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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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.
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.
Endeavor Health
Skokie, Illinois, United States
Weill Cornell Medicine
New York, New York, United States
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
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
Postoperative Pain Measured by Pain Medication Use
Participants will complete an assessment of pain medication use.
Time frame: 24 months post-operatively
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
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
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
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
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
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
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
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
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
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