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Laparoscopy versus laparotomy in treatment of early stage endometrial cancer: a multi-centre cost-effectiveness study.


- candidate number2329
- NTR NumberNTR821
- ISRCTNISRCTN49542560
- Date ISRCTN created28-dec-2006
- date ISRCTN requested18-dec-2006
- Date Registered NTR20-nov-2006
- Secondary IDsN/A 
- Public TitleLaparoscopy versus laparotomy in treatment of early stage endometrial cancer: a multi-centre cost-effectiveness study.
- Scientific TitleLaparoscopy versus laparotomy in treatment of early stage endometrial cancer: a multi-centre cost-effectiveness study.
- ACRONYMTLH-RCT
- hypothesisThe laparoscopic approach is a cost-effective and safe alternative to laparotomy in early stage endometrial cancer patients with less major complications in the laparoscopy group.
- Healt Condition(s) or Problem(s) studiedEndometrial carcinoma
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 1-jan-2007
- planned closingdate1-jan-2010
- Target number of participants275
- InterventionsLaparoscopy (TLH+BSO) compared to the standard approach by laparotomy (TAH+BSO) through a vertical abdominal midline incision.
- Primary outcomeOur 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.
- Secondary outcome1. Costs and cost-effectiveness; 2. Minor complications; 3. Quality of life, sexual functioning, body image and VAS pain.
- Timepoints
- Trial web sitehttp://www.studies-obsgyn.nl/tlh/page.asp?page_id=411
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDrs. Claudia B.M. Bijen
- CONTACT for SCIENTIFIC QUERIESDr. Marian J.E. Mourits
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryObjective: Comparison of treatment related morbidity and cost-effectiveness in early stage endometrial cancer patients treated by laparoscopy (total laparoscopic hysterectomy and bilateral salpingo-oophorectomy (TLH+BSO)) versus laparotomy (the standard approach by total abdominal hysterectomy and bilateral salpingo-oophorectomy (TAH+BSO) through a vertical abdominal midline incision). Study design: A multicentre prospective randomized clinical phase 3 trial (RCT) (including at least 15 centres). After inclusion and informed consent 275 patients will be randomized to laparoscopy or laparotomy (2:1). Standardized care regarding anticoagulants and antibiotics is provided. The gynecologist will record outcomes on a structured case record form (CRF). These CRF's will be checked by the research nurse afterwards. Patients will be asked to fill in questionnaires pre-operatively, after 6 weeks, 3 and 6 months. Study population: Inclusion criteria: Patients with early stage endometrial cancer (endometrioid adenocarcinoma grade 1 or 2, clinically stage I disease, negative endocervical curettage or biopsy), signed written informed consent, age 18 years and older. Before participating in the study of each participating gynecologist the laparoscopic skills in performing a TLH will be assessed by an experienced visiting gynecologist using a structured evaluation form. Only gynecologists with a sufficient score (>= 28 points) on an OSATS (Objective Structured Assessment of Technical Skills) form will be allowed to participate. Exclusion criteria: other histological types than grade 1 or 2 endometrioid adenocarcinoma, clinically advanced disease (stage II to IV), uterine size larger than 10 weeks gestation and cardio pulmonary contra indications for laparoscopy. Intervention: Laparoscopy (TLH+BSO) compared to the standard approach by laparotomy (TAH+BSO) through a vertical abdominal midline incision. Outcome measures: Our main outcome is the rate of major complications, being an indicator of clinically relevant treatment related morbidity. Secondary outcome measures are: 1) Costs and cost-effectiveness 2) Minor complications. 3) Quality of life.
- Main changes (audit trail)
- RECORD20-nov-2006 - 19-mrt-2009


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