Clinical trial NCT05747027: Prospective Randomized Controlled Trial of Obstructed Defecation Surgery
Official title: Prospective Randomized Controlled Trial Comparing Transvaginal Rectopexy and Ventral Mesh Rectopexy for Obstructed Defecation in Pelvic Organ Prolapse (PROD Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructed Defecation
Pelvic Organ Prolapse
Keywords: Rectopexy
Transvaginal rectopexy
Laparoscopic ventral rectopexy
Lead sponsor: Endeavor Health
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
name: University of Pittsburgh
First posted: 2023-02-28
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Degree of rectal hypermobility measured via ultrasound
timeFrame: 24 months post-operatively
Secondary outcomes:
measure: Postoperative pain measured by pain scale
timeFrame: 24 months post-operatively
measure: Postoperative pain measured by pain medication use
timeFrame: 24 months post-operatively
measure: Postoperative functional activity level
timeFrame: 24 months post-operatively
measure: Global improvement in bladder function
timeFrame: 24 months post-operatively
measure: Pelvic Floor Distress Inventory (PFDI) - POPDI
timeFrame: 24 months post-operatively
measure: Pelvic Floor Distress Inventory (PFDI) - CRADI
timeFrame: 24 months post-operatively
measure: Pelvic Floor Distress Inventory (PFDI) - UDI
timeFrame: 24 months post-operatively
measure: Quality of life measured by PFIQ
timeFrame: 24 months post-operatively
measure: Quality of life measured by SF-36
timeFrame: 24 months post-operatively
measure: Quality of life measured by EQ-5D
timeFrame: 24 months post-operatively
measure: Pelvic muscle strength
timeFrame: 24 months post-operatively
Other outcomes:
Locations:
city: Skokie
country: United States
facility: Endeavor Health
state: Illinois
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Endeavor Health
name: Ghazaleh Rostami Nia, MD
role: PRINCIPAL_INVESTIGATOR
References:
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