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OpenTrials
Completed

NCT Number: NCT01976000

Influence of CT 3D on the Learning Curve of Laparoscopic Colorectal Resection

Laparoscopic colorectal surgery has been widely accepted worldwide; however, despite the well-known benefits and comparable oncological outcomes, it is still limited by a lack of tactile sensation and a reduced operative field view. In addition, the inconsistency in the number and course of the mesenteric vessels significantly influences the learning curve with 30 to 70 cases required for proficiency. To overcome these limitations, the vascular anatomy can be mapped using CT-angiography, and the images can be processed with rendering software to reconstruct a three-dimensional model of the mesenteric vessels. The aim of this study was to assess the influence of visualizing the three-dimensional vascular anatomy on the learning curve for laparoscopic colorectal surgery.All patients who underwent laparoscopic left or right hemicolectomies between January 2012 and January 2014 were evaluated for inclusion in this study. To assess the influence of preliminary knowledge of colonic vascular anatomy on the learning curve, we considered 2 groups of two surgeons with different levels of experience. In the first group (group A), the surgeons were able to view 3D reconstructions before and during the surgery, while the surgeons in Group B were only able to view the 3D reconstructions after surgery.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliera Sant'Andrea

Rome, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients in which standard laparoscopic right or left hemicolectomy was planned

Exclusion criteria

  • patients who underwent extended right hemicolectomy and segmental colectomy or sigmoidectomy and patients for whom the surgical technique was modified intraoperatively
  • patients who underwent anterior rectal resection and emergency procedures for complicated diverticulitis were excluded because these procedures require higher technical skills.
  • Patients who had an ASA score of IV, a BMI over 40 or contraindications for laparoscopy were also excluded.

Treatment and study plan

multi-slice Computed Tomography angiography and three-dimensional reconstruction software

Procedure

Primary outcomes

  1. operating time

    Time frame: operating time

Secondary outcomes

  1. intraoperative and postoperative complications

    Time frame: first 2 week after surgery

  2. hospital stay

    Time frame: first 2 weeks after surgery

  3. oncological clearance

    Time frame: first 2 weeks after surgery

    radicality and number of harvested lymph nodes

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

The Impact of Preoperative Knowledge of the Colonic Vascular Anatomy on the Learning Curve for Laparoscopic Colorectal Resection

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 5, 2013
Registry last updated
Mar 17, 2015

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.