Question

Which interventions have a positive effect on the quality of life in patients with complaints of faecal incontinence after low anterior rectal resection due to rectal cancer?

Recommendation

Patients with faecal incontinence should receive guidance from a surgeon or in collaboration with a nurse specialist with relevant expertise.


The nature of the faecal continence problems (frequency, consistency, discrimination, uncontrollable loss, imperative urge to defaecate and fragmentation) must be ascertained in order to be able to explain the underlying cause to patients.


If the problems are not understood, imaging may help and other causes may be excluded.


Loperamide, fibre supplements, irrigation and pelvic physiotherapy may also be employed as supporting treatment.


Neurostimulation should only be offered within a trial context.

Literature summary

Biofeedback training or multimodal rehabilitation programme

Three observational studies described the effect of biofeedback training. The first study evaluated the effects of a biofeedback in combination with dietary advice and advice on coping strategies, for 19 patients with complaints of urgency, incontinence, frequency or incomplete evacuation who had not responded to diet, standard medication or pelvic floor physiotherapy for a duration of six months or longer (Bartlett, Sloots et al. 2011). All patients had undergone surgery for colorectal carcinoma, of which three a low-anterior resection and 10 an ultra-low anterior resection. A second observational study evaluating the effect of biofeedback included six patients with a low-anterior resection for rectal cancer, with faecal incontinence despite medication treatment (Ho and Tan 1997). The third retrospective study evaluated a series of 58 patients, referred for biofeedback training, with faecal incontinence after sphincter-sparing surgery for rectal cancer (Kim, Yu et al. 2011).

 

In addition, two observational studies and one case-control study described the effects of a rehabilitation programme, aimed at the treatment of faecal incontinence. The first of the two observational studies included 95 patients who had undergone a low-anterior resection and in which 41 patients had been irradiated (Allgayer, Dietrich et al. 2005). The patients were admitted to a rehabilitation programme of three weeks. Treatment consisted of pelvic floor physiotherapy, information, psychological support, a light training programme and biofeedback training. The two observational studies included 69 patients after a low-anterior resection or a colo-anal (Pucciani, Ringressi et al. 2008). The multimodal programme consisted of a combination of two or more components of: (1) pelvic floor physiotherapy; (2) biofeedback exercises; (3) volumetric exercise; and (4) electrostimulation. Twelve of the in total 88 patients underwent all four components of the programme; 41 patients underwent three components and 35 patients only used biofeedback exercises and volumetric exercises. The case-control study described 46 patients after a total mesenterial excision (Laforest, Bretagnol et al. 2012). Twenty-two patients underwent a training programme, with weekly sessions of 1 hour feedback training and pelvic floor exercises. These patients were matched with 24 control patients, for gender, age, tumour stage, height of the tumour, preoperative treatment and postoperative septic complications, but not for scores of incontinence or quality of life prior to treatment.

 

Quality of the evidence

The quality of evidence was very low. The value was lowered for all outcomes due to the lack of control groups, or not checking for confounders in the case-control study. In addition, the results of the two observational studies contradicted the results of the case control study in relation to a multimodal rehabilitation programme (inconsistency). The value was lowered for the outcome incontinence episodes with biofeedback training due to inconsistency and due to imprecision.

 

Desired effects

Quality of life with biofeedback (crucial outcome)

All three studies on biofeedback reported positive effects. In the first study, faecal incontinence quality of life (measured using the Fecal Incontinence Quality of Life (FIQL)) significantly improved directly after 4 weeks biofeedback for three of the four subscales (lifestyle, coping and embarrassment), but not for the subscale depression, compared to before biofeedback (Bartlett, Sloots et al. 2011). The Wexner incontinence score also significantly improved directly after biofeedback, although the median number of incontinence episodes was no different before or after biofeedback (1.0 (inter-quartile range (IQR): 0.0–6.5) versus 0.5 (0.0–3.0; p=0.183). Patients experienced a subjective improvement in control over their defaecation (generic score list improvement of 3.3 (IQR: 1.3–5) to 7.3 (IQR: 6–8.8) (p=0.006). In the second study, the average number of weekly incontinence episodes reduced from 14.8 (standard error (SE): 2.1) to 1.8 (SE: 0.8), after 4 weeks of biofeedback training (p<0.05) (Ho and Tan 1997). The number of patients that used anti-diarrhoea medication reduced from six to zero (p<0.05) and the number of patients that used incontinence material reduced from five to zero (p<0.05). It was reported that no regression was seen after an average follow-up of 12 months; however, previse follow-data was not provided. In the third study, the Wexner incontinence score measured before biofeedback therapy and on completion of the ten weekly session improved from 13.6 (SD: 5.0) to 8.7 (SD: 6.0) (p<0.001) (Kim, Yu et al. 2011).

 

Quality of life with multimodal rehabilitation programme (crucial outcome)

In the case-control study, no significant difference was found between cases and controls in relation to the Wexner score (average score: 8.3 versus 9.9, p=0.10) or the Kirwan classification (18 of the 22 cases and 21 of the 24 controls was incontinent in some form, p=1.00). Cases had a lower defaecation frequency (2.6 versus 4.0 per 24 hours, p=0.03). Cases scored significantly better on two of the 10 subscales of the SF-36 (on the subscales for vitality and mental functioning); for 8 of the 10 subscales there was no significant difference with controls. Cases scored better than control on 1 of the 4 FIQL scales, namely on the depression/self-perception subscale.

Both observational studies evaluated their rehabilitations programmes as positive. In the first study, the Modified Cleveland Incontinence Score (MCIS) was higher immediately after the rehabilitation programme, from 7.49 (SD: 2.2) to 9.49 (SD: 2.7) (p<0.0001) respectively in irradiated patients, and from 8.79 (SD: 2.7) to 11.49 (SD: 2.5) (p<0.0001) in non-irradiated patients (Kim, Yu et al. 2011). Even 1 year after follow-up, significantly better results were still found in both patient groups, in the 75% of patients who were available for follow-up. Nine/95 (9%) of patients were still completely incontinent for faeces directly after the programme, and 14/71 (20%) of patients were so after one year follow-up. In the second study, the Wexner incontinence scores decreased significantly, measured before the rehabilitation programme and directly after completion, from 12.28 (SD: 5.29) to 4.87 (SD: 3.91) (p<0.03) (Pucciani, Ringressi et al. 2008). This was also the case in only the patients who had undergone a low anterior resection: from 11.8 (SD: 5.09) to 6.4 (SD: 3.71) (p<0.05). 29 (33%) patients were assessed as ´good result´ and 21 (24%) patients were symptom-free. 37 patients (42%) were assessed as ‘poor result´: their Wexner score after the rehabilitation programme did not differ significantly from their score before the programme. No follow-up results were reported.

 

Undesirable effects

One study reported that after an average follow-up of 12 months, no complications were seen (Ho and Tan 1997). The other five studies did not report on undesirable effects (Allgayer, Dietrich et al. 2005; Pucciani, Ringressi et al. 2008; Bartlett, Sloots et al. 2011; Kim, Yu et al. 2011; Laforest, Bretagnol et al. 2012)

 

Oral diazepam
One observational study described the effect of oral 2 diazepam 2 mg/day in five patients with faecal incontinence after a low-anterior resection due to rectal cancer (Maeda, Maruta et al. 2002). None of the patients had been irradiated; all had been treated using diet, sphincter training and anti-diarrhoea medication without result.

 

Quality of the evidence

The value was lowered due to the lack of a control group and imprecision. The quality of evidence was extremely low.

 

Desired effects

Quality of life (crucial outcome)

The severity of the faecal incontinence, measured with the Median Cleveland Clinic´s continence scale, changed from a median of 14 (range: 9-16) for diazepam, to 0 (range: 0-12), 3 months after daily 2 mg diazepam (Maeda, Maruta et al. 2002). Before treatment, three of the five patients had daily incontinent episodes; one patient was incontinent once per week and the fifth patient was incontinent once every two weeks. With diazepam use, the incontinence disappeared for three patients; for two patients, it changed the frequency of the incontinence from daily to weekly. All patients used incontinence material before diazepam; two patients used incontinence material after diazepam.

 

Undesirable effects

No information was reported on undesirable effects.

 

Phenylephrine

One randomised, controlled trial (RCT) evaluated the effect of 30% phenylephrine cream on faecal incontinence after a low anterior resection for rectal cancer in 35 patients (Park, Kang et al. 2007). The cream was applied locally twice per day for four weeks.

 

Quality of the evidence

The value was lowered due to bias and inaccuracy; as a result, the quality of evidence was low.

 

Desired effects

Quality of life (crucial outcome)

After four weeks of local treatment with phenylephrine cream or placebo, no difference was found in the severity in faecal incontinence (measured using the Fecal Incontinence Severity Index), faecal incontinence quality of life (measured with the FIQL) or the subjective improvement (Park, Kang et al. 2007).

 

Undesirable effects

Five versus one patient developed a local dermatitis that disappeared two to three days after ceasing use of the cream (Park, Kang et al. 2007).

 

Postanal sphincter repair

One study described three cases of patients with faecal incontinence after a very low-anterior resection for rectal cancer who underwent a postanal sphincter repair (Ho 2001). Despite medication treatment and biofeedback exercises, these patients still suffered from faecal incontinence after more than 1.5 years after resection. Endoanal ultrasound kept showing a sphincter defect.  

 

Quality of the evidence

The quality of evidence was extremely low. The value was lowered due to an extremely high risk of bias and extreme inaccuracy.

 

Desired effects

Quality of life (crucial outcome)

Two patients developed complete continence; one patient remained incontinent for flatus with a frequency of once per month. Protective material, medication against diarrhoea or biofeedback exercises were no longer needed. The average incontinence score (not specified) changed from 13.7 (SD: 1.3) before sphincter repair, to 1.7 (SD: 0.3) after an average of 3.2 years of follow-up.

 

Undesirable effects

Undesirable effects were not reported.

 

Retrograde colon irrigation

One observational study described the effect of retrograde colon irrigation on faecal incontinence (Koch, Rietveld et al. 2009). They evaluated a series of 26 consecutive patients with faecal incontinence after low-anterior resection who applied retrograde colon irrigation (Koch, Rietveld et al. 2009).

 

Quality of the evidence

The quality of evidence was extremely low. The value was lowered due to the lack of a control group.

 

Desired effects

Effect on quality of life (crucial outcome)

Twelve of the 26 patients (46%) were fully (pseudo)continent. Three of the 26 (12%) patients were incontinent for flatus and six of the 26 patients (23%) were still incontinent for faeces, after an average of 1.6 years of retrograde irrigation (Koch, Rietveld et al. 2009). All patients were still using incontinence material.

 

Undesirable effects

Sixteen of the 26 patients (62%) developed side effects: abdominal cramps (n=7); leakage after irrigation (n=6); too time-consuming (n=2); other side effects such as pain or nausea (n=8) (Koch, Rietveld et al. 2009). Five patients stopped the irrigation due to side effects.

 

Sacral nerve stimulation

Eight studies evaluated the effect of sacral nerve stimulation in patients with faecal incontinence after a low-anterior resection due to rectal cancer (Table 1 Summary of studies evaluating sacral nerve stimulation for faecal incontinence in patients who underwent a low-anterior resection due to rectal cancer) (Matzel, Stadelmaier et al. 2002; Jarrett, Matzel et al. 2005; Ratto, Grillo et al. 2005; Holzer, Rosen et al. 2008; Ratto, Parello et al. 2009; de Miguel, Oteiza et al. 2011; Moya, Arroyo et al. 2012; Ortega, Ortega et al. 2012). All these studies concerned small series of patients without control groups. In five studies, patients received medication-based treatment (loperamide), dietary advice and biofeedback treatment without effect (Matzel, Stadelmaier et al. 2002; Jarrett, Matzel et al. 2005; Holzer, Rosen et al. 2008; de Miguel, Oteiza et al. 2011; Moya, Arroyo et al. 2012). This was not described in the remaining three studies.

 

Quality of the evidence

The quality of evidence was extremely low. The value was lowered due to the lack of a control group, and it kept concerning small series of patients. It was unclear in five studies what the population was from which the patients were derived.

 

Desired effects

Quality of life (crucial outcome)

Five studies described the outcomes 1 year after definitive implantation (Table 1 Summary of studies evaluating sacral nerve stimulation for faecal incontinence in patients who underwent a low-anterior resection due to rectal cancer). These five studies reported favourable effects of sacral nerve stimulation, measured with various questionnaires. The sixth study reported outcomes two months after implantation, after which patients reported an average of 2.5 incontinence episodes/week. That was an average of 9.5 less episodes than before implantation (Ratto, Grillo et al. 2005). Quality of life was measured here using the SF-36 questionnaire. On the eight subscales of this questionnaire, there was a median improvement of 12.3 points (average range: 4.8 to 20.5 points). The seventh study reported a reduction in the median Wexner score – after an unknown follow-up – of 15.5 before stimulation to 5.5 during stimulation (p<0.005) (Moya, Arroyo et al. 2012). The eighth study reported results after an average follow-up of 48 months (Ratto, Parello et al. 2009). The average Wexner score reduced from 18.2 (SD1.9) to 9.1 (SD:4.6) (p<0.05); the average number of incontinence episodes for flatus, liquid stools as well as solid faeces also reduced significantly. Quality of life improved significantly, without the associated data being reported.

 

Table 1 Summary of studies evaluating sacral nerve stimulation for faecal incontinence in patients who underwent a low-anterior resection due to rectal cancer

Study

Number of patients screened

Number of implanted patients

Follow-up (months)

Average change in   quality of life  (FIQL score) after 12   months in implanted patients

Other quality of   life outcomes after 12 months in implanted patients

(de   Miguel, Oteiza et al. 2011)

14

7

12

Behaviour : 0.92

Depression : 0.72

Embarassment : 0.86

Lifestyle :   0.94

Gemiddeld aantal dagen/week met incontinentie daalde van 7   (SD: 0)naar 0.2 (SD: 0.3) (p<0.001)

 

Gemiddelde CCF-FI score daalde van 19.2   (SD: 1;2) to 6.2 (SD: 1.7) (p< 0.01)

(Holzer, Rosen et al. 2008)

na

71

12

Behaviour : 1.6 2

Depression : 1.5 2

Embarassment : 2.3 2

Lifestyle : 2.0 2

na

(Jarrett,   Matzel et al. 2005)

3

2

12

The FIQL improved in all categories   (data not reported)

Average number of incontinence   episodes reduced from 10 to 1

 

SF-36 scores improved in all   categories except physical pain (data not reported)

(Moya, Arroyo et al. 2012)

4

4

na

na

na

(Matzel, Stadelmaier et al. 2002)

na

1

18

Behaviour : 0.9

Depression : 1.0

Embarassment : 1.6

Lifestyle : 1.5

The Cleveland   Clinic Continence Score reduced from 17 to 4

 

The % incontinence   episodes reduced from 37% to 1%

(Ortega,   Ortega et al. 2012)

6

6

12

All FIQL scores improved (data not   reported)

The average CCF-FI score reduced   from 18.5 (SD: 1.2) to 6 (SD:   1.7) (p<0.01)

 

The average number of incontinent   episodes per week reduced from 14 (SD: 2) to 4 (SD: 1.3)   (p<0.01)

(Ratto, Grillo et al. 2005)

4

4

2

na

na

(Ratto, Parello et al. 2009)

14

10

48

na

na

Abbreviations: CCF-FI: Cleveland Clinic Florida Fecal Incontinence; FIQL: Fecal Incontinence Quality of Life; na: not available; SD: standard deviation

  1. 1 patient underwent low-anterior resection due to Crohn’s disease
  2. Median

 

Undesirable effects

Five studies with a total of 23 implanted patients described undesirable effects (Matzel, Stadelmaier et al. 2002; Jarrett, Matzel et al. 2005; Holzer, Rosen et al. 2008; Ratto, Parello et al. 2009; Moya, Arroyo et al. 2012). In the study by Holzer et al., one postoperative haematoma was found, which was evacuated under local anaesthetics; and one patient developed an infection of the implant requiring explantation (Holzer, Rosen et al. 2008). The only patient described by Matzel et al. did not suffer complications (Matzel, Stadelmaier et al. 2002). In the study by Jarrett et al., one patient suffered migration of the temporary stimulator (Jarrett, Matzel et al. 2005). In the study by Moya et al., none of the patients suffered a complication; the duration of follow-up here was unknown (Moya, Arroyo et al. 2012). In the study by Ratto et al., one of the ten patients underwent a short-term explantation due to infection (Ratto, Parello et al. 2009).

 

Considerations

No considerations are described.

Authorization date and validity

Last review : 16-04-2014

Last authorization : 16-04-2014

The validity of this guideline and its associated modules is five years. For various reasons, it may be necessary to edit modules sooner than intended. The National Working Group on Gastrointestinal Cancers therefore annually assesses the content of the guideline and its associated modules. By 2016 it is decided whether a new multidisciplinary working group should be installed to revise the entire guideline.

Initiative and authorization

Initiative : Nederlandse Vereniging voor Radiotherapie en Oncologie

Authorized by:
  • Nederlandse Internisten Vereniging
  • Nederlandse Vereniging van Maag-Darm-Leverartsen
  • Nederlandse Vereniging voor Heelkunde
  • Nederlandse Vereniging voor Klinische Geriatrie
  • Nederlandse Vereniging voor Nucleaire geneeskunde
  • Nederlandse Vereniging voor Pathologie
  • Nederlandse Vereniging voor Radiologie
  • Nederlandse Vereniging voor Radiotherapie en Oncologie
  • Vereniging Klinische Genetica Nederland

General details

All members were mandated by a scientific, professional or patient association. In the composition of the working group we tried to take national distribution, input from participants from both academic and general hospitals and representatives of various disciplines into account. Patients are also represented by delegation into the working group, as well as a focus group meeting.

Scope and target group

Goal

This guideline and its associated modules are - as much as possible - based on scientific research and / or consensus. It is a document with recommendations to support the daily practice of health care professionals involved in patients with (possible) colon cancer, rectal cancer or colorectal liver or lung metastases. It provides recommendations for diagnosis, treatment, follow-up and organization of care. The guideline and its associated modules are thus seeking to improve the quality of care, to increase transparency of choice for treatment and reduce diversity.

 

Target population

Each year colorectal cancer is identified in approximately 13,000 new patients. Rectal carcinoma occurs in about 1 in 3 patients of this. In the Netherlands, the colorectal cancer in both men and women rank third place in incidence of oncological diseases. The expected number of patients diagnosed with colorectal cancer are increased in 2020 to about 17,000, reflecting a slight increase in incidence (especially in men), population growth and aging.

Colorectal cancer is slightly more common in men than in women and ninety percent of patients 55 years or older. More information about the Dutch population can be found at the Netherlands Cancer Registry: www.cijfersoverkanker.nl

This guideline is applicable to all adult patients with (suspected) a primary colorectal carcinoma and patients with metastatic disease. Particular attention is given to the elderly. A separate guideline is available for adult patients with an increased risk of hereditary colon cancer.

Target Audience

This guideline and its associated modules are intended for all professionals involved in the diagnosis, treatment and rehabilitation of patients with (metastatic) colorectal cancer, such as surgeons, general practitioners, consultants, internists, gastroenterologists, (specialist) nurses, clinical geneticists, paramedics, pathologists, radiologists and radiotherapists. The complete guideline is used to develop a patient education text from the Dutch patients Consumer Federation (NPCF).

 

Members of the guideline panel

Name

Function

Hospital

Mandated

Mw. prof. dr. C.A.M. Marijnen chair

Radiotherapist

LUMC Leiden

NVRO

Mw. prof. dr. R.G.H. Beets-Tan

Radiologist

MUMC Maastricht

NVVR

Mw. S. de Bruijn

Specialist nurse

Renier de Graaf hospital Delft

V&VN

Mw. dr. A. Cats

Gastroenterologist

NKI-AVL Amsterdam

NVMDL

Prof. dr. E.F.I. Comans

Nuclear doctor

VUMC Amsterdam

NVNG

Dr. A.R. van Erkel

Intervention radiologist

LUMC Leiden

NVVR

Mw. dr. M.A.M. Frasa

Clinical chemist

Groene Hart hospitalGouda

NVKC

Mw. C. Gielen

Specialist nurse

MUMC Maastricht

V&VN

Dr. E.J.R. de Graaf

Surgeon

IJsselland hospital Capelle a/d IJssel

NVVH

Mw. dr. M. Hamaker

Geriatrician

Diakonessenhuis Utrecht

NVKG

Mw. dr. J.E. van Hooft

Gastroenterologist

AMC Amsterdam

NVMDL

Mw. H.J.A.M.. Kunneman

Researcher

LUMC Leiden

n.v.t.

Mw. dr. M.E. van Leerdam

Gastroenterologist

NKI-AVL Amsterdam

NVMDL

Dr. H. Martijn

Radiotherapist

Catharina-hospital Eindhoven

NVRO

Mw. dr. A.M. Mendez

Romero

Radiotherapist

EMC Cancer Insititute Rotterdam

NVRO

Mw. prof. dr. I.D. Nagtegaal

Pathologist

UMCN St Radboud Nijmegen

NVVP

Dr. L.A. Noorduyn

Pathologist

Lab. Voor Pathologie Dordrecht e.o.

NVVP

Mw. A. Ormeling

Patient

Stomavereniging

NFK

Drs. T.A.M. van Os

Klinisch Geneticus

AMC Amsterdam

VKGN

Dr. F.T.M. Peters

Gastroenterologist

UMCG Groningen

NVMDL

Mw. J. Pon

Patient

NFK/SPKS

NFK

Mw. dr. J.E.A. Portielje

Medical oncologist

Haga hospital Den Haag

Gerionne

Prof. dr. C.J.A. Punt

Medical oncologist

AMC Amsterdam

NIV

Mw. dr. H. Rütten

Radiotherapist

UMCN Radboud Nijmegen

NVRO

Prof. dr. H.J.T. Rutten

Surgeon

Catharina-hospitalEindhoven

NVVH

Prof. dr. J. Stoker

Radiologist

AMC Amsterdam

NVVR

Dr. P.J. Tanis

Surgeon

AMC Amsterdam

NVVH

Dr. J.H. von der Thüsen

Pathologist

MC Haaglanden Den Haag

NVVP

Prof. dr. H.M.W. Verheul

Medical oncologist

VUMC Amsterdam

NIV

Prof. dr. C. Verhoef

Surgeon

EMC Cancer Insititute Rotterdam

NVVH

Dr. Tj. Wiersma

General practitioner

NHG

NHG

 

 

Name

Function

Location

Mw. drs. A.Y. Steutel

process manager

Utrecht

Drs. T. van Vegchel

process manager

Amsterdam

Mw. S. Janssen-van Dijk

secretary

Rotterdam

M.P.  van den Berg

Researcher

Bilthoven

P.F. van Gils

Researcher

Bilthoven

Mw. J. Robays

Methodologist

Brussels

Mw. drs. Y Smit

Methodologist

Germany

Mw. A. Suijkerbuijk

Researcher

Bilthoven

Mw. dr. L. Veerbeek

Methodologist

Groningen

Mw. dr. L. Verheye

Methodologist

Brussels

Mw. dr. G.A. de Wit

Researcher

Bilthoven

 

Patient involvement

Two patient experts have been part of the guideline development group. One on behalf of the Dutch Ostomy Association and on behalf of SPKS/NFK. Based on a focus group meeting experiences of patients regarding care were collected. The guideline also has been used to develop a patient education text for the Dutch patients Consumer Federation (NPCF).

Method of development

Evidence based

Implementation

Promoting the use of recommendations begins with a broad (digital) distribution of the guideline, using direct mailing and an article published in the Dutch Journal of Oncology. In other journals or training sessions, for example, the guideline is brought to the attention. An implementation plan for this guideline contains the key recommendations and an overview of barriers and facilitators for implementation.

Methods and proces

The working group met in July 2012 for the first time. Based on an initial list of problems by working group members a survey among professionals involved in patients with colorectal carcinoma was held. Through this survey, sixty professionals supplied and prioritized possible subjects for revision. Also, a focus group meeting was held, collection patients' experiences. The eleven most relevant questions were answered, and translated into English. Also, alle recommendations were translated into English.

 

Each clinical question was andwered by a subgroup within the development group. External methodologists provided the literature search, review, critical assessment, evidence tables and a draft literature review. Workgroup members suggested other considerations and recommendations.

Responsibility

The Comprehensive Cancer Organisation the Netherlands (IKNL) promotes that people with cancer and their families have access to a consistent and qualitatively adequate care as close to home as possible. IKNL was established to improve treatment, care and clinical research in oncology. It also has a role in setting up and supporting networks for palliative care. IKNL supports multidisciplinary guideline development for oncology and palliative care and facilitates the maintenance, management, implementation and evaluation of these guidelines.

AGREE was used to check the methodological quality of the guideline.

Search strategy

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