Quality of Life Clinical Trial
Official title:
Prospective Multi-center Evaluation of the Value of Anorectal Manometry Before Closure of Protective Ileostomy or Sigmoidostomy After Rectal Resection in Patients With Rectal Carcinoma
Background: High prevalence of fecal incontinence after rectal resection in patients with
rectal carcinoma.
Hypothesis: Anorectal manometry done before ileostomy or sigmoidostomy closure can predict
fecal incontinence.
Methods: Anorectal manometry before, 1 month and 6 month after closure. Anorectal
endosonography before and 1 month after closure. Prediction of postoperative incontinence by
the surgeon (digital sphincter examination). Visual analog scales for continence, subjective
success of operation, and global well being; Wexner and Vaizey incontinence score; Parks
incontinence classification; Rockwood fecal incontinence quality of life score; each before,
1 and 6 month after closure.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | January 2015 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - all patients planned for ileo- or sigmoidostomy closure after rectal resection for rectal carcinoma Exclusion Criteria: - preoperative incontinence for solid stool - dementia - pregnancy - latex allergy |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Hosptial Landshut-Achdorf | Landshut | |
| Germany | Hospital Memmingen | Memmingen | |
| Germany | Hospital Vilsbiburg | Vilsbiburg |
| Lead Sponsor | Collaborator |
|---|---|
| German Society for Neurogastroenterology and Motility |
Germany,
Stadelmaier U, Bittorf B, Meyer M, Hohenberger W, Matzel KE. [Can continence function after rectal resection be prognostically estimated?]. Chirurg. 2000 Aug;71(8):932-8. German. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | prediction of postoperative fecal incontinence by the score of Stadelmaier and Matzel (Score =18.230 - 0.94x anastomotic level - 0.18 x resting pressure + 3.72 x radiochemotherapy (done 1, not done 0) | Analysis of correlation between the preoperatively predicted Wexner score and the observed Wexner score six month postoperative. | six month postoperative | No |
| Primary | predictive value of preoperative anorectal manometry for postoperative fecal incontinence | Anorectal manometry is done preoperatively. Fecal incontinence is determined at 6 month postoperatively. Analysis of correlation between preoperative manometry parameter and incidence of postoperative fecal incontinence. | 6 month postoperative | No |
| Secondary | fecal incontinence in patients with/without neoadjuvant radiochemotherapy | Comparison of the percentage of patients with postoperative fecal incontinence after rectal resection in patients with or without neoadjuvant radiochemotherapy | six month postoperative | No |
| Secondary | predictive value of the surgeon`s preoperative evaluation | Clinical evaluation of the patient preoperatively with estimation (written statement) about postoperative continence/incontinence. Fecal incontinence is determined at 6 month postoperatively. Analysis of correlation between the surgeons´ predictions and the incidence of postoperative fecal incontinence | six month postoperative | No |
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