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临床试验/NCT06391060
NCT06391060已完成不适用

Gender Differences in Robotic Surgery for Rectal Cancer: a Retrospective Study

Daorong Wang1 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2021年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
155
试验地点
1
主要终点
Gender Differences in Robotic Surgery for Rectal Cancer: a retrospective study

研究概览

简要总结

Objective: To investigate gender-based differences in outcomes following robotic surgery for rectal cancer.

Methods: A retrospective study was conducted on 155 patients (82 males, 73 females) who underwent robotic surgery for rectal cancer. Demographic, pre-operative, operative, and post-operative data were collected and analyzed.

Pre-operative study:

All patients underwent a standardized pre-operative work-up, which included a physical examination, comprehensive colonoscopy with biopsy, rigid rectoscopy, pelvic magnetic resonance imaging (MRI) scan, computed tomography (CT) of the thorax and abdomen, and measurement of carcinoembryonic antigen (CEA) levels. Tumor staging followed the TNM staging criteria (American Joint Committee on Cancer), with the T and N stages determined by the most advanced findings from any imaging modality

Data collected:

Retrospective evaluation and comparison of demographic characteristics, pre-operative TNM stage, distance from anal verge, tumor size, tumor grade, American Society of Anesthesiologists (ASA) score, and body mass index (BMI) were conducted among both patient groups. Peri-operative and post-operative data, including morbidity and mortality, were assessed, alongside parameters such as distal resection margin (DRM), proximal resection margin (PRM), harvested lymph nodes (HLN), and Clavien-Dindo Classification (CDC) scores. Diagnosis of anastomotic leakage was confirmed by clinical suspicion (e.g., changes in drainage, fever, abdominal pain) and further validated through contrast enema observed during follow-up computed tomography (CT). Hospital stay and readmission rates were monitored for up to 90 days post-surgery.

Post-operative follow-up:

Post-operative outcomes encompassed operative duration, estimated blood loss, time to first flatus passage, duration of liquid diet, and length of hospital stay following surgery. Operative duration comprised the time from initial skin incision to closure, including the time needed for robotic surgery docking and undocking. Upon experiencing initial flatulence, patients transitioned to a liquid diet. Hospital stay duration was measured from the time of surgery to discharge. The overall cost of surgery, including surgical procedures, anesthesia, medications, and post-operative care, was considered in the total expenditure analysis.

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
All
接受健康志愿者

入选标准

  • A confirmed histological diagnosis of colorectal malignancy was a prerequisite for enrollment in this study. Additionally, obtaining informed consent from patients for surgical intervention was mandatory.

排除标准

  • Patients with bleeding of the gastrointestinal tract, inflammatory bowel disease, synchronous tumors, benign conditions, and clinical T4 stage tumors unresponsive to neoadjuvant therapy were excluded from the study.

结局指标

主要结局

Gender Differences in Robotic Surgery for Rectal Cancer: a retrospective study

时间窗: 15th of April 2024

gender-specific considerations in the surgical management and post-operative care of rectal cancer patients undergoing robotic surgery

次要结局

未报告次要终点

研究者

发起方
Daorong Wang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Daorong Wang

Professor

Northern Jiangsu People's Hospital

研究点 (1)

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