FindTrial
Sign In

Traditional invasive vs. minimally invasive esophagectomy

Traditional invasive vs. minimally invasive esophagectomy - TIME-trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33887
Enrollment
Unknown
Registered
2009-04-24
Start date
2009-05-25
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oesophageal cancer

Interventions

Traditional three stage (thoracotomy, laparotomy, cervicotomy) esophageal resection versus minimally invasive three stage (thoracoscopy, laparoscopy, cervicotomy) transthoracic esophageal resection

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus. 2. Surgical resectable (T1-3, N0-1, M0). 3. Age * 18 and * 75 years. 4. European Clinical Oncology Group (ECOG) performance status 0,1 or 2. 5. Written, informed consent.

Exclusion criteria

Exclusion criteria: 1. Cervical and gastro-esophageal junction carcinoma. 2. Prior thoracic surgery. 3. No informed consent

Design outcomes

Secondary

MeasureTime frame
General morbidity, mortality, operation related events (operation time, per-operative complications), pain, length of ICU-MCU stay, length of hospital stay, return to normal diet, quality of life, costs, pathologic examination of the specimen.—

Primary

MeasureTime frame
Pulmonary complications.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)