K62.3
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Full-thickness rectal prolapse, externally visible on straining • ASA-Score I-III • Patient is suited for both standardized surgical approaches • Patient is able to cooperate and understands character and individual consequences of clinical trial • Patient has given written informed consent
Exclusion criteria
Exclusion criteria: • Recurrent full-thickness rectal prolapse • Patient with stoma • Patient with inflammatory bowel disease • Pregnancy or nursing • Patients currently undergoing chemotherapy • Active malignant disease and life expectancy lower than 24 months • Body mass index greater than 40 • Participation in another intervention-trial with interference of intervention and outcome of this study • Expected lack of compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to recurrence of full-thickness rectal prolapse until 24 months after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Descriptive analyses of differences in treatment groups regarding operation time, morbidity, mortality, postoperative duration hospital stay, quality of life and obstipation as well as incontinence as important complications of rectal prolapse. Exploratory assessment of prognostic factors and subgroups. | — |
Countries
Germany, Switzerland
Contacts
University Medical Centre Mannheim (UMM)