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

Completed

• Conditions: Colorectal Cancer; Obesity
• Interventions: Procedure: Open or Laparoscopic-assisted Colorectal surgery

• Registration Number: NCT04716062
• Lead Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

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.

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 Timeline

• Study Start: 2018-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-01
• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-17
• Last Update Submitted: 2021-01-17
• Study First Posted: 2021-01-20
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Hospitalization	baseline	days
Lymph Nodes number	baseline	Lymph Nodes number
Clavien Dindo score (post-operative complications)	baseline	1 to 5 point

Secondary Outcome Measures

Name	Time	Method
Age	Baseline	years
Body mass index	Baseline	Kilograms/m2
Lenght of specimen	Baseline	centimeters

Trial Locations

Locations (1)

National Institute of Gastroenterology IRCCS S. de Bellis; 🇮🇹 Castellana Grotte, Bari, Italy