Status:
COMPLETED
Rectal Prolapse With ODS. STARR vs LVR.
Lead Sponsor:
University Hospital of Ferrara
Conditions:
Rectal Prolapse
Defecation Disorder
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The objective of the study will be to evaluate the clinical and functional outcome of patients with obstructed defecation sndrome (ODS) associated to internal rectal prolapse, treated with transanal p...
Detailed Description
This randomized controlled trial (single center, prospective, randomized controlled, parallel, and single-blind trial) is designed to compare the outcome of patients with ODS and rectal prolapse under...
Eligibility Criteria
Inclusion
- female gender,
- the presence of rectorectal or rectoanal intussusception as main cause of ODS, confirmed by defecography,
- type of operation performed (STARR or LVR),
- ODS score \> 14 \[17\]
- PACQoL \>32 \[18\]
- ODS symptoms for at least 12 months prior to enrollment
- Failure of at least 6 months of medical therapy
Exclusion
- male gender,
- severe fecal incontinence (CCS score\>6, Maximum Resting Pressure at rectal manometry \< 50 mmHg),
- combined procedures
- previous surgery on rectum or anus for cancer or rectal prolapse, inflammatory bowel disease, other type of surgery to relieve ODS
- pregnancy,
- anismus or dissinergic defecation
- full-thickness prolapse
- stress urinary incontinence associated
- histerocele or cystocele associated (since we usually correct both defects in the same surgical procedure)
- prior pelvic radiotherapy
- slow transit constipation defined as ≤ 2 bowel movements per week,
- any psychiatric diseases.
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04892108
Start Date
January 1 2017
End Date
March 1 2021
Last Update
May 28 2021
Active Locations (1)
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1
Surgery 2 Surgical Department, Sant'Anna University Hospital Ferrara, Italy
Ferrara, Italy, 44124