Clinical trial NCT03895255: Selective sPlenic flExure Mobilization for Low colorEctal Anastomosis After D3 lYmph Node Dissection (Speedy Trial)
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Keywords: lymph node dissection
high tie
low tie
splenic flexure mobilization
anastomotic leak
Lead sponsor: Russian Society of Colorectal Surgeons
Sponsor class: OTHER
First posted: 2019-03-29
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Anastomotic Leakage Rate
timeFrame: 4-6 weeks
Secondary outcomes:
measure: Operating time
timeFrame: 1 day
measure: Intraoperative complications rate
timeFrame: 1 day
measure: Splenic flexure mobilization rate
timeFrame: 1 day
measure: Conversion rate
timeFrame: 1 day
measure: IMA architectonics
timeFrame: 1 day
measure: The length of IMA trunk
timeFrame: 1 day
measure: Early postoperative complications rate
timeFrame: 30 days
measure: Specimen morphometry
timeFrame: 30 days
measure: Positive Apical Lymph Nodes Rate
timeFrame: 30 days
measure: Complications of defunctioning stoma
timeFrame: 3 month
measure: The postoperative hospital stay
timeFrame: 1 month
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Clinic of Colorectal and Minimally Invasive Surgery
Study officials:
affiliation: Russian Society of Colorectal Surgeons
name: Petr Tsarkov, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Ho 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.
citation: Kanemitsu 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.
citation: Lange 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.
citation: Mouw 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.
citation: Katory 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.