Colorectal Resections and Reconstructions in Patients With Retroperitoneal Sarcoma: Evaluation of Surgical Strategies and Postoperative Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 20
- 主要终点
- Evaluation of resection and reconstruction procedures of the colon and rectum in the context of multivisceral resections of retroperitoneal sarcomas
研究概览
简要总结
COLOSARC-Q is a multicenter study with the objective of providing an up-to-date assessment of colorectal resections and reconstruction techniques in the context of multivisceral resections for retroperitoneal sarcomas, as well as colorectal surgery-associated complications and their impact on patients' quality of life.
In multivisceral resections involving the colon and rectum, the primary aim is to achieve complete resection and preserve organ function. However, multivisceral resections have a high risk of perioperative morbidity including anastomotic leakage. The proposed project aims to determine the number of primary anastomoses, their insufficiency rates, and the fraction of patients with primary and secondary stomas. In addition, the patients' quality of life after multivisceral sarcoma resection is to be recorded using standardized surveys.
The analysis has the potential to facilitate intraoperative decision-making for colorectal resections in the context of multivisceral resections.
详细描述
The primary goal of retroperitoneal sarcoma surgery is to achieve complete resection. The resection of retroperitoneal sarcomas (RPS) usually involves the removal of parts of the colon. While there is good data on surgical principles and postoperative complications of multivisceral resections in RPS as a whole (1, 2), there is little evidence on the frequency of temporary or permanent stomas and complications associated with intestinal surgery (e.g., number of anastomotic leackages in relation to the number of intestinal anastomoses performed) and their impact on the quality of life of those affected.
The COLOSARC-Q study is a multicenter, non-interventional study with the aim of documenting
- colorectal resection and reconstruction techniques in connection with multivisceral resections in retroperitoneal sarcomas (RPS),
- complications associated with intestinal surgery in multivisceral resections, and
- the resulting effects on the quality of life of sarcoma patients. The project plans to include 120 patients with retroperitoneal sarcomas who have undergone colon resection as part of a multivisceral resection at a DKG-certified sarcoma center or hospital that meets certification-equivalent criteria. For these patients, patient-, tumor-, and treatment-specific parameters (all patients), standardized questionnaires on health-related quality of life (EORTC QLQ - C30 (version 3.0)) and bowel function (EORTC QLQ - CR29) (expected response rate ≥ 50%) and semi-structured interviews with the aim of recording specific problems that may not be covered in the questionnaires (e.g., regarding stoma placement, nutritional status, treatment sequence, or home care; n = 10-15).
COLOSARC-Q has the potential to improve preoperative participatory decision-making and intraoperative strategy in colorectal resections as part of multivisceral resections in order to reduce complication rates and develop surgical strategies tailored to specific patient needs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Histological confirmation with evidence of a retroperitoneal sarcoma
- •Tumor resection with colorectal resection
- •Surgery in a DKG-certified sarcoma center or hospital that meets certification-equivalent criteria
- •Age 18 years or older
- •Written consent
排除标准
- •Absence of consent
结局指标
主要结局
Evaluation of resection and reconstruction procedures of the colon and rectum in the context of multivisceral resections of retroperitoneal sarcomas
时间窗: immediately after the surgery
Description of the surgical procedure, e.g. righ hemicolectomy with primary anastomosis
次要结局
- Assessment of quality of life after colorectal resections in the context of RPS resections(through study completion, an average of 1 year)
- Assessment of changes in bowel function after resection of retroperitoneal sarcomas(through study completion, an average of 1 year)
- Postoperative complications associated with resections and reconstructions of the bowel(up to 90 days after surgery)
- Identification of problems and needs of RPS patients(through study completion, an average of 1 year)
- Determination of patient-, tumor- and treatment-related factors influencing the above-mentioned primary and secondary study objectives(through study completion, an average of 1 year)
研究者
Jens Jakob, MD
Head Sarcoma Surgery and Sarcoma Center Mannheim, Heidelberg University
Heidelberg University