Plain English Summary
Background and study aims
Rectal cancer is treated with surgery to partially or totally remove the rectum along with the surrounding tissue containing blood vessels and lymph nodes. It is important to remove the local lymphatic system because it may contain cancer that has spread (metastases). Lymph nodes are found by the artery that supplies blood to the rectum. The extent of lymph node removal is determined by where the artery is tied (ligated) by the surgeon. Different surgeons remove more or less of the lymphatic system. There are usually two locations of arterial ligation, called “high tie” and “low tie”. The aim of our study is to find out whether the level of arterial ligation affects the incidence of complications after the operation and the patients’ long-term survival.
Who can participate?
Patients aged 18 or over undergoing surgery for rectal cancer
What does the study involve?
Participants are randomly allocated to one of two groups. One group undergoes high arterial ligation, and the other low arterial ligation. After hospital discharge participants are invited to routine follow-up visits every three months over the next 5 years. Participants should contact the department in case of any adverse symptoms or events. Quality of life, disease recurrence and complications are assessed.
What are the possible benefits and risk of participating?
There are neither direct benefits nor special risks of participating in the study since all of the proposed methods of the surgery are normally performed by different surgeons. Both methods of arterial ligation are recommended in rectal cancer treatment. Participation in the study will improve treatment for rectal cancer in the future by determining the best range of lymphatic system removal.
Where is the study run from?
Gdynia Centre of Oncology of Maritime Hospital in collaboration with the Medical University of Gdansk, Poland
When is the study starting and how long is expected to run for?
September 2009 to June 2019
Who is funding the study?
Foundation for the Development of Surgery [Fundacja na Rzecz Rozwoju Chirurgii], Gdynia, Poland
Who is the main contact?
Prof. Wieslaw Janusz Kruszewski
Oncological and surgical outcome after high versus low ligation of inferior mesenteric artery during curative surgery from rectal cancer
Oncological and surgical outcome after ligation and division of superior rectal artery just beneath the origin of left colic artery (low tie) is not inferior than after ligation of inferior mesenteric artery at its origin (high tie) during curative surgery for rectal cancer.
Bioethics for Research Committee of Medical Univeristy of Gdañsk, Poland ref: NKEBN/373/2009
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Rectal cancer suitable for curative R0 resection with or without prior neoadiuvant treatment
The ligation and division of inferior mesenteric artery at its origin from aorta or just beneath the origin of the left colic artery from inferior mesenteric artery during curative R0 resection from rectal cancer.
Primary outcome measure
1. Postoperative mortality and morbidity (special reference to the rate of clinical anastomotic leakage)
2. The need for splenic flexure mobilization
3. The number of lymph nodes resected and their pathological estimation
4. Need for blood transfusion
5. Time to disease recurrence
6. Way of spread of disease
7. Cancer related death rate
8. Overall survival
Secondary outcome measures
1. Permanent stoma rate
2. The rate of stoma reversal
3. Quality of life (QLQ C30 questionnaire)
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Adult patient with the history of any other neoplasm than rectal and skin cancer
2. Any history of colorectal surgery except the laparoscopic ileostomy in patient awaiting for radical treatment of rectal cancer.
Target number of participants
At least 120
Total final enrolment
Participant exclusion criteria
1. Urgent operation
2. Potentially unresectable disease
3. Comorbid condtions excluding the possibility of standard therapy
4. T4 tumour
5. Any other malignant neoplasm except skin cancer
6. Synchronic distant metastases
7. Lack of patient consent for participation in the study
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Powstania Styczniowego 1 str.
Szpital Morski [Maritime Hospital ]
Gdynia Centre of Oncology
Powstania Styczniowego 1
Foundation for the Development of Surgery [Fundacja na Rzecz Rozwoju Chirurgii] (Poland)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in 2020.
IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
Participant level data
Basic results (scientific)