跳至主要内容
临床试验/NCT05811585
NCT05811585已完成不适用

Post-Market Clinical Follow-up Study for ADEPT® in Laparoscopic Gynecologic Surgery

Baxter Healthcare Corporation2 个研究点 分布在 2 个国家目标入组 153 人开始时间: 2023年6月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
153
试验地点
2
主要终点
Incidence of hospital readmissions directly or possibly related to adhesions

研究概览

简要总结

Postoperative adhesions develop in most patients after gynecologic surgery, likely resulting in significant morbidity, complications, and considerable increases in healthcare costs. Good surgical techniques, including a minimally invasive approach, may reduce adhesions and minimize the abovementioned complications. The agents for prevention or reduction of adhesion formation are placed inside the abdominal cavity, and especially in the pelvic cavity, which contains the female reproductive organs. ADEPT Adhesion Reduction Solution, hereinafter referred to as ADEPT, is intended for use as an intraperitoneal instillate for the reduction of adhesions following gynecological laparoscopic surgeries. The objective of this study is to evaluate the effectiveness and safety of ADEPT by detecting the incidence of adhesion-related morbidities (adhesion-related readmissions, including reoperations) after laparoscopic gynecologic surgery through a single-arm, retrospective, chart review with a patient questionnaire intended to supplement the patient chart.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult female patients who, at the time of surgery, were ≥ 18 years of age and who had undergone an index laparoscopic gynecologic surgery at least 2 years prior to the start of the study.
  • Patients in whom ADEPT® was used as an irrigant during the index laparoscopic gynecologic surgical procedure and as an intraperitoneal instillate for the reduction of adhesions following laparoscopic surgery.

排除标准

  • Patients who had frank infection in the abdominopelvic cavity at the time of the surgery.
  • Patients who were pregnant or nursing at the time of the surgery.

结局指标

主要结局

Incidence of hospital readmissions directly or possibly related to adhesions

时间窗: Within 2 years of surgery

Patient charts will be reviewed to collect data on readmissions related to adhesions, which are defined as: * Directly related to adhesions (adhesiolysis, non-operative readmissions for adhesions, and adhesiolysis operations on female reproductive tract); * Possibly related to adhesions (gynecological operations, abdominal surgery, and non-operative readmissions); * Open or laparoscopic reoperations that could potentially be complicated by present adhesions.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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