Pelvic Organ ProlapseACCESSNCT01124916
Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies
A study testing Robotic assisted laparoscopic abdominal sacrocolpopexy and Standard laparoscopic abdominal sacrocolpopexy in people with Pelvic Organ Prolapse, run by Loyola University at 2 sites in United States.
Trial summary
The purpose of this research is to determine if there is a difference in total costs of care and return to health in women who undergo a laparoscopic abdominal sacrocolpopexy (ASC) compared to those undergoing the same procedure with the assistance of a robot. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Robotic assisted laparoscopic abdominal sacrocolpopexy and Standard laparoscopic abdominal sacrocolpopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2009to Mar 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage II to IV pelvic organ prolapse
- Prolapse of the vaginal apex or cervix to at least half way into the vaginal canal
- Vaginal bulge symptoms
- Minimally invasive surgery is planned
- Available for 12 months of follow-up
- Able to complete study assessments
- Able and willing to provide written informed consent
Who cannot join
- Contraindication to laparoscopic or robotically assisted laparoscopic abdominal sacrocolpopexy
- Subject wishes to retain her uterus (i.e., surgical assignment may involve removal of uterus, if not previously removed)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UCLA
Los Angeles, California, 90095
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
The purpose of this research is to determine if there is a difference in total costs of care and return to health in women who undergo a laparoscopic abdominal sacrocolpopexy (ASC) compared to those undergoing the same procedure with the assistance of a robot.
Both traditional laparoscopic and robotic assisted laparoscopic approaches have been found to result in shorter hospital stays, decreased blood loss and similar surgical outcomes as compared to open abdominal surgery. The decision to use robotic assistance is typically based on surgeon preference and robot availability. The study will compare the outcomes of cost, quality of life, and return to work among women who undergo a laparoscopic sacrocolpopexy utilizing the robot to those using traditional laparoscopic techniques.
This research study is designed to compare the total costs and treatment success of these two surgical techniques. In addition, the study will compare outcomes of post-operative pain, quality of life, sexual function, return to normal activities and satisfaction with treatment outcome.
Read the detailed description
Approximately one in ten women undergoes surgery for prolapse or incontinence in her lifetime. Of these, up to thirty percent require a re-operation for recurrence of their prolapse or incontinence symptoms. It has been estimated one in nine women will undergo a hysterectomy in her lifetime, and up to 10% of these women will require surgery for symptomatic vaginal vault prolapse. The search for the ideal repair for pelvic organ prolapse has led to the invention of several approaches to this problem.
Abdominal sacrocolpopexy (ASC) with synthetic mesh is considered the gold standard in the surgical management of pelvic organ prolapse with anatomic success rates ranging from 90 to 100%. Randomized comparative effectiveness trials and systematic literature reviews demonstrated the anatomic superiority of open ASC compared to vaginal sacrospinous ligament suspension.
Although ASC has the highest anatomic success rates for correcting apical prolapse, it is traditionally done via a laparotomy requiring an abdominal incision. Open technique is associated with more frequent short-term complications, including gastrointestinal.
Minimally invasive approaches to ASC using laparoscopy or robotic assisted laparoscopy demonstrate shorter hospital stays, decreased blood loss, and similar short-term anatomic outcomes when compared to open ASC. Increasing numbers of surgeons and patients choose minimally invasive ASC to maximize the benefits of abdominal placed mesh and the shorter-recovery associated with minimally invasive surgery. Few studies have compared laparoscopy to robotic assisted-laparoscopy in pelvic reconstructive surgery.
Like many techniques in pelvic surgery, trends in the management of pelvic organ prolapse continue to evolve. Unfortunately, such trends are not supported by robust data, specifically that provided by randomized clinical trials. Although robotic technology is new and rapidly spreading throughout the urologic and gynecologic communities, there are no randomized trials comparing outcomes of robotic to more traditional laparoscopic techniques for reconstructive pelvic surgery. Retrospective series indicate comparable efficacy with respect to cure of prolapse. However, to date is it unknown how robotic surgery compares to laparoscopic techniques with respect to cost, patient safety, pain, and ability to return to normal activities.
The use of the robot in laparoscopic surgery is costly. The costs of purchasing a robot has been estimated at $1.5 million dollars with annual maintenance costs of $112,0007. In addition, additional costs exist for the robotic equipment utilized with each case. It is arguable that the maintenance and operative equipment costs may overshadow any potential savings in length of hospital stay and patient convalescence. However, if robotic sacrocolpopexy can provide better immediate quality of life, less pain, and faster recovery compared to laparoscopic techniques, the investment in robotic techniques may very well be cost effective when a societal perspective is taken.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Robotic assisted laparoscopic abdominal sacrocolpopexy, Standard laparoscopic abdominal sacrocolpopexy
- Keywords
- incontinence, prolapse, Abdominal sacrocolpopexy
- Medical subject headings
- Pelvic Organ Prolapse, Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic assisted laparoscopic abdominal sacrocolpopexyProcedure or surgery
Also called RASC
Robotic assisted laparoscopic abdominal sacrocolpopexy for surgical repair of pelvic organ prolapse.
Standard laparoscopic abdominal sacrocolpopexyProcedure or surgery
Also called LASC
Standard laparoscopic abdominal sacrocolpopexy for surgical repair of pelvic organ prolapse.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Abdominal Sacrocolpopexy (LASC) | Active comparator | Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC) Receives: Procedure: Standard laparoscopic abdominal sacrocolpopexy |
| Robotic Assisted Laparoscopic (RASC) | Experimental | Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC) Receives: Procedure: Robotic assisted laparoscopic abdominal sacrocolpopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Cost of Care Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy
At 6-weeks following surgery, the study will measure the total cost of care in dollars and compare this estimate between women assigned to standard vs robotic-assisted laparoscopic abdominal sacrocolpopexy.
Measured: 6 Weeks
Secondary outcomes (1)
Urinary Distress Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy
At 6-months following surgery, the study will measure urinary distress using the Urinary Distress Inventory (UDI) and compare this estimate between women assigned to standard vs robotic-assisted laparoscopic abdominal sacrocolpopexy. The UDI measures urinary incontinence and distress and their effect on daily life. The score range is 0 to 300, with higher scores indicating worsening symptoms.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2010 (estimated)
- Study startNov 2009
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Sponsor
- Investigators
- Kimberly Kenton, M.D., Principal investigator, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124916
- Sponsor's protocol ID
- 201805
- Other IDs
- RC1EB010649-01
- Acronym
- ACCESS
- Status last verified
- Nov 2016
- First submitted
- 6 May 2010
- Last updated
- 4 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Abrams P, Andersson KE, Birder L, Brubaker L, Cardozo L, Chapple C, Cottenden A, Davila W, de Ridder D, Dmochowski R, Drake M, Dubeau C, Fry C, Hanno P, Smith JH, Herschorn S, Hosker G, Kelleher C, Koelbl H, Khoury S, Madoff R, Milsom I, Moore K, Newman D, Nitti V, Norton C, Nygaard I, Payne C, Smith A, Staskin D, Tekgul S, Thuroff J, Tubaro A, Vodusek D, Wein A, Wyndaele JJ; Members of Committees; Fourth International Consultation on Incontinence. Fourth International Consultation on Incontinence Recommendations of the International Scientific Committee: Evaluation and treatment of urinary incontinence, pelvic organ prolapse, and fecal incontinence. Neurourol Urodyn. 2010;29(1):213-40. doi: 10.1002/nau.20870. No abstract available.
PubMed 20025020Nygaard IE, McCreery R, Brubaker L, Connolly A, Cundiff G, Weber AM, Zyczynski H; Pelvic Floor Disorders Network. Abdominal sacrocolpopexy: a comprehensive review. Obstet Gynecol. 2004 Oct;104(4):805-23. doi: 10.1097/01.AOG.0000139514.90897.07.
PubMed 15458906Benson JT, Lucente V, McClellan E. Vaginal versus abdominal reconstructive surgery for the treatment of pelvic support defects: a prospective randomized study with long-term outcome evaluation. Am J Obstet Gynecol. 1996 Dec;175(6):1418-21; discussion 1421-2. doi: 10.1016/s0002-9378(96)70084-4.
PubMed 8987919Maher CF, Qatawneh AM, Dwyer PL, Carey MP, Cornish A, Schluter PJ. Abdominal sacral colpopexy or vaginal sacrospinous colpopexy for vaginal vault prolapse: a prospective randomized study. Am J Obstet Gynecol. 2004 Jan;190(1):20-6. doi: 10.1016/j.ajog.2003.08.031.
PubMed 14749629McDermott CD, Hale DS. Abdominal, laparoscopic, and robotic surgery for pelvic organ prolapse. Obstet Gynecol Clin North Am. 2009 Sep;36(3):585-614. doi: 10.1016/j.ogc.2009.09.004.
PubMed 19932417Barbash GI, Glied SA. New technology and health care costs--the case of robot-assisted surgery. N Engl J Med. 2010 Aug 19;363(8):701-4. doi: 10.1056/NEJMp1006602. No abstract available.
PubMed 20818872Holtz DO, Miroshnichenko G, Finnegan MO, Chernick M, Dunton CJ. Endometrial cancer surgery costs: robot vs laparoscopy. J Minim Invasive Gynecol. 2010 Jul-Aug;17(4):500-3. doi: 10.1016/j.jmig.2010.03.012. Epub 2010 May 23.
PubMed 20547112Sarlos D, Kots L, Stevanovic N, Schaer G. Robotic hysterectomy versus conventional laparoscopic hysterectomy: outcome and cost analyses of a matched case-control study. Eur J Obstet Gynecol Reprod Biol. 2010 May;150(1):92-6. doi: 10.1016/j.ejogrb.2010.02.012. Epub 2010 Mar 5.
PubMed 20207063Paraiso MFR, Jelovsek JE, Frick A, Chen CCG, Barber MD. Laparoscopic compared with robotic sacrocolpopexy for vaginal prolapse: a randomized controlled trial. Obstet Gynecol. 2011 Nov;118(5):1005-1013. doi: 10.1097/AOG.0b013e318231537c.
PubMed 21979458Patel M, O'Sullivan D, Tulikangas PK. A comparison of costs for abdominal, laparoscopic, and robot-assisted sacral colpopexy. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Feb;20(2):223-8. doi: 10.1007/s00192-008-0744-2. Epub 2008 Oct 16.
PubMed 18923803Brink CA, Wells TJ, Sampselle CM, Taillie ER, Mayer R. A digital test for pelvic muscle strength in women with urinary incontinence. Nurs Res. 1994 Nov-Dec;43(6):352-6.
PubMed 7971299Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
PubMed 1593914Shaw JW, Johnson JA, Coons SJ. US valuation of the EQ-5D health states: development and testing of the D1 valuation model. Med Care. 2005 Mar;43(3):203-20. doi: 10.1097/00005650-200503000-00003.
PubMed 15725977Barber MD, Walters MD, Cundiff GW; PESSRI Trial Group. Responsiveness of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ) in women undergoing vaginal surgery and pessary treatment for pelvic organ prolapse. Am J Obstet Gynecol. 2006 May;194(5):1492-8. doi: 10.1016/j.ajog.2006.01.076.
PubMed 16647933Rogers RG, Kammerer-Doak D, Villarreal A, Coates K, Qualls C. A new instrument to measure sexual function in women with urinary incontinence or pelvic organ prolapse. Am J Obstet Gynecol. 2001 Mar;184(4):552-8. doi: 10.1067/mob.2001.111100.
PubMed 11262452
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies
- ClinicalTrials.gov ID
- NCT01124916
- Acronym / sponsor ID
- ACCESS / 201805
- Conditions
- Pelvic Organ Prolapse
- Keywords
- incontinence, prolapse, Abdominal sacrocolpopexy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- Nov 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 17 May 2010 (estimated)
- Results
- Posted 4 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to determine if there is a difference in total costs of care and return to health in women who undergo a laparoscopic abdominal sacrocolpopexy (ASC) compared to those undergoing the same procedure with the assistance of a robot.
Both traditional laparoscopic and robotic assisted laparoscopic approaches have been found to result in shorter hospital stays, decreased blood loss and similar surgical outcomes as compared to open abdominal surgery. The decision to use robotic assistance is typically based on surgeon preference and robot availability. The study will compare the outcomes of cost, quality of life, and return to work among women who undergo a laparoscopic sacrocolpopexy utilizing the robot to those using traditional laparoscopic techniques.
This research study is designed to compare the total costs and treatment success of these two surgical techniques. In addition, the study will compare outcomes of post-operative pain, quality of life, sexual function, return to normal activities and satisfaction with treatment outcome.
Detailed description
Approximately one in ten women undergoes surgery for prolapse or incontinence in her lifetime. Of these, up to thirty percent require a re-operation for recurrence of their prolapse or incontinence symptoms. It has been estimated one in nine women will undergo a hysterectomy in her lifetime, and up to 10% of these women will require surgery for symptomatic vaginal vault prolapse. The search for the ideal repair for pelvic organ prolapse has led to the invention of several approaches to this problem.
Abdominal sacrocolpopexy (ASC) with synthetic mesh is considered the gold standard in the surgical management of pelvic organ prolapse with anatomic success rates ranging from 90 to 100%. Randomized comparative effectiveness trials and systematic literature reviews demonstrated the anatomic superiority of open ASC compared to vaginal sacrospinous ligament suspension.
Although ASC has the highest anatomic success rates for correcting apical prolapse, it is traditionally done via a laparotomy requiring an abdominal incision. Open technique is associated with more frequent short-term complications, including gastrointestinal.
Minimally invasive approaches to ASC using laparoscopy or robotic assisted laparoscopy demonstrate shorter hospital stays, decreased blood loss, and similar short-term anatomic outcomes when compared to open ASC. Increasing numbers of surgeons and patients choose minimally invasive ASC to maximize the benefits of abdominal placed mesh and the shorter-recovery associated with minimally invasive surgery. Few studies have compared laparoscopy to robotic assisted-laparoscopy in pelvic reconstructive surgery.
Like many techniques in pelvic surgery, trends in the management of pelvic organ prolapse continue to evolve. Unfortunately, such trends are not supported by robust data, specifically that provided by randomized clinical trials. Although robotic technology is new and rapidly spreading throughout the urologic and gynecologic communities, there are no randomized trials comparing outcomes of robotic to more traditional laparoscopic techniques for reconstructive pelvic surgery. Retrospective series indicate comparable efficacy with respect to cure of prolapse. However, to date is it unknown how robotic surgery compares to laparoscopic techniques with respect to cost, patient safety, pain, and ability to return to normal activities.
The use of the robot in laparoscopic surgery is costly. The costs of purchasing a robot has been estimated at $1.5 million dollars with annual maintenance costs of $112,0007. In addition, additional costs exist for the robotic equipment utilized with each case. It is arguable that the maintenance and operative equipment costs may overshadow any potential savings in length of hospital stay and patient convalescence. However, if robotic sacrocolpopexy can provide better immediate quality of life, less pain, and faster recovery compared to laparoscopic techniques, the investment in robotic techniques may very well be cost effective when a societal perspective is taken.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Abdominal Sacrocolpopexy (LASC) | Active comparator | Procedure: Standard laparoscopic abdominal sacrocolpopexyWomen assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC) |
| Robotic Assisted Laparoscopic (RASC) | Experimental | Procedure: Robotic assisted laparoscopic abdominal sacrocolpopexyWomen assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Stage II to IV pelvic organ prolapse
- Prolapse of the vaginal apex or cervix to at least half way into the vaginal canal
- Vaginal bulge symptoms
- Minimally invasive surgery is planned
- Available for 12 months of follow-up
Key exclusion criteria (2 listed)
- Contraindication to laparoscopic or robotically assisted laparoscopic abdominal sacrocolpopexy
- Subject wishes to retain her uterus (i.e., surgical assignment may involve removal of uterus, if not previously removed)
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 |
|---|---|---|
| Robotic assisted laparoscopic abdominal sacrocolpopexyAlso: RASCRobotic assisted laparoscopic abdominal sacrocolpopexy for surgical repair of pelvic organ prolapse. | Procedure or surgery | Robotic Assisted Laparoscopic (RASC) |
| Standard laparoscopic abdominal sacrocolpopexyAlso: LASCStandard laparoscopic abdominal sacrocolpopexy for surgical repair of pelvic organ prolapse. | Procedure or surgery | Laparoscopic Abdominal Sacrocolpopexy (LASC) |
Primary outcome
Total Cost of Care Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy
Time frame: 6 Weeks
At 6-weeks following surgery, the study will measure the total cost of care in dollars and compare this estimate between women assigned to standard vs robotic-assisted laparoscopic abdominal sacrocolpopexy.
1 secondary outcome
Urinary Distress Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy
Time frame: 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20025020Abrams P, Andersson KE, Birder L, Brubaker L, Cardozo L, Chapple C, Cottenden A, Davila W, de Ridder D, Dmochowski R, Drake M, Dubeau C, Fry C, Hanno P, Smith JH, Herschorn S, Hosker G, Kelleher C, Koelbl H, Khoury S, Madoff R, Milsom I, Moore K, Newman D, Nitti V, Norton C, Nygaard I, Payne C, Smith A, Staskin D, Tekgul S, Thuroff J, Tubaro A, Vodusek D, Wein A, Wyndaele JJ; Members of Committees; Fourth International Consultation on Incontinence. Fourth International Consultation on Incontinence Recommendations of the International Scientific Committee: Evaluation and treatment of urinary incontinence, pelvic organ prolapse, and fecal incontinence. Neurourol Urodyn. 2010;29(1):213-40. doi: 10.1002/nau.20870. No abstract available.
- Background: PubMed 15458906Nygaard IE, McCreery R, Brubaker L, Connolly A, Cundiff G, Weber AM, Zyczynski H; Pelvic Floor Disorders Network. Abdominal sacrocolpopexy: a comprehensive review. Obstet Gynecol. 2004 Oct;104(4):805-23. doi: 10.1097/01.AOG.0000139514.90897.07.
- Background: PubMed 8987919Benson JT, Lucente V, McClellan E. Vaginal versus abdominal reconstructive surgery for the treatment of pelvic support defects: a prospective randomized study with long-term outcome evaluation. Am J Obstet Gynecol. 1996 Dec;175(6):1418-21; discussion 1421-2. doi: 10.1016/s0002-9378(96)70084-4.
- Background: PubMed 14749629Maher CF, Qatawneh AM, Dwyer PL, Carey MP, Cornish A, Schluter PJ. Abdominal sacral colpopexy or vaginal sacrospinous colpopexy for vaginal vault prolapse: a prospective randomized study. Am J Obstet Gynecol. 2004 Jan;190(1):20-6. doi: 10.1016/j.ajog.2003.08.031.
- Background: PubMed 19932417McDermott CD, Hale DS. Abdominal, laparoscopic, and robotic surgery for pelvic organ prolapse. Obstet Gynecol Clin North Am. 2009 Sep;36(3):585-614. doi: 10.1016/j.ogc.2009.09.004.
- Background: PubMed 20818872Barbash GI, Glied SA. New technology and health care costs--the case of robot-assisted surgery. N Engl J Med. 2010 Aug 19;363(8):701-4. doi: 10.1056/NEJMp1006602. No abstract available.
- Background: PubMed 20547112Holtz DO, Miroshnichenko G, Finnegan MO, Chernick M, Dunton CJ. Endometrial cancer surgery costs: robot vs laparoscopy. J Minim Invasive Gynecol. 2010 Jul-Aug;17(4):500-3. doi: 10.1016/j.jmig.2010.03.012. Epub 2010 May 23.
- Background: PubMed 20207063Sarlos D, Kots L, Stevanovic N, Schaer G. Robotic hysterectomy versus conventional laparoscopic hysterectomy: outcome and cost analyses of a matched case-control study. Eur J Obstet Gynecol Reprod Biol. 2010 May;150(1):92-6. doi: 10.1016/j.ejogrb.2010.02.012. Epub 2010 Mar 5.
- Background: PubMed 21979458Paraiso MFR, Jelovsek JE, Frick A, Chen CCG, Barber MD. Laparoscopic compared with robotic sacrocolpopexy for vaginal prolapse: a randomized controlled trial. Obstet Gynecol. 2011 Nov;118(5):1005-1013. doi: 10.1097/AOG.0b013e318231537c.
- Background: PubMed 18923803Patel M, O'Sullivan D, Tulikangas PK. A comparison of costs for abdominal, laparoscopic, and robot-assisted sacral colpopexy. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Feb;20(2):223-8. doi: 10.1007/s00192-008-0744-2. Epub 2008 Oct 16.
- Background: PubMed 7971299Brink CA, Wells TJ, Sampselle CM, Taillie ER, Mayer R. A digital test for pelvic muscle strength in women with urinary incontinence. Nurs Res. 1994 Nov-Dec;43(6):352-6.
- Background: PubMed 1593914Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
- Individual participant dataSharing planned: No
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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.
Kimberly Kenton, M.D. principal investigator
Loyola University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic assisted laparoscopic abdominal sacrocolpopexy and Standard laparoscopic abdominal sacrocolpopexy in people with Pelvic Organ Prolapse, run by Loyola University at 2 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 7 inclusion and 2 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: finished, as of the sponsor's last update on 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 4 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Cost of Care Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy (time frame: 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01124916, which also lists 27 linked publications.
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 4 Jan 2017.