3510276665392290_comment
Reviewer's report
Title: Medical and surgical treatment of haemorrhoids and anal fissure in
Crohn's disease.
Version: 3 Date: 10 April 2011
Reviewer: Gabriele Böhm
Reviewer's report:
Major Compulsory Revisions:
Dear Authors,
1. Please, get a native speaker to correct the paper.
The language has been checked.
2. The aim of the study or hypothesis is not clearly explained.
Do you want to prove that treatment of haemorrhoids or fissure in ano have a
higher surgical complication rate in patients with Crohn’s disease (CD)?
Compared to what other group of patients? The groups are not clearly defined.
From the article it seems that all patients suffered from CD. You seem to
compare healing in active and dormant CD-groups. But this is not clearly
outlined.
And why do you not compare it to a matched patient group without any Crohn’s
disease. With the database you mention, this is probably easily done.
What did you expect to see in this particular CD group of patients compared to a
general mixed patient population? And what do you want to prove regarding
treatment options or decisions?
The aim of the study is explained in the last sentence of the section Background
and in the introductive part of the Discussion.
We don’t want primarily to prove that surgery is associated to higher
complication rate in CD patients with haemorrhoids or anal fissure. This report
is an analysis with a global overview on the medical treatment and possible
surgical options in a particular category of subjects affected by CD, considering
that the scientific literature on this topic is very scant, with just few reports in
many years and in absence of any published randomized clinical trial.
This is the reason why we did not insert a control group to compare just the
complication rate in the operative groups, beyond the purpose of the study.
In the study are included patients with diagnosis of haemorrhoids or anal fissure,
all suffering from CD. They are divided in two main groups, according with the
anal pathology, discussed in different sections. Then, in each group, we analyzed
the outcomes comparing patients with or without established diagnosis of CD
when they arrived at our attention for the first time, and discussing the incidence
of surgical complications in these two subgroups. This was made to understand
if the knowledge of the presence of CD influenced the choice of the main
treatment. We did not operate patients with active CD, but only those in a
remission state (explained at page 5-fifth paragraph and at page 7-fourth
paragraph).
This organization of the study is explained in the section Methods (page 4, fifth
paragraph).
Regarding treatment options or decisions, with this clinical research we don’t
want to give definitive guidelines about medical and surgical therapy of these
patients, but we want to outline our experience, maybe comparing with future
prospective randomized trial. In the Conclusion of the paper we added that
future unbiased studies are needed.
3. Ad: Conclusion: ‘try to avoid surgery unless it is quiet Crohn’s disease’: on
what evidence can you make this recommendation?
We added in the paper, explaining better our conclusion, that only patients with
a remission state, with CDAI < 150, underwent surgical treatment. From this
point of view we consider that is better to avoid surgery in presence of an active
disease.
From the presented tables I notice a high surgical complication rate in one of the
groups.
The Table 1 did not report the incidence of surgical complications. Anyway in
this series we observed a higher rate of complications, and we discussed about
that in the paper.
Again, if you want to show that surgical complications are higher in CD, I would
rather compare results to a matched patient group without CD. One can then
subdivide the CD group according to the degree of CD activity and compare
dormant CD (no clinical signs of perianal CD) with theresults of theother groups.
This may give a clear recommendation for the treating physician when and how
to approach haemorrhoids or fissure in ano in CD. A flow chart is appreciated.
We explained above the reason why we did not create a control group, and that
only patients with a remission of the pathology underwent the surgical
treatment.
4. Page 3, second and third paragraph: state references for all statements
mentioned
We added references.
Is the incidence of fissures or haemorrhoids higher in Crohn’s disease compared
to the general population? And if so, is it in active or dormant perianal Crohn’s?
And are we talking of a typical fissure in ano e.g. 6 o’clock position/idiopathic
type?
This information is reported in the paper: regarding haemorrhoids at page 8,
first paragraph; regarding anal fissure at page 9-10, first, second and third
paragraph.
5. Page3, paragraph 6: state, why you searched your database, what precisely
did you expect to clarify by this?
We explained the type of the study, specifically that is a retrospective analysis of
our prospective data, with the aim to investigate symptoms, medical and surgical
treatment and outcomes of CD patients with haemorrhoids or fissure in ano.
6. Page 4 Statistical analysis: You mention two groups for the first time. Define
your comparative group more detailed. Did these patients have underlying
diseases that may affect the healing? See also 2. of this review.
The legend for table 1 is not clarifying the two groups, which are now presented
as ‘before and after CD diagnosis’. Talking about two groups, do you really mean
the same patients before and after they were diagnosed with Crohn’s Disease?
You really have to clarify this most important point. I would also recommend to
present a table describing and grading their Crohn’s Disease.
Replying at the point 2, we gave a detailed definition of the two groups. We
explained that they are not the same patients, but we analyzed the outcomes
comparing patients with or without established diagnosis of CD when they
arrived at our attention for the first time. Considering this point of view, we
think that the legend of the Table 1 is clear. Moreover, we stated that all the
patients had a remission of the CD in case of surgery.
7. Ad Results: What is your normal approach to haemorrhoids according to their
degree? First and second degree haemorrhoids can be approached
conservatively, the latter with rubber band ligation. What do you do with third
degree haemorrhoids? What is your approach accordingly in CD?
We approach first degree haemorrhoids with medical therapy; second degree
with medical therapy and rubber band ligation. In the presence of third degree
haemorrhoids we do stapled haemorrhoidopexy if there is a prolapse associated;
otherwise we do conventional haemorrhoidectomy.
Our approach in CD patients is explained in the paper, section Results and
Discussion.
Describe for fissure in ano accordingly. I would recommend to separately
compare results of BOTOX and sphincterotomy patients. It may show an
advantage of BOTOX therapy, but this has to be proven.
The first line therapy after diagnosis of anal fissure is medical, with topic
application of either calcium channels blockers or GTN 0.4% for 8 weeks. In case
of failure of this treatment Botox + fissurectomy or Lateral internal
sphincterotomy is indicated, mainly according to manometric findings,
chronicity of the fissure, patient preference. As reported in the paper, in subjects
with definitive diagnosis of CD at the time of surgery, we did only Botox
injection, with fissurectomy only in two cases because of the presence of highly
fibrotic edges (page 6 – third paragraph; page 7 – second paragraph; page 11 –
third paragraph).
In the section Results – Anal fissure and in the Table 3 we put separately the
results of Botox and LIS in the two subgroups of patients, explaining also the
different complications. In the Discussion we highlighted the usefulness of the
Botox, avoiding the section of the sphincter, with a remark also in the
Conclusion.
Certainly in the future, with bigger numbers, could be possible specifically to
analyze the exact role of Botox therapy in anal fissure.
Try to be more precise with the key points, expand here, and shorten the general
information.
What is the time to complete healing in the different groups?
Present results more clearly in text and tables.
We précised better the key points and expanded the sections related to the
study.
We added in the paper the time to complete healing.
8. Ad Discussion: Too long. The first two pages appear more like a review of
literature. Shorten and discuss only the investigated points.
The first part of the Discussion has the objective of give a status of the art about
the topic of the article, and needs also to compare and discuss our results with
the available literature. Anyway as you suggested we removed several sentences.
Discretionary Revisions
9. Haemorrhoids and fissure are two distinct pathologies. Why do you want to
present them both in one paper? Especially with the fissure being potentially
Crohn’s related I would focus on the haemorrhoids and maybe skip the fissure
part completely.
Our aim is to publish in the future, with a bigger number of patients, the results
about haemorrhoids and anal fissure separately, in order to better underline
what can be the best approach of these pathologies in CD patients. However at
present, considering the scant literature data, we want to give our contribution
to the scientific community about the integrated treatment of perianal disease
other than fistulae in subjects suffering from CD; our opinion is that with this
paper some considerations can be made.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Not suitable for publication unless extensively
edited
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
'I declare that I have no competing interests'