Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01040013
Other study ID # oxylap-2009
Secondary ID
Status Completed
Phase Phase 2
First received December 24, 2009
Last updated December 24, 2009
Start date March 2008
Est. completion date September 2009

Study information

Verified date November 2009
Source University of Milano Bicocca
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial Summary

Patients with left-colon cancer will be randomized to laparoscopic or laparotomic operation. during surgery and for 6 days after operation, intestinal oxygen tension and ischemia-reperfusion injury markers will be evaluated to understand if pneumoperitoneum is associated with reduced splanchnic blood flow and ischemia-reperfusion injury.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date September 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Proven Cleft Colon Cancer, Signed Informed Consent

Exclusion Criteria:

- Emergency surgery,

- Cancer infiltrating adjacent organ (at CT scan),

- Severe cardiovascular (New York Heart Association class > 3 ),

- Respiratory (arterial PO2 < 70 mmHg),

- Renal (plasma creatinine > 3 MG/dL) or hepatic (Child C) dysfunction

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
Laparoscopy
Laparoscopic Left-Colectomy
left colectomy by laparotomy
PatientS will be operated by laparotomy

Locations

Country Name City State
Italy San Gerardo Hospital Monza

Sponsors (1)

Lead Sponsor Collaborator
University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Moore K, Roberts LJ 2nd. Measurement of lipid peroxidation. Free Radic Res. 1998 Jun;28(6):659-71. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Intestinal oxygenation 7 DAYS No
Secondary Ischemic reperfusion injury 7 DAYS No
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04515485 - A Volumetric Nomogram for Height, Weight, and Intra Abdominal Volume
Completed NCT01725477 - Laparoscopic Tubal Patency Assessment N/A
Recruiting NCT01093430 - Is the Anterior Superior Iliac Spine a Useful Landmark at Laparoscopy? N/A
Recruiting NCT01093079 - Laparoscopic Versus Open Partial Nephrectomy - Surgical and Oncological Outcomes N/A
Completed NCT01092013 - Comparative Evaluation of Simulator Based and Traditional In-surgery Laparoscopic Camera Training's Efficiency in Novices N/A
Completed NCT00535990 - Minimally Invasive Surgery (MIS) Database for the Purpose of Research
Recruiting NCT06044909 - Multimodal Image Registration for Helping Laparoscopic Liver Surgery Guidance
Completed NCT06255080 - Comparing Skills Acquisition on Different Laparoscopy Software N/A
Not yet recruiting NCT05389241 - Laparoscopic Augmented Reality for Identification of Liver Lesions - a Pre-clinical Randomized Cross-over Trial N/A
Enrolling by invitation NCT03234543 - Remote Ischemic Conditioning in Abdominal Surgery N/A
Recruiting NCT02827292 - Effect of Music on Inflammatory Response During Laparoscopic Surgery N/A
Not yet recruiting NCT06092684 - The Efficacy and Safety of Esketamine in Elective Laparoscopic Surgery Phase 3
Terminated NCT01008709 - Comparison Study of Two Different Surgical Clips During Laparoscopic Urologic Surgery N/A
Active, not recruiting NCT05363813 - Post-market Clinical Follow-up Study of Reusable Clip Applier Cartridge Devices for LAParoscopic Surgery N/A
Completed NCT03330236 - EEG - Guided Anesthetic Care and Postoperative Delirium N/A
Recruiting NCT05031182 - Tolerance of the vNOTES Surgical Technique in Total Hysterectomy for Benign Lesion. Clinical Trial of Non-inferiority Compared to the Laparoscopic Technique. N/A
Active, not recruiting NCT05302622 - Detecting the Most Efficient Residency Time for Laparoscopic Simulators N/A
Recruiting NCT03684291 - Hemodynamic Effects of Ventilation Modes
Recruiting NCT06117748 - Volume-Controlled Ventilation and Pressure-Controlled Ventilation Volume Guaranteed in Obese Patients in Laparoscopic-Assisted Surgery N/A
Recruiting NCT03739944 - Different Surgical Approaches in Patients of Early-stage Cervical Cancer Phase 3