Laparoscopic Colorectal Resection in Elderly

Colorectal Cancer Clinical Trial

Official title:

Safety and Effectiveness of Laparoscopic Colorectal Resection in Elderly Patients With Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05563441
• Other study ID #: OAMBP-03
• Status: Completed
• Start date: January 20, 2015
• Est. completion date: January 31, 2023

Study information

• Verified date: April 2023
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a nested cohort study of OAMBP-01. Patients over 70 years old were enrolled into the data-analysis.

The purpose of this study was to examine the feasibility and safety of laparoscopic colorectal resection in elderly patients from a single center, and to explore if there are advantages in laparoscopic surgery.

Description:

Surgical resection remains the primary treatment for CRC. Despite advancements in surgical techniques, treating elderly cancer patients remains challenging for surgeons. Perioperative risk increases as elderly patients are susceptible to cardiovascular and respiratory diseases. In addition, it has been demonstrated that elderly individuals come with more locally advanced tumor and are more likely to have obstructive or disseminated disease at the time of presentation. In addition, aging diminishes a person's physiological capacity to withstand a major operation. Therefore, surgeons preferred to choose laparotomic colorectal resection to reduce surgical duration and morbidity..

The benefits of laparoscopic colorectal resections over laparotomic surgery have been clearly demonstrated in the general population. However, previous clinical trials comparing surgical approach between laparoscopy and laparotomy restricted the patient's age <75 years, we have limited information on short- and long-term safety and efficacy of elderly patients underwent laparoscopic colorectal resection.

The purpose of this study was to examine the feasibility and safety of laparoscopic colorectal resection in elderly patients from a single center, and to explore if there are advantages in laparoscopic surgery.

This is a nested cohort study of OAMBP-01. Patients over 70 years old were enrolled into the data-analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: January 31, 2023
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 100 Years

Eligibility

Inclusion Criteria:

• 1. Patient underwent elective laparoscopic or laparotomic colorectal resection for cancer treatment; 2. Patient baseline characteristics and surgical information were available; 3. Patients with complete follow-up data.

Exclusion Criteria:

• 1. Emergency surgery for causes including bowel obstruction, bleeding, or perforation;

2. Multiple primary malignancies; 3. Failure to follow-up.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• laparoscopic surgery
Patients over 70 years old underwent laparoscopic or laparotomic colorectal resection were enrolled.

Locations

Country	Name	City	State
China	Third Affiliated Hospital of Sun-Yat sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	perioperative complications	include anastomotic leakage, surgical site infection, postoperative ileus, respiratory/urinary tract infection, and deep vein thrombosis (DVT)	42 days after surgery
Secondary	overall survival	long term prognosis	5 years
Secondary	disease free survival	long term prognosis	5 years