An International Double Cohort Study to Compare Laparoscopic Ventral Rectopexy With Laparoscopic Resection Rectopexy (LaProS)
|ClinicalTrials.gov Identifier: NCT01595412|
Recruitment Status : Terminated (2 patients enrolled lost of follow-up after completing 1st year visits.PI decided to close)
First Posted : May 10, 2012
Last Update Posted : October 24, 2017
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.
To determine the optimal minimally invasive surgical treatment for patients with RP.
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. Preoperative 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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Rectal Prolapse Procidentia||Procedure: Laparoscopic Resection Rectopexy Procedure: Laparoscopic Ventral Rectopexy||Not Applicable|
A Rectal Prolapse (RP), or procidentia, is the descent of the upper rectum. This descensus in the full-thickness of the rectum, and can be either internal, called an internal rectal prolapse or intussusception (IRP), or through the anus (called an external rectal prolapse (ERP)).
RP mainly occurs in women (80-90%) of which most in the 6-7th decade. Risk factors for developing a rectal prolapse are the presence of an abnormal deep pouch of Douglas, laxity and atonic condition of the muscles of the pelvic floor and anal canal. Moreover, weakness of both internal and external sphincters, often with evidence of pudendal nerve neuropathy and the lack of normal fixation of the rectum may lead to RP. This also frequently leads to other pelvic organ prolapses like vesicoceles, enteroceles and genital prolapses. In this study the investigators will focus on the treatment of RP.
Rectal prolapses cause anal incontinence in more than half of the patients. Another frequent symptom of RP is constipation. Furthermore, the rectal prolapse can lead to anal pain as a result of incarceration leading to ulcers, necrosis and perforation.
Besides the fact that this disease has a considerable impact on the individual quality of life, it also carries significant socio-economic consequences as incontinence products have to be used in large amounts.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Laparoscopic Rectal Prolapse Surgery Study. An International, Double Cohort Study to Determine the Optimal Treatment for Rectal Prolapse.|
|Actual Study Start Date :||January 2010|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||October 2017|
Active Comparator: Cohort 2
Cohort 2 (two) will consist of 120 patients with an external rectal prolapse (Oxford Grade V)treated by Laparoscopic Resection Rectopexy (LRR). These patients will be included in the US centers involved in this study and treated by LRR.
Procedure: Laparoscopic Resection Rectopexy
laparoscopic sigmoidectomy with suture rectopexy
Other Name: Laparoscopic Resection Rectopexy,
Active Comparator: Cohort 1
Cohort one will consist of 120 patients with an external rectal prolapse (Oxford Grade V) which will be treated with Laparoscopic Ventral Rectopexy. As this is the standard treatment in the European centers involved in this study these patients will be selected in the participating centers in the Netherlands, Belgium and England.
Procedure: Laparoscopic Ventral Rectopexy
laparoscopic ventral rectopexy with mesh
- Quality of life [ Time Frame: 24 months ]Quality of Life objectified by the gastro-Intestinal Quality of Life Index and secondary by EuroQoL-5D and Short-Form 36 questionnaires.
- Optimal surgery and functional results [ Time Frame: 24 months ]Compare 2 laparoscopic approaches and functional results evaluated by questionnaires
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595412
|United States, Florida|
|The Florida Hospital|
|Orlando, Florida, United States, 32806|
|Tampa General Hospital|
|Tampa, Florida, United States, 33601|
|Cleveland Clinic Floria|
|Weston, Florida, United States, 33331|
|United States, Louisiana|
|Oschner Clinic North Shore|
|New Orleans, Louisiana, United States, 70448|
|United States, Maryland|
|Baltimore, Maryland, United States, 21287|
|United States, Massachusetts|
|Lahey Medical Center|
|Burlington, Massachusetts, United States, 01860|
|Principal Investigator:||Steven D Wexner, MD||Cleveland Clinic Floria|