Risk Factors for Anastomotic Leakage in Advanced Ovarian Cancer Surgery: A Large Single Centre Experience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 515
- 试验地点
- 1
- 主要终点
- Anastomotic leakage
研究概览
简要总结
Cytoreductive surgery is currently the main treatment for advanced epithelial ovarian cancer (AEOC), and the complete disease removal (RT=0) or the achievement of an optimal residual disease (RT < 1 cm) remain the factors with the greatest prognostic impact, both in primary debulking surgery (PDS) and interval debulking surgery (IDS).
To achieve the no residual disease (RT=0), several surgical manoeuvres are often needed both at the upper and lower abdomen, including intestinal resections.
Recto-sigmoid resection is certainly the most frequent of intestinal resections, and it is also the one with the highest risk of complication.
Albeit rare, anastomosis leakage (AL) is a life-threating condition and therefore it is the most feared of intestinal complications.
The aim of this large single-center retrospective study was to assess the AL rate in patients subjected to colorectal resection and anastomosis during primary surgery (PDS or IDS) for advanced ovarian cancer, in a third referral centre for gynecologic oncology with ESGO certification.
In addition, we evaluated several possible pre/intra and post-operative risk factors for AL in order to identify, at an early stage, the population at greatest risk, and attempt to reduce the morbidity and mortality of this severe post-operative complication
详细描述
The investigators performed a retrospective analysis of the pre-operative, intra-operative and post-operative (surgical outcomes and early complications rate) characteristics, of a series of patients undergoing primary surgery (PDS or IDS) for AEOC at"Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Department of Gynecologic Oncology" between December 2011 and October 2019.
The enrolled population included all patients with histological diagnosis of epithelial ovarian, fallopian or peritoneal cancer (FIGO stage IIB-IVB), judged suitable for surgery by clinicians, and who underwent recto-sigmoid resection and anastomosis with curative intent.
Patients with no evidence of colorectal involvement, and who therefore did not undergo recto-sigmoid resection, or patients with end-colostomy or end-ileostomy were excluded from the study.
Pre-operative clinical variables, surgical features and post-operative outcomes were retrospectively retrieved.
Several system scores, helpful in predicting operative risk, were used to classify patients' physiological status, as the American Society of Anesthesiologists (ASA) score, the Eastern Cooperative Oncology Group-Performance Status (ECOG-PS) and the Age-Adjusted Charlson Comorbidity Index (ACCI).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •histological diagnosis of epithelial ovarian, fallopian or peritoneal cancer
- •FIGO stage IIB-IVB
- •patients judged suitable for surgery by clinicians
- •patients subjected to recto-sigmoid resection and anastomosis with curative intent
排除标准
- •Patients with no evidence of colorectal involvement and did not undergo recto-sigmoid resection
- •patients with end-colostomy or end-ileostomy
结局指标
主要结局
Anastomotic leakage
时间窗: up to 30 days after surgery
To assess the anastomotic leakage rate in patients subjected to recto-sigmoid resection during debulking surgery for ovarian cancer
次要结局
- Intra-operative risk factors for anastomotic leakage(During surgery)
- Pre-operative risk factors for anastomotic leakage(just before surgery)
- Post-operative risk factors for anastomotic leakage(up to 30 days after surgery)
研究者
Prof. Giovanni Scambia
Professor
Catholic University of the Sacred Heart