The Outcomes of Laparoscopic Hybrid Surgery Versus Totally Open Surgery

The Outcomes of Simultaneous Resection for Colorectal Cancer Liver Metastases by Laparoscopic Hybrid Surgery Versus Totally Open Surgery: a Prospective Cohort Study

Simultaneous colorectal cancer liver metastasis (SCRLM) is one of the risk factors for poor prognosis in colorectal cancer. Surgical resection of primary and metastatic lesions is the first choice of treatment for patients with resectable SCRLM. Simultaneous resection of colorectal cancer liver metastases by totally open surgery (TOS) has been widely used. However, we propose that laparoscopic hybrid surgery (LHS) may have better short and long-term outcomes. This study aimed to compare the safety, short-term, and long-term efficacy of LHS versus TOS for patients with resectable SCRLMs.

Study Overview

• Status: Completed
• Conditions: Resectable Simultaneous Colorectal Cancer Liver Metastasis
• Intervention / Treatment: Procedure: laparoscopic hybrid surgery (LHS)

• Study Type: Observational
• Enrollment (Actual): 266

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Department of Colorectal Surgery in Changhai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study collected clinical data from patients who underwent simultaneous resection of colorectal cancer liver metastases at the Department of Colorectal Surgery in Changhai Hospital from January 2010 to June 2021.

Description

Inclusion Criteria:

• Liver metastasis was detected while the colorectal cancer was diagnosed.
• Both the primary lesions and liver metastases were confirmed by postoperative pathological examination.
• Clinical data is complete.

Exclusion Criteria:

• Patients with unresectable extrahepatic metastases.
• Patients with other malignant tumor diseases that have not been cured.
• Clinical and pathological data were missed or incomplete follow-up data.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
laparoscopic hybrid surgery (LHS) cohort; Routine colorectal surgery is performed first, followed by liver surgery. The LHS cohort first performed the laparoscopic exploration of the entire abdominal-pelvic cavity to determine the resectability of the primary and metastatic lesions. After the blood vessel detachment and bowel detachment, the distal bowel of the tumor was severed and the pneumoperitoneum was closed. The liver metastases were then removed in both cohorts by open resection through the right subcostal incision.	Procedure: laparoscopic hybrid surgery (LHS); First performed the laparoscopic exploration of the entire abdominal-pelvic cavity to determine the resectability of the primary and metastatic lesions. After the blood vessel detachment and bowel detachment, the distal bowel of the tumor was severed and the pneumoperitoneum was closed. The liver metastases were then removed in both cohorts by open resection through the right subcostal incision.
totally open surgery (TOS) cohort; Routine colorectal surgery is performed first, followed by liver surgery. The blood vessel detachment, bowel detachment, the distal bowel of the tumor in the TOS cohort were accomplished by open surgery through the mid-abdominal incision approach. The liver metastases were then removed in both cohorts by open resection through the right subcostal incision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
short-term outcome: Operative time	Time taken for surgery	Within one week of the patient undergoing surgery
short-term outcome: Blood loss	Patient haemorrhage during surgery	Within one week of the patient undergoing surgery
short-term outcome: Time of liquid diet	Time for patients to eat fluids for the first time after surgery	Within one week of the patient undergoing surgery
short-term outcome: Postoperative hospital stay	Length of stay of patients after surgery	Within one week of the patient undergoing surgery
short-term outcome: Surgical complications	Complications that occur in patients after surgery	Within one week of the patient undergoing surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival (OS)	the time after surgical treatment until death for any reason	3years
disease-free survival (DFS)	the time after surgical treatment until the first observation of tumor recurrence or death for any reason	3years

Collaborators and Investigators

• Sponsor: Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): August 1, 2024

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: August 8, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: CHLM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No