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Total Mesorectum Excision With Left Colic Artery Preservation for the Treatment of Rectal Cancer

A Randomized Controlled Clinical Trial to Investigate the Effects of Total Mesorectum Excision With Left Colic Artery Preservation for the Treatment of Rectal Cancer

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03724591
Enrollment
600
Registered
2018-10-30
Start date
2019-01-31
Completion date
2024-01-31
Last updated
2018-10-30

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

Conditions

Rectal Cancer

Keywords

left colic artery, rectal cancer

Brief summary

A randomized controlled clinical trial to compare the short and long term outcomes of left colic artery preservation for the treatment of Rectal Cancer

Detailed description

Rectal cancer is one of most frequently diagnosed cancers and one of the leading causes of cancer death around the world. Surgery remains the main treatment for rectal cancer. Anastomosis leakage (AL) is an unresolved, devastating and lethal complication after rectal cancer surgery and remains to be a serious difficulty for surgeons despite its causes, preventions and treatments having been extensively studied. To achieve a radical dissection of lymph nodes, it is necessary to remove the central lymph nodes at the root of inferior mesenteric artery(IMA) trunk.From the perspectives of lymph nodes dissection and tension-free anastomosis, it is preferred to perform a high ligation of IMA. However, there is still a controversy whether IMA should be high ligated or not. The argument mainly focuses on whether this performance will compromise the blood perfusion of the proximal limb of the anastomosis leading to the occurrence of AL. Some studies suggested that a high ligation did not increase the rate of AL. There are still many surgeons prefer the transection of IMA distal to the left colic artery(LCA) with the intention to preserve a good blood supply of the left colon after the performance of lymph node dissection around IMA. Some studies suggests that the preservation of LCA in anterior resection for mid and low rectal cancer is associated with lower rates of AL. Further investigations are needed to resolve the controversy. In this study, eligible patients will be randomly allocated to receive total mesorectal excision (TME) for rectal cancer either by a high ligation of IMA without preservation of left colic artery or a low ligation of IMA with preservation of left colic artery. Postoperative complications, including anastomosis leakage, anastomosis bleeding, will be recorded. Patients will be followed up every 3 months for 2 year, every 6 months for 3 years postoperatively to study the long term effects.

Interventions

PROCEDUREa high ligation of IMA

total mesorectal excision (TME) for rectal cancer by a high ligation of IMA without preservation of left colic artery

PROCEDUREa low ligation of IMA

total mesorectal excision (TME) for rectal cancer by a low ligation of IMA with preservation of left colic artery

Sponsors

The First Affiliated Hospital with Nanjing Medical University
Lead SponsorOTHER

Study design

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

Eligibility

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

Inclusion criteria

* Patients suitable for curative surgery over 18 years old; * American Society of Anesthesiologists(ASA) grade I-III; * Pathological diagnosis of rectal adenocarcinoma; * Patients suitable for abdominalperineal resection * Informed consent; * No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.

Exclusion criteria

* Pregnant patient; * History of psychiatric disease; * Use of systemic steroids; * Simultaneous multiple primary colorectal cancer; * Preoperative imaging examination results show:1. Tumor involves the surrounding organs and combined organ resection need to be done;2. distant metastasis;3. unable to perform R0 resection; * History of any other malignant tumor in recent 5 years; * Patients need emergency operation: mechanic ileus, perforation.

Design outcomes

Primary

MeasureTime frame
Anastomosis leakage rate30 days

Secondary

MeasureTime frameDescription
disease-free survival5 years
local recurrence rate5 years
Anastomosis bleeding rate30 days
number of lymph nodes retrieved1 day
postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire5 yearsCompare the differences in postoperative quality of life of patients treated with these two regimens using EORTC QLQC30 questionnaire
operative time1 day

Contacts

Primary ContactYueming Sun, PhD
jssym@vip.sina.com02568306026
Backup ContactFumin Zhang, Professor
02568306026

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026