Prospective Randomized Controlled Trial of Obstructed Defecation Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Randomized Controlled Trial Comparing Transvaginal Rectopexy and Ventral Mesh Rectopexy for Obstructed Defecation in Pelvic Organ Prolapse (PROD Trial)

Conditions
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Obstructed Defecation

Intervention / Treatment
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* Procedure: laparoscopic abdominal ventral rectopexy
* Procedure: Transvaginal sacrospinous rectopexy
* Diagnostic Test: MR Defecography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 intent 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 written informed consent Exclusion Criteria: 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 History of two inpatient hospitalizations for medical comorbidities in the previous 12 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: laparoscopic abdominal ventral rectopexy<br> | Procedure: laparoscopic abdominal ventral rectopexy<br>* 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.<br>Diagnostic Test: MR Defecography<br>* MR imaging will be in the supine position with hips and knees bent at 45°using a closed-configuration 1.5T magnet (Siemens, Magnetom Avanto) and a Synergy body phased-array coil. Intravenous contrast will not be used. Three anatomic measurements relating to rectal support will be recorded at rest, and then also at the moment of maximum evacuation.<br>|
| Experimental: transvaginal sacrospinous rectopexy<br> | Procedure: Transvaginal sacrospinous rectopexy<br>* Transvaginal sacrospinous rectopexy is an innovative procedure which has shown to be safe and effective in the treatment of stool entrapment.<br>Diagnostic Test: MR Defecography<br>* MR imaging will be in the supine position with hips and knees bent at 45°using a closed-configuration 1.5T magnet (Siemens, Magnetom Avanto) and a Synergy body phased-array coil. Intravenous contrast will not be used. Three anatomic measurements relating to rectal support will be recorded at rest, and then also at the moment of maximum evacuation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of rectal hypermobility preoperatively | The degree of rectal hypermobility measured via ultrasound (i.e. compression ratio). | preoperatively | 
| Degree of rectal hypermobility 2 months post-operatively | The degree of rectal hypermobility measured via ultrasound (i.e. compression ratio). | 2 months post-operatively | 
| Degree of rectal hypermobility 12 months post-operatively | The degree of rectal hypermobility measured via ultrasound (i.e. compression ratio). | 12 months post-operatively | 
| Degree of rectal hypermobility 24 months post-operatively | The degree of rectal hypermobility measured via ultrasound (i.e. compression ratio). | 12 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain by pain scale | Subjects will complete the Pain Scale. The pain will be measured on a scale of no pain, mild pain, moderate pain, severe pain, very severe pain, or worst possible pain. No pain will indicate the best outcome whereas the worst possible pain will indicate the worst outcome. | preoperatively, and then at 2 weeks and 2, 12, and 24 months postoperatively | 
| Postoperative pain by an assessment of pain medication use | Subjects will complete an assessment of pain medication use. | preoperatively, and then at 2 weeks and 2, 12, and 24 months postoperatively | 
| Postoperative functional activity level | Subjects will complete the Activity Assessment Scale which measures functional activity. The activity level will be measured on a scale of no activity, moderate activity, and full activity. Full activity will indicate the best outcome whereas no activity will indicate the worst outcome. | preoperatively, and then at 2 weeks and 2, 12, and 24 months postoperatively | 
| Global improvement in bladder function | Subjects will complete the Patient Global Impression of Improvement | 2, 12, and 24 months postoperatively | 
| Pelvic Organ Prolapse Distress Inventory (POPDI) | Prolapse symptoms assessed by POPDI. The symptoms will be measured on a scale of 0, not present, to 4, quite a bit. | 2 and 24 months postoperatively | 
| Colorectal-Anal Distress Inventory (CRADI) | Colorectal symptoms assessed by CRADI. The symptoms will be measured on a scale of 0, not present, to 4, quite a bit. | 2 and 24 months postoperatively | 
| Urinary Distress Inventory (UDI) | Urinary symptoms assessed by UDI. The symptoms will be measured on a scale of 0, not present, to 4, quite a bit. | 2 and 24 months postoperatively | 
| Pelvic floor Impact Questionnaire (PFIQ) | Quality of life measured by PFIQ. | 2 and 24 months postoperatively | 
| Short Form 36 Health Survey Questionnaire (SF-36) | Quality of life measured by SF-36. | 2 weeks, 2 and 24 months postoperatively | 
| EuroQol-5D (EQ-5D) | Quality of life measured by EQ-5D. | 2 and 24 months postoperatively | 
| Pelvic floor muscle strength | Pelvic floor muscle strength will be measured by the Brink Scale in which the ratings are for a composite score of 3-12 added. A higher score means better muscle function. | 2 and 24 months postoperatively |