跳至主要内容
临床试验/CTRI/2024/08/071877
CTRI/2024/08/071877尚未招募不适用

Robotic multi-visceral resection for locally-advanced rectal cancer – an international multicenter study.

Portsmouth Hospitals NHS Trust (PHT)1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年8月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
试验地点
1
主要终点
To assess oncological safety and feasibility assessed by CRM involvement and conversion to open surgery

研究概览

简要总结

Cancers originating within 15 cm of the anal verge are defined as rectal cancers. They are quite common cancers in the western world and comprise about one quarter of all the colorectal cancers. The mainstay of treatment of these cancers is surgery either with or without neoadjuvant therapy (chemo- or radiotherapy). The surgical techniques have evolved over time in order to improve outcomes. There was a time when abdominoperineal excision of rectum was considered gold standard for low rectal cancers. Leaving everyone with a permanent colostomy and, despites having had treatment, with poor survival rates. Since the introduction of the TME surgery (Total Mesorectal Excision) by Heald et al. in 1982, the oncological outcome of rectal cancer patients has improved significantly. Improvement of the surgical technique in combination with the advent of modern instruments facilitated sphincter saving low and ultra-low anterior resections. During the same time as the introduction of the TME surgery,in the late 80’s, minimal invasivelaparoscopic colorectal surgery started and lead to significant improvements in the short term postoperative outcomes. Since 1992 the laparoscopic approach was applied to rectal cancer with promising results.However, there was criticism on the laparoscopic approach, based on a long learning curve, high conversion rates, lack of flexibility of the instruments and limited hand eye coordination with lack of tactile perception. In order to overcome these limitations, more recently, other minimal invasive techniques, such as robotic (assisted) surgery and the trans-anal approach (TaTME)were introduced as an alternative to laparoscopic surgery for better patient outcomes.The debate whether robotic assisted surgery is superior to laparoscopic surgery is anongoing debate without a clear answer at this moment in favour of either one of the techniques.The lack of significant difference between the two approaches might be caused by surgical trials being performed with robotic surgeons still in the beginning of their learning curve.The debate whether robotic assisted surgery is superior to laparoscopic surgery is anongoing debate without a clear answer at this moment in favour of either one of the techniques.The lack of significant difference between the two approaches might be caused by surgical trials being performed with robotic surgeons still in the beginning of their learning curve.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Age 18 years or above 2)Diagnosed with rectal cancer, up to 15cm from the anorectal junction 3)Preoperative scans suggest a T4 rectal cancer with involvement of one or more of the following structures-Urinary Bladder, Colon, Uterus, Vagina, Prostate, Seminal vesicles, Small bowel, Ovary 4)Patient assessed as fit for surgery (ASA I-III) 5)Elective surgery.

排除标准

  • Patients having signs of metastatic disease 2)Emergency resections 3)Palliative procedures.

结局指标

主要结局

To assess oncological safety and feasibility assessed by CRM involvement and conversion to open surgery

时间窗: Baseline assesment

次要结局

  • The secondary end points included duration of operation, amount of blood loss, length of hospital stay, & postoperative complications(30 days)

研究者

发起方
Portsmouth Hospitals NHS Trust (PHT)
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Avanish Saklani

Tata memorial hospital dr ernest Borges marg parel Mumbai

研究点 (1)

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