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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 Among
patients 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 Various
types 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 shortterm 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 (Prolapse)
Methodology 134 patients
7 centers
Exclusion criteria acute hemorrhoidal episodes w/ thrombosis prior hemorrhoidectomy
SH group 63 patients
MM group 63 patients
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, dextropropoxypheneparacetamol) >5 Class III (morphine administered systematically + paracetamol)
Follow up
Results
VA S >5
CLASS III analgesic (morphine + paracetamol CLASS II
VA 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 4
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 Complications
M 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
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 Among
patients 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 Various
types 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 shortterm 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 (Prolapse)
Methodology 134 patients
7 centers
Exclusion criteria acute hemorrhoidal episodes w/ thrombosis prior hemorrhoidectomy
SH group 63 patients
MM group 63 patients
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, dextropropoxypheneparacetamol) >5 Class III (morphine administered systematically + paracetamol)
Follow up
Results
VA S >5
CLASS III analgesic (morphine + paracetamol CLASS II
VA 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 4
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 Complications
M 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
