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

Rectal Cancer Clinical Trial

Official title:

With or Without Left Colic Artery Preservation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06376227
• Other study ID #: jamesdukeryan
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: December 28, 2023

Study information

• Verified date: April 2024
• Source: Northern Jiangsu People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1164
• Est. completion date: December 28, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colic
• Rectal Cancer
• Rectal Neoplasms
• Robotic Assisted Laparoscopic Surgery

Intervention

Procedure:
• with or without Left Colic Artery Preservation
low ligation (LL) which with preservation of LCA and high ligation (HL) which without preservation of LCA

Locations

Country	Name	City	State
China	Northern Jiangsu People's Hospital Affiliated to Yangzhou University, General Surgery Institute of Yangzhou, Yangzhou University , Yangzhou	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Northern Jiangsu People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	6 to 12 months after operation