Laparoscopic Colorectal Resection in Elderly

NCT05563441 | Completed

• 1 other identifier: OAMBP-03
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

laparoscopy; laparotomy; elderly

Outcome Measures

Primary Outcomes (1)

• perioperative complications

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

  42 days after surgery

Secondary Outcomes (2)

• overall survival

  5 years

• disease free survival

  5 years

Study Arms (2)

laparoscopic surgery

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

Procedure: laparoscopic surgery

laparotomic surgery

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

Interventions

laparoscopic surgery PROCEDURE

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

laparoscopic surgery

Eligibility Criteria

• Age: 70 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a nested cohort study of OAMBP-01, patients over 70 years old underwent laparotomic surgery were enrolled into the data analysis, compared with the laparotomic colorectal resection in the same time period. All eligible patients were identified by searching the database of the Gastrointestinal Surgery Centre, Third Affiliated Hospital of Sun Yat-sen University.

You may qualify if:

• \. 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.

You may not qualify if:

• \. Emergency surgery for causes including bowel obstruction, bleeding, or perforation; 2. Multiple primary malignancies; 3. Failure to follow-up.

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

Third Affiliated Hospital of Sun-Yat sen University

Guangzhou, Guangdong, 86510000, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Purun Lei, M.D.

  Third Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastrointestinal Surgery department

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 3, 2022
• Study Start: January 20, 2015
• Primary Completion: December 20, 2019
• Study Completion: January 31, 2023
• Last Updated: April 5, 2023

Record last verified: 2023-04

Locations

CN (1)