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

NCT04716062 | Completed

• 1 other identifier: Surg_2021
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Colorectal Cancer

Outcome Measures

Primary Outcomes (3)

• Hospitalization

  days

  baseline

• Lymph Nodes number

  Lymph Nodes number

  baseline

• Clavien Dindo score (post-operative complications)

  1 to 5 point

  baseline

Secondary Outcomes (3)

• Age

  Baseline

• Body mass index

  Baseline

• Lenght of specimen

  Baseline

Study Arms (2)

subjects who underwent open-air surgery

Fifty-one (37%) out of 138 subjects underwent open-air surgery.

Procedure: Open or Laparoscopic-assisted 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

Interventions

Open or Laparoscopic-assisted Colorectal surgery PROCEDURE

Colorectal surgery

subjects underwent laparoscopic-assisted surgery; subjects who underwent open-air surgery

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead

Study Sites (1)

National Institute of Gastroenterology IRCCS S. de Bellis

Castellana Grotte, Bari, 70132, Italy

Location

MeSH Terms

Conditions

Obesity; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Professor

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 20, 2021
• Study Start: January 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)