The purpose of this study is to explore the different impacts of high and low ligation in laparoscopic rectal interior resection on postoperative anastomotic leakage and proximal bowel necrosis and stenosis, as well as the quality of life and long-term survival. In the anterior resection of rectum, the section level of inferior mesenteric artery (IMA) is still a controversial subject between the advocates of high and low ligation. The low ligation is defined as the IMA is ligated below the origin of the left colic artery while the high ligation refers to the IMA is ligated at its origin from the aorta. Nowadays the spread of laparoscopy has encouraged more frequent execution of the high ligation, which appears easier to achieve than the low ligation and also with the advantage of lower anastomosis traction but with the disadvantage of worse vascularization of the stumps as well.
It has long been debated that whether to tie off the inferior mesenteric artery (IMA) at its origin or just below the origin of the left colic artery (LCA) of the anterior resection of the rectum. Thus far, no clear consensus has been achieved, and the level of arterial ligation still varies among institutions and patients. In the previous studies, high or low ligation takes advantage on both sides. However, there are still some researches that have demonstrated no significant difference had been found in the incidence of anastomotic leakage and other complications between the high and low ligation groups. Therefore, to provide a clear and definite answer to surgeons of how they should deal with the IMA in laparoscopy rectal surgery. We plan to explore the impacts of high and low tie in laparoscopic anterior rectal resection on postoperative anastomotic leakage and proximal bowel necrosis and stenosis, as well as the quality of life and long-term survival by prospective and multi-center clinical trial. Surgery will be described as follows: For low ligation group: 1. Laparoscopic surgery is performed. Tie the sigmoid artery and superior rectal artery, LCA is preserved. Lymphadenectomy to Apical lymph nodes is performed. Strip the beginning part of upper rectal artery and the first sigmoid artery. Strip the left colic artery until reaching the inferior mesenteric vein (IMV). The abdominal aorta lymph nodes need to be cleaned if it's been spotted swollen. 2. Vascular ligation level: Left colonic artery needs to be preserved, the rectal artery and the first sigmoid artery are ligated. Ligate inferior mesenteric artery below left colonic artery come across the inferior mesenteric vein level. For high ligation groups: Laparoscopic surgery is performed. The IMA is ligated and divided at 2 cm. from its origin. Dissect the adipose tissue and lymph nodes around IMA. The inferior mesenteric vein (IMV) is divided and ligated below the duodenal margin. The abdominal aorta lymph nodes need to be cleaned if it's been spotted swollen. For both groups Total Mesolectal Excision (TME) is performed according to the principles of Heald.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
466
Left colic artery (LCA) is identified, Tie the sigmoid artery and superior rectal artery, Apical lymph node dissection with the left colic artery preservation is performed.
The IMA is ligated and divided at 2 cm from its origin. Apicallymph nodes dissection is performed.
Xiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGAnastomotic leakage
Anastomosis leakage rate after surgery, acute or chronic
Time frame: 3 months
proximal bowel necrosis
Proximal bowel necrosis rate after surgery, acute or chronic
Time frame: 3 months
proximal bowel stenosis
Proximal bowel stenosis rate after surgery, acute or chronic
Time frame: 3 months
Characteristics of the division branches of the inferior mesenteric artery in Chinese people
e.g.,The distance from the left colon artery to the root of inferior mesenteric artery(cm).
Time frame: 1-2 days
Apical Lymph Nodes Positive Rate
Apical Lymph Nodes Positive Rate
Time frame: 14 days
Conversion rate to laparotomy
Conversion rate to laparotomy
Time frame: 5-years
Complications of defunctioning stoma
Complications of defunctioning stoma
Time frame: 3 months
Early postoperative complications: Anastomotic bleeding, etc.
Early postoperative complications: Anastomotic bleeding, etc.
Time frame: 30 days
Anastomosis stenosis rate after surgery
Anastomosis stenosis rate after surgery
Time frame: 30 days
Mortality rate in 3 months after surgery
Mortality rate in 3 months after surgery
Time frame: 3 months
Life quality
Life quality is measured by questionnaire(EORTC QLQ-C30 (version 3)).
Time frame: 5-years
Micturition function scoring
Micturition function is measured by questionnaire(IPSS).
Time frame: 3 months
Sexual function scoring
Sexual function is measured by questionnaire(The IIEF-5 questionnaire).
Time frame: 3 months
5-years overall survival rate
5-years overall survival rate
Time frame: 5-years
5-years disease free survival rate
5-years disease free survival rate
Time frame: 5-years
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