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OpenTrials
Completed

NCT Number: NCT05563441

Laparoscopic Colorectal Resection in Elderly

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.

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Key information

Age range

70 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Third Affiliated Hospital of Sun-Yat sen University

Guangzhou, Guangdong, 86510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laparoscopic surgery

Procedure

Patients over 70 years old underwent laparoscopic or laparotomic colorectal resection were enrolled.

Primary outcomes

  1. perioperative complications

    Time frame: 42 days after surgery

    include anastomotic leakage, surgical site infection, postoperative ileus, respiratory/urinary tract infection, and deep vein thrombosis (DVT)

Secondary outcomes

  1. overall survival

    Time frame: 5 years

    long term prognosis

  2. disease free survival

    Time frame: 5 years

    long term prognosis

Sponsors and collaborators

Lead sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2023
First posted
Oct 3, 2022
Registry last updated
Apr 5, 2023

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.

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