SURGERY

Stapled Stapled Hemorrhoidopexy Versus Hemorrhoidopexy Versus Milligan-Morgan Milligan-Morgan HemorrhoidectomyHemorrhoidectomy

CRITICAL APPRAISAL CRITICAL APPRAISAL

3-D3-D

Tongson, Michael

Traboco, Lisa

Tuason, Zsarin

Clinical ScenarioClinical Scenario

A 42 year old female patient with A 42 year old female patient with symptomatic hemorrhoids consulted symptomatic hemorrhoids consulted at the clinic. at the clinic.

Pain, itching and palpable massPain, itching and palpable mass

Clinical QuestionClinical Question

Among patients with symptomatic Among patients with symptomatic hemorrhoids, would Stapled hemorrhoids, would Stapled Hemorrhoidopexy be beneficial?Hemorrhoidopexy be beneficial?

Stapled Stapled Hemorrhoidopexy Versus Hemorrhoidopexy Versus Milligan-Morgan Milligan-Morgan HemorrhoidectomyHemorrhoidectomy

Gravie, J; Lehur, P; Huten, N; Gravie, J; Lehur, P; Huten, N; Papillon, M; Fantoli, M; Papillon, M; Fantoli, M; Descottes, B; Pessaux, P; Descottes, B; Pessaux, P; Arnaud, JArnaud, J

Annals of Surgery; Volume 242, Number 1; July 2005

Purpose of the StudyPurpose of the Study

To compare the outcome of Stapled To compare the outcome of Stapled Hemorrhoidopexy (SH group) with Hemorrhoidopexy (SH group) with that of the Milligan Morgan technique that of the Milligan Morgan technique (MM group)(MM group)

Post-operative data (short and long Post-operative data (short and long term)term)– PainPain– Hospital Stay Hospital Stay – ComplicationsComplications

Various types of hemorrhoidectomies Various types of hemorrhoidectomies have developed throughout the years have developed throughout the years but they are all associated with the but they are all associated with the same basic principle:same basic principle:

– This is decreasing blood flow to the This is decreasing blood flow to the anorectal ring and anorectal ring and

– removing redundant hemorrhoidal removing redundant hemorrhoidal tissue. tissue.

Milligan-Morgan Milligan-Morgan HemorrhoidectomyHemorrhoidectomy

In the United Kingdom, the Milligan and Morgan In the United Kingdom, the Milligan and Morgan hemorrhoidectomy is most commonly used. This hemorrhoidectomy is most commonly used. This technique involves:technique involves:

– ligation and excision of the hemorrhoids while leaving ligation and excision of the hemorrhoids while leaving the wound open. the wound open.

– In this technique, the anus is gently dilated and the In this technique, the anus is gently dilated and the hemorrhoidal tissue and perianal skin are everted just hemorrhoidal tissue and perianal skin are everted just outside the anorectal ring. outside the anorectal ring.

– The triangular shaped hemorrhoid is excised down to the The triangular shaped hemorrhoid is excised down to the underlying sphincter muscle. underlying sphincter muscle.

– The pedicle is then ligated with suture. The pedicle is then ligated with suture. – The wound is left open and a light dressing applied. The wound is left open and a light dressing applied. – One, two or three hemorrhoids may be treated in this One, two or three hemorrhoids may be treated in this

manner. manner.


Stapled Stapled HemorrhoidopexyHemorrhoidopexy

Stapled HemorrhoidopexyStapled Hemorrhoidopexy Also called Procedure for Prolapse & Hemorrhoids Also called Procedure for Prolapse & Hemorrhoids

(PPH), Stapled Hemorrhoidectomy, and (PPH), Stapled Hemorrhoidectomy, and Circumferential Mucosectomy Circumferential Mucosectomy

treats bleeding or prolapsed internal hemorrhoidstreats bleeding or prolapsed internal hemorrhoids reduces the prolapse of hemorrhoidal tissue by reduces the prolapse of hemorrhoidal tissue by

excising a band of the prolapsed anal mucosa excising a band of the prolapsed anal mucosa membrane with the use of a circular stapling device membrane with the use of a circular stapling device

the prolapsed tissue is pulled into a device that the prolapsed tissue is pulled into a device that allows the excess tissue to be removed while the allows the excess tissue to be removed while the remaining hemorrhoidal tissue is stapledremaining hemorrhoidal tissue is stapled

restores the hemorrhoidal tissue back to its original restores the hemorrhoidal tissue back to its original anatomical position. anatomical position.

under general anesthesia as day surgeryunder general anesthesia as day surgery

ProcedureProcedure

• reduction of the prolapsed tissue• gentle dilatation of the anal canal to accept the instrument• placement of a purse-string suture• placement and firing of the stapling device

• The Hemorrhoidal Circular Stapler is opened to its maximum position

• The ends of the suture are knotted externally

• Moderate traction draws the prolapsed mucous membrane into the casing of the circular stapling device. The instrument is then tightened and fired to staple the prolapse.

• A circular knife excises the redundant tissue. A circumferential column of mucosa is removed from the upper anal canal.

•Finally, the staple line is examined using the anoscope and control any bleeding from the stapling line

MethodologyMethodology134 patients 7 centers

SH group MM group63 patients

63 patients

Inclusion Criteria:

Symptomatic hemorrhoidal disease (Prolapse)

Exclusion criteria

acute hemorrhoidal episodes w/ thrombosis

prior hemorrhoidectomy

intercurrent anal pathology (fistula/fissure)

2 year follow up

Critical AppraisalCritical Appraisal

Primary ValidityPrimary Validity

1. Was the assignment of patients to 1. Was the assignment of patients to treatments randomized?treatments randomized?

Was the randomization concealed?Was the randomization concealed?

- 134 patients were randomized 134 patients were randomized - 15-month period15-month period- 7 different centers (both teaching and 7 different centers (both teaching and

private hospital)private hospital)- 2 groups, SH (63); MM(63)2 groups, SH (63); MM(63)- Randomization method was concealedRandomization method was concealed

2. Were all the patients who entered the 2. Were all the patients who entered the trial accounted for at its conclusion?trial accounted for at its conclusion?

Were they analyzed in the groups to Were they analyzed in the groups to which they were randomized?which they were randomized?

- Yes.Yes.- Follow-up periodFollow-up period

- 6 weeks6 weeks- 1 and 2 years1 and 2 years

- Total of 17 patients (11 SH and 6MM) failed to return 2-Total of 17 patients (11 SH and 6MM) failed to return 2-year follow upyear follow up

3. Was the follow-up complete?3. Was the follow-up complete?- Patient monitoring Patient monitoring

- Clinical examination by the surgeonClinical examination by the surgeon- Pre-operativelyPre-operatively- Post-operativelyPost-operatively

- 6 weeks, 1 year, and minimum of 2 years6 weeks, 1 year, and minimum of 2 years

- 53-item questionnaire53-item questionnaire- Pre-operativelyPre-operatively- 1 year post-operation1 year post-operation

Intention to treat analysisIntention to treat analysis

53-item questionnaire53-item questionnaire1.1. SymptomsSymptoms

- Anal mass (90%)- Anal mass (90%)- Frequent bleeding (47%)- Frequent bleeding (47%)- Itching (35%)- Itching (35%)- Discharge and soiling (31%)- Discharge and soiling (31%)- Pain (15%)- Pain (15%)

2.2. Sphincter functionSphincter function3.3. DefecationDefecation4.4. Quality of lifeQuality of life- Allowed the assessment of the effectiveness in the:Allowed the assessment of the effectiveness in the:

- Symptom controlSymptom control- Functional outcomeFunctional outcome- Patient’s overall satisfactionPatient’s overall satisfaction backback

Secondary ValiditySecondary Validity

1. Was the study Blind?1. Was the study Blind? Patients: NO Patients: NO

– After assignment to the groups, they After assignment to the groups, they were informed of the result of the were informed of the result of the randomizationrandomization

Investigators: NOInvestigators: NO

Secondary ValiditySecondary Validity2. Were the groups similar at the start of the trial?2. Were the groups similar at the start of the trial? ““There were no significant differences between the 2 There were no significant differences between the 2

groups with respect to sex, weight, history…. groups with respect to sex, weight, history…. … … Mean age was higher in the SH group (51 versus 44 in Mean age was higher in the SH group (51 versus 44 in

the MM)”the MM)” Inclusion & Exclusion CriteriaInclusion & Exclusion Criteria Adjustment for significant differences/Baseline Adjustment for significant differences/Baseline

characteristicscharacteristics– Symptomatic hemorrhoidal disease (impression of a mass, frequent Symptomatic hemorrhoidal disease (impression of a mass, frequent

bleeding, puritus ani/itching, discharge and soiling and pain) could bleeding, puritus ani/itching, discharge and soiling and pain) could be treated by surgical technique be treated by surgical technique

– Prolapse of internal hemorrhods was the most common reason for Prolapse of internal hemorrhods was the most common reason for decision to operate ; reducible prolapse considered as not amenable decision to operate ; reducible prolapse considered as not amenable by banding or have failed to respond to previous bandingby banding or have failed to respond to previous banding

Randomization and adequate sample sizeRandomization and adequate sample size– Random assignment to the groupsRandom assignment to the groups– 126 patients126 patients

Secondary ValiditySecondary Validity3. Were the groups treated equally?3. Were the groups treated equally? Co-interventionsCo-interventions

– Anesthesia was left up to the investigating centerAnesthesia was left up to the investigating center– Administration of analgesicsAdministration of analgesics

Sytematic anti-inflammatory medication + subcutaneous Sytematic anti-inflammatory medication + subcutaneous morphine during operation and immediately aftermorphine during operation and immediately after

During hospitalization: based on the Visual Analogue Scale During hospitalization: based on the Visual Analogue Scale (VAS)(VAS)

0 = “no pain”0 = “no pain” 10 = “maximum pain”10 = “maximum pain”<3 WHO Class I analgesic (paracetamol)<3 WHO Class I analgesic (paracetamol)3-5 Class II (paracetamol codeine, dextropropoxyphene- 3-5 Class II (paracetamol codeine, dextropropoxyphene- paracetamol) paracetamol)>5 Class III (morphine administered systematically + >5 Class III (morphine administered systematically +

paracetamol) paracetamol)

Follow upFollow up

ResultsResults

VAVAS S >5>5

CLASS III CLASS III analgesic analgesic (morphine + (morphine + paracetamolparacetamol

VAVAS 3-S 3-55

CLASS II CLASS II analgesic analgesic (paracetamol (paracetamol codeine, codeine, dextropropoxyphdextropropoxyphene-paracetamol)ene-paracetamol)

VAVAS S <3 <3

CLASS I analgesic CLASS I analgesic (paracetamol)(paracetamol)

ResultsResults

Results at 6 weeksResults at 6 weeks

Results Results

MM group SH group

RRRR: Likelihood of an event occuring in 1 group in comparison to a : Likelihood of an event occuring in 1 group in comparison to a reference group (EER/CER)reference group (EER/CER)ARRARR: Difference between event rates of control group & : Difference between event rates of control group & experimental group (CER-EER)experimental group (CER-EER)RRRRRR: The extent to which a treatment reduces a risk, in comparison : The extent to which a treatment reduces a risk, in comparison with patients not receiving the treatment of interest (CER-EER)/CERwith patients not receiving the treatment of interest (CER-EER)/CERNNTNNT: The number of extra patients needed to be treated to prevent 1 : The number of extra patients needed to be treated to prevent 1 harmful outcome (1/ARR)harmful outcome (1/ARR)

NNTNNT

INFINF

6262

44

Results in 1 yearResults in 1 year

Adverse Effects of Surgery on Adverse Effects of Surgery on Anorectal Function after 1 yearAnorectal Function after 1 year

ComplicationsComplications MMMM SHSH CERCER EEREER RRRRRR ARRARR NNTNNT

Urgency 4 7 0.063 0.111 -0.75 -0.05 -21

Anal Incontinence 6 2 0.095 0.032 0.67 0.06 16

Tenesmus 2 1 0.032 0.016 0.5 0.02 63

Discrimination problems 2 1 0.032 0.016 0.5 0.02 63

N = 63

Results within 2 yearsResults within 2 years

Other ComplicationsOther Complications MMMM SHSH CERCER EEREER RRRRRR ARRARR NNTNNT

Fecaloma 8 1 0.127 0.016 0.88 0.11 9

Continence problems 5 6 0.079 0.095 -0.2 -0.02 -63

Stenosis involving hospitalization 1 0 0.016 0 1 0.02 63

Urine retention 3 1 0.048 0.016 0.67 0.03 32

Complications during the follow Complications during the follow up periodup period

Do these results apply to your Do these results apply to your patient? patient?

YesYes

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