Final Research Paper - Mitch
Final Research Paper - Mitch
Final Research Paper - Mitch
Introduction
Background of the Study The surgical treatment for simple fistula-in-ano in our institution is fistulotomy that is frequently resulting in post-op anal pain, recurrence and anal incontinence. These had been a major concern for surgeons in treating fistula-in-ano. These undesirable outcomes could be due to many factors. However, the surgical approach is a major contributory factor. Ligation of intersphincteric fistula tract (LIFT) procedure was first described by a Thai surgeon in 2006, Dr. Arun Rojanasakul, a colorectal surgeon at Chulalongkorn University. This technique aimed at preserving the anal sphincters and eliminates the intersphincteric septic nidus. This procedure does not sever the anal sphincters and post-operative anal function can remain intact. This technique is new in our institution and had been started to be performed by our senior residents last April 2010 but the procedure was known to them last December 2009 from the Philippine College of Surgeons (PCS) annual convention. 1 The technique was not immediately accepted by the institution due to lack of data on the clinical outcomes. However, initial results showed promising clinical outcomes. The technique was again shown in the 1st Philippine Society of Colorectal Surgeons last March 25, 2010 by Dr. Arun Rojanasakul at Diamond Hotel, Manila when he was invited as a speaker for the said convention. 2 The technique is simple and can be done under local or spinal anesthesia similar to fistulotomy procedure. Initial clinical outcomes such as decreased post-operative pain, negligible anal incontinence and lesser recurrence rate lead to the approval of this technique to be used among patients in our institution. The procedure was explained properly to the patient and possible complications of bleeding, recurrence and anal incontinence were presented. Percentage of incidence of recurrence and anal incontinence for both LIFT and fistulotomy were also presented to the patient. It was also disclosed to the patient that LIFT technique is a new procedure and that it is new to the surgeon. The consent for the
operation after explaining the procedure was similar to all patients who will undergo the operation. This study is conducted to compare the clinical outcomes of LIFT versus Fistulotomy in fistula-in-ano from January October 2010 in reference to post-operative pain, recurrence, anal incontinence, mean operative time, mean length of hospital stay after the operation.
Significance of the Study The undesirable outcome of the traditional technique in the management of fistula-in-ano in our institution which is post-operative pain, recurrence and anal incontinence inspired the surgical residents to do the LIFT technique. It had been observed that our patients who undergone the procedure had no post-op pain and one week post-operatively, no anal incontinence was noted. This study reviewed the incidence of post-operative anal pain, recurrence and anal incontinence among patients with fistula-in-ano at Baguio General Hospital and Medical Center from January to Ocytober 2010. The early outcome is quite impressive and the results of this study initially justified the use of this procedure as an alternative or standard form of treatment in the treatment of fistula-in-ano in our institution. The results of this procedure might also convince other surgical consultants to consider this technique on their patients. Likewise, this will serve as a reference for future researchers wherein a prospective study with larger number of cases will be reviewed to determine the long term clinical outcomes and the use of this technique on complex and recurrent fistulas.
Limitations of the Study The study reviewed the medical records of patients with fistula-in-ano from January 1, 2010 to October 31, 2010 who were treated by our institution using fistulotomy and LIFT technique. The primary outcome measure of this study was limited on severity of anal pain, incidence of anal incontinence and 1-week post-operation wound discharges. Secondary measures included the mean operative time of LIFT versus fistulotomy and the mean length of hospital stay of patients after the operation.
Review of Related Literature Fistula-in-ano is the chronic phase of anorectal infection and is characterized by chronic purulent drainage or cyclical pain associated with abscess reaccumulation followed by intermittent spontaneous decompression.3 Multiple series have shown that the formation of a fistula tract following anorectal abscess occurs in 7-40% of cases.
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system defines four types of fistula-in-ano that result from cryptoglandular infections. These are the intersphincteric that is the most common of anal fistulae, transsphincteric, suprasphincteric and the extrasphincteric. The surgical treatment of this disease frequently resulted in recurrence ranging from 0-32%
3, 5
3, 5
there is no single technique appropriate for all types of fistula-in-ano, either simple or complex, which have superior outcomes, and authorities are still searching for such an ideal technique. Current surgical techniques for fistula-in-ano are based on three main concepts. The first concept is cutting through the whole tissue overlying the fistula tract, such as fistulotomy or placement of seton.
6
The Practice Parameters for the treatment of perianal abscess and fistula-in-ano by Whiteford et.al stated that simple anal fistula may be treated by fistulotomy with a class II level of evidence.
3
The fundamentals of fistulotomy include defining the entire tract from internal
opening to the external opening with identification and obliteration of primary and secondary tracts. The recurrence rate for fistulotomy is generally 2- 9% with a functional impairment at 017%. However, when used in complex fistulas such as high transphincteric fistula, suprasphincteric, extrasphincteric fistulas and other complex fistulas, the rates for minor and major incontinence are significant with 34-63% and 2-26% respectively. 3 In 2006, a new technique was introduced by Dr. Arun Rojanasakul as a form of treatment for fistula-in-ano. This technique is based on the concept of secure closure of the internal opening and concomitant removal of infected cryptoglandular tissue in the intersphincteric plane.6 The technique is almost similar to the procedure described by Matos et. al. that is based on the concept of excision of intersphincteric anal gland infection through the intersphincteric approach.
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Likewise the novel technique was also documented in Cormans textbook of colon
8
The Matos technique was used by Dr. Aruns group last 2004-2005. The
outcome in 20 patients was disappointing with only 9 (45%) successes. 9 The proposed reasons for the unfavorable outcome include dissection in the intersphincteric plane damaging the blood supply to the internal opening area and suturing delicate areas with increased risk of suture breakdown. In order to solve this problem, Dr. Aruns group thought that the ligation of intersphincteric tract close to the internal opening might solve the problem. 9 That idea became the essence of the LIFT technique. The preliminary outcomes using the LIFT technique among patients with simple and complex fistula-in-ano had been satisfactory with 5.6% recurrence rate, decreased post-op pain and negligible incontinence. 6 It had been realized by Dr. Aruns group
that the technique reported by Matos et. al. wherein the excision of the whole fistula tract plus primary repair with intersphincteric plane approach for excision of fistula tract and suturing the internal anal sphincter defect will result to unsatisfactory outcomes. The LIFT technique howerever, was claimed to be pioneered by Dr. Robin Phillips from St. Marks hospital according to Dr. Peter J. Lunniss as described by Matos et. al study.
10
The
statement given by Dr. Lunniss however was commented back by Dr. Arun Rojanasakul explaining the difference of his technique as previously described earlier in the literature. The technique became popularly known among Asian countries and was adopted in their own institution. A study done by Dr. A. Shanwani et. al.from Malaysia revealed that LIFT technique was both safe and easy to perform with encouraging early outcomes. No clinically significant morbidity was noted in any of the 45 patients wherein LIFT technique was done. 11 LIFT technique was also popular among colorectal surgeons of Hongkong and Singapore. There had been ongoing researches on the efficacy of LIFT in the management of simple and complex fistula-in-ano as was presented last PCS annual convention of 2009. The results of these studies will be published soon. 1 LIFT was introduced in the United States by Dr. Stanley Goldberg last 2008, a colorectal surgeon from University of Minnesota and who was a visiting professor in Thailand. The technique was introduced to his five rotating fellows and a study was conducted on 31 patients wherein LIFT technique was done. The study demonstrated a 58% success rate in an American patient.12 It likewise demonstrated that LIFT technique can be used again for recurrent fistula-inano with no difficulty.12
Objectives of the Study General Objective: The study aimed to determine the efficacy of LIFT compared to Fistulotomy in treating patients with simple fistula- in-ano. Specific objectives: 1. To compare the mean operative times of LIFT vs fistulotomy 2. To measure the incidence of post operative complications in patients who underwent LIFT compared to patients who underwent fistulotomy in terms of: a. One week post-operative wound discharges b. Anal Incontinence 3. To compare the severity of post operative pain of patients who underwent LIFT vs patients who underwent fistulotomy 4. To compare the mean length of hospital stay of patients who underwent LIFT vs patients who underwent fistulotomy
Methodology
Study Design: The study is a retrospective cohort Population: all patients at BGH-MC who underwent LIFT and Fistulotomy for simple fistula-inano Inclusion criteria: 1. All patients 18-60 years who underwent either LIFT or Fistulotomy are included 2. Patient with simple fistula-in-ano who underwent LIFT performed by a senior resident or consultant 3. Patient with simple fistula-in-ano who underwent fistulotomy performed by any member of the surgery staff Exclusion criteria: 1. Patients with complex fistulas 2. Patients with recurrent fistulas 3. Patients with synchronous rectoanal pathology ex. Rectal ca, perianal abscess, fourniers gangrene
Intervention: Ligation of intersphincteric fistula tract Control: Fistulotomy Outcome: Length of surgery Incidence of anal incontinence and wound discharge Severity of post op pain Length of hospital stays after the operative procedure
Operational Definitions: Simple fistula-in-ano: includes intersphincteric and transsphincteric fistula-in-ano, the track crosses < 30% - 50% of the external sphincter Complex fistula-in-ano: the track crosses >30-50% of the external sphincter which includes: high transphincteric, suprasphincteric, and extrasphincteric, anterior in a female, have multiple tracks, is recurrent or the patient has pre-existing incontinence, local irradiation, or Crohns disease.13 LIFT ligation of intersphincteric fistula tract after defining the internal opening with curetting the fistulous tract and closure of the external sphincter defect Fistulotomy lay-open technique of the fistulous tract after defining the internal opening of the fistula-in-ano Anal incontinence involuntary or uncontrolled passage of stool Wound discharge presence of purulent material 7 days post-operation Recurrence formation of a new fistula at 3 months after fistulotomy/LIFT
Description of the Study Procedure All patients from January 1, 2010 to October 31, 2010 with simple fistula-in-ano who were treated with fistulotomy and LIFT were noted from the Operation Record logbook and the charts were gathered from the Medical Records of Baguio General Hospital and Medical Center (BGHMC). The primary outcome measure of this study such as: severity of anal pain, incidence of anal incontinence and 1-week post-operation wound discharges and secondary measures such as: mean operative time of LIFT versus fistulotomy and the mean length of hospital stay of patients after the operation were gathered. The Operative technique was evaluated for the length of the surgical procedure and the progress notes done by the surgical residents on the evaluation of severity of post-operative pain using the Numerical Pain Scale were collected. Likewise, the data on the presence or absence of anal incontinence and wound discharge one week post-
operation was taken from the medical records of Out-patient department. Records of repeated follow-ups from patients were also gathered. It had been found out that there were 20 recorded operations for fistula-in-ano, however; only 17 charts were available for review. There were three missing charts and not available at the time of data gathering. There were 12 cases of patients who underwent fistulotomy and 8 patients who underwent LIFT but only 11 charts for fistulotomy and 6 charts for LIFT were available for review. There were no records of cases of complex fistula-in-ano or recurrent fistulas that had been admitted and operated on with fistulotomy or LIFT for the entire covered period of this study. Incidentally, all cases were simple fistula-in-ano. The general data of the patient and the results gathered with regards to the length of the surgical procedure in minutes, length of hospital stay post-operation in days, the severity of postoperative pain, presence or absence of anal incontinence and presence of wound discharges after a week post-operation were all placed in a dummy table. (table 1)
RESULTS A. Operative Time In order to compare the mean operative time for LIFT technique and fistulotomy, the average time in minutes for each technique was computed and the standard deviation was computed based from the mean operative time. T test was used to compare whether the results are statistically significantly. (table 2) Table 2: operative time
Operative (minutes) time mean LIFT Standard deviation 58.1667 minutes 17.93786 21.1818 minutes Fistulotomy mean Standard deviation 18.56243 .00215 P value
The table shows above the mean and standard deviation of fistulotomy which is 21.1818 minutes and 18.56243 respectively as compared with LIFT which is 58.1667 minutes and 17.93786 respectively, using the t-test, the p value taken was 0.00215. The null hypothesis stated that there is no difference in the mean operative time between fistulotomy and LIFT. Using the significance level of 0.05 at 95% level of significance, the null hypothesis is rejected. The two operative means differ significantly.
B. Incidence of Anal Incontinence and wound discharges 1-week post-operation The incidence of anal incontinence and incidence of the presence of wound discharges 1week post-operation were noted using frequency tables. (table 3) Table 3 Frequency LIFT Anal Incontinence 0 Fistulotomy 3 7 Percentage LIFT 0% 0% Fistulotomy 27.27% 63.63%
Table 3 shows that there are no anal incontinence and no wound discharges present after a week for LIFT as compared with fistulotomy showing 3 patients with anal incontinence and 7 patients with wound discharges after a week post-operation. There are 27.27% of anal incontinence and 63.63 % of patients presented with a wound discharge 1-week post-operation for fistulotomy procedure.
In order to compare if the results taken were different between the two groups, the fishers exact test was used. Table 4 Anal incontinence
LIFT With anal incontinence Without anal incontinence Total Fistulotomy Total P value
0 6 6
3 8 11
3 14 17
0.242647
Table 4 showed that there are no anal incontinence using the LIFT technique however, using the fistulotomy procedure, there are 3 patients who presented with anal incontinence. The null hypothesis stated that there is no difference between the two techniques in terms of occurrence of anal incontinence post-operation. The p value taken using the fishers exact test was 0.242647, using the 0.05 level of significance at 95% confidence level, the null hypothesis is accepted.
0 6 6
7 4 11
7 10 17
0.016968
Table 5 showed that there are no patients who presented with wound discharge after a week post-operation using the LIFT technique; however, there are 7 out of 11 patients who presented with wound discharges using the fistulotomy procedure. The null hypothesis stated that there is no difference in the occurrence of wound discharges one-week post-operation between the two procedures. Using the 0.05 level of significance at 95% confidence level, the null hypothesis is rejected. The two groups differ significantly.
C. Severity of Post-operative Pain To compare the severity of post-operative pain among patients who underwent LIFT and fistulotomy, a numerical pain scale ranging from 0-10 was used. Mean pain scale was calculated to determine which procedure has lesser post-op pain. The t-test was employed to determine if the two groups are statistically significant. (Table 6) Table 6 Severity of Post-op Pain
LIFT mean standard deviation Fistulotomy mean standard deviation P value
3.81818
1.60114
1.3013
Table 6 showed that the mean pain scale for LIFT and fistulotomy is 0 and 3.818 respectively. To test whether the mean pain scale for LIFT technique is statistically significant compared with fistulotomy, the t-test was employed showing a 1.3013 p value. The null hypothesis stated that there is no difference in the severity of post-operative pain between the two procedures. The p value taken using the t-test is > 0.05 level of significance at 95% confidence level, the null hypothesis is accepted. The mean pain scale did not differ between the two groups.
D. Length of hospital stay after Operation There are factors that affected the length of hospital stay such as delayed operation scheduling and medical comorbidities that is to be corrected prior scheduling. In order to minimize bias, the mean length of hospital stay after operation for both LIFT and Fistulotomy was the one included in the study. Standard deviation was computed based on the mean. T-test was employed to compare if the two groups are statistically significant. (Table 7) Table 7 Length of Hospital stay after operation
LIFT mean 27.43667 hours Standard deviation 13.06633 FISTULOTOMY mean 38.26273 hours Standard deviation 28.67021 0.30362 P value
Table 7 showed the mean hospital stay of patients after the operation for LIFT and fistulotomy of 27.43667 hours and 38.26273 hours respectively. Using the t-test, the p value taken is 0.30362. The null hypothesis stated that there is no difference in the mean length of hospital stay between the two procedures. Using the 0.05 level of significance at 95 % confidence level, the null hypothesis is accepted. The results are not statistically different between the two procedures.
DISCUSSIONS Fistulotomy has been the standard form of treatment for fistula-in-ano at Baguio General Hospital and Medical Center. The outcome is generally acceptable. However, fistulotomy causes some various injuries to the anal sphincter causing incontinence. This may however not generally seen among patients who undergo fistulotomy, but when it occurs, it is debilitating to the patient. The literature cited some technique to minimize anal incontinence such as placement of seton but with moderate success, endorectal advancement flap, anoderm island flap, excision and closure of the internal opening, fibrin glue and fistula plug. These techniques have less risk of anal incontinence, despite some recurrences. The techniques previously mentioned, however, are technically demanding, operator dependent and reoperation cannot occur because of the previously applied materials that cause scarring. Fistulotomy, likewise, leave the wound open attracting infections from the fecal matter that comes out from the anal opening, thus, causing the wound not to heal or could heal longer leaving a wound discharges for many weeks. There is no single technique appropriate for all types of fistulas at present; researchers are still looking for the ideal technique. The LIFT technique is the novel modified approach through the intersphincteric plane for the fistula-in-ano, known as LIFT (ligation of intersphincteric fistula tract) procedure. The technique disconnects the internal opening from the fistulous tract and removes the infected anal gland residual, without dividing any part of the anal sphincter complex. The LIFT procedure is started by identifying the internal opening, followed by the incision at the intersphincteric groove, dissection through intersphincteric plane to find the intersphincteric fistula tract, then secure suture ligation of the tract. The remaining fistula tract distally will be curetted from external opening followed by suturing and closing the external sphincter muscle defect then
closure of the intersphincteric wound. (figure 1)14 The technique is easy and safe. It is easily learned. It had been found out from the study that using the LIFT technique in simple fistula-inano, no post-operative complications were noted. There is no anal incontinence, no anal pain and wound discharges noted after a week post-operation on their follow-up. Comparing the results taken from LIFT with that of fistulotomy, it can be deduced that the LIFT is superior to fistulotomy, however, using the ttest and fishers exact test, there is no difference between the two procedures in the occurrence of anal incontinence and post-operative pain (table 4 and 6). The mean operative time however, is longer than fistulotomy with a difference of 36.98 minutes. The t-test (table 2) showed that the difference is statistically significant. The LIFT is a new procedure among the surgeons and it is a new technique to be learned; it might explain the difference in performing it as compared with fistulotomy. There is no difference in the length of hospital stay after the operation. The patient could go home after a day post-operation. However, during follow-up, persistent or recurrent wound discharges were noted among seven patients who were operated on with fistulotomy (table 1). The two among the seven patients, who had their follow-up on the third and 7th week still presented with wound discharges (table 1). Primary healing among patients with fistulotomy could be longer for the surgical site is left open. These could be cause by many factors; it could be hygiene, poor compliance to antibiotics, unidentified fistula tract or complex fistulas, unidentified medical comorbidities predisposing to non-healing and synchronous rectoanal pathology. The goals in the treatment of fistula-in-ano are eliminating the septic foci and any associated epithelialized tracts and minimizing functional derangement.
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There is no single
technique appropriate for the treatment of fistula-in-ano, therefore, introduction of a safe and a
new technique is welcome. The outcome among the six patients in this study was successful and comparable to fistulotomy.
CONCLUSIONS The LIFT technique is simple, safe, and based on surgical principles in the treatment of fistula-in-ano. It is equally effective with fistulotomy in the treatment of simple anal fistulas. The early clinical outcomes were satisfactory. Although the procedure is longer than fistulotomy, post-operative complications such as anal incontinence, anal pain and presence of wound discharges were not seen after doing the LIFT procedure.
Recommendations The author wish to recommend the following: a. The use of LIFT for simple fistula-in-ano at BGHMC b. The study failed to present the long term follow-up of patients to assess recurrence rate, it is recommended that long-term follow-up study in the future will be carried out c. The study presented only with 6 cases of LIFT as compared to 11 cases of fistulotomy, it is then recommended that more patients should be enrolled using the LIFT technique to assess its efficacy. d. Randomized controlled trials for future studies e. Study on the use of LIFT on complex fistulas since it was initially used in complex fistulas before Dr. Aruns group used in other simple fistulas. f. The use of LIFT on recurrent anal fistulas
Ethical Considerations The study is a retrospective cohort on the clinical outcomes of LIFT and fistulotomy on simple fistula-in-ano. An initials was used to identify the patients under study. The identity of the patients included in the study was strictly confidential. All data from the study was confidential unless needed for verification of results.
Dummy Table and Figures Table 1: Dummy table for general data of patient Patients Surgical Initials Procedure done Length of surgical procedure (minutes) Length of hospital stay (days) 4 days Length of hospital stay after OR 34 hours and 30 minutes Severity of postop pain (0-10 numerical scoring) 1/10, with post-op pain at 1 week post-op 2/10 Presence or absence of anal incontinence Presence or absence of wound discharges
R.A, 29 male
fistulotomy
10 minutes
R. P, 41 male
fistulotomy
22 minutes
3 days
J.C, 25 male
fistulotomy
10 minutes
1 day
J. E, 29 male
LIFT
48 minutes
2 days
J.Q, 23 male
LIFT
50 minutes
4 days
90 minutes
2 days
N. P, 44 female
fistulotomy
12 minutes
3 days
72 minutes
8 days
39 hours and 40 minutes 22 hours and 18 minutes 24 hours and 3 minutes 17 hours and 25 minutes 27 hours and 50 minutes 24 hours and 33 minutes 4 days, 21 hours and 18 minutes
3/10
0/10
with anal With incontinence discharge on 1 week postop No anal With incontinence discharge at 1 week postop No anal None incontinence
0/10
0/10
3/10
4/10
D.F, 49 male
2 days
12 5/10 hours and 31 minutes 52 hours and 18 minutes 38 hours and 8 minutes 44 hours and 37 minutes 47 hours and 40 minutes 24 hours and 23 minutes 26 hours and 40 minutes 15 hours and 15 minutes 16 hours and 21 minutes 0/10
J. M, 39 LIFT male
67 minutes
5 days
With anal None incontinence at 1 week and 3 weeks post-op No anal None incontinence
R. A, 38 fistulotomy male
22 minutes
4 days
R.B, 37 male
fistulotomy
24 minutes
3 days
No anal Wound incontinence discharges persisted on the 7th week No anal None incontinence
C.A, 25 male
fistulotomy
10 minutes
3 days
3/10
R.D, 37 male
fistulotomy
2 minutes
3 days
4/10
R.T, 26 male
LIFT
40 minutes
2 days
0/10
R. G, 28 fistulotomy male
23 minutes
3 days
6/10
D.B, 50 male
LIFT
54 minutes
2 days
0/10
TIME SCHEDULE
October 2010
November 2010
ERC approval Encoding Collation and analysis of data Presentation of Results Writing of manuscript
December 2010
References: 1 Rojanasakul, A. LIFT 65th PCS Annual Convention 2009.Dec 6-9, 2009.SMX Convention Center Pasay, Metro Manila Philippines 2 Rojanasaku, A. The Riddle of Fistula-in-ano. PSCRS 1st National Convention. March 25-26, 2010. Diamond Hotel, Manila Philippines 3 Whiteford MH, Kilkenny J III, Hyman N, Buie WD,Cohen J, Orsay C, et al. Practice parameters for the treatment of perianal abscess and fistula-in-ano (revised). Dis Colon Rectum 2005; 48: 1337-42 4 Hancock BD. ABC of Colorectal diseases. Anal fissures and Fistulas. BMJ. Apr 4 1992; 304(6831): 904-7 5 van Tets WF, Kuijpers HC. Continence disorders after anal fistulotomy. Dis Colon Rectum 1994; 37: 1194-7. 6 Rojanasakul,A. LIFT procedure: a simplified technique for fistula-in-ano. Spinger-Verlag 2009 7 Matos D., Lunniss, PJ, Philips, RKS (1993) Total Sphincter Conservation in fistula-in-ano: results of a new approach. Br J Surg 80:802-804 8 Corman ML (2004) Anal Fistula in-ano:Colon and Rectal Surgery, 5th ed. Lippincott Williams & Wilkins p. 316 9 Rojanasakul A. Comments to the invited comment: LIFT procedure: a simplified technique for fistula-in-ano by P.J. Lunniss. Published online: 12 January 2010. Springer-Verlag 2010 10 Lunniss P. Invited comment: LIFT procedure: a simplified technique for fistula-in-ano. Published online. 25 July 2009. Springer_Verlag 11 Shanwani,A M.S., MD et.al. Ligation of Intersphincteric Fistula Tract (LIFT): A sphincter saving technique for fistula-in-ano. Dis Colon Rectum 2010;53:39-42 12 Beals,J., PhD. Novel Surgical Correction of Intersphincteric Perianal Fistulas Preserves Anal Sphincter. Medscape.com 13 Parks AG, Stitz RW. The treatment of high fistula-in-ano.Dis Colon Rectum 1976;19:487499 14 LIFT technique. Wikipedia