Department of Colorectal Surgery in Changhai Hospital
Shanghai, Shanghai Municipality, 200433, China
Completed
NCT Number: NCT06550700
The Outcomes of Laparoscopic Hybrid Surgery Versus Totally Open Surgery
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.
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Notify MeKey information
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
laparoscopic hybrid surgery (LHS)
ProcedureFirst 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 outcomes
-
short-term outcome: Operative time
Time frame: Within one week of the patient undergoing surgery
Time taken for surgery
-
short-term outcome: Blood loss
Time frame: Within one week of the patient undergoing surgery
Patient haemorrhage during surgery
-
short-term outcome: Time of liquid diet
Time frame: Within one week of the patient undergoing surgery
Time for patients to eat fluids for the first time after surgery
-
short-term outcome: Postoperative hospital stay
Time frame: Within one week of the patient undergoing surgery
Length of stay of patients after surgery
-
short-term outcome: Surgical complications
Time frame: Within one week of the patient undergoing surgery
Complications that occur in patients after surgery
Secondary outcomes
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overall survival (OS)
Time frame: 3years
the time after surgical treatment until death for any reason
-
disease-free survival (DFS)
Time frame: 3years
the time after surgical treatment until the first observation of tumor recurrence or death for any reason
Sponsors and collaborators
Lead sponsor
Changhai Hospital
Other
Registry information
Official study title
The Outcomes of Simultaneous Resection for Colorectal Cancer Liver Metastases by Laparoscopic Hybrid Surgery Versus Totally Open Surgery: a Prospective Cohort Study
Important dates
- Study start
- 2010
- Primary completion
- 2024
- Study completion
- 2024
- First posted
- Aug 13, 2024
- Registry last updated
- Apr 11, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.