CTRI/2009/091/000311已完成4 期
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
Johnson and Johnson Ltd3 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2009年7月4日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Time of surgery
研究概览
简要总结
This will be a prospective, randomized, interventional, parallel, controlled trial to compare surgical and patient outcomes across stapled (Group II) versus hand-sutured (Group I) groups. At least 300 patients, male and female, admitted on emergency or elective admissions will be enrolled in the study. Subjects enrolled in the study will be randomly assigned to one of two treatment groups i.e Group I - Hand Sutured and Group II - Stapled.
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •a.Able to comprehend and sign or, if illiterate, leave their thumb impression on the study informed consent document;b.18 years to 75 years (inclusive);c.Admitted on an emergency or elective basis requiring a single gastrointestinal anastomosis;d.Willing to adhere to standard postoperative care, including ventilator support if required;e.Female subject is postmenopausal (for at least 2 years) or surgically incapable of child bearing (at least 3 months post-surgical sterilizilation, with appropriate documentation);f.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; andg.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
- •a.Women of childbearing potential who are pregnant at the time of screening or at the time of surgery;b.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;c.Subject has connective tissue disease, renal failure necessitating chronic hemodialysis or chronic ambulatory peritoneal dialysis as evidenced by serum creatinine of > 3mg/dL;d.Subject has liver failure as evidenced by CP category C;e.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;f.Subject has extensive disseminated malignancy and unlikely to survive for more than 3 months based on investigator judgment;g.Any subject that the investigator determines is not likely to be compliant during the study period;h.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;i.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; andj.Participation in any other investigational device or drug study (non survey based trial) within 30 days of enrollment.
结局指标
主要结局
Time of surgery
时间窗: The trial will consist of the following visits: | ?Visit 1 ? Screening | ?Visit 2 ? Surgery | ?Visit 3 ? Immediate Post-surgical period until day of suture removal | ?Visit 4 ? Final Visit (approximately Day 25 post surgery)
Time of anastomosis
时间窗: The trial will consist of the following visits: | ?Visit 1 ? Screening | ?Visit 2 ? Surgery | ?Visit 3 ? Immediate Post-surgical period until day of suture removal | ?Visit 4 ? Final Visit (approximately Day 25 post surgery)
Return to bowel activity movement
时间窗: The trial will consist of the following visits: | ?Visit 1 ? Screening | ?Visit 2 ? Surgery | ?Visit 3 ? Immediate Post-surgical period until day of suture removal | ?Visit 4 ? Final Visit (approximately Day 25 post surgery)
次要结局
- Days to be fit for resuming normal lifeTotal anesthesia timeReturn to normal dietFrequency of post-surgical leak confirmed by medical or radiological examinationAdmission to Intensive Care Unit (ICU) due to post surgical complications related to anastomotic procedureLength of stay in ICUIntra-operative resource utilization: OR, Staff, anesthesia, Medications and medical suppliesICU resource utilization: staff, medications, medical interventions, diagnostic tests, and medical supplies.Post-operative ward stay resource utilization: staff, medications, medical interventions, diagnostic tests, and medical suppliesNumber of follow-up visits Days to be fit for medical/surgical discharge Days to discharge(The trial will consist of the following visits:?Visit 1 ? Screening?Visit 2 ? Surgery?Visit 3 ? Immediate Post-surgical period until day of suture removal?Visit 4 ? Final Visit (approximately Day 25 post surgery))
研究者
研究点 (3)
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