Gastrostomy Complications Clinical Trial
Official title:
Radical Gastrectomy Within Enhanced Recovery Programs: a Prospective Randomized Controlled Trial
This study is a prospective, single-center, randomized controlled trial. The study protocol was approved by the Ethics Committee at the First Hospital of Jilin University.ERAS is combined with the laprascopic gastrectomy to assess the efficacy and safety in patients with advanced gastric carcinoma.The hospitalized patients were randomly divided into ERAS group and conventional pathway group . Inter-group differences were evaluated for clinical recovery index, economic indicators, length of hospital stay, 3 years to 5 years long-term survival, etc.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | January 30, 2019 |
Est. primary completion date | March 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - (1) A preoperative cancer stage of T2, T3, T4, Any N, M0 without digestive obstruction confirmed by whole body CT scan, which could be treated with laparoscopic gastrectomy; (2) age 18-75 years; (3) pathologic confirmation of gastric adenocarcinoma by endoscopic biopsy; (4) normal hematological, renal, hepatic, and cardiac parameters, ASA score < III without severe systemic disease; and (5) no history of treatment with neoadjuvant chemotherapy and/or radiotherapy. Exclusion Criteria: - patients requiring conversion to open gastrectomy; excessive bleeding (? 500 mL);and patients opting out of the study. |
Country | Name | City | State |
---|---|---|---|
China | First Hospital of Jilin University | Changchun | Jilin |
Lead Sponsor | Collaborator |
---|---|
First Hospital of Jilin University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | clinical parameters | length of post-operative stay | One week after operation | |
Secondary | Postoperative complications | wound infection;post-opeartion bleeding;ileus;stenosis;leakage | 30 days after operation |
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