Stapled

Hemorrhoidopexy Versus
Milligan-Morgan
Hemorrhoidectomy
CRITICAL APPRAISAL
3-D

Tongson, Michael
Traboco, Lisa
Tuason, Zsarin
 Clinical Scenario
A 42 year old female patient with
symptomatic hemorrhoids consulted
at the clinic.
 Pain, itching and palpable mass
 Clinical Question
 Amongpatients with symptomatic
hemorrhoids, would Stapled
Hemorrhoidopexy be beneficial?
 Stapled
Hemorrhoidopexy Versus
Milligan-Morgan
Hemorrhoidectomy
Gravie, J; Lehur, P; Huten, N;
Papillon, M; Fantoli, M;
Descottes, B; Pessaux, P;
Arnaud, J

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

 Purpose of the Study
 To compare the outcome of Stapled
Hemorrhoidopexy (SH group) with
that of the Milligan Morgan technique
(MM group)
 Post-operative data (short and long
term)
– Pain
– Hospital Stay
– Complications
 Milligan-Morgan
Hemorrhoidectomy
 Varioustypes of hemorrhoidectomies
have developed throughout the years
but they are all associated with the
same basic principle:

– This is decreasing blood flow to the

anorectal ring and
– removing redundant hemorrhoidal
tissue.
 Milligan-Morgan
Hemorrhoidectomy
 In the United Kingdom, the Milligan and Morgan
hemorrhoidectomy is most commonly used. This
technique involves:

– ligation and excision of the hemorrhoids while leaving

the wound open.
– In this technique, the anus is gently dilated and the
hemorrhoidal tissue and perianal skin are everted just
outside the anorectal ring.
– The triangular shaped hemorrhoid is excised down to the
underlying sphincter muscle.
– The pedicle is then ligated with suture.
– The wound is left open and a light dressing applied.
– One, two or three hemorrhoids may be treated in this
manner.
 Milligan-Morgan
Hemorrhoidectomy
 Stapled
Hemorrhoidopexy
 Anatomy of Hemorrhoids
Hemorrhoids are
distended blood
vessels that form
either externally
(around the anus)
or internally
(in the lower rectum).
 Stapled Hemorrhoidopexy
 Also called Procedure for Prolapse & Hemorrhoids
(PPH), Stapled Hemorrhoidectomy, and
Circumferential Mucosectomy
 treats bleeding or prolapsed internal hemorrhoids
 reduces the prolapse of hemorrhoidal tissue by
excising a band of the prolapsed anal mucosa
membrane with the use of a circular stapling device
 the prolapsed tissue is pulled into a device that
allows the excess tissue to be removed while the
remaining hemorrhoidal tissue is stapled
 restores the hemorrhoidal tissue back to its original
anatomical position.
 under general anesthesia as day surgery
 Procedure

• 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
 Benefits of PPH
– less pain
– quicker return to normal activities
– inpatient stay was lower
– leaves the richly innervated anal canal tissue and perianal skin
intact

 Risks
Although rare, there are risks that accompany PPH:
– damage to the rectal wall if too much muscle tissue is drawn into
the device
– internal muscles of the sphincter may stretch, resulting in short-
term or long-term dysfunction
– pelvic sepsis have been reported
– may be unsuccessful in patients with large confluent hemorrhoids.
Gaining access to the anal canal can be difficult and the tissue
may by too bulky to be incorporated into the housing of the
stapling device.
– Persistent pain and fecal urgency after stapled hemorrhoidectomy,
although rare, has been reported.
Inclusion Criteria:
 Symptomatic
hemorrhoidal disease
Methodology
(Prolapse)
134 patients 7 centers
Exclusion criteria
 acute
hemorrhoidal
episodes w/ SH group MM group
thrombosis 63 63
 prior patients patients
hemorrhoidectomy
 intercurrent anal
pathology
(fistula/fissure)

2 year follow up
Critical Appraisal
 Primary Validity
1. Was the assignment of patients to
treatments randomized?
Was the randomization concealed?

- 134 patients were randomized

- 15-month period
- 7 different centers (both teaching and
private hospital)
- 2 groups, SH (63); MM(63)
- Randomization method was concealed
2. Were all the patients who entered
the trial accounted for at its
conclusion?
Were they analyzed in the groups to
which they were randomized?

- Yes.
- Follow-up period
- 6 weeks
- 1 and 2 years
- Total of 17 patients (11 SH and 6MM) failed to
return 2-year follow up
3. Was the follow-up complete?
- Patient monitoring
- Clinical examination by the surgeon
- Pre-operatively
- Post-operatively
- 6 weeks, 1 year, and minimum of 2 years
- 53-item questionnaire
- Pre-operatively
- 1 year post-operation

 Intention to treat analysis

53-item questionnaire
2. Symptoms
- Anal mass (90%)
- Frequent bleeding (47%)
- Itching (35%)
- Discharge and soiling (31%)
- Pain (15%)

• Sphincter function
• Defecation
• Quality of life
- Allowed the assessment of the effectiveness in the:
- Symptom control
- Functional outcome
- Patient’s overall satisfaction back
 Secondary Validity
1. Was the study Blind?
 Patients: NO
– After assignment to the groups, they
were informed of the result of the
randomization
 Investigators: NO
 Secondary Validity
2. Were the groups similar at the start of the trial?
 “There were no significant differences between
the 2 groups with respect to sex, weight,
history….
 … Mean age was higher in the SH group (51
versus 44 in the MM)”
 Inclusion & Exclusion Criteria
 Adjustment for significant differences/Baseline
characteristics
– Symptomatic hemorrhoidal disease (impression of a
mass, frequent bleeding, puritus ani/itching, discharge
and soiling and pain) could be treated by surgical
technique
– Prolapse of internal hemorrhods was the most common
reason for decision to operate ; reducible prolapse
considered as not amenable by banding or have failed to
respond to previous banding
 Randomization and adequate sample size
 Secondary Validity
3. Were the groups treated equally?
 Co-interventions
– Anesthesia was left up to the investigating center
– Administration of analgesics
 Sytematic anti-inflammatory medication + subcutaneous
morphine during operation and immediately after
 During hospitalization: based on the Visual Analogue Scale
(VAS)
0 = “no pain” 10 = “maximum pain”
<3 WHO Class I analgesic (paracetamol)
3-5 Class II (paracetamol codeine,
dextropropoxyphene- paracetamol)
>5 Class III (morphine administered systematically +
paracetamol)

 Follow up
Results

VA CLASS III
S analgesic
>5 (morphine +
VA paracetamol
CLASS II
S 3- analgesic
5 (paracetamol
codeine,
dextropropoxyph
ene-paracetamol)
VA CLASS I analgesic
S (paracetamol)
<3
Results
Results at 6 weeks
Results
MM group SH group
 NNT

INF

62

RR: Likelihood of an event occuring in 1 group in comparison to a

reference group (EER/CER)
ARR: Difference between event rates of control group &
experimental group (CER-EER)
RRR: The extent to which a treatment reduces a risk, in comparison
with patients not receiving the treatment of interest (CER-EER)/CER
NNT: The number of extra patients needed to be treated to prevent 1
harmful outcome (1/ARR)
Results in 1 year
Results
Adverse Effects of Surgery on
Anorectal Function after 1 year
M
Complications M SH CER EER RRR ARR NNT

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 years
Results
Complications during the follow
up period

Other Complications MM SH CER EER RRR ARR NNT

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

Do these results apply to your
patient?
 Yes