Rectal CancerSpeeDyNCT03895255
Selective sPlenic flExure Mobilization for Low colorEctal Anastomosis After D3 lYmph Node Dissection (Speedy Trial)
A study testing Paraaortic lymph node dissection, IMA high ligation, TME, routine splenic flexure mobilization and Paraaortic lymph node dissection, IMA low ligation, TME, selective splenic flexure mobilization in people with Rectal Cancer, run by Russian Society of Colorectal Surgeons at 1 site in Russia.
Trial summary
In the Low Anterior Resection of rectum for cancer, the section level of IMA and the need of SFM is still debated. The aim of this study is to explore the different impacts of high and low ligation with peeling off vascular sheath of inferior mesenteric artery (IMA) in low anterior resection of the rectum for cancer. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Paraaortic lymph node dissection, IMA high ligation, TME, routine splenic flexure mobilization and Paraaortic lymph node dissection, IMA low ligation, TME, selective splenic flexure mobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteRussia
- Study dates
- 2 Oct 2016to 2 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven primary rectal adenocarcinoma located within 15 cm from anal verge not involving internal and/or external sphincter muscle
- Stage I-III
- Elective surgical treatment with TME and primary colorectal anastomosis
- Receive or not receive neoadjuvant radio-chemotherapy
- Overall health status according to American Society of Anesthesiologists (ASA) classification: I-III
- Signed informed consent with agreement to attend all study visits
- The patient is not pregnant
Who cannot join
- Unresectable tumour, inability to perform a TME with colorectal anastomosis, inability to complete R0 resection or presence of T4b tumour necessitating a multi-organ resection
- The patient wants to withdraw from the clinical trial
- Loss to follow-up
- Inability to complete all the trial procedures
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Clinic of Colorectal and Minimally Invasive Surgery
Moscow, 119435
Inna Tulina, MD, +79264086672, tulina@kkmx.ru
MD
About this study
Official title: Randomized Non-inferiority Trial of Selective Splenic Flexure Mobilization for the Formation of Low Colorectal Anastomosis After Total Mesorectal Excision and D3 Paraaortic Lymph Node Dissection in Low Rectal Cancer.
In the Low Anterior Resection of rectum for cancer, the section level of IMA and the need of SFM is still debated.
The aim of this study is to explore the different impacts of high and low ligation with peeling off vascular sheath of inferior mesenteric artery (IMA) in low anterior resection of the rectum for cancer. This study purpose to demonstrate that low IMA ligation, sparing of left colic artery (LCA) and selective SFM results in higher anastomotic leakage rate than high IMA ligation with routine SFM (with the difference of more than 5%).
Read the detailed description
Although TME is the standard curative operation for rectal cancer patients, who undergo low anterior resection (LAR) or abdominoperineal resection (APR) with a permanent colostomy, the strategy to restore the transit between colon and rectum (in case of LAR) is still debated in literature.
Several studies comparing high-tie with low-tie ligation reported a stage-specific survival benefit for high-tie, but on the other hand recent studies demonstrated that low-tie, without splenic flexure mobilization (SFM), decreases the complexity of the laparoscopic procedure and could reduces the operating time with comparable oncological outcomes.
The method of restorative surgery, after Total Mesorectal Excision (TME), largely depends on the length of the resected part of the colon, that is related to patient's anatomical features and the height of vascular ligation performed during the operation.
In attempt to perform a radical paraaortic lymph node dissection the inferior mesenteric artery (IMA) is usually ligated at its origin and the Arcade of Riolan provides bloody supply to any distal anastomosis. Unfortunately the Arcade of Riolan is an inconstant finding and sometimes (26% of cases) is mandatory to mobilize the splenic flexure to ensure a safe and tension-free anastomosis. SFM is a time-consuming component of LAR, has the additional risk of iatrogenic splenic injury and is very difficult during a laparoscopic resection.
In 2005 was demonstrated that routine SFM is not always necessary during anterior resection for rectal cancer.
A recent retrospective analysis by Mouw showed that SFM was associated with wider margins and a decreased rate of inadequate nodal staging in patients undergoing LAR.
This trial aims to demonstrate that low IMA ligation, sparing of LCA and selective SFM results in higher anastomotic leakage rate than high IMA ligation with routine SFM (with the difference of more than 5%). Furthermore this study purpose to evaluate the need to perform splenic flexure mobilization (SFM) in low ligation group and the, operation time, apical lymph nodes positive rate and short terms postoperative complication in both groups
- Conditions
- Rectal Cancer
- Being tested
- Paraaortic lymph node dissection, IMA high ligation, TME, routine splenic flexure mobilization, Paraaortic lymph node dissection, IMA low ligation, TME, selective splenic flexure mobilization
- Keywords
- lymph node dissection, high tie, low tie, splenic flexure mobilization, anastomotic leak
- Medical subject headings
- Rectal Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paraaortic lymph node dissection, IMA high ligation, TME, routine splenic flexure mobilizationProcedure or surgery
Also called High tie with routine SFM
Nerve-sparing paraaortic lymph node dissection is performed. The inferior mesenteric artery is divided at 1-2 cm from its origin from the aorta. Nerve-sparing total mesorectal excision is performed. Splenic flexure is mobilized. Side-to-end sigmoido-rectal anastomosis is created.
Paraaortic lymph node dissection, IMA low ligation, TME, selective splenic flexure mobilizationProcedure or surgery
Also called Low tie with selective SFM
Nerve-sparing paraaortic lymph node dissection is performed. Then inferior mesenteric artery is skeletonized down to the origin of left colic artery and divided below it. Nerve-sparing total mesorectal excision is performed. Splenic flexure is mobilized only if sigmoid colon is unsuitable for anastomosis or doesn't reach the rectal stump. Then descending-rectal side-to-end anastomosis is created.
| Study group | Role | What they receive |
|---|---|---|
| IMA high ligation with routine SFM | Active comparator | Inferior mesenteric artery is ligated close to its origin. Splenic flexure is always mobilized. Receives: Procedure: Paraaortic lymph node dissection, IMA high ligation, TME, routine splenic flexure mobilization |
| IMA skeletonization and low ligation with selective SFM | Experimental | Inferior mesenteric artery is ligated below the origin of left colic artery. Splenic flexure is mobilized only if needed. Receives: Procedure: Paraaortic lymph node dissection, IMA low ligation, TME, selective splenic flexure mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic Leakage Rate
The rate of symptomatic and asymptomatic colorectal anastomotic leakage
Measured: 4-6 weeks
Secondary outcomes (11)
Operating time
The duration of surgical procedure
Measured: 1 day
Intraoperative complications rate
The rate of complications during surgery
Measured: 1 day
Splenic flexure mobilization rate
The rate of splenic flexure mobilization in Low tie group
Measured: 1 day
Conversion rate
The rate of conversion from laparoscopic or robotic approach to open approach
Measured: 1 day
IMA architectonics
The incidence of left colic artery, first, second and third sigmoid arteries
Measured: 1 day
The length of IMA trunk
the length of inferior mesenteric artery trunk based on preoperative CT-scans and intraoperative findings
Measured: 1 day
Early postoperative complications rate
The rate of complications in first 30 days after surgery
Measured: 30 days
Specimen morphometry
The gross dimensions of resected specimen: length, the distal and proximal resection margins distance, vascular pedicle length
Measured: 30 days
Positive Apical Lymph Nodes Rate
The rate of metastatic lymph nodes found in the area of paraaortic lymph node dissection
Measured: 30 days
Complications of defunctioning stoma
Any complications of defunctioning stoma
Measured: 3 month
The postoperative hospital stay
the number of days from the first day after operation to discharge
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start2 Oct 2016
- Primary completion2 May 2020 (estimated)
- Study completion2 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russian Society of Colorectal Surgeons
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petr Tsarkov, Prof, Principal investigator, Russian Society of Colorectal Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895255
- Sponsor's protocol ID
- 683472
- Acronym
- SpeeDy
- Status last verified
- Feb 2020
- First submitted
- 28 Mar 2019
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Heald RJ, Ryall RD. Recurrence and survival after total mesorectal excision for rectal cancer. Lancet. 1986 Jun 28;1(8496):1479-82. doi: 10.1016/s0140-6736(86)91510-2.
PubMed 2425199Ho YH. Techniques for restoring bowel continuity and function after rectal cancer surgery. World J Gastroenterol. 2006 Oct 21;12(39):6252-60. doi: 10.3748/wjg.v12.i39.6252.
PubMed 17072945Kanemitsu Y, Hirai T, Komori K, Kato T. Survival benefit of high ligation of the inferior mesenteric artery in sigmoid colon or rectal cancer surgery. Br J Surg. 2006 May;93(5):609-15. doi: 10.1002/bjs.5327.
PubMed 16607682Lange MM, Buunen M, van de Velde CJ, Lange JF. Level of arterial ligation in rectal cancer surgery: low tie preferred over high tie. A review. Dis Colon Rectum. 2008 Jul;51(7):1139-45. doi: 10.1007/s10350-008-9328-y. Epub 2008 May 16.
PubMed 18483828Mouw TJ, King C, Ashcraft JH, Valentino JD, DiPasco PJ, Al-Kasspooles M. Routine splenic flexure mobilization may increase compliance with pathological quality metrics in patients undergoing low anterior resection. Colorectal Dis. 2019 Jan;21(1):23-29. doi: 10.1111/codi.14404. Epub 2018 Sep 29.
PubMed 30184316Katory M, Tang CL, Koh WL, Fook-Chong SM, Loi TT, Ooi BS, Ho KS, Eu KW. A 6-year review of surgical morbidity and oncological outcome after high anterior resection for colorectal malignancy with and without splenic flexure mobilization. Colorectal Dis. 2008 Feb;10(2):165-9. doi: 10.1111/j.1463-1318.2007.01265.x. Epub 2007 May 16.
PubMed 17506796
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Non-inferiority Trial of Selective Splenic Flexure Mobilization for the Formation of Low Colorectal Anastomosis After Total Mesorectal Excision and D3 Paraaortic Lymph Node Dissection in Low Rectal Cancer.
- ClinicalTrials.gov ID
- NCT03895255
- Acronym / sponsor ID
- SpeeDy / 683472
- Conditions
- Rectal Cancer
- Keywords
- lymph node dissection, high tie, low tie, splenic flexure mobilization, anastomotic leak
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Russian Society of Colorectal SurgeonsUniversity, hospital or other
- Study start
- 2 Oct 2016 (actual)
- Primary completion
- 2 May 2020 (estimated)
- Study completion
- 2 Nov 2021 (estimated)
- First posted
- 29 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the Low Anterior Resection of rectum for cancer, the section level of IMA and the need of SFM is still debated.
The aim of this study is to explore the different impacts of high and low ligation with peeling off vascular sheath of inferior mesenteric artery (IMA) in low anterior resection of the rectum for cancer. This study purpose to demonstrate that low IMA ligation, sparing of left colic artery (LCA) and selective SFM results in higher anastomotic leakage rate than high IMA ligation with routine SFM (with the difference of more than 5%).
Detailed description
Although TME is the standard curative operation for rectal cancer patients, who undergo low anterior resection (LAR) or abdominoperineal resection (APR) with a permanent colostomy, the strategy to restore the transit between colon and rectum (in case of LAR) is still debated in literature.
Several studies comparing high-tie with low-tie ligation reported a stage-specific survival benefit for high-tie, but on the other hand recent studies demonstrated that low-tie, without splenic flexure mobilization (SFM), decreases the complexity of the laparoscopic procedure and could reduces the operating time with comparable oncological outcomes.
The method of restorative surgery, after Total Mesorectal Excision (TME), largely depends on the length of the resected part of the colon, that is related to patient's anatomical features and the height of vascular ligation performed during the operation.
In attempt to perform a radical paraaortic lymph node dissection the inferior mesenteric artery (IMA) is usually ligated at its origin and the Arcade of Riolan provides bloody supply to any distal anastomosis. Unfortunately the Arcade of Riolan is an inconstant finding and sometimes (26% of cases) is mandatory to mobilize the splenic flexure to ensure a safe and tension-free anastomosis. SFM is a time-consuming component of LAR, has the additional risk of iatrogenic splenic injury and is very difficult during a laparoscopic resection.
In 2005 was demonstrated that routine SFM is not always necessary during anterior resection for rectal cancer.
A recent retrospective analysis by Mouw showed that SFM was associated with wider margins and a decreased rate of inadequate nodal staging in patients undergoing LAR.
This trial aims to demonstrate that low IMA ligation, sparing of LCA and selective SFM results in higher anastomotic leakage rate than high IMA ligation with routine SFM (with the difference of more than 5%). Furthermore this study purpose to evaluate the need to perform splenic flexure mobilization (SFM) in low ligation group and the, operation time, apical lymph nodes positive rate and short terms postoperative complication in both groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMA high ligation with routine SFM | Active comparator | Procedure: Paraaortic lymph node dissection, IMA high ligation, TME, routine splenic flexure mobilizationInferior mesenteric artery is ligated close to its origin. Splenic flexure is always mobilized. |
| IMA skeletonization and low ligation with selective SFM | Experimental | Procedure: Paraaortic lymph node dissection, IMA low ligation, TME, selective splenic flexure mobilizationInferior mesenteric artery is ligated below the origin of left colic artery. Splenic flexure is mobilized only if needed. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically proven primary rectal adenocarcinoma located within 15 cm from anal verge not involving internal and/or external sphincter muscle
- Stage I-III
- Elective surgical treatment with TME and primary colorectal anastomosis
- Receive or not receive neoadjuvant radio-chemotherapy
- Overall health status according to American Society of Anesthesiologists (ASA) classification: I-III
Key exclusion criteria (4 listed)
- Unresectable tumour, inability to perform a TME with colorectal anastomosis, inability to complete R0 resection or presence of T4b tumour necessitating a multi-organ resection
- The patient wants to withdraw from the clinical trial
- Loss to follow-up
- Inability to complete all the trial procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paraaortic lymph node dissection, IMA high ligation, TME, routine splenic flexure mobilizationAlso: High tie with routine SFMNerve-sparing paraaortic lymph node dissection is performed. The inferior mesenteric artery is divided at 1-2 cm from its origin from the aorta. Nerve-sparing total mesorectal excision is performed. Splenic flexure is mobilized. Side-to-end sigmoido-rectal anastomosis is created. | Procedure or surgery | IMA high ligation with routine SFM |
| Paraaortic lymph node dissection, IMA low ligation, TME, selective splenic flexure mobilizationAlso: Low tie with selective SFMNerve-sparing paraaortic lymph node dissection is performed. Then inferior mesenteric artery is skeletonized down to the origin of left colic artery and divided below it. Nerve-sparing total mesorectal excision is performed. Splenic flexure is mobilized only if sigmoid colon is unsuitable for anastomosis or doesn't reach the rectal stump. Then descending-rectal side-to-end anastomosis is created. | Procedure or surgery | IMA skeletonization and low ligation with selective SFM |
Primary outcome
Anastomotic Leakage Rate
Time frame: 4-6 weeks
The rate of symptomatic and asymptomatic colorectal anastomotic leakage
11 secondary outcomes
Operating time
Time frame: 1 day
Intraoperative complications rate
Time frame: 1 day
Splenic flexure mobilization rate
Time frame: 1 day
Conversion rate
Time frame: 1 day
IMA architectonics
Time frame: 1 day
The length of IMA trunk
Time frame: 1 day
Early postoperative complications rate
Time frame: 30 days
Specimen morphometry
Time frame: 30 days
Positive Apical Lymph Nodes Rate
Time frame: 30 days
Complications of defunctioning stoma
Time frame: 3 month
The postoperative hospital stay
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
- Results publication: PubMed 2425199Heald RJ, Ryall RD. Recurrence and survival after total mesorectal excision for rectal cancer. Lancet. 1986 Jun 28;1(8496):1479-82. doi: 10.1016/s0140-6736(86)91510-2.
- Results publication: PubMed 17072945Ho YH. Techniques for restoring bowel continuity and function after rectal cancer surgery. World J Gastroenterol. 2006 Oct 21;12(39):6252-60. doi: 10.3748/wjg.v12.i39.6252.
- Results publication: PubMed 16607682Kanemitsu Y, Hirai T, Komori K, Kato T. Survival benefit of high ligation of the inferior mesenteric artery in sigmoid colon or rectal cancer surgery. Br J Surg. 2006 May;93(5):609-15. doi: 10.1002/bjs.5327.
- Results publication: PubMed 18483828Lange MM, Buunen M, van de Velde CJ, Lange JF. Level of arterial ligation in rectal cancer surgery: low tie preferred over high tie. A review. Dis Colon Rectum. 2008 Jul;51(7):1139-45. doi: 10.1007/s10350-008-9328-y. Epub 2008 May 16.
- Results publication: PubMed 30184316Mouw TJ, King C, Ashcraft JH, Valentino JD, DiPasco PJ, Al-Kasspooles M. Routine splenic flexure mobilization may increase compliance with pathological quality metrics in patients undergoing low anterior resection. Colorectal Dis. 2019 Jan;21(1):23-29. doi: 10.1111/codi.14404. Epub 2018 Sep 29.
- Results publication: PubMed 17506796Katory M, Tang CL, Koh WL, Fook-Chong SM, Loi TT, Ooi BS, Ho KS, Eu KW. A 6-year review of surgical morbidity and oncological outcome after high anterior resection for colorectal malignancy with and without splenic flexure mobilization. Colorectal Dis. 2008 Feb;10(2):165-9. doi: 10.1111/j.1463-1318.2007.01265.x. Epub 2007 May 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petr Tsarkov, Prof principal investigator
Russian Society of Colorectal Surgeons
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paraaortic lymph node dissection, IMA high ligation, TME, routine splenic flexure mobilization and Paraaortic lymph node dissection, IMA low ligation, TME, selective splenic flexure mobilization in people with Rectal Cancer, run by Russian Society of Colorectal Surgeons at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arcangelo Picciariello, MD (+393492185104, picciariello@kkmx.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic Leakage Rate (time frame: 4-6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03895255, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2020; AzTrials last refreshed its copy on 6 Nov 2026.