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临床试验/NCT06783244
NCT06783244招募中不适用

Low Versus Standard Intraabdominal Pressure in Robot-assisted Colorectal Cancer Surgery: A Double Blinded Randomized Clinical Trial

Victoria Rosberg1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年2月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Quality of recovery 15 (QoR15) questionnaire 8 hours after surgery

研究概览

简要总结

The goal of this clinical trial is to investigate the influence of low intraabdominal pressure (compared to standard intraabdominal pressure) during robot-assisted colorectal cancer surgery on patients wellbeing after surgery. Patients included are diagnosed with colon- or rectal cancer, and scheduled for curatively intended surgery. The main question the trial aims to answer is:

Does low intraabdominal pressure during robot-assisted colorectal cancer surgery increase the patients wellbeing after surgery?

Researchers will compare low intraabdominal pressure (8 mmHg) to standard intraabdominal pressure (12 mmHg) to see if there is a difference in quality of recovery scores, pain scores and analgetic consumption.

Participants will be asked to fill out the Quality of Recovery 15 (QoR15) questionnaire 8 hours, 24 hours and 48 hours after surgery. Furthermore, patients will be asked to evaluate abdominal pain and shoulder tip pain using the visual analog scale (VAS).

详细描述

  1. Introduction

Colorectal cancer is the third most frequent malignancy worldwide with an increasing incidence. Surgical resection is considered the gold standard for the cure of colorectal cancer. It is well recognized that an uneventful postoperative course is pivotal for a favorable prognosis. The length of stay (LOS) after colorectal cancer surgery has traditionally been between 1 and 2 weeks after surgery. This period has rightfully received considerable attention, and in the 2000s, Enhanced Recovery after Surgery (ERAS) protocols emerged as evidence-based perioperative practice guidelines designed to optimize the postoperative outcome and thereby shorten LOS. The ERAS principle is based on multimodal strategies, which collectively accelerates recovery and helps patients return to their baseline physical function more rapidly. ERAS has significantly reduced LOS without compromising patient safety or satisfaction. Minimally invasive surgery (MIS), including laparoscopic and robot-assisted techniques, is now an integral part of modern ERAS and a cornerstone of colorectal cancer surgery.

In general, MIS has been proven to reduce morbidity, postoperative pain and analgesic consumption, duration of hospital stay and patient satisfaction after colectomy. To ensure proper visceral exposure during minimal invasive surgery CO2 needs to be insufflated into the abdominal cavity. However, the insufflation and the inevitable increased intraabdominal pressure has been associated with postoperative shoulder pain and deep abdominal pain. The standard level of intraabdominal pressure is set around 12 mmHg in most situations and lowering the pressure could possibly decrease the morbidity associated with insufflation.

The first studies investigating the benefits and disadvantages of low-pressure laparoscopic surgery were performed in patients undergoing cholecystectomy and three major meta-analyses have suggested advantages in low-pressure surgery including reduced postoperative pain, analgesic use, and a slight reduction in length of stay.

There are only few studies on low pressure colorectal surgery and even fewer using the robotic platform, where the increased dexterity improves the surgical conditions in smaller confined spaces, which may be the result of lowering the pressure. Previously, Diaz-Cambronero et al. demonstrated that 78% of these procedures could safely be completed at 8 mmHg.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • •age >18 years
  • •a diagnosis of colorectal cancer
  • •scheduled for curative intended robot-assisted resection

排除标准

  • •BMI above 35
  • •inability to fulfill QoR15 questionnaire
  • •construction of a stoma either proactive or permanent
  • •metastatic cancer disease
  • •recieving neoadjuvant treatment
  • •previous multiple abdominal operations defined as 3 or more

研究组 & 干预措施

Low pressure (8 mmHg)

Active Comparator

Patients diagnosed with colorectal cancer undergoing robot-assisted surgery performed with low intraabdominal pressure (8 mmHg)

干预措施: Low intraabdominal pressure (8 mmHg) (Other)

Standard pressure (12 mmHg)

No Intervention

Patients diagnosed with colorectal cancer undergoing robot-assisted surgery performed with standard intraabdominal pressure (12 mmHg)

结局指标

主要结局

Quality of recovery 15 (QoR15) questionnaire 8 hours after surgery

时间窗: From end of surgery until 8 hours later

The quality of recovery 15 (QoR15) questionnaire is a composite patient-centered rating scale measuring different important aspects of the postoperative recovery and fulfils the require-ments for outcome measurement instruments in clinical trials. The questionnaire consist of 15 questions, each being answered on a scale from 0-10. Thereby summed scores ranges from 0 to 150; 0 being the worst outcome and 150 being the best outcome. The questionnaire has been translated and validated in a Danish version and preserved the same validity, reliability, and high degree of responsiveness and clinical feasibility.

次要结局

  • QoR15 questionnaire 24 og 48 hours after surgery(From end of surgery until 24 and 48 hours later)
  • Postoperative pain score(From end of surgery until at 8 hours, 24 hours and 48 hours after surgery)
  • Postoperative opioid consumption(End of surgery until 3 days after surgery. Assessed up to 6 months after surgery.)
  • Change in intraabdominal pressure during surgery(From operation start until end of surgery. Assessed up to 6 months after surgery.)
  • Operation time(From operation start until end of surgery. Assessed up to 6 months after surgery.)
  • Surgeons experience(Assessed immediately after surgery)
  • Postoperative complications(End of surgery until discharge. Assessed up to 6 months after surgery.)
  • Intensive care unit stays(Until 30 days after surgery. Assessed up to 6 months after surgery.)
  • 30-day mortality rate(Until 30 days after surgery. Assessed up to 6 months after surgery.)
  • Length of stay (LOS)(From admission until discharge. Assessed up to 6 months after surgery.)
  • EQ-5D-5L questionnaire(Upon discharge from hospital. Assessed up to 6 months after surgey.)
  • 30-day readmission rates(Until 30 days after surgery. Assessed up to 6 months after surgery.)
  • Patient satisfaction assessment(From end of surgery until participant is discharged. Assessed up to 6 months after surgery.)

研究者

发起方
Victoria Rosberg
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Victoria Rosberg

Medical Doctor and PhD student

Bispebjerg Hospital

研究点 (1)

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