haemorroidectomy

1. METHOD
• The target population of this clinical study includes patients with symptomatic
hemorrhoids, who require wound treatment after Milligan-Morgan or Parks
hemorrhoidectomy.
• All adult patients (age ≥ 18 years) suffering from symptomatic hemorrhoids of
grade III or IV and scheduled for hemorrhoidectomy by the Milligan-Morgan or
Parks procedure were eligible for this study.
• Patients with inflammatory anal diseases such as abscesses, fistulas, or gangrene,
and pregnant women (according to the patient’s self-report) were excluded from
participation in this clinical study.

2. • Participants were randomly allocated in a 1:1 ratio to each treatment group (intervention
vs control group).
• Allocation to treatment groups was performed using a centralized web-based tool.
• The duration of the clinical trial for each randomized patient is 7 days.
• In the ‘‘intervention group’’, no tamponade dressing was placed in the rectum of the
patient after achieving complete hemostasis. The rectum and anus were cleaned and a
pad with high-absorbence capacity was placed on the aperture to absorb potential blood
loss.
• In the “control group” a tamponade dressing was placed in the patient’s anal canal and
lower rectum after complete hemostasis. The intraoperatively inserted tamponade
remains in the rectum of the patient at least until first defecation and possible
spontaneous removal, but usually for a maximum of 24 h.

3. • Primary outcomes of the study are maximum postoperative pain, at four time
points within 48 h after the surgical procedure, and the occurrence of
postoperative bleeding with the need for surgical revision within 7 days after
hemorrhoidectomy.
• Postoperative pain is measured at rest within routine care at 6, 12, 24, and 48 h
after the surgical procedure. The most severe pain within 48 h of the surgical
procedure will be compared between the treatment groups.
• As a secondary outcome, the postoperative pain at each predetermined
evaluation time point (6, 12, 24, and 48 h and 7 days after surgery) will be
compared between treatment groups.
• Further secondary endpoints that were compared between the treatment groups
are the use of analgesics; the lowest hemoglobin documented in clinical routine
within 7 days; quality of life using EuroQuol 5 dimensions (EQ. 5D) at screening,
on discharge and on day 7 ; and patient satisfaction on day 7.

5. DISCUSSION
• This study provides a comprehensive review of patients undergoing
hemorrhoidectomy and all patients treatment and follow-up where performed
prospectively.
• The results of the present trial confirm the findings of the pilot investigation.
First, it was shown that the use of tamponade dressings correlates with increased
postoperative pain after haemorrhoidectomy.
• It can be safely postulated that the omission of tamponade dressings after
haemorrhoidectomy does not correlate with an increased risk of bleeding.

6. LIMITATIONS
• Of note, the COVID19 pandemic led to a steep decline in recruitment and
rendered follow-up visits very difficult.Thus recruitment rates remained low and
the sample size was less than that of initially planned numbers.
• Not blinding study participants and investigators regarding the treatment
assingment as well as performing the randomization up to 12 h prior to surgery
may be seen as a limitation of this study.

7. RESULTS
• Of the 725 patients that were randomized; in 359 patients, tamponade of
different types were inserted in the operating room and was kept in situ until
spontaneous removal or first episode of defecation.
• Whereas in 366 patients no tamponade was inserted in the anal canal.
• Maximum pain intensity during the first 48 h after haemorrhoidectomy was
higher in patients who had received a tamponade.
• Despite use of similar analgesic regimen in both treatment groups ,the pain
intensity show significantly less pain in the no-tamponade group 6 and 12 hrs
after surgery.

8. • Postoperative haemoglobin levels were available for 37 per cent of patients and
showed no difference between patients who did and did not receive tamponade
dressing.
• Testing of subgroups with different tamponade dressings showed no significant
differences in bleeding or pain development.

11. CONCLUSION
• The practice of inserting tamponade dressings after haemorrhoidectomy
correlates with increased postoperative pain and does not provide benefits in
terms of reduced postoperative bleeding.

12. THANK YOU.