Informativeness to Digital Rectal Examination (RIFIONA)

Centre Hospitalier Universitaire, Amiens

Status and phase: Completed; Phase 3

Conditions: Rectal Bleeding; Upper Rectum Cancer; Hernia; Colon Cancer; Diverticulitis

Treatments: Procedure: supine decubitus; Procedure: lateral decubitus

Study type: Interventional

Funder types: Other

Identifiers

NCT01727388

PI11-PR-REGIMBEAU

2011-AO1485-36 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 320 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

lateral decubitus

Experimental group

Description:

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.

Treatment:

Procedure: lateral decubitus

supine decubitus

Active Comparator group

Description:

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.

Treatment:

Procedure: supine decubitus