N/A
ID
Bron
Verkorte titel
Aandoening
Rectal prolapse (Full thickness, external)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Improvement of Quality of life, objectified by the Gastro-intestinal Quality of life Index (GIQLI).
Achtergrond van het onderzoek
Background:
Rectal prolapse (RP) is the descent of the upper rectum and
is a common problem in the western world. Surgery is the only definite treatment and is preferably performed minimally invasive. High-level prospective studies on treatment strategies for RP currently are lacking and, thus, no consensus exist regarding the optimal treatment for
patients with RP. Furthermore, remarkable transatlantic differences exist, as in Europe, laparoscopic ventral rectopexy (LVR) is regarded the treatment of choice, while in the USA Laparoscopic Resection Rectopexy (LRR) remains the golden standard.
Objective:
To determine the optimal minimally invasive surgical
treatment for patients with RP.
Design:
International, prospective, comparative double cohort study. The first cohort will consist of 120 European patients with a RP and will be treated with LVR. Centres in The Netherlands, Belgium and the UK are enlisted for participation. The second cohort will consist of 120
American patients with a RP, treated with LRR. Several US centres are enlisted. Pre-operative work-up consists of radiological imaging and standardised questionnaires. Follow-up (FU) is set on two years. During FU, pre-operative imaging and questionnaires will be repeated.
Primary & secondary outcomes:
Primary endpoint will be improvement on the Gastro-Intestinal-Quality-of-Life-Index (GIQLI). Secondary endpoints will be generic Quality-of-Life, functional results, morbidity, mortality, recurrences and cost-effectiveness.
Time frame:
Study and inclusion start will be on January the 1st, 2011
and will take approximately 18-24 months. Therefore, total study duration will be 42-48 months.
Doel van het onderzoek
N/A
Onderzoeksopzet
Follow-up will be performed on the following moments:
1. 3-6 months after operation;
2. 12 months after operation;
3. 24 months after operation.
Onderzoeksproduct en/of interventie
Cohort 1 (European Cohort): Laparoscopic Ventral Rectopexy;
Cohort 2 (US Cohort): Laparoscopic Resection Rectopexy.
Publiek
Utrechtseweg 160
H.A. Formijne Jonkers
Amersfoort 3818 ES
The Netherlands
+31 (0)33 8502072
ha.formijnejonkers@meandermc.nl
Wetenschappelijk
Utrechtseweg 160
H.A. Formijne Jonkers
Amersfoort 3818 ES
The Netherlands
+31 (0)33 8502072
ha.formijnejonkers@meandermc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
All patients with an external rectal prolapse and an indication for laparoscopic ventral rectopexy (for European centers) or laparoscopic resection rectopexy (for US centers).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Under 18 years of age;
2. Former rectosigmoid resection;
3. Former rectal prolapse surgery;
4. Rectosigmoid tumor;
5. Severe mental retardation;
6. Pregnant women.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2615 |
| NTR-old | NTR2743 |
| Ander register | : |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |