The primary objective of this study is to compare the function results between two methods for surgically repairing rectoceles: vaginal versus endo-anal surgery. Our working hypothesis is that the relatively new type of endo-anal surgery will result in better voiding function compared to the traditional vaginal surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
The STARR transanal stapling system is used to repair a rectocele.
A posterior Elevate mesh is placed transvaginally to repair a rectocele.
Centre Hospitalier Universitaire de Nîmes
Nîmes, Gard, France
Hôpital de la Conception
Marseille, France
Clinique Beau Soleil
Montpellier, France
Clinique Adassa
Strasbourg, France
presence/absence of a 50% drop in the ODS score
presence/absence of a 50% drop in the ODS score: constipation score defined by Altomare et al, 2008.
Time frame: 12 months
presence/absence of prolapse recurrence
presence/absence of prolapse recurrence: determined by prolapse staging
Time frame: 6 weeks
Frequency of laxative use
Time frame: 6 weeks
Intervention time (min)
Time frame: 1 day
Questionnaire PFDI 20
Time frame: 6 weeks
Questionnaire PFIQ 7
Time frame: 6 weeks
Questionnaire SF 36
Time frame: 6 weeks
Questionnaire PISQ-12
Time frame: 6 weeks
presence/absence of prolapse recurrence
presence/absence of prolapse recurrence: determined by prolapse staging
Time frame: 6 months
presence/absence of prolapse recurrence
presence/absence of prolapse recurrence: determined by prolapse staging
Time frame: 12 months
presence/absence of prolapse recurrence
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hôpital Paule de Viguier, CHU de Toulouse
Toulouse, France
Hôpital Purpan, CHU de Toulouse
Toulouse, France
presence/absence of prolapse recurrence: determined by prolapse staging
Time frame: 36 months
Frequency of laxative use
Time frame: 6 months
Frequency of laxative use
Time frame: 12 months
Frequency of laxative use
Time frame: 36 months
Questionnaire PFDI 20
Time frame: 6 months
Questionnaire PFDI 20
Time frame: 12 months
Questionnaire PFDI 20
Time frame: 36 months
Questionnaire PFIQ 7
Time frame: 6 months
Questionnaire PFIQ 7
Time frame: 12 months
Questionnaire PFIQ 7
Time frame: 36 months
Questionnaire SF 36
Time frame: 6 months
Questionnaire SF 36
Time frame: 12 months
Questionnaire SF 36
Time frame: 36 months
Questionnaire PISQ-12
Time frame: 6 months
Questionnaire PISQ-12
Time frame: 12 months
Questionnaire PISQ-12
Time frame: 36 months