Laparoscopic Colorectal Resection in Elderly

Sponsor
Third Affiliated Hospital, Sun Yat-Sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05563441
Collaborator
(none)
360
1
83.3
4.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: laparoscopic surgery

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
360 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Safety and Effectiveness of Laparoscopic Colorectal Resection in Elderly Patients With Colorectal Cancer
Actual Study Start Date :
Jan 20, 2017
Anticipated Primary Completion Date :
Dec 20, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
laparoscopic surgery

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

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

laparotomic surgery

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

Outcome Measures

Primary Outcome Measures

  1. perioperative complications [42 days after surgery]

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

Secondary Outcome Measures

  1. overall survival [5 years]

    long term prognosis

  2. disease free survival [5 years]

    long term prognosis

Eligibility Criteria

Criteria

Ages Eligible for Study:
70 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;
  1. Multiple primary malignancies; 3. Failure to follow-up.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Third Affiliated Hospital of Sun-Yat sen University Guangzhou Guangdong China 86510000

Sponsors and Collaborators

  • Third Affiliated Hospital, Sun Yat-Sen University

Investigators

  • Principal Investigator: Purun Lei, M.D., Third Affiliated Hospital, Sun Yat-Sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hongbo Wei, Director of Gastrointestinal Surgery department, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT05563441
Other Study ID Numbers:
  • OAMBP-03
First Posted:
Oct 3, 2022
Last Update Posted:
Nov 28, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hongbo Wei, Director of Gastrointestinal Surgery department, Third Affiliated Hospital, Sun Yat-Sen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 28, 2022