ClinicalTrials.gg
CompletedNCT06376227Updated Apr 22, 2024

Robotic-Assisted or Laparoscopic Radical Resection for Rectal Cancer With or Without Left Colic Artery Preservation

An observational study in Rectal Cancer, Left Colic Artery Stenosis (Diagnosis) and Robotic Assisted Laparoscopic Surgery, sponsored by Northern Jiangsu People's Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-22.

Sponsored by Northern Jiangsu People's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,164
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 460 studies in Rectal Neoplasms with a site in China — 225 open to participants now, 264 under way, 40 of them phase 3. Rectal Neoplasms · China.

Enrollment
10th of 89
1,164 · median 200
Started
2020
with 31 others
Observational
89 of 460
29 open now
Registered
298th of 460
by date

Among the 460 studies in Rectal Neoplasms with a site in China, this one is the 10th largest by enrollment of the 89 observational ones, is one of 32 that started in 2020, is one of 89 observational ones, and was the 298th registered.

By phase

460 studies; the count open now beside each. This study's row is marked.

Phase 2155 · 95 open
No phase132 · 57 open
Observationalthis study89 · 29 open
Phase 340 · 23 open
Phase 2/314 · 8 open
Phase 112 · 4 open
Phase 1/212 · 7 open
Phase 46 · 2 open

By the year they started

First in 1993; this study’s year is marked. 32 started in 2020.

Size and results

Median enrollment 100 across the 370 interventional studies, 200 across the 89 observational. Of the 89 that completed or were terminated, 4 (4%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 460 studies in Rectal Neoplasms with a site in China, or all of them as a file.
02

Study summary

Brief Summary

Background The preservation of the left colic artery (LCA) during rectal cancer resection remains a topic of controversy, and there is a notable absence of robust evidence regarding the outcomes associated with LCA preservation. And the advantages of robotic-assisted laparoscopy (RAL) surgery in rectal resection remain uncertain. The objective of this study was to assess the influence of LCA preservation surgery and RAL surgery on intraoperative and postoperative complications of rectal cancer resection.

Methods Participants who underwent laparoscopic (LSC) or RAL with or without LCA preservation resection for rectal cancer between April 2020 and May 2023 were retrospectively assessed. The patients were categorized into two groups: low ligation (LL) which with preservation of LCA and high ligation (HL) which without preservation of LCA. A one-to-one propensity score-matched analysis was performed to decrease confounding. The primary outcome was operative findings, operative morbidity, and postoperative genitourinary function.

Read the detailed description

The investigators retrospectively collected data from the medical records of participants who had rectal cancer at Northern Jiangsu People's Hospital, from April 2020 to May 2023. A total of 612 from 1164 cases were included in this study; in 462 cases, the LCA was preserved by LL intraoperatively (LL group), in which 202 cases underwent robotic-assisted laparoscopy (LL-RAL subgroup) and 260 cases underwent laparoscopy (LL-LSC subgroup). While in the remaining 150 cases, the LCA was not preserved by HL intraoperatively (HL group). in which 70 cases underwent robotic-assisted laparoscopy (HL-RAL subgroup) and 80 cases underwent laparoscopy (HL-LSC subgroup).

03

Conditions studied

  • Rectal Cancer
  • Left Colic Artery Stenosis (Diagnosis)
  • Robotic Assisted Laparoscopic Surgery

Keywords

  • Rectal cancer
  • Left colic artery
  • High ligation
  • Low ligation
  • Inferior mesenteric artery
  • Robotic-assisted laparoscopy
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

A total of 612 rectal cancer patients, including 245 (40.0%) men and 367(60.0%) women, were enrolled in this study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Low anterior resection for rectal cancer
  • Postoperative pathological diagnosis of rectal adenocarcinoma
  • signed prior to surgery.

Exclusion criteria

Exclusion Criteria:

  • Recurrent rectal cancer
  • Emergency surgery
  • Preoperative and intraoperative detection of distant organ or extensive
  • Implantation metastases in the abdominal cavity
  • Palliative surgery
  • A postoperative pathology report that showed residual cancer cells at the proximal or distal resection margin
  • No standard chemotherapy for tumor-node-metastasis (TNM) staging II or III after surgery
  • Synchronous colorectal carcinoma and other organ tumors
  • Incomplete case data.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,164 participants (actual)
Patient registry
No

Groups and cohorts

  • with or without Left Colic Artery Preservation
  • low ligation (LL) group and high ligation (HL) group

    low ligation (LL) which with preservation of LCA and high ligation (HL) which without preservation of LCA

    Procedure: with or without Left Colic Artery Preservation

Interventions

  • Procedurewith or without Left Colic Artery Preservation

    low ligation (LL) which with preservation of LCA and high ligation (HL) which without preservation of LCA

06

What researchers measure

Primary outcomes

  1. The incidence of anastomotic leakage in postoperative patients with or without left colic artery preservation.

    Within two weeks after surgery, the patient experienced abdominal pain, fever, and imaging diagnosis showed anastomotic leakage.

    Time frame: 2 weeks within the surgery

Secondary outcomes

  1. The genitourinary function of the patients after the radical resection with or without left colic artery preservation.

    The genitourinary function includes urinary dysfunction and sexual dysfunction. Residual urine volume and catheterization retention time for evaluating urinary function. Erectile and ejaculatory grading scores are used to evaluate sexual function.

    Time frame: 6 to 12 months after operation

07

Study locations

1 site
  • Northern Jiangsu People's Hospital Affiliated to Yangzhou University, General Surgery Institute of Yangzhou, Yangzhou University , Yangzhou
    Yangzhou, Jiangsu 225001, China
08

References and documents

Individual participant data

Plan to share: Undecided — Contains a large amount of personal information about patients and needs to be treated with caution.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2020 to primary completion in May 2023, 37 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 10, 2024
First posted
Apr 19, 2024
StartActual
Apr 1, 2020
Primary completionActual
May 31, 2023
CompletionActual
Dec 28, 2023
Last update
Apr 22, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06376227
Lead sponsor
Northern Jiangsu People's Hospital
Responsible party
Daorong Wang (Doctor, Northern Jiangsu People's Hospital) — Principal investigator
First posted
Apr 19, 2024
Start date
Apr 1, 2020
Primary completion
May 31, 2023
Completion
Dec 28, 2023
Last update
Apr 22, 2024

Study contacts

Daorong Wang, M.D., Professor
study director · Northern Jiangsu People's Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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