The Outcomes of Laparoscopic Hybrid Surgery Versus Totally Open Surgery

Completed

• Conditions: Resectable Simultaneous Colorectal Cancer Liver Metastasis
• Interventions: Procedure: laparoscopic hybrid surgery (LHS)

• Registration Number: NCT06550700
• Lead Sponsor: Changhai Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2024-05-01
• Study First Submitted: 2024-06-19
• Study Completion: 2024-08-01
• Study First Submitted QC: 2024-08-08
• Study First Posted: 2024-08-13
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 266

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
laparoscopic hybrid surgery (LHS) cohort	laparoscopic hybrid surgery (LHS)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Colorectal Surgery in Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China