search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Video recording of large bowel cancer to improve surgical quality


- candidate number27477
- NTR NumberNTR6552
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-jun-2017
- Secondary IDsMEC-2012-344 METC Erasmus MC
- Public TitleVideo recording of large bowel cancer to improve surgical quality
- Scientific TitleImaging for quality control. Video documentation in colorectal cancer surgery
- ACRONYMIQ-Trial
- hypothesisThe use of peroperative video recording increases the amount of accessible information concerning the surgical procedure and improves surgical quality due to the systematic approach of the procedure
- Healt Condition(s) or Problem(s) studiedColorectal cancer, Laparoscopic surgery
- Inclusion criteria- Patients aged 18 or older
- Elective laparoscopic colorectal cancer resection (right hemicolectomy, transverse colectomy, left hemicolectomy, sigmoid colectomy or anterior resection)
- Exclusion criteria- Incomplete medical record
- Patient aged under 18 years old
- Unresectable tumor
- Incomplete video recording
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-jan-2016
- planned closingdate1-dec-2017
- Target number of participants113
- InterventionsVideo recording of fragments of given surgical procedures according to predefined checklists
- Primary outcomeAvailability of information according to predefined checklists
- Secondary outcomeSurgical characteristics
Type of surgical procedure
Laparoscopic, open or converted surgery
Surgery duration in minutes
Hand sewn of stapled anastomosis
Type of anastomosis
Perforation during surgery
Blood loss in ml
Amount of blood transfusions necessary
Intra-operative surgical complications
Intra-operative anesthetic complication
Intra-operative medical complication
Drain placement
Stoma yes‎/no

Pathological characteristics
Pathology Benign/pre-malignant/Malignant
Proximal resection margin in mm
Quality of TME resection
Tumor size in cm
In case of second tumor: Benign/pre-malignant/Malignant
In case of second tumor: Proximal resection margin in mm
In case of second tumor: Quality of TME resection
In case of second tumor: Tumor size in cm
Total number of lymph nodes
Number of positive lymph nodes
Pathological Tumor stage
Pathological Nodal stage
In case of second tumor: Pathological Tumor stage
In case of second tumor: Pathological Nodal stage
Pathological Metastasis stage

Postoperative characteristics
Postoperative morbidity or mortality ≤30days according to the Clavien Dindo calssification
Postoperatie wound infection
Postoperative intra-abdominal abcess
Postoperative urinary tract infection
Postoperative respiratory tract infection
Postoperative cardiological complication
Postoperative neurological complication
Postoperative thrombosis (DVT‎/PE)
Postoperative Ileus
Time until first bowel movement (days)
Postoperative bleeding
Anastomotic leakage
Time of postoperative stay in hospital
Readmittance ≤30days postop
Oncological recurrance
- TimepointsUp to 30 days postoperative.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES F.W. van de Graaf
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.F. Lange
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Stichting Kwaliteitsgelden Medisch Specialisten, Olympus, the Netherlands
- Publicationsvan de Graaf FW, Lange MM, Menon AG, O'Mahoney PR, Milsom JW, Lange JF. Imaging for Quality Control: Comparison of Systematic Video Recording to the Operative Note in Colorectal Cancer Surgery. A Pilot Study. Ann Surg Oncol. 2016 Dec;23(Suppl 5):798-803. Epub 2016 Sep 22. Erratum in: Ann Surg Oncol. 2016 Dec;23 (Suppl 5):1065. PubMed PMID: 27660256; PubMed Central PMCID: PMC5149562.
- Brief summaryTo evaluate the added value of peroperative video recording to the traditional written operative report in providing objective and more complete documentation of surgical procedures, systematic video recording is applied to patients undergoing elective colorectal cancer surgery.
- Main changes (audit trail)
- RECORD29-jun-2017 - 11-nov-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl