To evaluate quality of life (QOL) in patients undergoing multivisceral resections and/or vascular resections for retroperitoneal sarcomas.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To evaluate Long-term ( more than 8 weeks) QOL in patients undergoing multivisceral and/or vascular resections for RP sarcomas
研究概览
简要总结
Type of study: Retrospective and Prospective study
This study aims to evaluate the quality of life (QOL) in patients undergoing multivisceral resections and/or vascular resections for retroperitoneal sarcomas. Retroperitoneal sarcomas are rare tumors that develop in the space behind abdominal organs and can grow to substantial sizes before causing symptoms. Due to their proximity to critical organs and blood vessels, surgical removal often requires extensive procedures involving multiple organs or blood vessel reconstruction. While surgery is essential for improving survival, it can lead to complications that significantly impact the physical, emotional, and social well-being of patients.
The study will assess both short-term and long-term outcomes, including post-operative complications such as kidney issues, bowel dysfunction, pain, weakness, and hospital readmissions. In the longer term, it will evaluate changes in renal function, nutritional status, limb strength, and the need for prolonged medication. Quality of life will be measured using the widely recognized EORTC QLQ-C30 questionnaire, which evaluates physical, emotional, and social functioning alongside symptoms experienced by patients after cancer treatment. Researchers will collect data retrospectively from January 2016 to January 2025 and prospectively until June 2026, covering a total of 200 patients.
The ethical aspects of this research will be carefully managed, with informed consent obtained from participants in a language they understand. Confidentiality and data privacy will be strictly maintained. Institutional ethics committee approval will be sought, and adverse events will be reported according to regulatory guidelines. The study will adhere to international and institutional standards for patient safety and research integrity.
By identifying key factors influencing recovery and quality of life, this research is expected to guide better clinical decision-making for patients undergoing complex surgeries for retroperitoneal sarcomas. The development of a sarcoma-specific QOL scoring system may help healthcare providers improve treatment strategies and patient support in both short- and long-term settings.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients who can be contacted in person or telephonically
- •All patients over 18-years of age, undergoing Multi-visceral resections for RP sarcomas
- •All patients undergoing Vascular resection (with/ without reconstructions) for RP sarcomas.
排除标准
- •1.Other RP tumors (non-sarcomas) 2.Patients not willing to participate in the study/ cannot give a valid informed consent.
结局指标
主要结局
To evaluate Long-term ( more than 8 weeks) QOL in patients undergoing multivisceral and/or vascular resections for RP sarcomas
时间窗: day 0 on the day of enrollment, 3 months and 6 months after enrollment
次要结局
- To evaluate short-term outcomes (less than 8 weeks) as Post op morbidity, Post-op Ileus, Acute renal failure, Diarrhoea, Clinically significant chyle leaks, Limb weakness, Lower limb edema , Length of ICU stay, ICU re-admission rates, Length of hospital stay, Hospital readmission rates, Re-operation rates, Fitness for adjuvant chemo(day 0 on the day of enrollment, 3 months and 6 months after enrollment)
研究者
Dr Mahesh Goel
Tata Memorial Hospital, Mumbai-12