Informativeness to Digital Rectal Examination

NCT ID: NCT01727388

Last Updated: 2025-09-19

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-03-31

Brief Summary

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Digital rectal examination is an act clinically performed daily by physicians and surgeons. It remains the key diagnostic test and directs the therapeutic management of cancer of the lower and middle rectum. It can be done in two main positions: lateral decubitus, and supine.

However, no randomized study in colorectal surgery is not interested in evaluating the best position to perform a full rectal exam.

Detailed Description

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Conditions

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Colon Cancer Upper Rectum Cancer Diverticulitis Rectal Bleeding Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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lateral decubitus

The digital rectal examination is performed in lateral decubitus i.e. curled up position . The patient in left lateral decubitus if the examiner is right handed and right lateral decubitus if the examiner is left handed.

Group Type EXPERIMENTAL

lateral decubitus

Intervention Type PROCEDURE

supine decubitus

The digital rectal examination is performed supine, spread legs, feet on the examination table. The examiner is in the patient's right side if he is right handed and in the patient's left side if he is left-handed.

Group Type ACTIVE_COMPARATOR

supine decubitus

Intervention Type PROCEDURE

Interventions

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lateral decubitus

Intervention Type PROCEDURE

supine decubitus

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* colon or upper rectum cancer operated or not
* recurrent of colon or upper rectum cancer
* rectal bleeding
* hernia

Exclusion Criteria

* woman
* paraplegic man
* bedridden patient
* current or previous pelvic radiotherapy
* History of prostatectomy
* emergency
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Amiens Universitary Hospital

Amiens, , France

Site Status

Beauvais General Hospital

Beauvais, , France

Site Status

Countries

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France

References

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Sabbagh C, Mauvais F, Vecten A, Ainseba N, Cosse C, Diouf M, Regimbeau JM. What is the best position for analyzing the lower and middle rectum and sphincter function in a digital rectal examination? a randomized, controlled study in men. Dig Liver Dis. 2014 Dec;46(12):1082-5. doi: 10.1016/j.dld.2014.08.045. Epub 2014 Sep 22.

Reference Type RESULT
PMID: 25245464 (View on PubMed)

Other Identifiers

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2011-AO1485-36

Identifier Type: OTHER

Identifier Source: secondary_id

PI11-PR-REGIMBEAU

Identifier Type: -

Identifier Source: org_study_id

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