The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prospective Randomized Controlled Trial of Obstructed Defecation Surgery (PROD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05747027
Recruitment Status : Recruiting
First Posted : February 28, 2023
Last Update Posted : May 9, 2024
Sponsor:
Collaborators:
Weill Medical College of Cornell University
University of Pittsburgh
Information provided by (Responsible Party):
Ghazaleh Rostami Nia, NorthShore University HealthSystem

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Obstructed Defecation Procedure: Laparoscopic abdominal ventral rectopexy Procedure: Transvaginal sacrospinous rectopexy Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: 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. Every attempt will be made to keep the research coordinator blinded when assessing symptoms via questionnaires during follow-up visits.
Primary Purpose: Treatment
Official Title: Prospective Randomized Controlled Trial Comparing Transvaginal Rectopexy and Ventral Mesh Rectopexy for Obstructed Defecation in Pelvic Organ Prolapse (PROD Trial)
Estimated Study Start Date : May 2024
Estimated Primary Completion Date : June 2027
Estimated Study Completion Date : February 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: laparoscopic abdominal ventral rectopexy Procedure: 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.
Experimental: transvaginal sacrospinous rectopexy Procedure: 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Degree of rectal hypermobility [ Time Frame: 24 months post-operatively ]
    The degree of rectal hypermobility measured via ultrasound (i.e. compression ratio).


Secondary Outcome Measures :
  1. Postoperative pain by pain scale [ Time Frame: 24 months post-operatively ]
    Participants will complete the Pain Scale. No pain will indicate the best outcome whereas the most intense pain imaginable will indicate the worst outcome.

  2. Postoperative pain by an assessment of pain medication use [ Time Frame: 24 months post-operatively ]
    Participants will be asked to indicate whether or not they are taking pain medication.

  3. Postoperative functional activity level [ Time Frame: 24 months post-operatively ]
    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.

  4. Global improvement in bladder function [ Time Frame: 24 months post-operatively ]
    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.

  5. Pelvic Organ Prolapse Distress Inventory (POPDI) [ Time Frame: 24 months post-operatively ]
    As a part of the pelvic floor distress inventory (PFDI) questionnaire, participants will complete the 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.

  6. Colorectal-Anal Distress Inventory (CRADI) [ Time Frame: 24 months post-operatively ]
    As a part of the pelvic floor distress inventory (PFDI) questionnaire, participants will complete the 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.

  7. Urinary Distress Inventory (UDI) [ Time Frame: 24 months post-operatively ]
    As a part of the pelvic floor distress inventory (PFDI) questionnaire, participants will complete the 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.

  8. Pelvic floor Impact Questionnaire (PFIQ) [ Time Frame: 24 months post-operatively ]
    Participants will complete 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.

  9. Short Form 36 Health Survey Questionnaire (SF-36) [ Time Frame: 24 months post-operatively ]
    Participants will complete 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.

  10. EuroQol-5D (EQ-5D) [ Time Frame: 24 months post-operatively ]
    Participants will complete 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.

  11. Brink Scale [ Time Frame: 24 months post-operatively ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female, between the age of 18 and 80

  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:

  1. Contraindication to abdominal and transvaginal rectopexy in the opinion of the treating surgeon
  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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05747027


Contacts
Layout table for location contacts
Contact: Ghazaleh Rostami Nia, MD 405-326-8143 GRostamiNia@northshore.org

Locations
Layout table for location information
United States, Illinois
Endeavor Health Recruiting
Skokie, Illinois, United States, 60076
Contact: Jungeun Lee, MS    847-570-4729    JLee5@northshore.org   
Sponsors and Collaborators
NorthShore University HealthSystem
Weill Medical College of Cornell University
University of Pittsburgh
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ghazaleh Rostami Nia, Director of Research Division of Urogynecology, NorthShore University HealthSystem, NorthShore University HealthSystem
ClinicalTrials.gov Identifier: NCT05747027    
Other Study ID Numbers: EH22-284
First Posted: February 28, 2023    Key Record Dates
Last Update Posted: May 9, 2024
Last Verified: May 2024

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No