Obstructed DefecationPRODNCT05747027
Prospective Randomized Controlled Trial of Obstructed Defecation Surgery
A study testing Laparoscopic abdominal ventral rectopexy and Transvaginal sacrospinous rectopexy in people with Obstructed Defecation and Pelvic Organ Prolapse, run by Endeavor Health at 2 sites in United States.
Trial summary
Obstructive defecatory syndrome (ODS) or inability to completely empty bowel is characterized by a combination of straining, incomplete evacuation, and the use of digital manipulation with bowel movement. This is a common condition with estimated incidence of 15-20% in the adult female population. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Obstructed Defecation, Pelvic Organ Prolapse
- What is being tested?
- Laparoscopic abdominal ventral rectopexy and Transvaginal sacrospinous rectopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 May 2024to 30 May 2025
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, between the age of 18 and 80
- OD symptoms as indicated by an affirmative response to either questions 7, 8 or 14 of the Pelvic Floor Distress Inventory (PFDI):
- Do you feel you need to strain too hard to have a bowel movement?
- Do you feel you have not completely emptied your bowels at the end of a bowel movement?
- Does part of your bowel ever pass through the rectum and bulge outside during or after a bowel movement?
- Rectal hypermobility defined as a compression ratio greater than 50% according to ultrasound
Show all 13Show fewer
- Patient planning on undergoing surgery for the repair of pelvic organ prolapse within the next 12 months
- Patient who is not pregnant and does not intend to become pregnant in the next 2 years
- Available for 24-months of follow-up
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Able to complete study assessments, per clinician judgment
- Able and willing to provide independent written informed consent
- Stable cardiovascular and respiratory status to meet candidacy in vaginal or laparoscopic surgeries
Who cannot join
- Contraindication to abdominal and transvaginal rectopexy in the opinion of the treating surgeon
- History of previous surgery that included any type of surgery for rectal prolapse
- Pelvic pain or dyspareunia due to levator ani spasm that would preclude a PMT program
- Previous adverse reaction to synthetic mesh
- Current cytotoxic chemotherapy or current or history of pelvic radiation therapy within 12 months
- History of two inpatient hospitalizations for medical comorbidities in the previous 12 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Weill Cornell Medicine
New York, New York, 10065
Endeavor Health
Skokie, Illinois, 60076
About this study
Official title: Prospective Randomized Controlled Trial Comparing Transvaginal Rectopexy and Ventral Mesh Rectopexy for Obstructed Defecation in Pelvic Organ Prolapse (PROD Trial)
Obstructive defecatory syndrome (ODS) or inability to completely empty bowel is characterized by a combination of straining, incomplete evacuation, and the use of digital manipulation with bowel movement. This is a common condition with estimated incidence of 15-20% in the adult female population.
Laparoscopic abdominal ventral rectopexy is an established surgical technique aimed at restoring rectal support in women with this condition. It is the most common surgery used nowadays to treat ODS. Transvaginal sacrospinous rectopexy, is an innovative procedure which has been shown to be safe and effective in the treatment of stool entrapment. Currently it is unknown whether one of the procedures mentioned is superior to the other regarding surgical outcomes and patient experience. The purpose of this research is to compare the outcomes of these two procedures considering their efficacy to improve symptoms.
During the study, participants will be randomized to undergo one of two procedures for treatment of inability to completely empty their bowel and/or rectal prolapse: 1) laparoscopic abdominal ventral rectopexy; 2) transvaginal sacrospinous rectopexy. Following the procedure, participants will be asked to return to the office for a follow-up visit 2-weeks, 2-, 12- and 24-months after the surgery. During each follow-up visit participants will undergo symptom evaluation, pelvic exam and transvaginal pelvic ultrasound to evaluate surgical success.
- Conditions
- Obstructed Defecation, Pelvic Organ Prolapse
- Being tested
- Laparoscopic abdominal ventral rectopexy, Transvaginal sacrospinous rectopexy
- Keywords
- Rectopexy, Transvaginal rectopexy, Laparoscopic ventral rectopexy
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic abdominal ventral rectopexyProcedure or surgery
Laparoscopic abdominal ventral rectopexy is an established surgical technique used to restore rectal support in women with obstructive defecatory syndrome (ODS). It is the most common surgery used to treat ODS. It involves a series of small cuts in the abdomen and the use of mesh to hold the rectum in the correct position.
Transvaginal sacrospinous rectopexyProcedure or surgery
Transvaginal sacrospinous rectopexy is an innovative procedure which has shown to be safe and effective in the treatment of stool entrapment. This is a mesh-free and vaginal route procedure.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic abdominal ventral rectopexy | Experimental | Not described Receives: Procedure: Laparoscopic abdominal ventral rectopexy |
| Transvaginal sacrospinous rectopexy | Experimental | Not described Receives: Procedure: Transvaginal sacrospinous rectopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Rectal Hypermobility Measured Via Ultrasound
The degree of rectal hypermobility measured via ultrasound (i.e. compression ratio).
Measured: 24 months post-operatively
Secondary outcomes (11)
Postoperative Pain Measured by Pain Scale
Participants will complete the pain scale. No pain will indicate the best outcome whereas the most intense pain imaginable will indicate the worst outcome.
Measured: 24 months post-operatively
Postoperative Pain Measured by Pain Medication Use
Participants will complete an assessment of pain medication use.
Measured: 24 months post-operatively
Postoperative Functional Activity Level
Participants will complete the Activity Assessment Scale which measures functional activity. The activity level will be measured on a scale of no difficulty, a little difficulty, some difficulty, a lot of difficulty, not able to do it, and did not do it for other reasons.
Measured: 24 months post-operatively
Global Improvement in Bladder Function
Participants will complete the Patient Global Impression of Improvement. The improvement will be measured on a scale of very much better, much better, a little better, no change, a little worse, much worse, and very much worse.
Measured: 24 months post-operatively
Pelvic Floor Distress Inventory (PFDI) - POPDI
As a part of the pelvic floor distress inventory (PFDI) questionnaire, participants will complete prolapse symptoms assessments using pelvic organ prolapse distress inventory (POPDI). The symptoms will be measured on a scale of 0, present, to 4, quite a bit. A higher score will indicate a higher symptom burden.
Measured: 24 months post-operatively
Pelvic Floor Distress Inventory (PFDI) - CRADI
As a part of the pelvic floor distress inventory (PFDI) questionnaire, participants will complete colorectal symptoms assessments using colorectal anal distress inventory (CRADI). The symptoms will be measured on a scale of 0, present, to 4, quite a bit. A higher score will indicate a higher symptom burden.
Measured: 24 months post-operatively
Pelvic Floor Distress Inventory (PFDI) - UDI
As a part of the pelvic floor distress inventory (PFDI) questionnaire, participants will complete urinary symptoms assessments using urinary distress inventory (UDI). The symptoms will be measured on a scale of 0, present, to 4, quite a bit. A higher score will indicate a higher symptom burden.
Measured: 24 months post-operatively
Quality of Life Measured by PFIQ
Participants will complete pelvic floor impact questionnaire (PFIQ), a condition-specific health-related quality of life questionnaire. The measurement will be on a scale of 0, not at all, to 3, quite a bit. Higher scores indicate greater impact.
Measured: 24 months post-operatively
Quality of Life Measured by SF-36
Participants will also complete short form health survey (SF-36), which measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Higher scores indicate better health status.
Measured: 24 months post-operatively
Quality of Life Measured by EQ-5D
Participants will complete EuroQol-5D (EQ-5D), an instrument that evaluates quality of life on five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The measurement will be on a scale of 1 to 5.
Measured: 24 months post-operatively
Pelvic Muscle Strength
Participants will complete the Brink Scale, a digital assessment of pelvic floor muscle strength. It consists of 3 separate 4-point rating scales for pressure, vertical finger displacement, and duration.
Measured: 24 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start16 May 2024
- Primary completion30 May 2025
- Study completion30 May 2025
Why it stopped: Due to low recruitment rate
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 (20)Papers the sponsor has linked to this study.
- Other trials for Obstructed DefecationStudies 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
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University, University of Pittsburgh
- Responsible party
- Principal investigator, Ghazaleh Rostami Nia, Endeavor Health
- Investigators
- Ghazaleh Rostami Nia, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747027
- Sponsor's protocol ID
- EH22-284
- Acronym
- PROD
- Status last verified
- Jul 2025
- First submitted
- 5 Feb 2023
- Last updated
- 15 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bove A, Pucciani F, Bellini M, Battaglia E, Bocchini R, Altomare DF, Dodi G, Sciaudone G, Falletto E, Piloni V, Gambaccini D, Bove V. Consensus statement AIGO/SICCR: diagnosis and treatment of chronic constipation and obstructed defecation (part I: diagnosis). World J Gastroenterol. 2012 Apr 14;18(14):1555-64. doi: 10.3748/wjg.v18.i14.1555.
PubMed 22529683Bove A, Bellini M, Battaglia E, Bocchini R, Gambaccini D, Bove V, Pucciani F, Altomare DF, Dodi G, Sciaudone G, Falletto E, Piloni V. Consensus statement AIGO/SICCR diagnosis and treatment of chronic constipation and obstructed defecation (part II: treatment). World J Gastroenterol. 2012 Sep 28;18(36):4994-5013. doi: 10.3748/wjg.v18.i36.4994.
PubMed 23049207Lembo A, Camilleri M. Chronic constipation. N Engl J Med. 2003 Oct 2;349(14):1360-8. doi: 10.1056/NEJMra020995. No abstract available.
PubMed 14523145D'Hoore A, Penninckx F. Obstructed defecation. Colorectal Dis. 2003 Jul;5(4):280-7. doi: 10.1046/j.1463-1318.2003.00497.x.
PubMed 12814403Rostaminia G, Abramowitch S, Chang C, Goldberg RP. The role of conventional pelvic floor reconstructive surgeries in obstructed defecation symptoms change: CARE and OPTIMAL trials sub-analysis of 2-year follow-up data. Int Urogynecol J. 2020 Jul;31(7):1325-1334. doi: 10.1007/s00192-019-04190-7. Epub 2019 Dec 24.
PubMed 31875258Bradley CS, Brown MB, Cundiff GW, Goode PS, Kenton KS, Nygaard IE, Whitehead WE, Wren PA, Weber AM; Pelvic Floor Disorders Network. Bowel symptoms in women planning surgery for pelvic organ prolapse. Am J Obstet Gynecol. 2006 Dec;195(6):1814-9. doi: 10.1016/j.ajog.2006.07.008. Epub 2006 Sep 25.
PubMed 16996465Bradley CS, Nygaard IE, Brown MB, Gutman RE, Kenton KS, Whitehead WE, Goode PS, Wren PA, Ghetti C, Weber AM; Pelvic Floor Disorders Network. Bowel symptoms in women 1 year after sacrocolpopexy. Am J Obstet Gynecol. 2007 Dec;197(6):642.e1-8. doi: 10.1016/j.ajog.2007.08.023.
PubMed 18060963Rostaminia G, Abramowitch S, Chang C, Goldberg RP. Descent and hypermobility of the rectum in women with obstructed defecation symptoms. Int Urogynecol J. 2020 Feb;31(2):337-349. doi: 10.1007/s00192-019-03934-9. Epub 2019 Apr 23.
PubMed 31016336Bordeianou L, Paquette I, Johnson E, Holubar SD, Gaertner W, Feingold DL, Steele SR. Clinical Practice Guidelines for the Treatment of Rectal Prolapse. Dis Colon Rectum. 2017 Nov;60(11):1121-1131. doi: 10.1097/DCR.0000000000000889. No abstract available.
PubMed 28991074Steele SR, Mellgren A. Constipation and obstructed defecation. Clin Colon Rectal Surg. 2007 May;20(2):110-7. doi: 10.1055/s-2007-977489.
PubMed 20011385Khaikin M, Wexner SD. Treatment strategies in obstructed defecation and fecal incontinence. World J Gastroenterol. 2006 May 28;12(20):3168-73. doi: 10.3748/wjg.v12.i20.3168.
PubMed 16718835VanderPas Lamb S, Massengill J, Sheridan MJ, Stern LE, von Pechmann W. Safety of combined abdominal sacral colpopexy and sigmoid resection with suture rectopexy: a retrospective cohort study. Female Pelvic Med Reconstr Surg. 2015 Jan-Feb;21(1):18-24. doi: 10.1097/SPV.0000000000000119.
PubMed 25185604Slawik S, Soulsby R, Carter H, Payne H, Dixon AR. Laparoscopic ventral rectopexy, posterior colporrhaphy and vaginal sacrocolpopexy for the treatment of recto-genital prolapse and mechanical outlet obstruction. Colorectal Dis. 2008 Feb;10(2):138-43. doi: 10.1111/j.1463-1318.2007.01259.x. Epub 2007 May 10.
PubMed 17498206Routzong MR, Abramowitch SD, Chang C, Goldberg RP, Rostaminia G. Obstructed Defecation Symptom Severity and Degree of Rectal Hypermobility and Folding Detected by Dynamic Ultrasound. Ultrasound Q. 2021 Sep 1;37(3):229-236. doi: 10.1097/RUQ.0000000000000565.
PubMed 34478420Rostaminia G, Abramowitch S, Chang C, Goldberg RP. Transvaginal sacrospinous ligament suture rectopexy for obstructed defecation symptoms: 1-year outcomes. Int Urogynecol J. 2021 Nov;32(11):3045-3052. doi: 10.1007/s00192-020-04611-y. Epub 2020 Nov 25.
PubMed 33237356
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial Comparing Transvaginal Rectopexy and Ventral Mesh Rectopexy for Obstructed Defecation in Pelvic Organ Prolapse (PROD Trial)
- ClinicalTrials.gov ID
- NCT05747027
- Acronym / sponsor ID
- PROD / EH22-284
- Conditions
- Obstructed Defecation, Pelvic Organ Prolapse
- Keywords
- Rectopexy, Transvaginal rectopexy, Laparoscopic ventral rectopexy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to low recruitment rate
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University, University of Pittsburgh
- Study start
- 16 May 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 28 Feb 2023 (actual)
- Results
- Posted 15 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obstructive defecatory syndrome (ODS) or inability to completely empty bowel is characterized by a combination of straining, incomplete evacuation, and the use of digital manipulation with bowel movement. This is a common condition with estimated incidence of 15-20% in the adult female population.
Laparoscopic abdominal ventral rectopexy is an established surgical technique aimed at restoring rectal support in women with this condition. It is the most common surgery used nowadays to treat ODS. Transvaginal sacrospinous rectopexy, is an innovative procedure which has been shown to be safe and effective in the treatment of stool entrapment. Currently it is unknown whether one of the procedures mentioned is superior to the other regarding surgical outcomes and patient experience. The purpose of this research is to compare the outcomes of these two procedures considering their efficacy to improve symptoms.
During the study, participants will be randomized to undergo one of two procedures for treatment of inability to completely empty their bowel and/or rectal prolapse: 1) laparoscopic abdominal ventral rectopexy; 2) transvaginal sacrospinous rectopexy. Following the procedure, participants will be asked to return to the office for a follow-up visit 2-weeks, 2-, 12- and 24-months after the surgery. During each follow-up visit participants will undergo symptom evaluation, pelvic exam and transvaginal pelvic ultrasound to evaluate surgical success.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic abdominal ventral rectopexy | Experimental | Procedure: Laparoscopic abdominal ventral rectopexy |
| Transvaginal sacrospinous rectopexy | Experimental | Procedure: Transvaginal sacrospinous rectopexy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Female, between the age of 18 and 80
- OD symptoms as indicated by an affirmative response to either questions 7, 8 or 14 of the Pelvic Floor Distress Inventory (PFDI):
- Rectal hypermobility defined as a compression ratio greater than 50% according to ultrasound
- Patient planning on undergoing surgery for the repair of pelvic organ prolapse within the next 12 months
- Patient who is not pregnant and does not intend to become pregnant in the next 2 years
Key exclusion criteria (6 listed)
- Contraindication to abdominal and transvaginal rectopexy in the opinion of the treating surgeon
- History of previous surgery that included any type of surgery for rectal prolapse
- Pelvic pain or dyspareunia due to levator ani spasm that would preclude a PMT program
- Previous adverse reaction to synthetic mesh
- Current cytotoxic chemotherapy or current or history of pelvic radiation therapy within 12 months
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 abdominal ventral rectopexyLaparoscopic abdominal ventral rectopexy is an established surgical technique used to restore rectal support in women with obstructive defecatory syndrome (ODS). It is the most common surgery used to treat ODS. It involves a series of small cuts in the abdomen and the use of mesh to hold the rectum in the correct position. | Procedure or surgery | Laparoscopic abdominal ventral rectopexy |
| Transvaginal sacrospinous rectopexyTransvaginal sacrospinous rectopexy is an innovative procedure which has shown to be safe and effective in the treatment of stool entrapment. This is a mesh-free and vaginal route procedure. | Procedure or surgery | Transvaginal sacrospinous rectopexy |
Primary outcome
Degree of Rectal Hypermobility Measured Via Ultrasound
Time frame: 24 months post-operatively
The degree of rectal hypermobility measured via ultrasound (i.e. compression ratio).
11 secondary outcomes
Postoperative Pain Measured by Pain Scale
Time frame: 24 months post-operatively
Postoperative Pain Measured by Pain Medication Use
Time frame: 24 months post-operatively
Postoperative Functional Activity Level
Time frame: 24 months post-operatively
Global Improvement in Bladder Function
Time frame: 24 months post-operatively
Pelvic Floor Distress Inventory (PFDI) - POPDI
Time frame: 24 months post-operatively
Pelvic Floor Distress Inventory (PFDI) - CRADI
Time frame: 24 months post-operatively
Pelvic Floor Distress Inventory (PFDI) - UDI
Time frame: 24 months post-operatively
Quality of Life Measured by PFIQ
Time frame: 24 months post-operatively
Quality of Life Measured by SF-36
Time frame: 24 months post-operatively
Quality of Life Measured by EQ-5D
Time frame: 24 months post-operatively
Pelvic Muscle Strength
Time frame: 24 months post-operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22529683Bove A, Pucciani F, Bellini M, Battaglia E, Bocchini R, Altomare DF, Dodi G, Sciaudone G, Falletto E, Piloni V, Gambaccini D, Bove V. Consensus statement AIGO/SICCR: diagnosis and treatment of chronic constipation and obstructed defecation (part I: diagnosis). World J Gastroenterol. 2012 Apr 14;18(14):1555-64. doi: 10.3748/wjg.v18.i14.1555.
- Background: PubMed 23049207Bove A, Bellini M, Battaglia E, Bocchini R, Gambaccini D, Bove V, Pucciani F, Altomare DF, Dodi G, Sciaudone G, Falletto E, Piloni V. Consensus statement AIGO/SICCR diagnosis and treatment of chronic constipation and obstructed defecation (part II: treatment). World J Gastroenterol. 2012 Sep 28;18(36):4994-5013. doi: 10.3748/wjg.v18.i36.4994.
- Background: PubMed 14523145Lembo A, Camilleri M. Chronic constipation. N Engl J Med. 2003 Oct 2;349(14):1360-8. doi: 10.1056/NEJMra020995. No abstract available.
- Background: PubMed 12814403D'Hoore A, Penninckx F. Obstructed defecation. Colorectal Dis. 2003 Jul;5(4):280-7. doi: 10.1046/j.1463-1318.2003.00497.x.
- Background: PubMed 31875258Rostaminia G, Abramowitch S, Chang C, Goldberg RP. The role of conventional pelvic floor reconstructive surgeries in obstructed defecation symptoms change: CARE and OPTIMAL trials sub-analysis of 2-year follow-up data. Int Urogynecol J. 2020 Jul;31(7):1325-1334. doi: 10.1007/s00192-019-04190-7. Epub 2019 Dec 24.
- Background: PubMed 16996465Bradley CS, Brown MB, Cundiff GW, Goode PS, Kenton KS, Nygaard IE, Whitehead WE, Wren PA, Weber AM; Pelvic Floor Disorders Network. Bowel symptoms in women planning surgery for pelvic organ prolapse. Am J Obstet Gynecol. 2006 Dec;195(6):1814-9. doi: 10.1016/j.ajog.2006.07.008. Epub 2006 Sep 25.
- Background: PubMed 18060963Bradley CS, Nygaard IE, Brown MB, Gutman RE, Kenton KS, Whitehead WE, Goode PS, Wren PA, Ghetti C, Weber AM; Pelvic Floor Disorders Network. Bowel symptoms in women 1 year after sacrocolpopexy. Am J Obstet Gynecol. 2007 Dec;197(6):642.e1-8. doi: 10.1016/j.ajog.2007.08.023.
- Background: PubMed 31016336Rostaminia G, Abramowitch S, Chang C, Goldberg RP. Descent and hypermobility of the rectum in women with obstructed defecation symptoms. Int Urogynecol J. 2020 Feb;31(2):337-349. doi: 10.1007/s00192-019-03934-9. Epub 2019 Apr 23.
- Background: PubMed 28991074Bordeianou L, Paquette I, Johnson E, Holubar SD, Gaertner W, Feingold DL, Steele SR. Clinical Practice Guidelines for the Treatment of Rectal Prolapse. Dis Colon Rectum. 2017 Nov;60(11):1121-1131. doi: 10.1097/DCR.0000000000000889. No abstract available.
- Background: PubMed 20011385Steele SR, Mellgren A. Constipation and obstructed defecation. Clin Colon Rectal Surg. 2007 May;20(2):110-7. doi: 10.1055/s-2007-977489.
- Background: PubMed 16718835Khaikin M, Wexner SD. Treatment strategies in obstructed defecation and fecal incontinence. World J Gastroenterol. 2006 May 28;12(20):3168-73. doi: 10.3748/wjg.v12.i20.3168.
- Background: PubMed 25185604VanderPas Lamb S, Massengill J, Sheridan MJ, Stern LE, von Pechmann W. Safety of combined abdominal sacral colpopexy and sigmoid resection with suture rectopexy: a retrospective cohort study. Female Pelvic Med Reconstr Surg. 2015 Jan-Feb;21(1):18-24. doi: 10.1097/SPV.0000000000000119.
- Individual participant dataSharing planned: Undecided
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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.
Ghazaleh Rostami Nia, MD principal investigator
Endeavor Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic abdominal ventral rectopexy and Transvaginal sacrospinous rectopexy in people with Obstructed Defecation and Pelvic Organ Prolapse, run by Endeavor Health 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 13 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 15 Jul 2025. 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 15 Jul 2025). 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?
Degree of Rectal Hypermobility Measured Via Ultrasound (time frame: 24 months post-operatively). 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 NCT05747027, which also lists 20 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 15 Jul 2025; AzTrials last refreshed its copy on 1 Nov 2026.