Adoption of Advanced Endoscopic Resection Methods in the Treatment of Rectal Neoplasms
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Major intraprocedural bleeding rate
研究概览
简要总结
This study evaluates how advanced endoscopic resection techniques affect treatment outcomes in adults with rectal cancer.
Rectal cancer has traditionally been treated with standard abdominal surgery. Newer endoscopic techniques allow removal of selected early tumors and may reduce treatment-related complications. However, their effectiveness and safety in tumors with deeper invasion are not yet fully established.
This multicenter retrospective observational study uses existing medical records from adults who underwent endoscopic or surgical resection of rectal tumors between 2015 and 2025. Researchers will analyze anonymized information on procedures performed and treatment outcomes to assess the safety and effectiveness of advanced endoscopic approaches.
The results of this study may help guide treatment selection and improve care for people with rectal cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients with rectal neoplasms treated by advanced endoscopic resection
排除标准
- •hybrid resection performed
- •full-thickness resection performed
- •essential procedural or outcome data were unavailable
研究组 & 干预措施
ESD
Patients who underwent endoscopic submucosal dissection for rectal neoplasm
干预措施: Endoscopic submucosal dissection (Procedure)
EID
Patients who underwent endoscopic intermuscular dissection for rectal neoplasm
干预措施: Endoscopic intramuscular dissection (Procedure)
结局指标
主要结局
Major intraprocedural bleeding rate
时间窗: During the procedure
Bleeding occurring during the procedure that required advanced endoscopic hemostatic interventions beyond standard coagulation with the tip of the knife of coagulation forceps, resulted in hemodynamic instability, caused a significant prolongation of the procedure over 15 minutes (based on video), or led to procedure interruption or conversion
Intraprocedural perforation rate
时间窗: During the procedure
Full-thickness defect of the gastrointestinal wall identified during the procedure, evidenced by direct visualization of extraluminal structures (mesorectum or peritoneal cavity), or confirmed by the presence of free air on imaging performed immediately after the procedure.
Delayed bleeding rate
时间窗: Within 28 days after the procedure
Symptomatic bleeding including hematemesis, melena, or a hemoglobin decrease of more than 2 g/dL.
Delayed perforation rate
时间窗: Within 14 days after the procedure
Clinical signs of peritonitis accompanied by radiological evidence of free intraperitoneal air.
Post-coagulation syndrome rate
时间窗: Within 28 days following the procedure
The occurrence of localized abdominal pain or peritoneal irritation signs after EID, accompanied by inflammatory response (elevated white blood cell count or C-reactive protein), in the absence of radiological or endoscopic evidence of perforation.
The need for emergency interventions
时间窗: Within 30 days after the procedure
Any unplanned therapeutic intervention related to the index procedure during hospitalization or follow-up, including repeat endoscopy, endoscopic or radiological intervention, blood transfusion, or surgical treatment. Planned surveillance procedures were not considered additional interventions.
Procedure-related mortality rate
时间窗: Within 30 days after the procedure
Number of deaths occurring within 30 days of the index procedure that was directly attributable to the procedure or to procedure-related complications. Deaths unrelated to the procedure were reported but not considered procedure-related mortality.
次要结局
- Length of hospital stay(Within 30 days after the procedure)
- The need for additional treatment(Within 12 months after the procedure)
- En bloc resection rate(Intraprocedural)
- Complete resection rate(Within 30 days after the procedure)
- Procedure time(Intraprocedural)
研究者
Zofia Orzeszko
MD, Consultant General Surgeon
Jagiellonian University