Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01466777
Other study ID # R10081
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 2010
Est. completion date September 2019

Study information

Verified date June 2019
Source Tampere University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to compare the robotic-assisted laparoscopic surgery to the traditional laparoscopic surgery in endometrial cancer patients.

The study is prospective and the patients are randomised into two groups of 50 patients each. Randomisation is done with Minim-programme and patients age and Body mass index are taken into account.

The primary endpoint is the operation time. The number of patients in this study is based on the non-inferiority design. Presumption is that the operation time in robotic-assisted laparoscopy will be 25% longer.

Secondary endpoints include:

1. bleeding

2. complications

3. conversions

4. number of pelvic lymph nodes


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date September 2019
Est. primary completion date August 2019
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 85 Years
Eligibility Inclusion Criteria:

- Endometrial cancer operations, which means hysterectomy, bilateral salphingo-oophorectomy and pelvic lymphadenectomy

- Gr 1 and 2 differentiation type

Exclusion Criteria:

- The operation cannot be made with an laparoscopy operation

- Age more than 85 years or young under 30 years patient

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Traditional surgery type
Traditional laparoscopic surgery for endometrial cancer
Robotic assisted laparoscopic surgery
Robotic assisted laparoscopic surgery for endometrial cancer

Locations

Country Name City State
Finland Tampere University Hospital Tampere P.O.Box 2000

Sponsors (1)

Lead Sponsor Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary the operation time From the beginning of first wound incision to the closure of the wounds, an expected average of 3 hours
Secondary bleeding Duration of hospital stay, an expected average of 5 weeks
Secondary Number of participants with adverse events Duration of hospital stay, an expected average of 5 weeks
Secondary Pain visual analogue scale Duration of hospital stay, an expected average of 5 weeks
Secondary pelvic lymph node volumes Duration of hospital stay, an expected average of 5 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05036681 - A Phase II Study of Futibatinib and Pembrolizumab in Metastatic Microsatellite Stable Endometrial Carcinoma Phase 2
Completed NCT00377520 - A Trial for Patients With Advanced/Recurrent Endometrial Cancer Phase 2
Recruiting NCT05902988 - A Phase I/II Study of VLS-1488 in Subjects With Advanced Cancer Phase 1/Phase 2
Recruiting NCT06192017 - Development of a Molecular Diagnostic Tool for Endometrial Cancer.
Completed NCT03899441 - Multimedia Aid Gynecologic Counseling and Consent N/A
Completed NCT02552121 - Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors Phase 1/Phase 2
Completed NCT02001623 - Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors Phase 1/Phase 2
Completed NCT02997553 - Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery Phase 3
Suspended NCT03095664 - Effect of a Lifestyle Intervention on Nutritional Status and Prognosis of Endometrial Cancer Survivors N/A
Completed NCT01068483 - Safety of BKM120 Monotherapy in Advanced Solid Tumor Patients Phase 1
Recruiting NCT03896113 - Neoadjuvant Celecoxib in Newly Diagnosed Patients With Endometrial Carcinoma Phase 2
Not yet recruiting NCT03570866 - PET/CT in the Management of Patients With Early Stage Endometrial Cancer
Completed NCT05246462 - The Effect of Logotherapy on Mental Health in Gynecological Cancer Patients N/A
Withdrawn NCT04464967 - Safety and Preliminary Efficacy of SNK01 in Combination With Trastuzumab or Cetuximab in Subjects With Advanced HER2 or EGFR Cancers Phase 1/Phase 2
Recruiting NCT05651282 - Risk Evaluation and Screening to Tailor Prevention and Reduce the Incidence of Endometrial Cancer Phase 4
Completed NCT06187558 - Suspension of the Pelvic and Abdominal Organs During Minimally Invasive Surgery
Completed NCT06312917 - Effect of Physical Activity Intervention on Overweight and Obese Patients With Endometrial Cancer N/A
Active, not recruiting NCT03951415 - Durvalumab and Olaparib in Metastatic or Recurrent Endometrial Cancer Phase 2
Recruiting NCT04212910 - Stratifying Endometrial Cancer Patients Using a PET/MRI Prognostic Model
Completed NCT02221076 - Probe-based and Needle-based Confocal Laser Endomicroscopy During Gynaecological Procedures. N/A