Condition category
Cancer
Date applied
09/11/2012
Date assigned
18/12/2012
Last edited
17/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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
wjkrusz@gumed.edu.pl

Trial website

Contact information

Type

Scientific

Primary contact

Prof Wieslaw Kruszewski

ORCID ID

http://orcid.org/0000-0002-5929-5232

Contact details

Maritime Hospital
Gdynia Centre of Oncology
Powstania Styczniowego 1
Gdynia
81-519
Poland
+48 (0)587 260 250
wjkrusz@gumed.edu.pl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Oncological and surgical outcome after high versus low ligation of inferior mesenteric artery during curative surgery from rectal cancer

Acronym

Study hypothesis

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.

Ethics approval

Bioethics for Research Committee of Medical Univeristy of Gdañsk, Poland ref: NKEBN/373/2009

Study design

Randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Rectal cancer suitable for curative R0 resection with or without prior neoadiuvant treatment

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

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

01/09/2009

Overall trial end date

30/06/2019

Reason abandoned (if study stopped)

Eligibility

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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

At least 120

Total final enrolment

130

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

22/04/2010

Recruitment end date

08/03/2016

Locations

Countries of recruitment

Poland

Trial participating centre

Maritime Hospital
Powstania Styczniowego 1 str.
Gdynia
81-519
Poland

Sponsor information

Organisation

Szpital Morski [Maritime Hospital ]

Sponsor details

Gdynia Centre of Oncology
81-519 Gdynia
Powstania Styczniowego 1
Gdynia
1
Poland

Sponsor type

Hospital/treatment centre

Website

http://www.szpital-morski.pl

Funders

Funder type

Hospital/treatment centre

Funder name

Foundation for the Development of Surgery [Fundacja na Rzecz Rozwoju Chirurgii] (Poland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

31/12/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

17/06/2020: The overall trial end date was changed from 01/04/2011 to 01/09/2009. ORCID ID added. 16/06/2020: The following changes were made to the trial record: 1. The recruitment start date was changed from 01/04/2011 to 22/04/2010. 2. The recruitment end date was changed from 30/06/2014 to 08/03/2016. 3. Total final enrolment number added. 4. Publication and dissemination plan, intention to publish date and IPD sharing statement added. 09/01/2020: Internal review.