Level of arterial ligation in rectal cancer surgery
| ISRCTN | ISRCTN12189372 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12189372 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/11/2012
- Registration date
- 18/12/2012
- Last edited
- 01/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
Maritime Hospital
Gdynia Centre of Oncology
Powstania Styczniowego 1
Gdynia
81-519
Poland
 ORCID ID |
0000-0002-5929-5232 |
|---|---|
| Phone | +48 (0)587 260 250 |
| wjkrusz@gumed.edu.pl |
Study information
| Study design | Randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Oncological and surgical outcome after high versus low ligation of inferior mesenteric artery during curative surgery from rectal cancer |
| Study objectives | 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(s) | Bioethics for Research Committee of Medical Univeristy of Gdañsk, Poland ref: NKEBN/373/2009 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/09/2009 |
| Completion date | 30/06/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | At least 120 |
| Total final enrolment | 130 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 22/04/2010 |
| Date of final enrolment | 08/03/2016 |
Locations
Countries of recruitment
- Poland
Study participating centre
Gdynia
81-519
Poland
Sponsor information
Hospital/treatment centre
Gdynia Centre of Oncology
81-519 Gdynia
Powstania Styczniowego 1
Gdynia
1
Poland
| Website | http://www.szpital-morski.pl |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/06/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in 2021. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 16/07/2021 | 01/02/2022 | Yes | No |
Editorial Notes
01/02/2022: The following changes have been made:
1. Publication reference added.
2. The intention to publish date was changed from 14/07/2021 to 01/06/2021.
23/06/2021: The intention to publish date was changed from 31/12/2020 to 14/07/2021.
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.
