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

NCT06376227 | Completed

• 1 other identifier: jamesdukeryan
• Study Type: observational
• Target: 1,164
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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.

  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.

  6 to 12 months after operation

Study Arms (2)

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

with or without Left Colic Artery Preservation PROCEDURE

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

low ligation (LL) group and high ligation (HL) group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Recurrent rectal cancer
• Emergency surgery
• Preoperative and intraoperative detection of distant organ metastases 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.

Sponsors & Collaborators

• Northern Jiangsu People's Hospital: lead

Study Sites (1)

Northern Jiangsu People's Hospital Affiliated to Yangzhou University, General Surgery Institute of Yangzhou, Yangzhou University , Yangzhou

Yangzhou, Jiangsu, 225001, China

Location

MeSH Terms

Conditions

Rectal Neoplasms; Disease

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daorong Wang, M.D., Professor

  Northern Jiangsu People's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 19, 2024
• Study Start: April 1, 2020
• Primary Completion: May 31, 2023
• Study Completion: December 28, 2023
• Last Updated: April 22, 2024

Record last verified: 2024-04

Locations

CN (1)