ISRCTN13334746进行中（未招募）未知
IntAct: Intraoperative Fluorescence Angiography to Prevent Anastomotic Leak in Rectal Cancer Surgery
niversity of Leeds0 个研究点目标入组 880 人开始时间: 2017年5月2日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 880
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 18 years and over
- •2. Able to provide written informed consent.
- •3. Diagnosis of rectal cancer (defined as a lower margin up to 15cm from the anal verge as assessed by endoscopic or radiological assessment)
- •4. Suitable for curative resection by high or low anterior resection
- •5. Suitable for elective laparoscopic or robotic surgery
- •6. ASA less than or equal to 3
- •7. Able and willing to comply with the terms of the protocol including QoL questionnaires
排除标准
- •Current participant exclusion criteria as of 19/02/2021:
- •1. Patients not undergoing colo-rectal/anal anastomosis e.g. abdominoperineal excision of rectum (APER), Hartmann’s procedure
- •2. Patients undergoing synchronous colonic resections
- •3. Locally advanced rectal cancer requiring extended or multi-visceral excision
- •4. Recurrent rectal cancer
- •5. Coexistent colorectal pathology e.g. synchronous cancers, inflammatory bowel disease
- •6. Previous pelvic radiotherapy for pathology unrelated to diagnosis with rectal cancer e.g. treatment for prostate cancer
- •7. Hepatic dysfunction, defined as Model for End-Stage Liver Disease (MELD) Score > 10
- •8. Renal dysfunction, defined as eGFR < 40mmol/l
- •9. Known allergy to ICG, iodine, iodine dyes, or taking drugs known to interact with ICG e.g. anticonvulsants, bisulphite containing drugs, methadone, nitrofuratoin
- •10. Pregnant or likely to become pregnant within 3 months of surgery
- •11. Immunocompromised patients e.g. taking steroids or receiving immunotherapy
- •Previous participant exclusion criteria:
- •1. Patients not undergoing colo-rectal/anal anastomosis e.g. abdominoperineal excision of rectum (APER), Hartmann’s procedure
- •2. Patients undergoing synchronous colonic resections
- •3. Locally advanced rectal cancer requiring extended or multi-visceral excision
- •4. Recurrent rectal cancer
- •5. Coexistent colorectal pathology e.g. synchronous cancers, inflammatory bowel disease
- •6. Previous pelvic radiotherapy for pathology unrelated to diagnosis with rectal cancer e.g. treatment for prostate cancer
- •7. Hepatic dysfunction, defined as Model for End-Stage Liver Disease (MELD) Score > 10
- •8. Renal dysfunction, defined as eGFR < 40mmol/l
- •9. Known allergy to ICG, iodine, iodine dyes, or drugs known to interact with ICG e.g. anticonvulsants, bisulphite containing drugs, methadone, nitrofuratoin
- •10. Use of oral antibiotics within 8 weeks prior to randomisation
- •11. Pregnant or likely to become pregnant within 3 months of surgery
研究者
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