Prospective Randomized Controlled Trial of Obstructed Defecation Surgery

NCT05747027 | Terminated Results DMC

• 1 other identifier: EH22-284
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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. 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

Keywords

Rectopexy; Transvaginal rectopexy; Laparoscopic ventral rectopexy

Outcome Measures

Primary Outcomes (1)

• Degree of Rectal Hypermobility Measured Via Ultrasound

  The degree of rectal hypermobility measured via ultrasound (i.e. compression ratio).

  24 months post-operatively

Secondary Outcomes (11)

• Postoperative Pain Measured by Pain Scale

  24 months post-operatively

• Postoperative Pain Measured by Pain Medication Use

  24 months post-operatively

• Postoperative Functional Activity Level

  24 months post-operatively

• Global Improvement in Bladder Function

  24 months post-operatively

• Pelvic Floor Distress Inventory (PFDI) - POPDI

  24 months post-operatively

Study Arms (2)

Laparoscopic abdominal ventral rectopexy

EXPERIMENTAL

Procedure: Laparoscopic abdominal ventral rectopexy

Transvaginal sacrospinous rectopexy

EXPERIMENTAL

Procedure: Transvaginal sacrospinous rectopexy

Interventions

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.

Laparoscopic abdominal ventral rectopexy

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.

Transvaginal sacrospinous rectopexy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endeavor Health: lead
• Weill Medical College of Cornell University: collaborator
• University of Pittsburgh: collaborator

Study Sites (2)

Endeavor Health

Skokie, Illinois, 60076, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Related Publications (20)

• 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.

  PMID: 22529683 BACKGROUND

• 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.

  PMID: 23049207 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.

  PMID: 14523145 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.

  PMID: 12814403 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.

  PMID: 31875258 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.

  PMID: 16996465 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.

  PMID: 18060963 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.

  PMID: 31016336 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.

  PMID: 28991074 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.

  PMID: 20011385 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.

  PMID: 16718835 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.

  PMID: 25185604 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.

  PMID: 17498206 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.

  PMID: 34478420 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.

  PMID: 33237356 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.

  PMID: 15089911 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.

  PMID: 12504955 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.

  PMID: 20219700 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.

  PMID: 25632177 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.

  PMID: 21160318 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Urogynecology Research Coordinator
• Organization: Endeavor Health

JLee5@northshore.org

847-570-4729

Study Officials

• Ghazaleh Rostami Nia, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research Division of Urogynecology, NorthShore University HealthSystem

Study Record Dates

• First Submitted: February 5, 2023
• First Posted: February 28, 2023
• Study Start: May 16, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: July 15, 2025
• Results First Posted: July 15, 2025

Record last verified: 2025-07

Locations

US (2)