2024-519529-40-00招募中3 期
“USE OF A FIBRIN ADHESIVE TO REDUCE ESOPHAGOYEJUNAL ANASTOMOSIS DEHISCENCE IN TOTAL GASTRECTOMIES FOR CANCER: RANDOMIZED AND MULTICENTER STUDY”
Hospital Germans Trias I Pujol13 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2025年1月15日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 13
- 主要终点
- Suture dehiscence diagnosed within the first seven days after surgery, using clinical and/or radiological parameters. Csendes classification
研究概览
简要总结
The trial would be conducted with the aim of evaluating the efficacy of fibrin-based adhesive in reducing the incidence of dehiscence in esophagojejunal anastomoses in total gastrectomies for cancer.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes over 18 years of age.
- •Diagnosis of gastric cancer with AP of gastric adenocarcinoma and possibility of total gastrectomy with curative intent. Tumors with AP characteristics other than gastric adenocarcinoma are excluded (see ‘Exclusion Criteria’)
- •Patients undergoing surgery in trial participants hospital centers
- •understand and accept the trial procedures and sign an informed consent.
排除标准
- •Not meeting the inclusion criteria.
- •Intraoperative diagnosis (during surgery) of non-epithelial neoplasia,metastasis, patients with unresected tumor or undergoing palliative resections.
- •Use of other sealing or anastomosis reinforcing products other than the drug under study (TISSEEL Solutions for tissue adhesive)
- •Subjects who are intolerant or have experienced serious adverse events to products made from fibrin adhesive
- •Pregnant or lactating women
- •Subjects who are unable to understand the nature of the trial and the procedures they are required to follow.
- •Failure to sign the informed consent.
结局指标
主要结局
Suture dehiscence diagnosed within the first seven days after surgery, using clinical and/or radiological parameters. Csendes classification
Suture dehiscence diagnosed within the first seven days after surgery, using clinical and/or radiological parameters. Csendes classification
次要结局
- Type of anastomosis performed: manual, mechanical (circular or linear)
- Amylases in drainage on days 1,3,5,7 postoperatively or until the drainage is removed.
- Leukocytes, procalcitonin, C-reactive protein in blood on days 0,1,3,5,7 postoperatively.
- Day of CT with oral contrast. CT findings according to Goense score
- Postoperative complication and type (Clavien Dindo Classification)
- Need for urgent surgical reintervention
- In-hospital and 90-day mortality
- Date of hospital discharge
- Readmissions at 30 and 90 days
研究者
Yolanda Soler Gonzalez
Scientific
Hospital Germans Trias I Pujol
研究点 (13)
Loading locations...
相似试验
尚未招募
3 期
Investigating the effect of anti-adhesion substances in reducing adhesion after laparoscopic endometriosis surgeryEndometriosis.EndometriosisIRCT20221121056562N1Karaj University of Medical Sciences60
已完成
不适用
The effect of adhesion prevention absorbing barrier wrapping method for temporary ileostomy creatiocolorectal carcinomaJPRN-UMIN000035755Sapporo medical university20
进行中（未招募）
1 期
FIBRINOGEN REPLACEMENT TO PREVENT INTRACRANIAL HAEMORRHAGE IN ISCHEMIC STROKE PATIENTS AFTER THROMBOLYSIS: A PILOT PROBE RANDOMIZED CONTROLLED TRIAEUCTR2020-005242-41-ITAZIENDA USL DI BOLOGNA200
已完成
不适用
Does the application of adhesive skin drapes reduce the risk of early wound infection after implantation of central-venous port systems? A randomized trialOPS-2020: 5-399.5 (Implantation of a venous access port system)C00-C75Malignant neoplasms, stated or presumed to be primary, of specified sites, except of lymphoid, haematopoietic and related tissueDRKS00020933Klinik für Allgemein- und Viszeralchirurgie, Evangelisches Krankenhaus Lippstadt gemeinnützige GmbH100
终止
不适用
A Trial to Reduce Adhesions Following a Primary Cesarean SectionTissue AdhesionsNCT01819467South East Area Health Education Center, Wilmington, NC29