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临床试验/NCT01626963
NCT01626963Unknown1 期

Randomised-controlled Trial on the Immune Response to Single-port Access Versus Conventional Laparoscopic Colorectal Surgery

North Tees and Hartlepool NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
1 期
入组人数
50
试验地点
2
主要终点
Operative Time

研究概览

简要总结

Conventional multi-port laparoscopic surgery (CL) is now a standard approach to colorectal resections, due to it's short-term benefits over conventional open surgery. In recent years, several studies have demonstrated that - in suitable patients - single-port access surgery (SPA) has similar clinical outcome compared to CL, with additional cosmetic benefits. It remains, however, unclear whether the trauma of surgery is also less for SPA compared to CL.

In this study, the investigators aim to randomise patients who are deemed suitable for SPA surgery to either SPA approach, or CL; in addition to clinical outcomes including length of operating time, post-operative pain scores, complications, quality of life indicators and cosmetic appearance, the investigators aim to compare the physiological response to trauma through biochemical markers (including C-reactive protein, White Blood Cell count) and cytokine expression (i.e. Interleukins IL-6 and IL-8). Patients will be analysed according to intention-to-treat analysis, with 25 patients in the SPA and 25 patients in the CL group. The patients will be operated by surgeons proficient in both CL and SPA surgery, and followed-up for the duration of their hospitalisation as well as at their routine out-patient visits, using questionnaires.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • large bowel disorder requiring surgical resection
  • body habitus suitable for single-port access surgery

排除标准

  • patients not capable of informed consent and/or quality of life assessment
  • planned open procedure for surgical reason
  • multiple previous abdominal operations
  • body-mass index > 40

结局指标

主要结局

Operative Time

时间窗: assessment of electronic records at 30 days from surgery

Operative Time

次要结局

  • Pain scores(change from baseline at 1,2,3,4 and 5 days from surgery)
  • Complication / Conversion-to-open-surgery rates(assessment at 30 days post-op)
  • Quality of Life indicators(change from baseline at 2, 4 weeks, & 3 months after surgery)
  • Cosmetic appearance(change from baseline at 2, 4 weeks and three months after surgery)
  • Cost comparison(assessment at the end of the study, up to 2 years post-op)
  • LoS(assessment at 30 days from surgery)
  • IL-6(change from baseline at 2,6,24 and 72 hours from surgery)
  • IL-8(change from baseline at 2,6,24 and 72 hours from surgery)
  • CRP(change from baseline at 2,6,24 and 72 hours from surgery)
  • WBCC(change from baseline at 2,6,24 and 72 hours from surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David W Borowski

Consultant General and Colorectal Surgeon

North Tees and Hartlepool NHS Foundation Trust

研究点 (2)

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