonged NGD may increase the incidence of postoperative pulmonary complications by promoting aspiration. Considering the numerous complications caused by using the tube and the uncertainty about its usefulness and the scarcity of studies conducted on the subject, particularly in patients with esophageal cancer, the necessity of using the tube in these types of cases is investigated in the present study.
Methods In this clinical trial, patients with esophageal cancer were randomized into groups with NG tube and without NG tube after surgery. Sequence generation was performed using a computer-generated sequence of random numbers with permuted blocks. Standard postoperative management protocols were followed in both groups to avoid potential bias, which including preoperation nasogastric decompression. Thoracic esophageal mobilization and mediastinal lymphadenectomy were performed by open thoracotomy surgery. The abdominal part of the surgery was performed by laparotomy, gastric tube reconstruction was performed using linear staplers, and the conduit was brought up to the neck through the posterior mediastinal route. A cervical esophagogastric anastomosis was performed by stapled (linear) techniques. All patients were mobilized early, began early enteral feeding through jejunostomy tubes. Randomization was performed during the surgery. The group without NG tube after surgery will discharge the NG tube during the surgery. While the control group(group with NG tube after surgery) will discharge the NG tube 6-7days after surgery. The variables recorded for each patient included pulmonary complications, wound complications, anastomosis leak as well as the duration of postoperative hospitalization and the need for placing replacing the NG tube.
Patients who were fit for esophageal resection and underwent transthoracic or transhiatal esophagectomy with gastric tube reconstruction.
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Exclusion Criteria:
In this goup, patients will undergo preoperative gastrointestinal decompression and investigators will discharge the NG tube during the surgery.
Procedure: Discharge the NG tube during the surgery
In this goup, patients will undergo preoperative gastrointestinal decompression and investigators will discharge the NG tube 6-7 days after the surgery.
Discharge the NG tube during the surgery.
postoperative complication
the occurrence of major pulmonary complications and anastomotic leaks.
Time frame: an expected average of 4 weeks
the need for placing/ replacing the NG tube
the need for placing/ replacing the NG tube
Time frame: an expected average of 2 weeks
Length of postoperative stay
Length of postoperative stay
Time frame: an expected average of 2 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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Fudan University