Prospective Randomized Controlled Trial of Obstructed Defecation Surgery
NCT ID: NCT05747027
Last Updated: 2025-07-15
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
15 participants
INTERVENTIONAL
2024-05-16
2025-05-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Early Versus Late Voiding Trials After Prolapse Repair
NCT02739256
Pelvic Organ Prolapse Repair With or Without Concomitant Burch Colposuspension in Patients With Urinary Incontinence
NCT00576004
Long-term Effectiveness of Abdominal Sacrocolpopexy for the Treatment of Pelvic Organ Prolapse
NCT00099372
Surgical Study Comparing 2 Procedures for the Treatment of a Dropped Bladder
NCT00271102
Impact of Level III Support Procedure on Enlarged Genital Hiatus After Minimally Invasive Sacrocolpopexy
NCT04480671
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. OD symptoms as indicated by an affirmative response to either questions 7, 8 or 14 of the Pelvic Floor Distress Inventory (PFDI):
1. Do you feel you need to strain too hard to have a bowel movement?
2. Do you feel you have not completely emptied your bowels at the end of a bowel movement?
3. Does part of your bowel ever pass through the rectum and bulge outside during or after a bowel movement?
3. Rectal hypermobility defined as a compression ratio greater than 50% according to ultrasound
4. Patient planning on undergoing surgery for the repair of pelvic organ prolapse within the next 12 months
5. Patient who is not pregnant and does not intend to become pregnant in the next 2 years
6. Available for 24-months of follow-up
7. Stated willingness to comply with all study procedures and availability for the duration of the study
8. Able to complete study assessments, per clinician judgment
9. Able and willing to provide independent written informed consent
10. Stable cardiovascular and respiratory status to meet candidacy in vaginal or laparoscopic surgeries
Exclusion Criteria
2. History of previous surgery that included any type of surgery for rectal prolapse
3. Pelvic pain or dyspareunia due to levator ani spasm that would preclude a PMT program
4. Previous adverse reaction to synthetic mesh
5. Current cytotoxic chemotherapy or current or history of pelvic radiation therapy within 12 months
6. History of two inpatient hospitalizations for medical comorbidities in the previous 12 months
18 Years
80 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Weill Medical College of Cornell University
OTHER
University of Pittsburgh
OTHER
Endeavor Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ghazaleh Rostami Nia
Director of Research Division of Urogynecology, NorthShore University HealthSystem
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ghazaleh Rostami Nia, MD
Role: PRINCIPAL_INVESTIGATOR
Endeavor Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Endeavor Health
Skokie, Illinois, United States
Weill Cornell Medicine
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Lembo A, Camilleri M. Chronic constipation. N Engl J Med. 2003 Oct 2;349(14):1360-8. doi: 10.1056/NEJMra020995. No abstract available.
D'Hoore A, Penninckx F. Obstructed defecation. Colorectal Dis. 2003 Jul;5(4):280-7. doi: 10.1046/j.1463-1318.2003.00497.x.
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.
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.
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.
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.
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.
Steele SR, Mellgren A. Constipation and obstructed defecation. Clin Colon Rectal Surg. 2007 May;20(2):110-7. doi: 10.1055/s-2007-977489.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EH22-284
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.