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Due to low recruitment rate
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| Name | Class |
|---|---|
| Weill Medical College of Cornell University | OTHER |
| University of Pittsburgh | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic abdominal ventral rectopexy | Experimental |
| |
| Transvaginal sacrospinous rectopexy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic abdominal ventral rectopexy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Rectal Hypermobility Measured Via Ultrasound | The degree of rectal hypermobility measured via ultrasound (i.e. compression ratio). | 24 months post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months post-operatively |
| Postoperative Pain Measured by Pain Medication Use |
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Inclusion Criteria:
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
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ghazaleh Rostami Nia, MD | Endeavor Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endeavor Health | Skokie | Illinois | 60076 | United States | ||
| Weill Cornell Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22529683 | Background | 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. | |
| 23049207 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Laparoscopic Abdominal Ventral Rectopexy | Laparoscopic abdominal ventral rectopexy: 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. |
| FG001 | Transvaginal Sacrospinous Rectopexy | Transvaginal sacrospinous rectopexy: 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. |
| FG002 | Unassigned | Due to early termination of the study, some enrolled participants remained as unassigned. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Laparoscopic Abdominal Ventral Rectopexy | Laparoscopic abdominal ventral rectopexy: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Degree of Rectal Hypermobility Measured Via Ultrasound | The degree of rectal hypermobility measured via ultrasound (i.e. compression ratio). | Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed. | Posted | 24 months post-operatively |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Laparoscopic Abdominal Ventral Rectopexy | Laparoscopic abdominal ventral rectopexy: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Urogynecology Research Coordinator | Endeavor Health | 847-570-4729 | JLee5@northshore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 3, 2025 | Jun 26, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 11, 2025 | Jun 26, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The study surgeon is providing clinical care to enrolled subjects, thus masking the surgeon to treatment allocation or subject symptoms is not practical or feasible, other than the allocation concealment prior to surgical randomization. Given the surgical procedure requires a transvaginal or abdominal incision, it is clinically not possible to mask the participant or other research personnel.
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|
| Transvaginal sacrospinous rectopexy | Procedure | 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. |
|
Participants will complete an assessment of pain medication use. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 24 months post-operatively |
| New York |
| New York |
| 10065 |
| United States |
| Bove 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. |
| 14523145 | Background | Lembo A, Camilleri M. Chronic constipation. N Engl J Med. 2003 Oct 2;349(14):1360-8. doi: 10.1056/NEJMra020995. No abstract available. |
| 12814403 | Background | D'Hoore A, Penninckx F. Obstructed defecation. Colorectal Dis. 2003 Jul;5(4):280-7. doi: 10.1046/j.1463-1318.2003.00497.x. |
| 31875258 | Background | Rostaminia 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. |
| 16996465 | Background | Bradley 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. |
| 18060963 | Background | Bradley 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. |
| 31016336 | Background | Rostaminia 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. |
| 28991074 | Background | Bordeianou 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. |
| 20011385 | Background | Steele SR, Mellgren A. Constipation and obstructed defecation. Clin Colon Rectal Surg. 2007 May;20(2):110-7. doi: 10.1055/s-2007-977489. |
| 16718835 | Background | Khaikin 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. |
| 25185604 | Background | VanderPas 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. |
| 17498206 | Background | Slawik 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. |
| 34478420 | Background | Routzong 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. |
| 33237356 | Background | Rostaminia 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. |
| 15089911 | Background | Higgins PD, Johanson JF. Epidemiology of constipation in North America: a systematic review. Am J Gastroenterol. 2004 Apr;99(4):750-9. doi: 10.1111/j.1572-0241.2004.04114.x. |
| 12504955 | Background | Blanchette G. The prevalence of pelvic floor disorders and their relationship to gender, age and mode of delivery. BJOG. 2003 Jan;110(1):88; author reply 88-9. doi: 10.1046/j.1471-0528.2003.01016_1.x. No abstract available. |
| 20219700 | Background | Elshazly WG, El Nekady Ael A, Hassan H. Role of dynamic magnetic resonance imaging in management of obstructed defecation case series. Int J Surg. 2010;8(4):274-82. doi: 10.1016/j.ijsu.2010.02.008. Epub 2010 Feb 26. |
| 25632177 | Background | Podzemny V, Pescatori LC, Pescatori M. Management of obstructed defecation. World J Gastroenterol. 2015 Jan 28;21(4):1053-60. doi: 10.3748/wjg.v21.i4.1053. |
| 21160318 | Background | Kepenekci I, Keskinkilic B, Akinsu F, Cakir P, Elhan AH, Erkek AB, Kuzu MA. Prevalence of pelvic floor disorders in the female population and the impact of age, mode of delivery, and parity. Dis Colon Rectum. 2011 Jan;54(1):85-94. doi: 10.1007/DCR.0b013e3181fd2356. |
| BG001 | Transvaginal Sacrospinous Rectopexy | Transvaginal sacrospinous rectopexy: 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. |
| BG002 | Unassigned | Due to the early termination of the study, some of the enrolled participants remained unassigned. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Transvaginal sacrospinous rectopexy: 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. |
|
| Secondary | 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. | Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed. | Posted | 24 months post-operatively |
|
|
| Secondary | Postoperative Pain Measured by Pain Medication Use | Participants will complete an assessment of pain medication use. | Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed. | Posted | 24 months post-operatively |
|
|
| Secondary | 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. | Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed. | Posted | 24 months post-operatively |
|
|
| Secondary | 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. | Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed. | Posted | 24 months post-operatively |
|
|
| Secondary | 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. | Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed. | Posted | 24 months post-operatively |
|
|
| Secondary | 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. | Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed. | Posted | 24 months post-operatively |
|
|
| Secondary | 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. | Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed. | Posted | 24 months post-operatively |
|
|
| Secondary | 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. | Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed. | Posted | 24 months post-operatively |
|
|
| Secondary | 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. | Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed. | Posted | 24 months post-operatively |
|
|
| Secondary | 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. | Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed. | Posted | 24 months post-operatively |
|
|
| Secondary | 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. | Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed. | Posted | 24 months post-operatively |
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Transvaginal Sacrospinous Rectopexy | Transvaginal sacrospinous rectopexy: 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. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Unassigned | Due to the early termination of the study, some of the enrolled participants remained unassigned. | 0 | 4 | 0 | 4 | 0 | 4 |
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