Rectal Prolapse With ODS. STARR vs LVR. (NCT04892108) | Clinical Trial Compass
CompletedNot Applicable
Rectal Prolapse With ODS. STARR vs LVR.
Italy70 participantsStarted 2017-01-01
Plain-language 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 prolassectomy (STARR) surgery compared to those treated with laparoscopic ventral rectopexy (LVR).
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
What they're measuring
1
Evaluation of different outcomes in relief from ODS after surgery in both groups