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

Obesity Clinical Trial

— Surg_2021  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04716062
• Other study ID #: Surg_2021
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Obesity

Intervention

Procedure:
• Open or Laparoscopic-assisted Colorectal surgery
Colorectal surgery

Locations

Country	Name	City	State
Italy	National Institute of Gastroenterology IRCCS S. de Bellis	Castellana Grotte	Bari

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization	days	baseline
Primary	Lymph Nodes number	Lymph Nodes number	baseline
Primary	Clavien Dindo score (post-operative complications)	1 to 5 point	baseline
Secondary	Age	years	Baseline
Secondary	Body mass index	Kilograms/m2	Baseline
Secondary	Lenght of specimen	centimeters	Baseline