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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR821 |
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Date of registration:
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20/11/2006 |
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Primary sponsor: |
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Public title:
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Laparoscopy versus laparotomy in treatment of early stage endometrial cancer: a multi-centre cost-effectiveness study.
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Scientific title:
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Laparoscopy versus laparotomy in treatment of early stage endometrial cancer: a multi-centre cost-effectiveness study. - TLH-RCT |
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Date of first enrolment:
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1/1/2007 |
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Target sample size:
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275 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=821 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Single; Control: Active; Group: Parallel; Type: [default]
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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Claudia B.M.
Bijen |
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Address:
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University Medical Center Groningen (UMCG), Department of Gynaecology,
Hanzeplein 1
9700 RB
Groningen
The Netherlands |
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Telephone:
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+31 (0)50 3611528 |
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Email:
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c.b.m.bijen@og.umcg.nl |
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Affiliation:
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Name:
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Marian J.E.
Mourits |
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Address:
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University Medical Center Groningen (UMCG), Department of Gynecologic Oncology,
Hanzeplein 1
9700 RB
Groningen
The Netherlands |
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Telephone:
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+31 (0)50 3613008 |
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Email:
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m.j.e.mourits@og.umcg.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients with early stage endometrial cancer (endometrioid adenocarcinoma grade 1 or 2, clinically stage I disease, negative endocervical curettage);
2. Signed written informed consent;
3. Age 18 years and older.
Exclusion criteria: 1. Other histological types than grade 1 or 2 endometrioid adenocarcinoma;
2. Clinically advanced disease (stage II to IV);
3. Uterine size larger than 10 weeks gestation;
4. Cardio pulmonary contra indications for laparoscopy.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Endometrial carcinoma
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Intervention(s)
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Laparoscopy (TLH+BSO) compared to the standard approach by laparotomy (TAH+BSO) through a vertical abdominal midline incision.
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Primary Outcome(s)
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Our main outcome is the rate of major complications, being an indicator of clinically relevant treatment related morbidity. Major complications considered are: injuries of bowel, bladder, ureter, vessel, nerves; thrombo-embolic events such as deep venous thrombosis or pulmonary embolism; haematoma requiring surgical intervention; haemorrhage requiring transfusion and/or surgical intervention; wound dehiscence requiring surgical intervention or re-admission; wound infections including vaginal vault abscess, requiring surgical intervention and/or prolonged hospital stay and/or readmission and/or treatment; other
major complications.
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Secondary Outcome(s)
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1. Costs and cost-effectiveness;
2. Minor complications;
3. Quality of life, sexual functioning, body image and VAS pain.
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Secondary ID(s)
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ISRCTN49542560
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N/A
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Source(s) of Monetary Support
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ZON-MW, The Netherlands Organization for Health Research and Development
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