Short-term and Oncological Outcomes of Laparoscopic Colorectal Cancer Surgery in Obese Patients (Surg_2021)

January 17, 2021 updated by: Gianluigi Giannelli, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
A total of 138 consecutive patients who underwent laparoscopic-assisted or open colectomy for colorectal cancer (CRC) were included in the present study. Subjects commonly shared a condition of overweight or obesity. The investigators aimed to define any difference between the two different groups (open vs laparoscopic-assisted surgery) and a series of outcomes, i.e. hospitalization, Lymph nodes number, Intra-Surgery complications, and Clavien Dindo score.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 138 consecutive patients who underwent laparoscopic-assisted or open colectomy for colorectal cancer (CRC) were included in the present study. Intra-Surgery complications, Previous surgery, Readmission Post Intervention, Location of surgery, Duration of Surgery, Re-intervention (yes), Clearance, and CRM were collected. Subjects commonly shared overweight or obesity. The investigators aimed to define any difference between the two different groups (open vs laparoscopic-assisted surgery) and a series of outcomes, i.e. hospitalization, Lymph nodes number, Intra-Surgery complications, and Clavien Dindo score.

Study Type

Observational

Enrollment (Actual)

138

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Bari
      • Castellana Grotte, Bari, Italy, 70132
        • National Institute of Gastroenterology IRCCS S. de Bellis

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

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

138 overweight or obese subjects. Fifty-one (37%) subjects underwent open-air surgery and 87 (63%) to VL surgery.

Description

Inclusion Criteria:

  • Body mass index >25 Kg/m2
  • Colorectal cancer (CRC)

Exclusion Criteria:

  • Current emergency conditions (i.e., perforation and\or occlusion)
  • Pregnancy,
  • Co-existing peritoneal carcinomatosis
  • Contraindications to LS, such as cardiorespiratory comorbidities (CHD, CHF, and other severe CVD)
  • Prior transverse resections

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
subjects who underwent open-air surgery
Fifty-one (37%) out of 138 subjects underwent open-air surgery.
Procedure: Open or Laparoscopic-assisted Colorectal surgery
Colorectal surgery
subjects underwent laparoscopic-assisted surgery
A total of 87 (63%) out of 138 subjects underwent laparoscopic-assisted surgery.
Procedure: Open or Laparoscopic-assisted Colorectal surgery
Colorectal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalization
Time Frame: baseline
days
baseline
Lymph Nodes number
Time Frame: baseline
Lymph Nodes number
baseline
Clavien Dindo score (post-operative complications)
Time Frame: baseline
1 to 5 point
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age
Time Frame: Baseline
years
Baseline
Body mass index
Time Frame: Baseline
Kilograms/m2
Baseline
Lenght of specimen
Time Frame: Baseline
centimeters
Baseline

Collaborators and Investigators

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

Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

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, 2018

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

December 31, 2020

Study Registration Dates

First Submitted

January 14, 2021

First Submitted That Met QC Criteria

January 17, 2021

First Posted (ACTUAL)

January 20, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 17, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Surg_2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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