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ROBOT trial: Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy vs. open transthoracic esophagectomy: A randomized controlled trial.


- candidate number11141
- NTR NumberNTR3291
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-feb-2012
- Secondary IDsNL35048.041.11 CCMO
- Public TitleROBOT trial: Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy vs. open transthoracic esophagectomy: A randomized controlled trial.
- Scientific TitleROBOT trial: Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy vs. open transthoracic esophagectomy: A randomized controlled trial.
- ACRONYMROBOT trial
- hypothesis
- Healt Condition(s) or Problem(s) studiedEsophageal cancer
- Inclusion criteria1. Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus;
2. Surgical resectable (T1-4a, N0-3, M0);
3. Age ≥ 18 and ≤ 75 years;
4. European Clinical Oncology Group (ECOG) performance status 0,1 or 2;
5. Written informed consent.
- Exclusion criteria1. Carcinoma of the cervical esophagus;
2. Carcinoma of the gastro-esophageal junction (GEJ) with major tumor in the gastric cardia (Siewert III);
3. Prior thoracic surgery at the right hemithorax or thorax trauma (rationale: these patients will undergo open resection).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2012
- planned closingdate1-sep-2016
- Target number of participants112
- Interventions1. Robot-assisted thoraco-laparoscopic esophagectomy (n=56);
2. Open transthoracic esophagectomy (n=56).
- Primary outcomeThe percentage of overall complications (Grade 2 and higher) as stated by the modified Clavien-Dindo classification.
- Secondary outcomeIindividual components of the primary endpoint (major and minor complications), (in hospital) mortality within 30 and 60 days, R0 resections, operation related events, postoperative recovery, oncologic outcomes, cost-effectiveness and quality of life.
- TimepointsAfter surgical treatment, patients will be followed at 2, 6 weeks, 6 months and 1 year after discharge. This follow-up will continue up to 5 years (60 months) after surgery.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD. PhD. R. Hillegersberg, van
- CONTACT for SCIENTIFIC QUERIESMD. PhD. R. Hillegersberg, van
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD15-feb-2012 - 27-aug-2017


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