Trial Outcomes & Findings for Prospective Randomized Controlled Trial of Obstructed Defecation Surgery (NCT NCT05747027)
NCT ID: NCT05747027
Last Updated: 2025-07-15
Results Overview
The degree of rectal hypermobility measured via ultrasound (i.e. compression ratio).
TERMINATED
NA
15 participants
24 months post-operatively
2025-07-15
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
Unassigned
Due to early termination of the study, some enrolled participants remained as unassigned.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prospective Randomized Controlled Trial of Obstructed Defecation Surgery
Baseline characteristics by cohort
| Measure |
Laparoscopic Abdominal Ventral Rectopexy
n=5 Participants
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.
|
Transvaginal Sacrospinous Rectopexy
n=6 Participants
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.
|
Unassigned
n=4 Participants
Due to the early termination of the study, some of the enrolled participants remained unassigned.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.4 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
56.7 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
59.5 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
60.7 years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 months post-operativelyPopulation: Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed.
The degree of rectal hypermobility measured via ultrasound (i.e. compression ratio).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 months post-operativelyPopulation: Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed.
Participants will complete the pain scale. No pain will indicate the best outcome whereas the most intense pain imaginable will indicate the worst outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 months post-operativelyPopulation: Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed.
Participants will complete an assessment of pain medication use.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 months post-operativelyPopulation: Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 months post-operativelyPopulation: Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 months post-operativelyPopulation: Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 months post-operativelyPopulation: Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 months post-operativelyPopulation: Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 months post-operativelyPopulation: Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 months post-operativelyPopulation: Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 months post-operativelyPopulation: Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 months post-operativelyPopulation: Due to the early termination of the study, the 24-month post-operative primary outcome measurements could not be completed.
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.
Outcome measures
Outcome data not reported
Adverse Events
Laparoscopic Abdominal Ventral Rectopexy
Transvaginal Sacrospinous Rectopexy
Unassigned
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place