Single Incision Laparoscopic Surgery (SILS) for Colorectal Disease - A Novel Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Operative time
研究概览
简要总结
This study is being done to evaluate single incision laparoscopic surgery (SILS) for colorectal diseases, compared to multi-port laparoscopic surgery. This study is also intended to standardize the SILS technique for colorectal diseases
详细描述
PRIMARY OBJECTIVES:
I. To report the experience of SILS procedure in the treatment of colorectal disease.
II. To standardize the SILS technique.
OUTLINE:
Patients undergo single incision laparoscopic surgery with GelPort® attachment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are willing to give consent and comply with the evaluation and the treatment schedule
- •Patients with disease processes limited to the right colon; this will include Crohn's disease, polyp disease, and cancers of the right colon
- •American Society of Anesthesiologists (ASA) =< 3
排除标准
- •Inability to obtain informed consent
- •Previous right colon surgery
- •Previous extensive abdominal surgery that would limit the laparoscopic approach
- •Stage IV disease at surgery
- •Metastatic disease diagnosed by computed tomography (CT), magnetic resonance imaging (MRI), or nuclear imaging
- •Patient enrolled in other interventional study
- •ASA score greater than 3
- •Any condition which precludes compliance with the study (Investigator discretion)
- •Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or that could impact the scientific integrity of the trial
研究组 & 干预措施
Treatment (single incision laparoscopic surgery)
Patients undergo single incision laparoscopic surgery with GelPort® attachment.
干预措施: therapeutic laparoscopic surgery (Procedure)
结局指标
主要结局
Operative time
时间窗: Up to 1 year
Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).
Length of skin and fascial incisions
时间窗: Up to 1 year
Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).
Estimated blood loss
时间窗: Up to 1 year
Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).
Oncologic sample including size of specimen removed, number of lymph nodes (LN) removed, pathological type and staging, lymph node, vessel or perineural invasion, and status of margins
时间窗: Up to 1 year
Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).
次要结局
- Quality of life measured using the short form (SF)-12 health related quality of life scale (HQRL) scored using quality metric licensed software(Baseline)
- Quality of life measured using the SF-12 HQRL scored using quality metric licensed software(6 months)
- Visual analogue pain scale scored on the scale from 0 to 10 where 0 is no pain, and 10 is the maximum pain(6 months)
- Visual analogue cosmesis scale scored on the scale from 0 to 10 where 0 is "worst scar", and 10 is the "best scar"(6 months)