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

• Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis (Other)
• Overall Status: Completed
• CT.gov ID: NCT04716062
• Collaborator: (none)
• Enrollment: 138
• Location: 1
• Actual Duration (Months): 36
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Colorectal Cancer	Procedure: Open or Laparoscopic-assisted Colorectal surgery

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 Design

• Study Type: Observational
• Actual Enrollment: 138 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Short-term and Oncological Outcomes of Laparoscopic Colorectal Cancer Surgery in Obese Patients
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Hospitalization [baseline]

   days

2. Lymph Nodes number [baseline]

   Lymph Nodes number

3. Clavien Dindo score (post-operative complications) [baseline]

   1 to 5 point

Secondary Outcome Measures

1. Age [Baseline]

   years

2. Body mass index [Baseline]

   Kilograms/m2

3. Lenght of specimen [Baseline]

   centimeters

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institute of Gastroenterology IRCCS S. de Bellis	Castellana Grotte	Bari	Italy	70132

Sponsors and Collaborators

• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gianluigi Giannelli, Medical Doctor, Professor, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
• ClinicalTrials.gov Identifier: NCT04716062
• Other Study ID Numbers: Surg_2021
• First Posted: Jan 20, 2021
• Last Update Posted: Jan 20, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

No Results Posted as of Jan 20, 2021