Safety and Feasibility of the Combined Medial and Caudal Approach in Open and Laparoscopic Radical Right Hemicolectomy for Right Colon Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Detection of organ or visceral injury in both groups
研究概览
简要总结
Right sided hemicolectomy is the standard type of operation for cancers in the caecum, the ascending colon, proximal transverse colon.The aim of this study was to assess the safety and feasibility of combined medial and caudal approach in performing right hemicolectomy and to compare outcome between laparoscopic and open surgery in right colon cancer.
详细描述
The incidence of colorectal cancer is increasing. Slight shift towards right colon cancer is noticed in the last 2 decades in Egypt. This can be attributed to advances in diagnostic tools and increased public health awareness as right sided colon cancer was almost presented late as most of tumors located in the capacious cecum. Hence, early diagnosis with good radical procedure offers better outcome, quality of life and survival. Many approaches for right colon resection were described. In this study we adopted the combined medial and caudal approach for right colon resection in cases of right colon cancer in both open and laparoscopic techniques.
Traditionally, approach to right colon cancer is through open exploration but this approach has more blood loss, prolonged postoperative hospital stay, sever postoperative pain and delayed recovery.
As combined medial and caudal approach is a radical procedure,the purpose of the present study was to compare between laparoscopic and open right hemicolectomy both done with combined medial and caudal approach in right colon cancer as regards technical feasibility, advantages and disadvantages of both procedures.
This was prospective randomized study and was carried out on 26 participants as number of cases with right hemicolon cancer is about 2 per month in our center. Those participants diagnosed as operable right sided colon cancer and the participants were divided into two groups:
Group I: Open combined medial and caudal right hemicolectomy included 13 participants Group II: Laparoscopic combined medial and caudal right hemicolectomy included 13 participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed right colon cancer with colonoscopic biopsy.
- •No invasion of the surrounding tissue.
- •No distant metastasis except the liver.
排除标准
- •Informed consent refusal
- •Malignancy recurrence
- •Distant metastasis except the liver.
- •Locally advanced tumor.
- •participants need emergent intervention e.g., intestinal obstruction or perforation.
- •Contraindications specific for laparoscopy for laparoscopy cases
研究组 & 干预措施
open right hemicolectomy
participants diagnosed as operable right sided colon cancer were enrolled in this study and did open combined medial and caudal resection procedure
干预措施: combined medial and caudal approach right hemicolectomy open and laparoscopic (Procedure)
laparoscopic right hemicolectomy
participants diagnosed as operable right sided colon cancer were enrolled in this study and did laparoscopic combined medial and caudal resection procedure
干预措施: combined medial and caudal approach right hemicolectomy open and laparoscopic (Procedure)
结局指标
主要结局
Detection of organ or visceral injury in both groups
时间窗: detection of organ injury was detected intra operatively for 4 hours after skin incision.
detection of organ or visceral injury was done intra operatively by naked eye in both groups.
calculate the duration of operation in both groups
时间窗: The duration of operation was calculated intra operatively from skin incision to skin closure. it was ranging from 2 to 4 hours after skin incision.
The duration of operation was calculated in minutes in both groups. group I: open combined medial and caudal right hemicolectomy and group II: laparoscopic combined medial and caudal right hemicolectomy from skin incision till skin closure intraoperatively.
detection of post operative wound infection in both groups
时间窗: post operative wound infection in both groups was detected from 2 days to one month post operatively.
post operative wound infection in both groups was detected by vision of wound discharge or pus.
detection of the duration of hospital stay in both groups
时间窗: duration of hospital stay was detected from the day of operation till the day of discharge (4 to 7 days postoperatively)
the duration of hospital stay was detected in days in both groups
detection of number of resected lymph nodes in both groups
时间窗: number of resected lymph nodes was detected from 7th to 10th day post operatively
the number of resected lymph nodes was detected in post operative histopathological reports in both groups.
detection of occurrence of postoperative pain in both groups
时间窗: detection of post operative pain in both groups was done from the day of operation to 7 days postoperatively.
detection of post operative pain was detected in both groups using a written scale fulfilled by the participant giving a score from 1 out of 10 points (1 to 3 points referred as minimal) (4 to 6 points referred as mild) (7 to 10 points referred as sever).
detection of occurrence fecal fistula in both groups
时间窗: detection of occurrence of fecal fistula in both groups was detected from 2 to 7 days postoperatively
occurrence of fecal fistula in both groups was detected by vision of fecal discharge in drains from 48 hours post operatively till discharge day.
Detection of the amount of blood loss during operation in both groups.
时间窗: the amount of blood loss was detected intra operatively for 4 hours after skin incision.
the amount of blood loss during operation is calculated in cubic centimetres using scaled container connected to suction device in both groups.
次要结局
未报告次要终点
研究者
Reham Zakaria Mohamed Ahmed
assistant lecturer of general surgery
Zagazig University