NCT01745432已完成1 期
Assessment of the Manageability and Safety of ADBLOCK Adhesion Barrier System in Laparoscopic Gynaecological Surgery
Terumo Europe N.V.6 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年8月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Safety as evaluated by assessment of adverse events in ADBLOCK and surgery only group
研究概览
简要总结
Adhesions are the most frequent complication of abdominopelvic surgery. They are internal scar tissues which form as a result of surgery which may abnormally join together what were once separate tissues and organs.
This study will assess the safety and usability of anti-adhesion agent (gel) when used after laparoscopic surgery.
The study will enroll 30 patients, (randomised 2:1) with safety primary endpoint (adverse events in ADBLOCK and surgery only group) assessed at 28 days
详细描述
Title: Assessment of the Manageability and Safety of ADBLOCK Adhesion Barrier System in Laparoscopic Gynaecological surgery
Design: Randomised controlled study to assess the safety, manageability and usability of ADBLOCK when used as an adjunct to laparoscopic surgery for the primary removal of ('virgin') myomas in women wishing to improve pregnancy outcomes.
Use of ADBLOCK will be assessed against laparoscopic surgery alone in 30 patients (randomised 2:1 ADBLOCK/surgery) with a pneumoperitoneum ≤90minutes.
Clinical Site Locations:
- Oldenburg, Germany
- Neuss, Germany
- Berlin, Germany
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-45 years
- •Indication for laparoscopic myomectomy according to the medical standard
- •Negative pregnancy test before study entry
- •Using adequate forms of contraception for 12 weeks following surgery (e.g. oral contraceptive pill, condom, no sexual intercourse)
- •In good health including an ASA (American Society of Anesthesiologists) score of 2 or less
- •No clinically significant and relevant abnormalities as evaluated by satisfactory medical assessment
- •Planned de novo removal of myoma (includes mural and combination of mural and pedunculated myoma)
- •Willing, able and likely to fully comply with study procedures and restrictions
- •Given written, personally signed and dated informed consent to participate in the study as approved by the Institutional Review Board/Ethics Committee of the respective Clinical Study Site.
排除标准
- •Pre-Operative Exclusion Criteria:
- •Women who have completed their family planning
- •Current pregnancy including ectopic pregnancy
- •Breastfeeding
- •6 weeks post-partum
- •Participation in another clinical study currently or within the last 30 days prior to enrolment
- •SGOT, SGPT and/or bilirubin > 20% above the upper range of normal and considered clinically significant
- •BUN and creatinine > 30% above the upper range of normal and considered clinically significant
- •Concurrent use of systemic corticosteroids, antineoplastic agents and/or radiation
- •Previous radiation therapy
- •Clinically relevant haemochromatosis, hepatic, renal, autoimmune, lymphatic, haematological or coagulation disorders
- •Active pelvic or abdominal infection, or other infection with fever (>38°C)
- •Extensive keloid scarring
- •Known allergy to starch-based polymers
- •Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of the stated ingredients -Additional surgical procedure non-obstetrics and gynaecology (non- OB/GYN) planned to be performed during the laparoscopic procedure
- •>4 myoma larger than 2 cms on preoperative ultrasound screen
- •Largest myoma < 2 cms or > 8 cms diameter on pre-operative screen -GNRH agonist/antagonist treatment (except oral contraceptive - combined oestrogen/progesterone) in the 4 weeks prior to study
- •Prior surgery for myoma
- •Previous bowl surgery, excluding appendectomy
- •Prior intra-abdominopelvic adhesive complications Intraoperative Exclusion Criteria
- •Clinical evidence of cancer
- •Clinical evidence of pregnancy including ectopic pregnancy
- •Clinical evidence of rectovaginal endometriosis
- •Clinical evidence of endometriosis American Fertility Society (AFS) class III or IV
- •Use, during this procedure, of any approved or unapproved product or strategy for the purpose of preventing adhesion formation including use of O2 enhanced insufflation
- •If the procedure needs to be performed by a laparotomy (decision made after laparoscopy has commenced) the patient must be withdrawn
- •Any unplanned surgery which involves opening of the bowel or urinary tract
- •Where hysteroscopy is required and it cannot be delayed until after removal of fibroid
- •Only pedunculated fibroids
- •Extensive pelvic adhesions (AFS severe adhesion score) or frozen pelvis
- •Adhesions that would require lysing during planned myomectomy surgery Other than inconsequential filmy adhesions that do not require specific lysing to access operative site
- •If pneumoperitoneum exceeds 90 minutes duration the patient will be assessed as a separate surgical covariate group for secondary endpoints only
- •Use of fibrin glue
- •Detection of myoma which are not suitable for surgery during the study procedure
结局指标
主要结局
Safety as evaluated by assessment of adverse events in ADBLOCK and surgery only group
时间窗: up to 28 days
The rate of adverse events will be compared in treatment arm and control arm
次要结局
- Safety as evaluated by assessment of adverse events in ADBLOCK and surgery only group(up to 24 months)
- Unanticipated device-related adverse events(before discharge, 7d, 14d, 1mo, 3mo, 6mo, 12mo, 24mo)
- Postoperative recovery(up to 28 days)
- Menstrual Cycle(1m, 3mo, 6mo, 12mo, 24mo)
- Pregnancy (in women seeking to become pregnant)(3mo, 6mo, 12mo, 24mo)
- Pain(before discharge, 7d, 14d, 1mo, 3mo, 6mo, 12mo, 24mo)
- Miscarriage(1mo, 3mo, 6mo, 12mo, 24mo)
- Impact of covariates / Including length of pneumoperitoneum(before discharge, 7d,14d, 1mo, 3mo, 6mo, 12mo, 24mo)
- Procedure related hospital readmission(7d,14d, 1mo, 3mo, 6mo, 12mo, 24mo)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
不适用
Adhesions After Open Versus Laparoscopic Resection of Colorectal Malignancies Detected During Liver ResectionAdhesionsNCT01720966Radboud University Medical Center150
终止
3 期
Seprafilm® for Prevention of Adhesions at Repeat CesareanAdhesion Formation After Primary Cesarean DeliveryNCT00697606Abington Memorial Hospital450
已完成
不适用
Prevalence and Severity of Surgical Adhesions Among Women Undergoing Laparoscopic Surgery at Women's Health HospitalSurgical AdhesionsNCT05703451Assiut University127
已完成
不适用
The Effect of Adhesiolysis During Elective Abdominal Surgery on Per- and Postoperative Complication, Quality of Life and Socioeconomic CostsTissue AdhesionsNCT01236625Radboud University Medical Center752
招募中
不适用
A Safety and Effectiveness Study of DividPro Film in Open Abdominal SurgeryOpen Abdominal SurgeryAbdominal AdhesionNCT06142526Industrial Technology Research Institute, Taiwan60