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Selective sPlenic flExure Mobilization for Low colorEctal Anastomosis After D3 lYmph Node Dissection (Speedy Trial)

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03895255
Acronym
SpeeDy
Enrollment
142
Registered
2019-03-29
Start date
2016-10-02
Completion date
2021-11-02
Last updated
2020-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

lymph node dissection, high tie, low tie, splenic flexure mobilization, anastomotic leak

Brief 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. 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

Interventions

PROCEDUREParaaortic lymph node dissection, IMA high ligation, TME, routine splenic flexure mobilization

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.

PROCEDUREParaaortic lymph node dissection, IMA low ligation, TME, selective splenic flexure mobilization

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.

Sponsors

Russian Society of Colorectal Surgeons
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

1. Histologically proven primary rectal adenocarcinoma located within 15 cm from anal verge not involving internal and/or external sphincter muscle 2. Stage I-III 3. Elective surgical treatment with TME and primary colorectal anastomosis 4. Receive or not receive neoadjuvant radio-chemotherapy 5. Overall health status according to American Society of Anesthesiologists (ASA) classification: I-III 6. Signed informed consent with agreement to attend all study visits 7. The patient is not pregnant

Exclusion criteria

1. 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 2. The patient wants to withdraw from the clinical trial 3. Loss to follow-up 4. Inability to complete all the trial procedures

Design outcomes

Primary

MeasureTime frameDescription
Anastomotic Leakage Rate4-6 weeksThe rate of symptomatic and asymptomatic colorectal anastomotic leakage

Secondary

MeasureTime frameDescription
Intraoperative complications rate1 dayThe rate of complications during surgery
Splenic flexure mobilization rate1 dayThe rate of splenic flexure mobilization in Low tie group
Conversion rate1 dayThe rate of conversion from laparoscopic or robotic approach to open approach
IMA architectonics1 dayThe incidence of left colic artery, first, second and third sigmoid arteries
The length of IMA trunk1 daythe length of inferior mesenteric artery trunk based on preoperative CT-scans and intraoperative findings
Operating time1 dayThe duration of surgical procedure
Specimen morphometry30 daysThe gross dimensions of resected specimen: length, the distal and proximal resection margins distance, vascular pedicle length
Positive Apical Lymph Nodes Rate30 daysThe rate of metastatic lymph nodes found in the area of paraaortic lymph node dissection
Complications of defunctioning stoma3 monthAny complications of defunctioning stoma
The postoperative hospital stay1 monththe number of days from the first day after operation to discharge
Early postoperative complications rate30 daysThe rate of complications in first 30 days after surgery

Countries

Russia

Contacts

Primary ContactArcangelo Picciariello, MD
picciariello@kkmx.ru+393492185104
Backup ContactInna Tulina, MD
tulina@kkmx.ru+79264086672

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026