Fecal IncontinenceNCT02196597
Value of Anorectal Manometry Before Ileo- or Sigmoidostomy Closure After Rectal Resection
An observational study of Fecal Incontinence and Quality of Life, run by German Society for Neurogastroenterology and Motility at 3 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Incontinence, Quality of Life
- How many people
- 30 participants
- Where
- 3 sitesGermany
- Study dates
- Jan 2013to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients operated for rectal carcinoma in three German centers
Who may be able to join
- all patients planned for ileo- or sigmoidostomy closure after rectal resection for rectal carcinoma
Who cannot join
- preoperative incontinence for solid stool
- dementia
- pregnancy
- latex allergy
Trial locations and contacts
3 sites in 1 country.
Germany3 sites, 3 recruiting
- Recruiting
Hosptial Landshut-Achdorf
Landshut, 84036
Johannes Schmidt, MD, 0049 871 4042770, johannes.schmidt@lakumed.de
Johannes Schmidt, MD
- Recruiting
Hospital Memmingen
Memmingen, 87700
Albert Pfeiffer, MD, 0049 8331 702640, Silke.Eipper@klinikum-memmingen.de
Albert Pfeiffer, MD
- Recruiting
Hospital Vilsbiburg
Vilsbiburg, 81437
Christian Pehl, MD
Nikolaus Steigemann, MD
About this study
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.
- Conditions
- Fecal Incontinence, Quality of Life
- Keywords
- anorectal manometry
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| resection with RCT | rectal resection in the case of rectal carcinoma with preoperative radiochemotherapy | |
| resection without RCT | patients with rectal resection without preoperative radiochemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month postoperative
Secondary outcomes (2)
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
Measured: six month postoperative
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
Measured: six month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startJan 2013
- Primary completionDec 2014 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Society for Neurogastroenterology and Motility
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Christian Pehl, German Society for Neurogastroenterology and Motility
- Investigators
- Christian Pehl, MD, Principal investigator, German Society for Neurogastroenterology and Motility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196597
- Sponsor's protocol ID
- DGNM_ARM
- Status last verified
- Jul 2014
- First submitted
- 4 Nov 2013
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1007/s001040051158. German.
PubMed 11013813
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02196597
- Acronym / sponsor ID
- DGNM_ARM
- Conditions
- Fecal Incontinence, Quality of Life
- Keywords
- anorectal manometry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- German Society for Neurogastroenterology and MotilityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 22 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| resection with RCT | – | –rectal resection in the case of rectal carcinoma with preoperative radiochemotherapy |
| resection without RCT | – | –patients with rectal resection without preoperative radiochemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients operated for rectal carcinoma in three German centers
Key inclusion criteria (1 listed)
- all patients planned for ileo- or sigmoidostomy closure after rectal resection for rectal carcinoma
Key exclusion criteria (4 listed)
- preoperative incontinence for solid stool
- dementia
- pregnancy
- latex allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
predictive value of preoperative anorectal manometry for postoperative fecal incontinence
Time frame: 6 month postoperative
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.
2 secondary outcomes
fecal incontinence in patients with/without neoadjuvant radiochemotherapy
Time frame: six month postoperative
predictive value of the surgeon's preoperative evaluation
Time frame: six month postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2014.
- Results publication: PubMed 11013813Stadelmaier 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. doi: 10.1007/s001040051158. German.
- Homepage of the German Society for Neurogastroenterology and MotilityLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Pehl, MD principal investigator
German Society for Neurogastroenterology and Motility
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fecal Incontinence and Quality of Life, run by German Society for Neurogastroenterology and Motility at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Pehl, MD (+49 (0)8741 603152, christian.pehl@kkh-vilsbiburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
predictive value of preoperative anorectal manometry for postoperative fecal incontinence (time frame: 6 month postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02196597, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2014; AzTrials last refreshed its copy on 7 Nov 2026.