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

Completed

• Conditions: Left Colic Artery Stenosis (Diagnosis); Robotic Assisted Laparoscopic Surgery; Rectal Cancer
• Interventions: Procedure: with or without Left Colic Artery Preservation

• Registration Number: NCT06376227
• Lead Sponsor: Northern Jiangsu People's Hospital

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.

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).

Study Timeline

• Study Start: 2020-04-01
• Primary Completion: 2023-05-31
• Study Completion: 2023-12-28
• Status Verified: 2024-04
• Study First Submitted: 2024-04-10
• Study First Submitted QC: 2024-04-16
• Study First Posted: 2024-04-19
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1164

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
low ligation (LL) group and high ligation (HL) group	with or without Left Colic Artery Preservation	low ligation (LL) which with preservation of LCA and high ligation (HL) which without preservation of LCA

Primary Outcome Measures

Name	Time	Method
The incidence of anastomotic leakage in postoperative patients with or without left colic artery preservation.	2 weeks within the surgery	Within two weeks after surgery, the patient experienced abdominal pain, fever, and imaging diagnosis showed anastomotic leakage.

Secondary Outcome Measures

Name	Time	Method
The genitourinary function of the patients after the radical resection with or without left colic artery preservation.	6 to 12 months after operation	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.

Trial Locations

Locations (1)

Northern Jiangsu People's Hospital Affiliated to Yangzhou University, General Surgery Institute of Yangzhou, Yangzhou University , Yangzhou; 🇨🇳 Yangzhou, Jiangsu, China