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

Rectal Cancer Clinical Trial

— SpeeDy  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03895255
• Other study ID #: 683472
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2016
• Est. completion date: November 2, 2021

Study information

• Verified date: February 2020
• Source: Russian Society of Colorectal Surgeons
• Contact: Arcangelo Picciariello, MD
• Phone: +393492185104
• Email: picciariello[@]kkmx.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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%).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: November 2, 2021
• Est. primary completion date: May 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Paraaortic 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.
• Paraaortic 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.

Locations

Country	Name	City	State
Russian Federation	Clinic of Colorectal and Minimally Invasive Surgery	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Russian Society of Colorectal Surgeons

Country where clinical trial is conducted

Russian Federation, 

References & Publications (6)

Heald RJ, Ryall RD. Recurrence and survival after total mesorectal excision for rectal cancer. Lancet. 1986 Jun 28;1(8496):1479-82. — View Citation

Ho YH. Techniques for restoring bowel continuity and function after rectal cancer surgery. World J Gastroenterol. 2006 Oct 21;12(39):6252-60. Review. — View 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. — View 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. 20 — View 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. Review. — View 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. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anastomotic Leakage Rate	The rate of symptomatic and asymptomatic colorectal anastomotic leakage	4-6 weeks
Secondary	Operating time	The duration of surgical procedure	1 day
Secondary	Intraoperative complications rate	The rate of complications during surgery	1 day
Secondary	Splenic flexure mobilization rate	The rate of splenic flexure mobilization in Low tie group	1 day
Secondary	Conversion rate	The rate of conversion from laparoscopic or robotic approach to open approach	1 day
Secondary	IMA architectonics	The incidence of left colic artery, first, second and third sigmoid arteries	1 day
Secondary	The length of IMA trunk	the length of inferior mesenteric artery trunk based on preoperative CT-scans and intraoperative findings	1 day
Secondary	Early postoperative complications rate	The rate of complications in first 30 days after surgery	30 days
Secondary	Specimen morphometry	The gross dimensions of resected specimen: length, the distal and proximal resection margins distance, vascular pedicle length	30 days
Secondary	Positive Apical Lymph Nodes Rate	The rate of metastatic lymph nodes found in the area of paraaortic lymph node dissection	30 days
Secondary	Complications of defunctioning stoma	Any complications of defunctioning stoma	3 month
Secondary	The postoperative hospital stay	the number of days from the first day after operation to discharge	1 month