| - candidate number | 2329 |
| - NTR Number | NTR821 |
| - ISRCTN | ISRCTN49542560 |
| - Date ISRCTN created | 28-dec-2006 |
| - date ISRCTN requested | 18-dec-2006 |
| - Date Registered NTR | 20-nov-2006 |
| - Secondary IDs | N/A |
| - Public Title | Laparoscopy versus laparotomy in treatment of early stage endometrial cancer: a multi-centre cost-effectiveness study. |
| - Scientific Title | Laparoscopy versus laparotomy in treatment of early stage endometrial cancer: a multi-centre cost-effectiveness study. |
| - ACRONYM | TLH-RCT |
| - hypothesis | The 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) studied | Endometrial carcinoma |
| - 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. |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | Single |
| - control | Active |
| - group | Parallel |
| - Type | [default] |
| - Studytype | intervention |
| - planned startdate | 1-jan-2007 |
| - planned closingdate | 1-jan-2010 |
| - Target number of participants | 275 |
| - Interventions | Laparoscopy (TLH+BSO) compared to the standard approach by laparotomy (TAH+BSO) through a vertical abdominal midline incision. |
| - Primary outcome | 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. |
| - Secondary outcome | 1. Costs and cost-effectiveness; 2. Minor complications; 3. Quality of life, sexual functioning, body image and VAS pain. |
| - Timepoints | |
| - Trial web site | http://www.studies-obsgyn.nl/tlh/page.asp?page_id=411 |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | Drs. Claudia B.M. Bijen |
| - CONTACT for SCIENTIFIC QUERIES | Dr. 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 |
| - Publications | N/A |
| - Brief summary | Objective: 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) | |
| - RECORD | 20-nov-2006 - 19-mrt-2009 |
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