Predictive Factors of Conversion in Laparoscopic Colorectal Cancer Resection

October 20, 2020 updated by: Clinica Universidad de Navarra, Universidad de Navarra

CONVERSION TO OPEN SURGERY IN LAPAROSCOPIC COLORECTAL CANCER RESECTION: PREDICTIVE FACTORS AND ITS IMPACT ON LONG-TERM OUTCOMES. A RETROSPECTIVE COHORT STUDY

Background Laparoscopic resection is the treatment of choice for colorectal cancer. Rates of conversion to open surgery range between 7% and 30% and controversy exists as to the effect of this on oncologic outcomes. The objective of this study was to analyze what factors are predictive of conversion and what effect they have on oncologic outcomes.

Material & Methods From a prospective database of patients undergoing laparoscopic surgery between 2000 and 2018 a uni- and multivariate analyses were made of demographic, pathological and surgical variables together with complementary treatments comparing purely laparoscopic resection with conversions to open surgery. Overall and disease-free survival were compared using the Kaplan-Meier method.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Laparoscopic resection of colorectal cancer is the surgical option of choice provided that established oncologic principles are guaranteed [1-4].

Apart from the well-known advantages of minimally invasive surgery (shorter hospital stays, lower pain levels, faster return of bowel functions and rapid return to normal daily activities) reductions in operative morbidity and mortality have been reported together with oncologic outcomes which are similar to those of open surgery [5-7].

However, reported conversion rates to open surgery are highly variable (7% - 30%) as is the impact of conversion on oncologic outcomes [8-10]). The objectives of this study were to identify the risk factors associated with conversion and to assess their impact on operative morbidity and mortality and long-term oncologic outcomes.

Study Type

Observational

Enrollment (Actual)

829

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Colorectal cancer patient, surgical resected by laparoscopy

Description

Inclusion Criteria:

  • All laparoscopic colorectal neoplasia, laparoscopic resected

Exclusion Criteria:

  • Palliative and emergency procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Conversion to open rate: predictive factors oncological outcomes
Time Frame: 2000-2018
2000-2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2000

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

October 5, 2020

First Submitted That Met QC Criteria

October 9, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 20, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PFLC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Surgery

Clinical Trials on laparoscopic surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe