Informativeness to Digital Rectal Examination

Phase 3

Completed

• Conditions: Colon Cancer; Upper Rectum Cancer; Diverticulitis; Rectal Bleeding; Hernia
• Interventions: Procedure: supine decubitus; Procedure: lateral decubitus

• Registration Number: NCT01727388
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2012-10-22
• Study Start: 2012-11
• Study First Submitted QC: 2012-11-15
• Study First Posted: 2012-11-16
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-26
• Last Update Posted: 2013-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 320

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
supine decubitus	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.
lateral decubitus	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.

Primary Outcome Measures

Name	Time	Method
realization of a full digital rectal examination	The consult could be done prior to the surgery or one month after the surgery	Full digital rectal examination is defined by a rectal examination for investigating the superior pole of the prostate, to examine the entire circumference and the rectal sphincter.

Secondary Outcome Measures

Name	Time	Method
Conversion rate decided by the examiner	The consult can be performed prior to the surgery or one month after the surgery	the conversion rate decided by the examiner corresponds to the switch from one position to another
Evaluation of the position by the patient	The consult can be performed prior to the surgery or one month after the surgery	After the digital rectal examination, the examiner shows the patient a picture of the two positions and ask him the question: which position is the most embarrassing?
assessment of sphincter according to the DRESS score	The consult can be performed prior to the surgery or one month after the surgery	This score assesses the sphincter tone at rest and during exercise. This score classes the sphincter tone in both situations: tone undetectable (score = 0) to hypertonic sphincter that does not allow the introduction of a finger (score = 5)
missing information during the rectal examination	The consult can be performed prior to the surgery or one month after the surgery	This analysis aims to determine what information is missing most often in one group compared to another (height to digital rectal examination, circumference of the digital rectal examination , assessment of sphincter tone)

Trial Locations

Locations (2)

Amiens Universitary Hospital; 🇫🇷 Amiens, France

Beauvais General Hospital; 🇫🇷 Beauvais, France