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临床试验/NCT06212128
NCT06212128已完成不适用

Novel Objective Comparison of Short-term Surgical Outcomes From Total Mesorectal Excision Between Total Neoadjuvant Therapy - Rapido Protocol, Standard Long Course Radiotherapy and Upfront Surgery

Sengkang General Hospital0 个研究点目标入组 57 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
57
主要终点
operative time required for primary resection of rectal tumour

研究概览

简要总结

Aim: We evaluated the surgical outcomes of 3 groups of patients with rectal cancers - RAPIDO vs standard long course radiotherapy (LCRT) vs upfront surgery to objectively determine the effects of TNT on TME.

Methods: A review of prospectively collected data was performed for patients who have rectal cancer and underwent low anterior resection from January 2016 to May 2022. Data on patient demographics, disease staging, peri-operative details and up to 2-year follow-up outcomes were analysed. The surgical and oncological outcomes were compared. Patients were followed up until 31 May 2022.

详细描述

A review of prospectively collected data was performed for all patients who were diagnosed with rectal cancer and who underwent ultra-low anterior resection (ULAR) from January 2016 to May 2022 in a single institution in Singapore. Exclusion criteria of this study included patients who underwent emergency surgery and patients with unresectable metastatic disease at presentation. All patients were discussed at multi-disciplinary tumour board for recommendation and decision of the respective treatment protocols. Patients were analysed in 3 main categories: neoadjuvant therapy per RAPIDO protocol, LCRT and upfront surgery. Patients under RAPIDO group underwent 25Gy/5 sessions of short course radiotherapy followed by 6 cycles of neoadjuvant XELOX similar to that of the RAPIDO trial protocol while patients in LCRT group underwent conventional 50Gy/25-28 sessions of long course radiotherapy with concurrent oral capecitabine. All cases were performed by 7 consultant-grade colorectal surgeons in the department.

Patient demographics and peri-operative details were collected. Histopathological stage of disease was in accordance with the American Joint Committee on Cancer (AJCC) staging manual after surgical resection with review of the resected specimen by consultant-grade pathologists who were blinded to the type of pre-operative treatment the patients received.

Primary outcome for the study was the operative time required for primary resection of rectal tumour. If combined surgery was performed for oligometastatic disease, we removed the operating time for non-rectal component as this was separately defined in the operation notes.

Secondary outcomes included the intraoperative blood loss, duration to stoma function, failure to remove urinary catheter, presence of post-operative ileus, duration of hospitalisation after surgery. Presence of stoma function was defined as enteric content of significant amount (>200ml or presence of formed faecal material). Failure of removal of urinary catheter is defined as acute urinary retention requiring re-insertion of catheter post-operatively. Post-operative ileus is defined as ileus which persist beyond 7 days from operation.

Follow-up outcomes and data for patients were collected until 31 May 2022. Local-regional recurrence was defined as the first clinical, radiologic and/or pathologic evident tumour of the same histological type at the region of the anastomosis and pelvis. Distant recurrent was defined similarly at sites outside primary malignancy such as liver, lung, bone, brain, para-aortic region. Presence of recurrence in patients was recorded, disease-free interval was calculated in months from date of surgery to date of recurrence.

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
21 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosed with rectal cancer
  • due to undergo ultra-low anterior resection (ULAR)

排除标准

  • emergency surgery
  • unresectable metastatic disease at presentation

研究组 & 干预措施

LCRT

long course chemoradiotherapy

干预措施: LCRT (Combination Product)

upfront surgery

directly went for surgery after diagnosis of rectal cancer

RAPIDO TNT

neoadjuvant therapy per RAPIDO protocol

干预措施: RAPIDO TNT (Combination Product)

结局指标

主要结局

operative time required for primary resection of rectal tumour

时间窗: 1 day

operative time in minutes

次要结局

  • intraoperative blood loss(30 days post surgery)
  • duration to stoma functioning(14 days post surgery)
  • failure to remove urinary catheter(14 days post surgery)
  • presence of post op ileus (defined as >7 days intolerance to diet or no stoma output from time of operation)(14 days post surgery)
  • duration of hospitalisation(30 days after surgery)

研究者

发起方
Sengkang General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Koh Hong Xiang Frederick

Consultant

Sengkang General Hospital

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