Pain Evaluation Across Robotic and Laparoscopic Surgery for Colorectal Procedures
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Hospital Central de la Defensa Gómez Ulla
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Postoperative Pain
概览
简要总结
Minimally invasive surgery for colorectal conditions, such as laparoscopic or robotic surgery, has been shown to offer benefits over traditional open surgery. These benefits include less pain after surgery, shorter hospital stays, and fewer complications.
This study aims to compare two types of minimally invasive surgery-laparoscopic and robotic surgery-to determine which approach results in less postoperative pain for patients undergoing colon or rectal surgery. The central hypothesis is that robotic surgery, due to its higher precision and reduced tissue trauma, will lead to lower pain levels after surgery.
The study will enroll adult patients scheduled for elective colorectal surgery at the Hospital General Universitario Gregorio Marañón in Madrid. Participants will undergo either laparoscopic or robotic surgery based on clinical availability and surgical planning, as long as they meet all inclusion criteria under the hospital's enhanced recovery protocol (RICA program).
Researchers will assess patients' pain levels at different time points after surgery (immediately after recovery, at 24, 48, and 72 hours, and at discharge) using validated pain scales. The use of pain medications, hospital stay duration, complication rates, and quality of life up to 12 months after surgery will also be measured.
All patient data will be collected anonymously using a secure electronic system (REDCap). The study will last approximately 2 years and include about 80 patients (40 in each group).
The results could help surgeons and hospitals choose the most effective surgical approach to reduce postoperative pain and improve patient recovery in colorectal surgery.
详细描述
This is a prospective, single-center, observational study conducted at the Hospital General Universitario Gregorio Marañón in Madrid, Spain. The study compares postoperative pain outcomes in patients undergoing elective colorectal surgery via two different minimally invasive surgical approaches: laparoscopic and robotic-assisted surgery.
Eligible participants will be adults (≥18 years) undergoing elective colon or rectal surgery for benign or malignant disease, provided they meet the criteria of the hospital's Enhanced Recovery After Surgery (ERAS) program, known locally as the RICA protocol. Patients with open surgery indications, chronic analgesic use, or other exclusion criteria (e.g., inflammatory bowel disease, multivisceral resections, chronic opioid use, or inability to follow the RICA protocol) will not be included.
Pain will be assessed using the Visual Analog Scale (VAS) at standardized time points: on arrival at the post-anesthesia care unit, upon admission to the surgical ward, and at 24, 48, and 72 hours postoperatively, as well as at discharge. Intraoperative nociception will also be evaluated using the Nociception Level Index (NOL), an objective measure that reflects the patient's pain response during surgery.
Additional outcomes include postoperative opioid consumption, length of hospital stay, complication rates (using the Clavien-Dindo classification), hospital readmissions, reintervention rates, and patient-reported quality of life measures at 1, 3, 6, and 12 months after surgery, using validated questionnaires (QLQ-C30, QLQ-CR29, and EQ-5D).
Data will be collected and stored securely using the REDCap electronic data capture system, ensuring patient confidentiality. The estimated sample size is 80 patients (approximately 40 in each group), and the total study duration is expected to be 2 years for recruitment and follow-up, with an additional period for data analysis and publication.
The goal is to generate high-quality evidence to help guide clinical decision-making in the selection of surgical approaches for colorectal surgery, focusing on reducing postoperative pain and enhancing recovery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Adults aged 18 years or older
- •Signed informed consent
- •Meeting inclusion requirements of the hospital's Enhanced Recovery Protocol (RICA program), including:
- •Adequate cognitive status
- •ASA (American Society of Anesthesiologists) classification I, II, or III
- •Elective colon surgery (right or left hemicolectomy) for malignant disease
- •Planned laparoscopic or robotic surgical approach
- •Preoperative evaluation completed as per RICA protocol (nutritional, nursing, anesthetic, and pharmacy assessments)
排除标准
- •Patients with a preoperative decision for open surgery
- •Patients undergoing rectal surgery (partial or total mesorectal excision without protective stoma)
- •Patients with inflammatory bowel disease requiring colorectal resection
- •Patients requiring multivisceral resection due to oncologic indications identified intraoperatively
- •Extraction incision different from Pfannenstiel approach
- •Current or past history of chronic opioid use or opioid abuse
- •Current or past history of benzodiazepine use or abuse
- •Chronic use of analgesics for other comorbid medical conditions
- •Current or past history of recreational drug use or abuse
- •Non-compliance with the RICA protocol, including:
研究组 & 干预措施
Laparoscopic Surgery
Laparoscopic procedure
Robotic Surgery
Robotic Procedure
结局指标
主要结局
Postoperative Pain
时间窗: 24 hours
Assessment of patient-reported postoperative pain at 24 hours after surgery, using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).
次要结局
- Postoperative Pain at 48 Hours Measured by Visual Analog Scale (VAS)(48 hours post-surgery)
- Postoperative Pain at 72 Hours Measured by Visual Analog Scale (VAS)(72 hours post-surgery)
- Intraoperative Analgesic Consumption(Intraoperative period)
- Postoperative Analgesic Consumption(From recovery room admission up to 72 hours after surgery.)
- Postoperative Morbidity (Clavien-Dindo Classification)(Within 30 days after surgery)
- Conversion Rate to Open Surgery(Intraoperative period)
- Postoperative Inflammatory Response(Within the first 48 hours post-surgery)
- Quality of Life (QoL) After Surgery(1 month post-surgery)
- Quality of Life (QoL) After Surgery(3 month post-surgery)
- Quality of Life (QoL) After Surgery(6 month post-surgery)
研究者
Patricia Tejedor
M.D., Ph.D.
University Hospital Gregorio Marañón