Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01727388
Other study ID # PI11-PR-REGIMBEAU
Secondary ID 2011-AO1485-36
Status Completed
Phase Phase 3
First received October 22, 2012
Last updated November 26, 2013
Start date November 2012
Est. completion date March 2013

Study information

Verified date November 2013
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority France: Committee for the Protection of PersonnesFrance: The Commission nationale de l’informatique et des libertés
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 320
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

Procedure:
lateral decubitus

supine decubitus


Locations

Country Name City State
France Amiens Universitary Hospital Amiens
France Beauvais General Hospital Beauvais

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary realization of a full digital rectal examination 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. The consult could be done prior to the surgery or one month after the surgery No
Secondary assessment of sphincter according to the DRESS score 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) The consult can be performed prior to the surgery or one month after the surgery No
Secondary missing information during the rectal examination 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) The consult can be performed prior to the surgery or one month after the surgery No
Secondary Conversion rate decided by the examiner the conversion rate decided by the examiner corresponds to the switch from one position to another The consult can be performed prior to the surgery or one month after the surgery No
Secondary Evaluation of the position by the patient 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? The consult can be performed prior to the surgery or one month after the surgery No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05551052 - CRC Detection Reliable Assessment With Blood
Completed NCT03457454 - Reducing Rural Colon Cancer Disparities
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04088955 - A Digimed Oncology PharmacoTherapy Registry
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Terminated NCT01347645 - Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer Phase 1/Phase 2
Completed NCT03390907 - Hybrid APC Assisted EMR for Large Colon Polyps N/A
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Completed NCT04079478 - The AID Study: Artificial Intelligence for Colorectal Adenoma Detection
Active, not recruiting NCT04057274 - Acute Effect of modeRate-intensity aerOBIc Exercise on Colon Cancer Cell Growth N/A
Recruiting NCT03190941 - Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients Phase 1/Phase 2
Not yet recruiting NCT05147545 - Impact of Exercise and Hyperlipidic Meal on Free Circulating DNA in Patients With Metastatic Colonic Cancer and Healthy Subjects N/A
Recruiting NCT05026268 - The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis N/A
Not yet recruiting NCT03277235 - Effect of a Resilience Model-Based Care Plan in Newly Diagnosed Colorectal Cancer Patients N/A
Active, not recruiting NCT02730702 - Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure
Active, not recruiting NCT02959541 - PK/PD Investigation of Calciumfolinat in Blood, Tumor and Adjacent Mucosa in Patient With Colon Cancer N/A
Completed NCT02810652 - Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection N/A
Recruiting NCT02577627 - Multi-Indication, Retrospective Oncological Study to Validate the Accuracy in Predicting TTP by PrediCare in Patients Under SOC N/A
Terminated NCT02628535 - Safety Study of MGD009 in B7-H3-expressing Tumors Phase 1
Recruiting NCT02526836 - Complete Mesocolic Excision With Central Vessel Ligation Compared With Conventional Surgery for Colon Cancer Phase 2/Phase 3