Predictive Factors of Conversion in Laparoscopic Colorectal Cancer Resection

Sponsor
Clinica Universidad de Navarra, Universidad de Navarra (Other)
Overall Status
Completed
CT.gov ID
NCT04589975
Collaborator
(none)
829
227

Study Details

Study Description

Brief Summary

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.

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

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 Design

Study Type:
Observational
Actual Enrollment :
829 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
CONVERSION TO OPEN SURGERY IN LAPAROSCOPIC COLORECTAL CANCER RESECTION: PREDICTIVE FACTORS AND ITS IMPACT ON LONG-TERM OUTCOMES. A RETROSPECTIVE COHORT STUDY
Actual Study Start Date :
Jan 1, 2000
Actual Primary Completion Date :
Jul 1, 2018
Actual Study Completion Date :
Dec 1, 2018

Outcome Measures

Primary Outcome Measures

  1. Conversion to open rate: predictive factors oncological outcomes [2000-2018]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All laparoscopic colorectal neoplasia, laparoscopic resected
Exclusion Criteria:
  • Palliative and emergency procedures

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Clinica Universidad de Navarra, Universidad de Navarra

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT04589975
Other Study ID Numbers:
  • PFLC
First Posted:
Oct 19, 2020
Last Update Posted:
Oct 22, 2020
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 22, 2020