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Digestive and Liver Disease 46 (2014) 1082–1085

Contents lists available at ScienceDirect

Digestive and Liver Disease

journa l h om epage: www.elsev ier .com/ locate /d ld

limentary Tract

hat is the best position for analyzing the lower and middle rectum nd sphincter function in a digital rectal examination? A randomized, ontrolled study in men

harles Sabbagha,b,c, Franç ois Mauvaisd, Amaury Vectena, Najib Ainsebad, yril Cossea,b,c, Momar Dioufe, Jean-Marc Regimbeaua,b,∗

Department of Digestive and Oncological Surgery, Amiens University Hospital, Amiens, France Jules Verne University of Picardie, Amiens, France INSERM U1088, Amiens, France Department of Digestive Surgery, Beauvais General Hospital, Beauvais, France Clinical Research Directorate, Jules Verne University of Picardie, Amiens, France

r t i c l e i n f o

rticle history: eceived 28 April 2014 ccepted 25 August 2014 vailable online 22 September 2014

eywords: igital rectal examination osition andomized controlled trial ectum

a b s t r a c t

Background: Digital rectal examination is an essential tool in the evaluation of the rectum. The aim of this trial was to determine the best position for performing a digital rectal examination. Methods: A total of 321 patients were randomized into “dorsal” or “lateral” groups in this multicentre randomized controlled trial performed in an outpatient setting. The primary endpoint was the proportion of patients with a complete digital rectal examination, defined as the examination of the rectum (upper border of the prostate), the entire circumference, and the assessment of the sphincter tone. Results: The dorsal group included a total of 161 patients (mean age: 62.3 ± 13.04 years), while the lateral group included 160 patients (mean age: 62.7 ± 14.4 years). The proportion of patients with a complete digital rectal examination was 44% (n = 71) in the dorsal group and 49% (n = 79) in the lateral group (p = 0.3).

The entire circumference of the rectum could be examined in 66% of the patients (n = 106) in the dorsal group and in 79.5% of the patients (n = 128) in the lateral group (p = 0.007). Conclusion: The intergroup difference in terms of digital rectal examination completion rate was not significant. In the lateral position, however, the entire circumference of the rectum could be examined more thoroughly.

© 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

. Introduction

Digital rectal examination (DRE) is an essential tool for obtain- ng important information in the diagnosis and management of ectal cancer and other diseases, such as dyssynergic defecation, aecal incontinence, anal pain, functional anorectal disorders, and istal haemorrhage. DRE still has an important role in determin-

ng the application of preoperative treatments, sphincter-saving

rocedures, or a “watch and wait” policy [1–3]. The procedure is erformed by physicians on a daily basis. For the evaluation of rec- al tumours, DRE can be performed with the patient lying in the

∗ Corresponding author at: Department of Digestive Surgery, Amiens North Hos- ital, University of Picardy Medical Centre, Place Victor Pauchet, F-80054 Amiens edex 01, France. Tel.: +33 322 668301; fax: +33 322 668680.

E-mail address: [email protected] (J.-M. Regimbeau).

ttp://dx.doi.org/10.1016/j.dld.2014.08.045 590-8658/© 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All

lateral or the dorsal position. Despite the DRE’s importance in the screening of rectal cancer, little is known about the best way to perform this procedure. Furthermore, the factors that may influ- ence the ability to perform a complete DRE have been studied for prostate cancer [4] but not for rectal cancer.

The patient’s position for a DRE appears to depend mainly on the physician’s usual practice, however this parameter has not been studied in a clinical trial.

To determine the best position for DRE, we chose the prostate as a single landmark for an objective and reproducible reference feature. Hence, to allow for the best possible rectal examination, we only included men who had not undergone prostatectomy and who were free of rectal disease.

The objective of the present randomized, controlled trial in tumour-free subjects was to evaluate the best position for per- forming a thorough examination of the distal part of the rectal tube.

rights reserved.

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C. Sabbagh et al. / Digestive and

. Patients and methods

.1. Study overview

Patients were enrolled in two centres in France (Amiens and eauvais). The study was coordinated by the Department of Diges- ive and Oncologic Surgery at the Amiens University Hospital. The tudy protocol has been approved by the French National Com- ittee for Data Protection in Medical Research (Comité Consultatif

ur le Traitement de l’Information en Matière de Recherche dans le omaine de la Santé, Paris, France; reference 12.155) and the local

ndependent ethics committee (Comité de Protection des Person- es Nord-Ouest II, Amiens, France; reference CPP-SC-2011/06).

The above committees decided that the present non- nterventional study did not require written informed consent from he participants. All patients were provided with verbal informa- ion on the study’s protocol and the objectives. This study was egistered on ClinicalTrials.gov (reference: NCT01727388) after pproval of the protocol by the ethics committees, but before inclu- ion of the first patient.

.2. Patients

The main inclusion criteria were the following: male patients ged 18 years or more and requiring a DRE during an outpatient xamination for colon or upper rectal cancer, colon surgery for

benign disease, hernia surgery, or blood in the stools. Patients ho had undergone surgery or were scheduled for surgery were

ncluded. The main exclusion criteria were the following: a history f diseases that could interfere with the interpretation of the DRE esults (middle and lower rectal cancer, or other anal diseases).

omen were excluded as the prostate was used to evaluate the eight of the examination. Patients with restricted mobility or with revious prostatectomy were also excluded (Fig. 1).

.3. Study procedures

The study was performed at each hospital’s outpatient clinic. At ach centre, two rooms were available and each room had a net- orked computer and an examination table. The table was disposed

Fig. 1. Flowchart. Distribution

Disease 46 (2014) 1082–1085 1083

such that both left-handed and right-handed examiners were able to perform a complete examination (four examiners were involved, of whom one was left-handed, and all were consultants, i.e. experts in rectal examination).

The investigating examiner accessed an online data collection software package and randomized the patients to the dorsal group or the lateral group. The examiner then asked the patient to adopt the position that had been randomly assigned. If the investigator felt that the information obtained during the examination was not enough, the patient could be asked to switch to the other posi- tion. The examination was always performed with latex gloves and Vaseline.

2.4. Data collection

After the DRE, the examiner (i) entered all the study data online, and (ii) showed the patient schematic pictures of the two different positions and asked him in which position he thought he would feel most uncomfortable (“Which of these two positions do you think is the most uncomfortable?”).

2.5. Primary and secondary endpoints

The primary endpoint was the proportion of complete DREs in each group. A complete DRE was defined by three criteria, i.e. it had to be possible to: (i) examine the rectum as far as the upper border of the prostate, (ii) examine the entire circumference of the rectum, and (iii) assess anal sphincter tone according to the Digital Rectal Examination Scoring System [5]. When any one of these criteria was not met, the DRE was considered to be incomplete.

The secondary end points were: (i) the patient’s own evaluation of the DRE position; (ii) each of the three items defining a complete DRE (in order to determine which item was associated with the highest proportion of missing data and whether there were inter- group differences in these items); (iii) the proportion of complete

DREs, as a score in which each of the three items was scored as one point if achieved and zero if not (i.e. ranging from zero to three); (iv) risk factors for DRE failure (body mass index (BMI), height, indi- cation for DRE, and the examiner); (v) the rate of conversion to the

of the study population.

1084 C. Sabbagh et al. / Digestive and Liver Disease 46 (2014) 1082–1085

Table 1 Characteristics of the study groups.

Dorsal group Lateral group p

Number of patients 161 160 Mean age (years) 62.3 ± 13.04 62.7 ± 14.4 0.9 Mean BMIa (kg/m2) 26.2 ± 4.8 27.3 ± 4.2 0.8 Height 172.9 171.9 0.4 Height >180 cm 47.2 52.8 0.5 Examiner % (n) 0.0001

1 27.3 (9) 18.2 (6) 2 80.9 (38) 72.9 (35) 3 27.8 (10) 27.3 (9) 4 32.6 (14) 62.2 (28)

Indications (n) 0.6 Hernia 56 73 Colon 85 68

- Diverticulitis 20 15 - Colon cancer 65 53

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Table 3 Logistic regression assessment of the risk factors for the failure of digital rectal examination.

Variable p Odds ratio 95% confidence interval

BMI > 30 kg/m2 0.5 0.8 0.46–1.51 Height > 180 cm 0.1 0.6 0.39–1.15 Indication for DRE 0.6 0.9 0.66–1.27 DRE position 0.3 1.25 0.80–1.95 Investigator 0.0001 0.3 0.2–0.95

Other 19 20

a BMI: body mass index.

ther position; and (vi) the impact of the investigator’s habits on he proportion of complete DREs.

.6. Statistical analysis

We performed a multicentre, randomized, controlled, one- ided superiority trial with stratification for the examiner and the atient’s BMI. A total of 320 patients (160 per study group) were equired to detect a 15% intergroup difference in the proportion f complete DREs, with a power of 80% and type I error of 5%. We ypothesized that a complete DRE was possible in 70% of cases in he lateral group and in 55% in the dorsal group. The analysis was n intention-to-treat analysis.

Intergroup comparisons were performed with a chi-square test r Fisher’s exact test (for categorical variables) and a t-test (for ontinuous variables).

No interim analyses were planned. All statistical analyses were erformed with SAS software (SAS Institute Inc., Cary, NC, USA).

. Results

Over a 7-month period (between November 2012 and May 013), a total of 321 patients were included in the study (among 60 screened patients) (Fig. 1). No patients refused to enter the tudy. The two groups were well balanced in terms of their baseline emographic and clinical characteristics (Table 1).

.1. Primary endpoint

The proportion of complete DREs was 44% (n = 71) in the dorsal roup and 49% (n = 79) in the lateral group (p = 0.3) (Table 2).

able 2 he proportion of complete digital rectal examinations and the conversion rate.

Dorsal group Lateral group p

Number of patients 161 160 Complete DREa % (n) 44(71) 49 (79) 0.3 Score 0.02

0 0 2 1 47 27 2 43 50 3 71 79

Conversion rate % (n) 10 (16) 12.5 (20) 0.4

a DRE: digital rectal examination.

OR: odds ratio; CI: confidence interval; BMI: body mass index; DRE: digital rectal examination.

3.2. Secondary endpoints

3.2.1. Patient’s comfort In the dorsal group, 28.5% of the patients (n = 46) stated that

they would have preferred to change to the lateral position. In the lateral group, only 4% (n = 6) stated that they would have preferred to change to the dorsal position (p < 0.0001).

3.2.2. Depth of the DRE The upper border of the prostate had been identified in 55% of

the patients (n = 89) in the dorsal group and 56% of the patients (n = 89) in the lateral group (p = 0.9).

3.2.3. Rectal circumference The entire circumference of the rectum could be studied in 66%

of the patients (n = 106) in the dorsal group and in 80% of the patients (n = 128) in the lateral group (p = 0.007).

3.2.4. Evaluation of sphincter tone Sphincter tone could be evaluated in 100% of the patients

(n = 161) in the dorsal group and in 99% of the patients (n = 158) in the lateral group (p = 0.08).

3.2.5. The “complete DRE” score There was one significant intergroup difference in terms of

score: more patients had a score of 1 in the dorsal group (29%) than in the lateral group (17%) (p = 0.02) (Table 2).

3.2.6. Risk factors for DRE failure Only the identity of the examiner was found to be a risk factor

for DRE failure (odds ratio [95% confidence interval]: 0.3 [0.2–0.95]; Table 3). Also, it should be noted that the investigator with the longer finger did not have the highest rate of DRE.

3.2.7. Conversion rate The extent of conversion from one position to the other did not

differ significantly between the two groups. In the dorsal group 10% of the patients (n = 16) converted to the lateral position to com- plete the rectal examination, while in the lateral group 12.5% of the patients (n = 20) converted to the dorsal position (p = 0.4) (Table 2). No anomalies were found during rectal examination.

3.2.8. Influence of the investigator’s habits on the proportion of complete DREs

Investigators who usually performed a DRE in the lateral posi- tion examined 157 patients (78 in the lateral position and 79 in the dorsal position). The proportion of complete DREs was 47.4% (n = 37) in the lateral group and 30.3% (n = 24) in the dorsal group (p = 0.02). Investigators who usually performed a DRE in the dor-

sal position examined 164 patients (82 in the lateral position and 82 in the dorsal position). In this case, the proportion of complete DREs was 51.2% (n = 42) in the lateral group and 57.3% (n = 47) in the dorsal group (p = 0.4).

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C. Sabbagh et al. / Digestive and

. Discussion

DRE is a routine procedure and is of importance in the man- gement of colon and rectal tumours, anorectal diseases (anorectal anifestations of Crohn’s disease, ulcerative colitis, faecal inconti-

ence, constipation, and haemorrhoids), acute situations (such as bstruction), and urological diseases (prostate cancer and benign rostatic hyperplasia). However, it has been reported that 4.3% of atients refuse to undergo a DRE [6].

Despite the importance of DRE in daily practice and in teach- ng programmes at medical schools, little is known about the best

ay to perform this procedure. Moreover, it has been shown that he number of DREs performed each year by a given physician s correlated (r = 0.37, p < 0.01) with the number of years of clini- al experience (ranging from an average of 29 DREs/year among hysicians within 4 years of graduation to 123 DREs/year among hysicians with more than 20 years of practice). The use of DRE also epends in the physician’s speciality [6–9]. In the present study, we pecifically sought to determine the optimal patient’s position for RE. No specific data are available on the proportion of DREs that re completed. Marshall et al. studied the rate of complete exami- ation of the prostate as a function of the BMI. The authors found hat the prostate could be examined completely in 91.7% of patients ith a BMI below 25 kg/m2, and in 14.3% of those with a BMI above

0 kg/m2 [4]. In view of the lack of robust data in this field, we based ur hypothesis on our own clinical experience. We did not observe

significant intergroup difference in the DRE completion rate (44% n the dorsal group and 49% in the lateral position; p = 0.3). One ould suppose that this lack of difference and the low rate of DRE ompletion are due to the fact that, first, the primary endpoint is n arbitrary, composite criterion and, second, that three elements eeded to be present to define a complete DRE. On the basis of the riteria used here, no specific recommendations on the best way o perform a DRE can be made. Nevertheless, our results show that he lateral position better enabled the examination of the entire ircumference of the rectum (66% in the dorsal group vs. 80% in he lateral group, p = 0.007), which is a key element in rectal cancer

anagement. Hence, when examination of the entire circumfer- nce of the rectum is not possible in the dorsal position, a move o the lateral position may allow the successful completion of this rocedure.

Interestingly, we found that 28.5% of the patients in the dor- al group would have preferred the lateral position, whereas only % of the patients in the lateral group would have preferred the orsal position. Thus, randomization had an influence on patient’s

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Disease 46 (2014) 1082–1085 1085

preference, as significantly more patients in the dorsal group would have preferred to change position.

Patients preferred not to see the examiner during DRE. Hence, patients’ preference also argues in favour of performing a DRE in the lateral position.

The main limitation of the present study is that only men were included. This point was discussed extensively when the proto- col was being drafted. We chose a male-only design for this initial study in order to (i) assess a single landmark (the prostate) in a more homogeneous population, and (ii) limit the influence of potential anorectal anomalies (rectocele, prolapse, etc.). Investigation of the influence of pelvic floor anomalies or rectal cancer is probably nec- essary.

In conclusion, there was no difference between the dorsal group and the lateral group in terms of the proportion of complete DREs (according to our composite criteria). Nevertheless, the lateral posi- tion was associated with better evaluation of the full circumference of the rectum and less embarrassment for the patient. Therefore, at present the lateral position may be preferable.

Conflict of interest None declared.

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