NCT03895255

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%).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2016

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2021

Completed
Last Updated

February 27, 2020

Status Verified

February 1, 2020

Enrollment Period

3.6 years

First QC Date

March 28, 2019

Last Update Submit

February 26, 2020

Conditions

Rectal Cancer

Keywords

lymph node dissectionhigh tielow tiesplenic flexure mobilizationanastomotic leak

Outcome Measures

Primary Outcomes (1)

  • Anastomotic Leakage Rate

    The rate of symptomatic and asymptomatic colorectal anastomotic leakage

    4-6 weeks

Secondary Outcomes (11)

  • Operating time

    1 day

  • Intraoperative complications rate

    1 day

  • Splenic flexure mobilization rate

    1 day

  • Conversion rate

    1 day

  • IMA architectonics

    1 day

  • +6 more secondary outcomes

Study Arms (2)

IMA high ligation with routine SFM

ACTIVE COMPARATOR

Inferior mesenteric artery is ligated close to its origin. Splenic flexure is always mobilized.

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.

Procedure: Paraaortic lymph node dissection, IMA low ligation, TME, selective splenic flexure mobilization

Interventions

Paraaortic lymph node dissection, IMA high ligation, TME, routine splenic flexure mobilizationPROCEDURE

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.

Also known as: High tie with routine SFM
IMA high ligation with routine SFM
Paraaortic lymph node dissection, IMA low ligation, TME, selective splenic flexure mobilizationPROCEDURE

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.

Also known as: Low tie with selective SFM
IMA skeletonization and low ligation with selective SFM

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic of Colorectal and Minimally Invasive Surgery

Moscow, 119435, Russia

RECRUITING

Related Publications (6)

  • 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.

    PMID: 2425199RESULT

  • 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.

    PMID: 17072945RESULT

  • 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.

    PMID: 16607682RESULT

  • 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.

    PMID: 18483828RESULT

  • 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.

    PMID: 30184316RESULT

  • 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.

    PMID: 17506796RESULT

MeSH Terms

Conditions

Rectal NeoplasmsAnastomotic Leak

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Petr Tsarkov, Prof

    Russian Society of Colorectal Surgeons

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arcangelo Picciariello, MD

CONTACT

+393492185104picciariello@kkmx.ru

Inna Tulina, MD

CONTACT

+79264086672tulina@kkmx.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2019

First Posted

March 29, 2019

Study Start

October 2, 2016

Primary Completion

May 2, 2020

Study Completion

November 2, 2021

Last Updated

February 27, 2020

Record last verified: 2020-02

Locations

RU(1)