Saleh M. Al-Salamah ( The Department of General Surgery, King Saud University Unit, Riyadh Medical Complex, Riyadh, Kingdom of Saudi Arabia. )
Muhammad Ibrar Hussain, ( The Department of General Surgery, King Saud University Unit, Riyadh Medical Complex, Riyadh, Kingdom of Saudi Arabia. )
Shaukat Mahmood Mirza ( The Department of General Surgery, King Saud University Unit, Riyadh Medical Complex, Riyadh, Kingdom of Saudi Arabia. )
Objective:To evaluate the outcome of excision with or without primary closure in the management of chronic pilonidal sinus (PNS) disease. Methods:Between July 2002 and November 2006, a randomized trial was conducted in the Department of General Surgery, Riyadh Medical Complex, Riyadh, Kingdom of Saudi Arabia. All the patients who presented with chronic natal cleft PNS disease were included in the study. They underwent either excision with midlineclosure (EMC group), or excision without closure (EWC group). Patients, who came with an acute pilonidalabscess (complicated) were excluded from the study. The principle outcome measures recorded were woundinfection, healing time, time off work and the recurrence rate. Results:Atotal of 380 patients of chronic PNS were divided into EMC group, (188 patients) and EWC group(192 patients). Majority of the patients were male in both the groups (93%). The hospital stay ranged from 2 to5 days (mean=3.6±1.4 days) for EMC group, while it was 3-5 days (mean=4±1.1 days) for EWC group (p<0.002).Wound infection was 4.2% in EMC group, compared to 3.12% of EWC group (MS). The mean healing time andtime off work in EMC group was significantly shorter than the patients in EWC group. Median follow up of EMCgroup was 36.3 months (range10-52 months) while it was 35.2 months (range 13-51 months) for EWC group.Statistically there was no significant difference in the recurrence rate of both the groups (3.7% vs. 3%).Conclusions:Excision and primary closure is recommended, as a preferred procedure in the management ofchronic PNS disease. It has the advantages of early wound healing, rapid return to work and comparablerecurrence rate with excision and open wound (JPMA57:388:2007).
Pilonidal sinus (PNS) is a chronic, intermittentdisorder of the saccrococcygeal region.1The high incidenceof PNS among young males is well described.2,3
The management of PNS is frequently unsatisfactory.4
Many surgical and non- surgical treatment modalities have beensuggested, but the ideal and widely accepted treatment hasstill not yet been established. In this regard, low recurrencerate, shorter hospital stay, less cost, minimal inconvenienceand time off work are important considerations.5
Surgical techniques include laying the track open,wide excision with open wound, wide excision withmarsupialization, excision with primary midline orasymmetric closure and techniques involving various flapsprocedures.6
All the surgical procedures have their pros andcons.7
The most commonly performed surgical operationsare excision with primary closure and excision with layingopen the wound for healing by secondary intention.8 Simple excision and open wound causes morepatient discomfort, longer hospitalization and more time offwork. While excision and primary closure in the midline isassociated with wound related complications like woundfailure, wound infection and the recurrence of PNSdisease.9,10The objective of this trial was to compare theoutcome of both these procedures in terms of woundinfection, healing time, time off work and the recurrencerate, in the management of chronic PNS disease.
Patients and Methods
Randomized trial was conducted in theDepartment of General Surgery, Riyadh Medical Complex,Kingdom of Saudi Arabia from 1st July 2002 to 15thNovember 2006. The research protocol was approved bylocal research and ethical committee and informed consentwas obtained from all the patients. All the patients whopresented with, chronic natal cleft PNS were included,while the patients, who came with an acute pilonidalabscess, were excluded from the study. All the patients were admitted to the hospital, oneday prior to operation. They were divided to undergo, eithersimple excision with midline closure (EMC group) orsimple excision without closure, (EWC group) by using aclosed envelope randomization. The surgeons enclosed thetwo operating options on separate papers in opaqueenvelopes. An equal number of envelopes with the thesetwo options were available in the operating room. The nursemixed the envelopes and opened one to reveal therandomization arm after induction of anaesthesia.All the patients were operated under generalanaesthesia. The hair around the natal cleft was shaved before operation. The patients were positioned prone (JackKnife) and the buttocks were strapped apart by using theadhesive tapes. Methylene blue dye was injected to outlinethe sinus tract. Asymmetrical elliptical incision around themidline natal cleft was made to enclose all the sinuses andtracts. With continuous sharp dissection, the incision wascarried down to saccro-coccygeal fascia. All the sinuses andtheir extensions were excised completely. Goodhaemostasis was secured. In EMC group, the subcutaneousfat is undermined and lifted as a flap from the gluteal fasciato close the wound in a tension free manner. Radivacsuction drain was placed in the wound cavity, through aseparate stab incision. Subcutaneous tissue wasapproximated with Polyglycolic acid No 2/0 (Vicryl®).Skin was closed with polypropylene 2/0, (Prolene®)mattress interrupted stitches.In EWC group, the sinuses were excised, byemploying the similar procedure, but the wound was leftopened and packed with povidone soaked gauzes. All thepatients from the two groups received one dose ofprophylactic antibiotics (Cefuroxime sodium andmetronidazole), at the time of induction of anaesthesia untiland unless indicated for a prolonged period of time. Thepatients of EWC group were discharged once they weremobile, pain free and comfortable to go home, with theadvice of good wound cleansing and daily dressing in theprimary clinic. In patients of EMC group, sutures wereremoved on 10th post operative day. These patients wereadvised to return to normal activities after removal ofstitches, but to avoid excessive physical strain and strenuoussports for following 3 to 4 weeks. Follow up of all patients was performed on anoutpatient basis, every month for 3 months, after every 3months for one year and on annual basis for a mean periodof 36.3 and 35.2 months for EMC and EWC grouprespectively. It included the detailed history and clinicalexamination by trained personnel. The outcome measuresrecorded were wound infection, healing time, time off workand recurrence rate. Wound infection was defined as thesystemic signs associated with purulent discharge from thewound, necessitating open drainage or debridement.Recurrence was defined as, the reappearance of symptomsand sinus after complete healing of the wound. Data wasanalyzed by using SPSS software (version 11). Categoricaldata comparison was made by Chi-Square test. Numericalvariables were compared by student's t-test. Pvalue lessthan 0.05 was considered significant.
A total of 427 patients of natal cleft PNS wereadmitted from 1st, July 2002 to 15th November 2006 in theDepartment of General Surgery, Riyadh Medical Complex, Riyadh. Forty three out of 427, underwent incision drainagefor acute pilonidal abscess, and were excluded from thestudy before randomization. Rest of 384 patients weredivided into 192 patients both in EMC group and EWCgroup. Four patients of EMC group were excluded from thestudy, after randomization, because of overt signs of deepsepsis found during surgery. They were managed by leavingthe wound open for secondary healing. Regarding the base line characteristics, the patientsof EMC group were statistically similar to those of EWCgroup (Table). Mean operative time of EMC and EWCgroup was 58 ± 4.5 and 43 ± 5.1 minutes respectively(p<0.0001). The hospital stay ranged from 2 to 5 days(mean =3.6±1.4 days) for EMC group, while it was 3-5 days(mean = 4±1.1 days) for EWC group B (p<0.0021). Woundinfection was 4.2% in EMC group, compared to 3.12% ofEWC group. The healing time and time off work wassignificantly shorter in EMC group than EWC group.Median follow up of EMC group was 36.3 months(range10-52 months) while it was 35.2 months (range 13-51months) for EWC group. Statistically there was nosignificant difference in the recurrence rate of both thegroups (Table)
Pilonidal sinus is a blind track lined by granulationtissue that leads to a cystic cavity, which usually containsloose hair.11The incidence is highest among Caucasians and less among Africans and Asians.9The etiology andpathogenesis of PNS, has been a matter of controversy overthe decades. At present accumulated evidence support thatPNS is an acquired disease.9,12,13The suggested twoimportant causes of PNS are deep natal cleft, causingbuttock friction and poor personal hygiene causingaccumulation of loose hair and debris in the cleft.11Pilonidal sinus disease is one of the most commonproblems, requiring surgical management in the populationof Kingdom of Saudi Arabia.8Almost all the patientsincluded in this study were young and majority of themwere male. This is in accordance with worldwidedistribution of disease.4-9The poor representation of femalepatients has also been noticed elsewhere in the Kingdom.8,14This may be because of reluctance among the female to seekmedical advice for personal problems or may represent therelatively low incidence of PNS in female population.Anumber of procedures have been advocated in thetreatment of chronic PNS. They range from an extremeconservative, non-surgical approach to extensive surgicalprocedures with full thickness flaps techniques.15-17Theideal treatment of PNS remains a topic of debate. The idealsurgery should be simple, with short hospital stay, have alow recurrence rate, associated with minimum pain andwound problems. It should also be cost effective.11None ofthe surgical procedures for PNS proved to be idealaccording to the results of wound infection, wound failure,or recurrence.18Simple excision and healing by secondary intentionwould cause more patient discomfort, more outpatientattendance for many painful dressings; require longer timefor healing and more time off work.6,8Primary closureprovides an earlier wound healing, reduced hospitalizationand less time off work when compared to lay opentechniques or marsupialization.6,8-10In this study, thehealing time and time off work in EMC group wassignificantly shorter than the patients in EWC group. Theadvantages of early wound healing and early return to workoutweigh an increase in the wound infection and recurrencerate observed by some authors by this technique.18,19The operation time for EMC group was longer thanthe time recorded for EWC group. This may be explained bythe fact that wound closure necessitates additional time overthat needed for dissection. The hospital stay of the patientsin EMC group was significantly shorter than the patients inEWC group. Recently, primary closure procedures appearto be appropriate as day care in majority of the patients.7The cost of a day care surgery has been calculated bySenapati et al22to about 60% of the cost for same procedureas in patient care in the United Kingdom.The main controversy among the surgeons revolvesaround the wound related complications, like wound failure,wound infection and higher recurrence rate in primaryclosure techniques. We did not encounter any significantdifference in the wound infection rate (4.2% vs. 3.12%) ofboth the groups. The recurrence rate in EMC and EWCgroup was 3.7% and 3.12% respectively, which wasstatistically not significant. These figures correlate wellwith the literature.4,6-9Recurrence after the treatment ofPNS are usually evident within first 3 years.11We had amedian follow up of 36.3 and 35.2 months for EMC andEWC group respectively, which is quite acceptable to detectthe recurrence.In author's view, it is not justified to leave the woundopen, in a good number of patients because of the fear ofrecurrence. Wound remains a constant source of nuisance tothe patient, till complete healing. Early recurrence may bedue to the presence of midline wound, acting as portal forhair entry and late recurrence may be due to deep natal cleftin which loose hair may collect.6By improving personalhygiene and regular shaving the natal cleft, we can decreasethe number of recurrence.5,7,11,13The recurrence rate is alsorelated to remaining pilonidal cyst or pits.18The meticuloussurgical techniques, with complete excision of all sinustracks can reduce the recurrence rate after midlineclosure.7,11
Excision and primary closure is recommended as apreferred procedure in the management of chronic PNSdisease. It has the advantages of short hospital stay, earlywound healing, rapid return to work and comparablerecurrence rate with excision and the open wound
The authors are grateful to the statistician Mr AmirS. Marzouk, from the research centre, College of Medicine,King Saud University, Riyadh, Kingdom of Saudi Arabiafor his valuable help in the statistical analysis of the results.
1.Tritapepa R, Di Padova C. Excision and primary closure of pilonidal sinususing a drain for aseptic wound flushing. Am J Surg 2002; 183: 209-11.
2.Akinci OF, Bozer M, Uzunkoy A, Duzgun SA, Coskun A. Incidence andaetiological factors in pilonidal sinus among Turkish soldiers. Eur J Surg1999;165:339-42.
3.Sondenaa K, Andersen E, Nesvik I, Soreide JA. Patient characteristics andsymptoms in chronic pilonidal sinus disease. Int J colorectal Dis 1995;10:39-42.
4.Mohamed HA, Kadry I, Adly S. Comparison between three therapeuticmodalities for non complicated pilonidal sinus disease. Surgeon 2005; 3:73-7.
5.Akinci OF, Coskun A, Uzunkoy A. Simple and effective surgical treatment ofpilonidal sinus: asymmetric excision and primary closure using suction drainand subcuticular skin closure. Dis Colon Rectum 2000; 43:701-6.
6.Khalid K. Outcome of surgery for chronic natal cleft pilonidal sinus: Arandomized trial of open compared with closed technique. JCPSP2001;11:32-5.
7.Dalenback J, Magnusson O, Wedel N, Rimback G. Prospective follow up afterambulatory plain midline excision of pilonidal sinus and primary closureunder local anaesthesia- efficient, sufficient, and persistent. Colorectal Dis2004;6:488-93.
8.Chiedozi LC, Al-Rayyes FA, Salem MM, Al-Haddi FH, Al-Bidewi AA.Management of pilonidal sinus. Saudi Med J 2002; 23:786-8.
9.Allen-Mersh TG. Pilonidal sinus: finding the right track for treatment. Br JSurg1990; 77:123-32.
10.Da Silva JH. Pilonidal cyst: cause and treatment. Dis Colon Rectum2000;43:1146-56.
11.Aldean I, Shankar PJ, Mathew J, Safarani N, Haboubi NY. Simple excisionand primary closure of pilonidal sinus: a simple modification of conventionaltechnique with excellent results. Colorectal Dis 2005; 7:81-5.
12.Bascom J. Pilonidal disease: origin from follicles of hair and results of follicleremoval as treatment. Surgery 1980:87:567-72.
13.Karydakis GE. Easy and successful treatment of pilonidal sinus afterexplanation of its causative process. Aust N Z J Surg 1992; 62:385-9.
14.Al-Homoud SJ, Habib ZA, Abdul Jabbar AS, Isbister WH. Management ofsacrococcygeal pilonidal sinus disease. Saudi Med J2001; 22:762-4.
15.Armstrong JH, Barcia PJ, Pilonidal sinus disease. The conservative approach.Arch Surg 1994; 129:914-7.
16.Tekin A. Pilonidal sinus: experience with Limberg flap. Colorectal Dis 1999;1:29-33.
17.Milito G, Gortese F, Casciani CU. Rhomboid flap procedure for pilonidalsinus: results from 67 cases. Int J Colorectal Dis 1998; 13:113-5.
18.Petersen S, Koch R, Stelzner S, Wendlantd TP, Ludwig K. Primary closuretechniques in chronic pilonidal sinus: a survey of the results of differentsurgical approaches. Dis Colon Rectum 2002; 45:1458-67.
19.Lesalneiks I, Furst A, Rentsch M, Jauch KW. Primary midline closure afterexcision of a pilonidal sinus is associated with a high recurrence rate. Chirurg2003; 74: 461-8.
20.Kronborg O, Christensen KI, Zimmermann- Nielsen O. Chronic pilonidaldisease: a randomized trial with complete 3-years follow up. Br J Surg1986;72:303-4.
21.Oncel M, Kurt N, Kement M, Colak E, Eser M, Uzun H. Excision andmarsupialization versus sinus excision for the treatment of limited chronicpilonidal disease: a prospective randomized trial. Tech Coloproctol 2002;6:165-9.
2.Senapati A, Cripps NP, Thompson MR. Basom's operation in the day- surgicalmanagement of symptomatic pilonidal sinus. Br J Surg 2000; 87:1067-70. 0..