NCT00888849已完成不适用
An Open-label, Randomized, Prospective Study of the Effectiveness, Safety, and Clinical Outcomes of Stapled Anastomoses Versus Hand-Sutured Anastomoses in Patients Undergoing Gastrointestinal End to End or Side to Side Anastomoses
Ethicon Endo-Surgery6 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2009年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 试验地点
- 6
- 主要终点
- Time of Surgery (Skin Open to Skin Close)
研究概览
简要总结
This study is being conducted to compare surgical and patient outcomes across stapled (Group II) versus hand-sutured (Group I) groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to comprehend and sign or, if illiterate, leave their thumb impression on the study informed consent document
- •18 years to 75 years (inclusive)
- •Admitted on an emergency or elective basis requiring a single gastrointestinal anastomosis
- •Willing to adhere to standard postoperative care, including ventilator support if required
- •Female subject is postmenopausal (for at least 2 years) or surgically incapable of child bearing (at least 3 months post-surgical sterilization, with appropriate documentation)
- •If female subject is capable of child bearing, must use an acceptable method of birth control (hormonal or IUD) for at least 3 months prior to surgery and continue use throughout the study; maintained normal menstrual pattern for the past three months and has a negative urine pregnancy test prior to day of surgical procedure
- •Absence of medical history of psychiatric disorders that could limit the subject's ability to understand the procedure, comply with medical, surgical, and/or behavioral recommendations.
排除标准
- •Women of childbearing potential who are pregnant at the time of screening or at the time of surgery
- •Subject is on treatment with Corticosteroid maintenance therapy (equivalent to > 10mg/day of Prednisone), immunosuppressive or chemotherapeutic agents within 14 days prior to enrollment; or likely to receive one of these drugs during study period
- •Subject has connective tissue disease, renal failure necessitating chronic hemodialysis or chronic ambulatory peritoneal dialysis as evidenced by serum creatinine of > 3mg/dL
- •Subject has liver failure as evidenced by CP category C
- •Immunocompromised subjects (hematological malignancies, history of bone marrow transplantation, splenectomized subjects, genetic disorders such as Lupus, severe combined immunodeficiency, etc.) or a positive HIV test result
- •Subject has extensive disseminated malignancy and unlikely to survive for more than 3 months based on investigator judgment
- •Any subject that the investigator determines is not likely to be compliant during the study period
- •Subjects determined or suspected to engage in substance abuse, or any subject who is currently, or has in the past 6 months, undergone substance abuse therapy
- •The investigator feels that the primary anastomosis is not feasible due to local conditions of the bowel or subject has unstable hemodynamic status requiring stoma
- •Participation in any other investigational device or drug study (non survey based trial) within 30 days of enrollment.
研究组 & 干预措施
Stapling
Experimental
干预措施: Advant 55 Linear Cutter/Stapler (Procedure)
Suturing
Active Comparator
4 layered hand-sutured anastomosis
干预措施: Suturing (Procedure)
结局指标
主要结局
Time of Surgery (Skin Open to Skin Close)
时间窗: Day 1
Time of Anastomosis
时间窗: Total time (minutes) from placement of stay suture to final anastomotic staple (Group II) or final anastomotic suture (Group I)
Return to Bowel Activity
时间窗: Number of days post-surgery to appearance of peristaltic movement
次要结局
未报告次要终点
研究者
研究点 (6)
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