Clinical trial · Interventional

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.

NCT03895255CI-TRIAL-00043681SpeeDyunknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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%).

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Rectal Cancer	Malignant Rectal Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Paraaortic lymph node dissection, IMA high ligation, TME, routine splenic flexure mobilization	Procedure	—	UNRESOLVED
Paraaortic lymph node dissection, IMA low ligation, TME, selective splenic flexure mobilization	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
IMA high ligation with routine SFM
description
Inferior mesenteric artery is ligated close to its origin. Splenic flexure is always mobilized.
interventionNames
1. Procedure: Paraaortic lymph node dissection, IMA high ligation, TME, routine splenic flexure mobilization
type
EXPERIMENTAL
label
IMA skeletonization and low ligation with selective SFM
description
Inferior mesenteric artery is ligated below the origin of left colic artery. Splenic flexure is mobilized only if needed.
interventionNames
1. Procedure: Paraaortic lymph node dissection, IMA low ligation, TME, selective splenic flexure mobilization

Primary outcomes (1)

measure

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 85 Years

Show eligibility criteria text

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

References

Publications (6)

RESULTHeald 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. PMID 2425199
RESULTHo 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. PMID 17072945
RESULTKanemitsu 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. PMID 16607682
RESULTLange 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. PMID 18483828
RESULTMouw 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. PMID 30184316
RESULTKatory 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. PMID 17506796

Registry

Dates and enrollment

Start: Oct 2, 2016
Primary completion: May 2, 2020
Completion: Nov 2, 2021
First posted: Mar 29, 2019
Last update posted: Feb 27, 2020
Enrollment: 142 (estimated)
Lead sponsor: Russian Society of Colorectal Surgeons OTHER
Keywords: lymph node dissection, high tie, low tie, splenic flexure mobilization, anastomotic leak

Data updated 22 days agoSource updated Feb 27, 2020source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
Russia	1	1

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.