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Procedure

Surgery for Constipation (PROD Trial)

N/A
Recruiting
Research Sponsored by NorthShore University HealthSystem
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months post-operatively
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to compare two surgical procedures for treating the inability to completely empty the bowels in women. One procedure is called laparoscopic abdominal ventral rectopexy, which is a common

Who is the study for?
This trial is for adult women suffering from obstructive defecatory syndrome (ODS), who often strain, can't fully empty their bowels, or need to manually assist bowel movements. Participants must be able to complete study assessments and provide consent, have rectal hypermobility as shown by ultrasound, and commit to a 24-month follow-up.
What is being tested?
The trial compares two surgeries for ODS: laparoscopic abdominal ventral rectopexy and transvaginal sacrospinous rectopexy. Women will be randomly assigned one of these procedures and followed up at intervals over two years to assess symptoms and surgical success.
What are the potential side effects?
Potential side effects may include discomfort or pain at the surgery site, bleeding, infection risk post-surgery, possible pelvic organ injury during operation, and general anesthesia risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My ultrasound shows my rectum moves more than normal.
Select...
I am planning to have surgery for pelvic organ prolapse.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months post-operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months post-operatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Degree of rectal hypermobility
Secondary study objectives
Brink Scale
Colorectal-Anal Distress Inventory (CRADI)
EuroQol-5D (EQ-5D)
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: transvaginal sacrospinous rectopexyExperimental Treatment1 Intervention
Group II: laparoscopic abdominal ventral rectopexyExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityOTHER
1,084 Previous Clinical Trials
1,138,783 Total Patients Enrolled
NorthShore University HealthSystemLead Sponsor
132 Previous Clinical Trials
737,526 Total Patients Enrolled
University of PittsburghOTHER
1,787 Previous Clinical Trials
16,359,237 Total Patients Enrolled
1 Trials studying Constipation
120,000 Patients Enrolled for Constipation
~77 spots leftby Jun 2027
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