Learning Curve of Laparoscopic Colorectal Resections Clinical Trial
Official title:
The Impact of Preoperative Knowledge of the Colonic Vascular Anatomy on the Learning Curve for Laparoscopic Colorectal Resection
| Verified date | February 2014 |
| Source | University of Roma La Sapienza |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ethics Committee |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | January 2014 |
| Est. primary completion date | January 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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. |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Italy | Azienda Ospedaliera Sant'Andrea | Rome |
| Lead Sponsor | Collaborator |
|---|---|
| University of Roma La Sapienza |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | operating time | operating time | No | |
| Secondary | intraoperative and postoperative complications | first 2 week after surgery | Yes | |
| Secondary | hospital stay | first 2 weeks after surgery | No | |
| Secondary | oncological clearance | radicality and number of harvested lymph nodes | first 2 weeks after surgery | No |