Obstructed Defecation, Pelvic Organ Prolapse
Conditions
Keywords
Rectopexy, Transvaginal rectopexy, Laparoscopic ventral rectopexy
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.
Interventions
PROCEDURELaparoscopic 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.
PROCEDURETransvaginal 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.
Sponsors
Weill Medical College of Cornell University
University of Pittsburgh
Endeavor Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Rectal Hypermobility Measured Via Ultrasound | 24 months post-operatively | The degree of rectal hypermobility measured via ultrasound (i.e. compression ratio). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Measured by Pain Medication Use | 24 months post-operatively | Participants will complete an assessment of pain medication use. |
| Postoperative Functional Activity Level | 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. |
| Global Improvement in Bladder Function | 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. |
| Pelvic Floor Distress Inventory (PFDI) - POPDI | 24 months post-operatively | As a part of the pelvic floor distress inventory (PFDI) questionnaire, participants will complete prolapse symptoms assessments using pelvic organ prolapse distress inventory (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. |
| Pelvic Floor Distress Inventory (PFDI) - CRADI | 24 months post-operatively | As a part of the pelvic floor distress inventory (PFDI) questionnaire, participants will complete colorectal symptoms assessments using colorectal anal distress inventory (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. |
| Postoperative Pain Measured by Pain Scale | 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. |
| Quality of Life Measured by PFIQ | 24 months post-operatively | Participants will complete pelvic floor impact questionnaire (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. |
| Quality of Life Measured by SF-36 | 24 months post-operatively | Participants will also complete short form health survey (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. |
| Quality of Life Measured by EQ-5D | 24 months post-operatively | Participants will complete EuroQol-5D (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. |
| Pelvic Muscle Strength | 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. |
| Pelvic Floor Distress Inventory (PFDI) - UDI | 24 months post-operatively | As a part of the pelvic floor distress inventory (PFDI) questionnaire, participants will complete urinary symptoms assessments using urinary distress inventory (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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Laparoscopic Abdominal Ventral Rectopexy 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. | 5 |
| Transvaginal Sacrospinous Rectopexy 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. | 6 |
| Unassigned Due to the early termination of the study, some of the enrolled participants remained unassigned. | 4 |
| Total | 15 |
Baseline characteristics
| Characteristic | Laparoscopic Abdominal Ventral Rectopexy | Transvaginal Sacrospinous Rectopexy | Unassigned | Total |
|---|---|---|---|---|
| Age, Continuous | 66.4 years STANDARD_DEVIATION 6.5 | 56.7 years STANDARD_DEVIATION 8.9 | 59.5 years STANDARD_DEVIATION 12.4 | 60.7 years STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 6 Participants | 4 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 6 Participants | 3 Participants | 13 Participants |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 4 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 6 | 0 / 4 |
| other Total, other adverse events | 0 / 5 | 0 / 6 | 0 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 6 | 0 / 4 |
Outcome results
Primary
Degree of Rectal Hypermobility Measured Via Ultrasound
The degree of rectal hypermobility measured via ultrasound (i.e. compression ratio).
Time frame: 24 months post-operatively
Population: Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed.
Secondary
Global Improvement in Bladder Function
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.
Time frame: 24 months post-operatively
Population: Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed.
Secondary
Pelvic Floor Distress Inventory (PFDI) - CRADI
As a part of the pelvic floor distress inventory (PFDI) questionnaire, participants will complete colorectal symptoms assessments using colorectal anal distress inventory (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.
Time frame: 24 months post-operatively
Population: Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed.
Secondary
Pelvic Floor Distress Inventory (PFDI) - POPDI
As a part of the pelvic floor distress inventory (PFDI) questionnaire, participants will complete prolapse symptoms assessments using pelvic organ prolapse distress inventory (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.
Time frame: 24 months post-operatively
Population: Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed.
Secondary
Pelvic Floor Distress Inventory (PFDI) - UDI
As a part of the pelvic floor distress inventory (PFDI) questionnaire, participants will complete urinary symptoms assessments using urinary distress inventory (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.
Time frame: 24 months post-operatively
Population: Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed.
Secondary
Pelvic Muscle Strength
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.
Time frame: 24 months post-operatively
Population: Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed.
Secondary
Postoperative Functional Activity Level
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.
Time frame: 24 months post-operatively
Population: Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed.
Secondary
Postoperative Pain Measured by Pain Medication Use
Participants will complete an assessment of pain medication use.
Time frame: 24 months post-operatively
Population: Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed.
Secondary
Postoperative Pain Measured by Pain Scale
Participants will complete the pain scale. No pain will indicate the best outcome whereas the most intense pain imaginable will indicate the worst outcome.
Time frame: 24 months post-operatively
Population: Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed.
Secondary
Quality of Life Measured by EQ-5D
Participants will complete EuroQol-5D (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.
Time frame: 24 months post-operatively
Population: Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed.
Secondary
Quality of Life Measured by PFIQ
Participants will complete pelvic floor impact questionnaire (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.
Time frame: 24 months post-operatively
Population: Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed.
Secondary
Quality of Life Measured by SF-36
Participants will also complete short form health survey (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.
Time frame: 24 months post-operatively
Population: Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed.