Rectal ProlapseLaProSNCT01595412
An International Double Cohort Study to Compare Laparoscopic Ventral Rectopexy With Laparoscopic Resection Rectopexy
A study testing Laparoscopic Resection Rectopexy and Laparoscopic Ventral Rectopexy in people with Rectal Prolapse and Procidentia, run by The Cleveland Clinic at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Prolapse, Procidentia
- What is being tested?
- Laparoscopic Resection Rectopexy and Laparoscopic Ventral Rectopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2010to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with an indication for Laparoscopic Resection Rectopexy* for External Rectal Prolapse (Oxford Grade V)
Who cannot join
- Under 18 years of age
- Former rectosigmoid resection
- Former rectal prolapse surgery
- Rectosigmoid tumor
- Severe mental retardation
- Pregnant women
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
John Hopkins
Baltimore, Maryland, 21287
Lahey Medical Center
Burlington, Massachusetts, 01860
Oschner Clinic North Shore
New Orleans, Louisiana, 70448
The Florida Hospital
Orlando, Florida, 32806
Tampa General Hospital
Tampa, Florida, 33601
Cleveland Clinic Floria
Weston, Florida, 33331
About this study
Official title: Laparoscopic Rectal Prolapse Surgery Study. An International, Double Cohort Study to Determine the Optimal Treatment for Rectal Prolapse.
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.
Read more
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. 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.
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.
Read the detailed description
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.
- Conditions
- Rectal Prolapse, Procidentia
- Being tested
- Laparoscopic Resection Rectopexy, Laparoscopic Ventral Rectopexy
- Keywords
- Laparoscopic surgery, Colorectal Surgery, Quality of Life, Rectal Prolapse, Anorectal Physiology
- Medical subject headings
- Rectal Prolapse, Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Resection RectopexyProcedure or surgery
Also called Laparoscopic Resection Rectopexy,
laparoscopic sigmoidectomy with suture rectopexy
Laparoscopic Ventral RectopexyProcedure or surgery
Also called Laparoscopic ventral mesh rectopexy, Ventral mesh rectopexy
laparoscopic ventral rectopexy with mesh
| Study group | Role | What they receive |
|---|---|---|
| Cohort 2 | Active comparator | 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. Receives: Procedure: Laparoscopic Resection Rectopexy |
| Cohort 1 | Active comparator | 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. Receives: Procedure: Laparoscopic Ventral Rectopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Quality of Life objectified by the gastro-Intestinal Quality of Life Index and secondary by EuroQoL-5D and Short-Form 36 questionnaires.
Measured: 24 months
Secondary outcomes (1)
Optimal surgery and functional results
Compare 2 laparoscopic approaches and functional results evaluated by questionnaires
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startJan 2010
- Primary completionOct 2017
- Study completionOct 2017
Why it stopped: 2 patients enrolled lost of follow-up after completing 1st year visits.PI decided to close
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal ProlapseStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven D Wexner, MD, Principal investigator, Cleveland Clinic Floria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595412
- Sponsor's protocol ID
- NTR2743
- Acronym
- LaProS
- Status last verified
- Oct 2017
- First submitted
- 8 May 2012
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Rectal Prolapse Surgery Study. An International, Double Cohort Study to Determine the Optimal Treatment for Rectal Prolapse.
- ClinicalTrials.gov ID
- NCT01595412
- Acronym / sponsor ID
- LaProS / NTR2743
- Conditions
- Rectal Prolapse, Procidentia
- Keywords
- Laparoscopic surgery, Colorectal Surgery, Quality of Life, Rectal Prolapse, Anorectal Physiology
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 2 patients enrolled lost of follow-up after completing 1st year visits.PI decided to close
- Enrolment
- 2 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 10 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 2 | Active comparator | Procedure: Laparoscopic Resection RectopexyCohort 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. |
| Cohort 1 | Active comparator | Procedure: Laparoscopic Ventral RectopexyCohort 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with an indication for Laparoscopic Resection Rectopexy* for External Rectal Prolapse (Oxford Grade V)
Key exclusion criteria (6 listed)
- Under 18 years of age
- Former rectosigmoid resection
- Former rectal prolapse surgery
- Rectosigmoid tumor
- Severe mental retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Resection RectopexyAlso: Laparoscopic Resection Rectopexy,laparoscopic sigmoidectomy with suture rectopexy | Procedure or surgery | Cohort 2 |
| Laparoscopic Ventral RectopexyAlso: Laparoscopic ventral mesh rectopexy, Ventral mesh rectopexylaparoscopic ventral rectopexy with mesh | Procedure or surgery | Cohort 1 |
Primary outcome
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.
1 secondary outcome
Optimal surgery and functional results
Time frame: 24 months
Results and safety
The study was stopped early (reason given: 2 patients enrolled lost of follow-up after completing 1st year visits.PI decided to close). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
- Individual participant dataSharing planned: No
Related trials for Rectal Prolapse
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingObservational study
Clinical Outcomes of Rectopexy for Rectal Prolapse
Rectal Prolapse, Fecal Incontinence
Enrolling by invitationObservational study
Data-driven Clustering in Hemorrhoid Surgery: Retrospective Monocentric Study for the Identification of Clinical Phenotypes
Hemorrhoid, Hemorrhoid Prolapse
Active, not recruiting
RECTOSACROUTEROPEXY vs. WELLS
Rectal Prolapse, Pelvic Organ Prolapse (POP)
Recruiting
Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery
Colo-rectal Cancer, Rectal Prolapse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven D Wexner, MD principal investigator
Cleveland Clinic Floria
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Resection Rectopexy and Laparoscopic Ventral Rectopexy in people with Rectal Prolapse and Procidentia, run by The Cleveland Clinic at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 2 patients enrolled lost of follow-up after completing 1st year visits.PI decided to close). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2017.