Value of Anorectal Manometry Before Ileo- or Sigmoidostomy Closure After Rectal Resection

NCT ID: NCT02196597

Last Updated: 2014-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Fecal Incontinence Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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resection with RCT

rectal resection in the case of rectal carcinoma with preoperative radiochemotherapy

No interventions assigned to this group

resection without RCT

patients with rectal resection without preoperative radiochemotherapy

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Society for Neurogastroenterology and Motility

OTHER

Sponsor Role lead

Responsible Party

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Dr. Christian Pehl

Chairman

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian Pehl, MD

Role: PRINCIPAL_INVESTIGATOR

German Society for Neurogastroenterology and Motility

Locations

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Hosptial Landshut-Achdorf

Landshut, , Germany

Site Status RECRUITING

Hospital Memmingen

Memmingen, , Germany

Site Status RECRUITING

Hospital Vilsbiburg

Vilsbiburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Christian Pehl, MD

Role: CONTACT

+49 (0)8741 603152

Facility Contacts

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Johannes Schmidt, MD

Role: primary

0049 871 4042770

Albert Pfeiffer, MD

Role: primary

0049 8331 702640

References

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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.

Reference Type RESULT
PMID: 11013813 (View on PubMed)

Related Links

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http://www.neurogastro.de

Homepage of the German Society for Neurogastroenterology and Motility

Other Identifiers

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DGNM_ARM

Identifier Type: -

Identifier Source: org_study_id

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