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OpenTrials
Completed

NCT Number: NCT04716062

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

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.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institute of Gastroenterology IRCCS S. de Bellis

Castellana Grotte, Bari, 70132, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Open or Laparoscopic-assisted Colorectal surgery

Procedure

Colorectal surgery

Primary outcomes

  1. Hospitalization

    Time frame: baseline

    days

  2. Lymph Nodes number

    Time frame: baseline

    Lymph Nodes number

  3. Clavien Dindo score (post-operative complications)

    Time frame: baseline

    1 to 5 point

Secondary outcomes

  1. Age

    Time frame: Baseline

    years

  2. Body mass index

    Time frame: Baseline

    Kilograms/m2

  3. Lenght of specimen

    Time frame: Baseline

    centimeters

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Other

Registry information

Acronym: Surg_2021

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 20, 2021
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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