Comparison of Low and High Ligation With Apical Lymph Node Dissection in the Laparoscopy Rectal Cancer

Not Applicable

Recruiting

• Conditions: Rectal Cancer
• Interventions: Procedure: Low ligation; Procedure: High ligation

• Registration Number: NCT03498885
• Lead Sponsor: WEIDONG LIU，MD

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-01-16
• Study First Submitted QC: 2018-04-07
• Study First Posted: 2018-04-17
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-07
• Last Update Posted: 2020-09-09
• Primary Completion: 2022-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 466

Inclusion Criteria

• 18 Years to 75 Years (Adult, Senior).
• Colonoscopy and pathology shows rectal or sigmoid adenocarcinoma.
• Tumor located at 4-15 cm from the dentate line.
• The clinical staging of tumor by MRI within T1-4a when tumor Above the peritoneum and T3N0-2 when tumor below the peritoneum.
• Receive or not receive neoadjuvant chemotherapy based on 5-fluorouracil before surgery and radical resection is available after neoadjuvant chemotherapy.
• Anus-saving operation is available.
• ASA class: I-III.
• Well tolerate to general anesthesia.
• ECOG score: 0-1.
• Patients - can understand and are willing to take part in the clinical trial.

Exclusion Criteria

• Severe cardiovascular disease, uncontrollable infection or other severe complications.
• Severe mental illness.
• Suffer with other carcinoma simultaneously or sequentially in 5 years.
• Familial polyposis coli or Multiple -colorectal tumor.
• History of abdominal surgery and with severe abdominal adhesions.
• Combine with acute intestinal obstruction, intestinal bleeding, intestinal perforation and emergency surgery is needed.
• Multiple organs resection surgery is needed.
• Abdominoperineal resection need to be performed.
• ASA class: IV to V.
• Pregnant, suckling period or reject to birth control.
• Patient who unable to go through the clinical trial because of familial,social or religious factors.
• Refuse to take part in the trial.
• Patients without an informed consent.
• Non-compliant patient
• The patient or their family members want to withdraw from the clinical trial.
• Loss to follow-up
• Researchers think the participants need to withdraw from the clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low ligation	Low ligation	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.
High ligation	High ligation	The IMA is ligated and divided at 2 cm from its origin. Apical lymph nodes dissection is performed.

Primary Outcome Measures

Name	Time	Method
Anastomotic leakage	3 months	Anastomosis leakage rate after surgery, acute or chronic

Secondary Outcome Measures

Name	Time	Method
Early postoperative complications: Anastomotic bleeding, etc.	30 days	Early postoperative complications: Anastomotic bleeding, etc.
Anastomosis stenosis rate after surgery	30 days	Anastomosis stenosis rate after surgery
proximal bowel necrosis	3 months	Proximal bowel necrosis rate after surgery, acute or chronic
proximal bowel stenosis	3 months	Proximal bowel stenosis rate after surgery, acute or chronic
Characteristics of the division branches of the inferior mesenteric artery in Chinese people	1-2 days	e.g.,The distance from the left colon artery to the root of inferior mesenteric artery(cm).
Apical Lymph Nodes Positive Rate	14 days	Apical Lymph Nodes Positive Rate
Conversion rate to laparotomy	5-years	Conversion rate to laparotomy
Mortality rate in 3 months after surgery	3 months	Mortality rate in 3 months after surgery
Life quality	5-years	Life quality is measured by questionnaire(EORTC QLQ-C30 (version 3)).
Micturition function scoring	3 months	Micturition function is measured by questionnaire(IPSS).
Sexual function scoring	3 months	Sexual function is measured by questionnaire(The IIEF-5 questionnaire).
5-years overall survival rate	5-years	5-years overall survival rate
5-years disease free survival rate	5-years	5-years disease free survival rate
Complications of defunctioning stoma	3 months	Complications of defunctioning stoma

Trial Locations

Locations (1)

Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China