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## Complete Summary

#### GUIDELINE TITLE

Practice parameters for the management of rectal cancer (revised).

#### BIBLIOGRAPHIC SOURCE(S)

Tjandra JJ, Kilkenny JW, Buie WD, Hyman N, Simmang C, Anthony T, Orsay
C, Church J, Otchy D, Cohen J, Place R, Denstman F, Rakinic J, Moore R,
Whiteford M. Practice parameters for the management of rectal cancer
(revised). Dis Colon Rectum 2005 Mar;48(3):411-23. \[143 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15875292)

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: American Society of Colon and
Rectal Surgeons. Practice parameters for the treatment of rectal
carcinoma. Arlington Heights (IL): American Society of Colon and Rectal
Surgeons; 1998-1999. 3 p.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Rectal cancer

#### GUIDELINE CATEGORY

Evaluation\
Management\
Treatment

#### CLINICAL SPECIALTY

Colon and Rectal Surgery\
Gastroenterology\
Internal Medicine\
Oncology

#### INTENDED USERS

Health Care Providers\
Patients\
Physicians

#### GUIDELINE OBJECTIVE(S)

To provide appropriate recommendations for the management of patients
with rectal cancer

#### TARGET POPULATION

Patients with rectal cancer

#### INTERVENTIONS AND PRACTICES CONSIDERED

**[Evaluation]{.underline}**

**Preoperative Assessment**

1.  Examination

    -   Evaluation for medical fitness to undergo surgery

    -   Clinical assessment including family history to evaluate
        familial risk

    -   Digital rectal examination and rigid proctosigmoidoscopy

    -   Full colonoscopy

    -   Barium enema

2.  Imaging studies

    -   Computed tomography (CT) scanning of the abdomen and pelvis

    -   Transrectal ultrasound (TRUS)

    -   Magnetic resonance imaging (MRI)

    -   Routine chest radiographs or chest CT scanning

3.  Laboratory studies

    -   Carcinoembryonic antigen (CEA) level

**[Treatment/Management]{.underline}**

**Surgical Techniques**

1.  Use of a 2-cm distal margin (a 1-cm distal margin is acceptable in
    smaller cancers of the low rectum)

2.  Proximal lymphovascular ligation at the origin of the superior
    rectal artery

3.  Total mesorectal excision (TME) (distal rectal cancers)

4.  Tumor-specific mesorectal resection (upper rectal cancers)

5.  *En bloc* resection (rectal cancers with adjacent organ involvement)

6.  Routine prophylactic oophorectomy (considered, but not recommended)

7.  Intraoperative rectal washout (considered, but not recommended)

8.  Curative local excision (T1 rectal cancers)

9.  Laparoscopic-assisted resection (oncologic effectiveness remains
    uncertain)

10. Emergency primary resection of an obstructing or perforated
    carcinoma

**Adjuvant Therapy (Preoperative or Postoperative)**

1.  Adjuvant or neoadjuvant chemotherapy

2.  Pelvic radiation

3.  Combined modality therapy

#### MAJOR OUTCOMES CONSIDERED

-   Morbidity and mortality

-   Tumor recurrence rate

-   Sensitivity and specificity of diagnostic tests

-   Survival and disease-free survival

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Not stated

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

**Levels of Evidence**

I.  Meta-analysis of multiple well-designed, controlled studies,
    randomized trials with low false-positive and low false-negative
    errors (high-power)

II. At least one well-designed experimental study; randomized trials
    with high false-positive or high false-negative errors or both
    (low-power)

III. Well-designed, quasi-experimental studies, such as nonrandomized,
     controlled, single-group, preoperative-postoperative comparison,
     cohort, time, or matched case-control series

IV. Well-designed, nonexperimental studies, such as comparative and
    correlational descriptive and case studies

V.  Case reports and clinical examples

#### METHODS USED TO ANALYZE THE EVIDENCE

Review of Published Meta-Analyses\
Systematic Review

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Not stated

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

**Grades of Recommendations**

A.  Evidence of Type I or consistent findings from multiple studies of
    Type II, III, or IV

B.  Evidence of Type II, III, or IV and generally consistent findings

C.  Evidence of Type II, III, or IV but inconsistent findings

D.  Little or no systematic empirical evidence

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Not stated

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Not applicable

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

The levels of evidence (classes I-V) and the grades of recommendations
(A-D) are defined at the end of the \"Major Recommendations\" field.

**[Preoperative Assessment]{.underline}**

1.  Patients should be evaluated for their medical fitness to undergo
    surgery. When an ostomy is a consideration, preoperative counseling
    with an enterostomal therapist should be offered when available.
    **Level of Evidence: III; Grade of Recommendation: B**.

> Appraisal of operative risk, especially with respect to
> cardiopulmonary comorbidity, is an essential part of the preoperative
> process. History and physical examination are the cornerstones of
> diagnostic evaluation and may prompt further investigation and
> intervention to optimize operative risk. In selected cases, a
> nonsurgical approach to the lesion may be necessary. Several
> perioperative, risk-assessment scoring systems have been published to
> help guide the surgeon. The need for ancillary laboratory tests is
> guided by history and physical examination.

2.  Clinical assessment should include a family history to identify
    patients with familial cancer syndromes and to evaluate familial
    risk. **Level of Evidence: III; Grade of Recommendation: B**.

> A family medical history should be taken from patients with rectal
> cancer to identify close relatives with a cancer diagnosis. The
> clinician should look for patterns consistent with the genetic
> syndromes of hereditary nonpolyposis colorectal cancer, familial
> adenomatous polyposis, and familial colorectal cancer because this may
> affect surgical decisions.
>
> The colorectal cancer risk in family members increases with the number
> of affected members, the closeness of the relationship to the patient,
> and earlier age of onset. Medical information that patients provide
> about their relatives often is inaccurate. If a family medical history
> seems to be significant but proves difficult to confirm, it may be
> appropriate to seek expert help from a familial cancer clinic.

3.  Digital rectal examination and rigid proctosigmoidoscopy are
    typically required for accurate tumor assessment. **Level of
    Evidence: Class V; Grade of Recommendation: D**.

> Digital rectal examination enables detection and assessment of the
> size and degree of fixation of mid and low rectal tumors. Although
> digital assessment of the extent of local disease may be imprecise, it
> provides a rough estimate of the local staging of rectal cancer. Rigid
> proctosigmoidoscopy is usually performed in conjunction with the
> digital rectal examination. It usually allows the most precise
> assessment of tumor location and the distance of the lesions from the
> anal verge. These issues are critical in optimizing preoperative
> planning.

4.  Full colonoscopy should be performed to exclude synchronous
    neoplasms. Barium enema may be used for those patients unable to
    undergo complete colonoscopy. **Level of Evidence: III; Grade of
    Recommendation: B**.

> Colonoscopy is currently the most accurate tool for screening the
> colon and rectum for neoplasms. The sensitivity of colonoscopy for
> colon cancer is typically in the range of 95 percent. Colonoscopy
> allows biopsy and histologic confirmation of the diagnosis. It also
> allows for identification and endoscopic removal of synchronous
> polyps.

5.  Computed tomography (CT) scanning of the abdomen and pelvis and
    transrectal ultrasound (TRUS) or magnetic resonance imaging (MRI)
    should typically be performed in patients who are potentially
    surgical candidates. **Level of Evidence: III; Grade of
    Recommendation: B**.

6.  Routine chest radiographs or chest CT scanning should usually be
    performed. **Level of Evidence: III; Grade of Recommendation: B**.

> Rectal cancer is more likely than colon cancer to be associated with
> lung metastases without liver metastases. The finding of pulmonary
> metastases often will alter patient management decisions and therefore
> is warranted in most clinical situations. Abnormal findings on plain
> radiographs usually warrant chest CT scanning.

7.  Carcinoembryonic antigen (CEA) level should usually be determined
    preoperatively. **Level of Evidence: III; Grade of Recommendation:
    B**.

**[Treatment Considerations]{.underline}**

Surgery is the mainstay of treatment for rectal cancer. The risk of
recurrence is dependent on the TNM stage (See Table 1 in the original
guideline document titled, \"Definition of TNM\"). Early stage cancer
can be treated by surgical resection alone. More advanced lesions
require adjuvant therapy to increase the probability of cure.

**Surgical Therapy**

*Resection Margin*

A 2-cm distal margin is adequate for most rectal cancers. **Level of
Evidence: Class III; Grade of Recommendation: B**.

In smaller cancers of the low rectum without adverse histologic
features, a 1-cm distal margin is acceptable. **Level of Evidence: Class
III; Grade of Recommendation: B**.

Margins \>1 cm should be obtained with larger tumors, especially those
demonstrating adverse histologic features. The margins of resection
should be measured in the fresh, pinned out specimen. The formalin-fixed
specimen may shrink up to 50 percent in length.

*Level of Proximal Vascular Ligation*

Proximal lymphovascular ligation at the origin of the superior rectal
artery is adequate for most rectal cancers. **Level of Evidence: Class
III; Grade of Recommendation: B**.

Appropriate lymphadenectomy is based on the ligation of the major
vascular trunks. There is no demonstrable survival advantage for a high
ligation of the inferior mesenteric artery at its origin. Available
evidence suggests that for colorectal cancer without clinically
suspicious nodal disease, removal of lymphovascular vessels up to the
origin of the primary feeding vessel is adequate. Thus for rectal
cancer, this is at the origin of the superior rectal artery, just distal
to the origin of the left colic artery. In patients with lymph nodes
thought to be involved clinically, removal of all suspicious nodal
disease up to the origin of inferior mesenteric artery is recommended.
Suspicious periaortic nodes may be biopsied for staging purposes. High
ligation of the inferior mesenteric vessels may be helpful to provide
additional mobility of the left colon, as often is required for a low
colorectal anastomosis or a colonic J-pouch construction.

*Circumferential Resection Margin*

For distal rectal cancers, total mesorectal excision (TME) is
recommended. For upper rectal cancers, a tumor-specific mesorectal
resection is adequate. **Level of Evidence: Class II; Grade of
Recommendation: A**.

*En Bloc Resection of Adherent (T4) Tumors*

Rectal cancers with adjacent organ involvement should be treated by en
bloc resection. **Level of Evidence: Class III; Grade of Recommendation:
B**.

**Inadvertent Perforation**

Inadvertent perforation of the rectum worsens oncologic outcome and
should be documented. Level of Evidence: **Class III; Grade of
Recommendation: B**.

**Other Operative Considerations**

1.  Grossly normal ovaries need not be removed. **Level of Evidence:
    Class III; Grade of Recommendation: B**.

> Ovarian metastases from rectal cancer occur in up to 6 percent of
> patients and are usually associated with widespread disease and poor
> prognosis. There are no data to support routine prophylactic
> oophorectomy. Direct invasion of the ovary is treated with an en bloc
> resection. Oophorectomy should be considered if the organ is grossly
> abnormal in postmenopausal females or in females who have received
> preoperative pelvic radiotherapy. Bilateral oophorectomy is indicated
> if only one ovary is involved, because there is a high risk of occult
> metastatic disease in the contralateral ovary.

2.  There is insufficient evidence to recommend intraoperative rectal
    washout. **Level of Evidence: Class IV; Grade of Recommendation:
    C**.

3.  Curative local excision is an appropriate treatment modality for
    carefully selected T1 rectal cancers. **Level of Evidence: Class II;
    Grade of Recommendation: B**.

> Local excision of rectal cancer is an appropriate alternative therapy
> for selected cases of rectal cancer with a low likelihood of nodal
> metastases. This probability is dependent on the depth of tumor
> invasion (T stage), tumor differentiation, and lymphovascular
> invasion. Comparative trials to abdominoperineal resection support
> transanal local excision with curative intent for T1,
> well-differentiated cancers that are \<3 cm in diameter and occupy
> \<40 percent of the circumference of the rectal wall.
>
> The tumor must be excised intact by full-thickness excision with clear
> margins. It should be orientated and pinned out for complete
> pathologic examination. If unfavorable features are observed on
> pathologic examination, a radical excision is warranted.

4.  Laparoscopic-assisted resection of rectal cancer is feasible but
    requires specific surgical expertise. Its oncologic effectiveness
    remains uncertain at this time. **Level of Evidence: Class II; Grade
    of Recommendation: B**.

5.  Emergency intervention: Primary resection of an obstructing or
    perforated carcinoma is recommended unless medically
    contraindicated. **Level of Evidence: Class III; Grade of
    Recommendation: A**.

> Hemorrhage, obstruction, and bowel perforation are the most common
> indications for emergency intervention for rectal cancer. Appropriate
> management must be individualized with options, including resection
> with anastomosis and proximal diversion, or diversion alone followed
> by radiation. Other alternatives include endoluminal stenting or
> laser/cautery recanalization. Self-expandable metallic stents can be
> used to relieve obstruction by a proximal rectal cancer. This allows
> for mechanical bowel preparation, elective resection, and anastomosis.
> In some cases with advanced metastatic disease or major comorbidities,
> it may constitute definitive treatment.

**[Adjuvant Therapy]{.underline}**

Adjuvant chemoradiation should be offered to patients with Stage II and
III rectal cancers. **Level of Evidence: Class I; Grade of
Recommendation: A**.

**[Definitions]{.underline}**:

**Levels of Evidence**

1.  Meta-analysis of multiple well-designed, controlled studies,
    randomized trials with low false-positive and low false-negative
    errors (high-power)

2.  At least one well-designed experimental study; randomized trials
    with high false-positive or high false-negative errors or both
    (low-power)

3.  Well-designed, quasi-experimental studies, such as nonrandomized,
    controlled, single-group, preoperative-postoperative comparison,
    cohort, time, or matched case-control series

4.  Well-designed, nonexperimental studies, such as comparative and
    correlational descriptive and case studies

5.  Case reports and clinical examples

**Grades of Recommendations**

A.  Evidence of Type I or consistent findings from multiple studies of
    Type II, III, or IV

B.  Evidence of Type II, III, or IV and generally consistent findings

C.  Evidence of Type II, III, or IV but inconsistent findings

D.  Little or no systematic empirical evidence

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for each of the
recommendations (see \"Major Recommendations\" field).

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Appropriate evaluation and management of patients with rectal cancer

#### POTENTIAL HARMS

-   The surgeon is a critical variable with respect to morbidity,
    sphincter preservation rate, and local recurrence. One study found
    that local recurrence ranged from \<5 to 15 percent amongst
    different surgeons with no difference in case mix. In a Scottish
    study, the operative mortality and ten-year survival rate after
    \"curative\" surgery varied with the surgeon, ranging from 0 to 20
    percent and 20 to 63 percent, respectively.

-   Inadvertent rectal perforation during the resection of rectal cancer
    is associated with a statistically significant reduction in
    five-year survival and an increase in local recurrent rates.

-   Self-expandable metallic stents can be used to relieve obstruction
    by a proximal rectal cancer. Complications include perforation (5
    percent), stent migration (10 percent), bleeding (5 percent), pain
    (5 percent), and reobstruction (10 percent).

-   The morbidity associated with postoperative adjuvant therapy can be
    significant. In the Danish, Dutch, and Medical Research Council
    (MRC) postoperative therapy trials, \>20 percent of patients did not
    complete their allocated treatment because of postoperative
    complications and/or patient refusal. Furthermore, functional
    outcomes may be compromised by postoperative combined modality
    therapy (CMT). In a review of two National Surgical and Adjuvant
    Breast and Bowel Project (NSABP) trials, a significant increase in
    severe diarrhea was noted from CMT particularly in patients
    receiving a low anterior resection. Other acute side effects
    included cystitis, skin reactions, and fatigue. One study emphasized
    both acute and chronic effects, including radiation enteritis,
    small-bowel obstruction, and rectal stricture.

-   A major concern of short-course radiotherapy (RT) remains the
    increase in short-term and long-term toxicity, as has been noted
    with short-course RT at other sites. A subgroup of patients from the
    Swedish Rectal Cancer Trial completed a questionnaire regarding
    anorectal dysfunction. Abnormal function included frequency, urgency
    and incontinence, and reduced social activities in 30 percent of
    patients who received short-course radiation *vs*. 10 percent of
    patients after surgery alone (*P* \< 0.01). The authors suggested a
    radiation effect on the anal sphincter or its nerve supply. These
    complications are similar to those after postoperative radiotherapy.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   These guidelines are inclusive, and not prescriptive. Their purpose
    is to provide information on which decisions can be made, rather
    than dictate a specific form of treatment. It should be recognized
    that these guidelines should not be deemed inclusive of all proper
    methods of care or exclusive of methods of care reasonably directed
    to obtaining the same results. The ultimate judgment regarding the
    propriety of any specific procedure must be made by the physician in
    light of all of the circumstances presented by the individual
    patient.

-   The practice parameters set forth in this document have been
    developed from sources believed to be reliable. The American Society
    of Colon and Rectal Surgeons makes no warranty, guarantee, or
    representation whatsoever as to the absolute validity or sufficiency
    of any parameter included in this document, and the Society assumes
    no responsibility for the use or misuse of the material contained.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Living with Illness

#### IOM DOMAIN

Effectiveness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Tjandra JJ, Kilkenny JW, Buie WD, Hyman N, Simmang C, Anthony T, Orsay
C, Church J, Otchy D, Cohen J, Place R, Denstman F, Rakinic J, Moore R,
Whiteford M. Practice parameters for the management of rectal cancer
(revised). Dis Colon Rectum 2005 Mar;48(3):411-23. \[143 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15875292)

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

1993 (revised 2005 Mar)

#### GUIDELINE DEVELOPER(S)

American Society of Colon and Rectal Surgeons - Medical Specialty
Society

#### SOURCE(S) OF FUNDING

Not stated

#### GUIDELINE COMMITTEE

Standards Task Force of the American Society of Colon and Rectal
Surgeons

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Task Force Members*: Joe J. Tjandra, MD; John W. Kilkenny, MD; W.
Donald Buie, MD; Neil Hyman, MD; Clifford Simmang, MD; Thomas Anthony,
MD; Charles Orsay, MD; James Church, MD; Daniel Otchy, MD; Jeffrey
Cohen, MD; Ronald Place, MD; Frederick Denstman, MD; Jan Rakinic, MD;
Richard Moore, MD; Mark Whiteford, MD

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: American Society of Colon and
Rectal Surgeons. Practice parameters for the treatment of rectal
carcinoma. Arlington Heights (IL): American Society of Colon and Rectal
Surgeons; 1998-1999. 3 p.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the
[American Society of Colon and Rectal Surgeons Web
site](http://www.fascrs.org/files/rectal_cancer_0605.pdf).

Print copies: Available from the ASCRS, 85 W. Algonquin Road, Suite 550,
Arlington Heights, Illinois 60005.

#### AVAILABILITY OF COMPANION DOCUMENTS

None available

#### PATIENT RESOURCES

None available

#### NGC STATUS

This summary was completed by ECRI on February 15, 2000. The information
was verified by the guideline developer on November 7, 2000. This
summary was updated by ECRI on July 15, 2005.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to
the guideline developer\'s copyright restrictions.

### DISCLAIMER

#### NGC DISCLAIMER

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/10/2008