Combined Open and Closed Approach for Management of Pilonidal Sinus by Special U-shaped Sutures Without Drain.
Condition: Pilonidal Sinus
MeSH terms: Pilonidal Sinus
Study type: Interventional

Summary: 
      Introduction: Pilonidal sinus disease (PSD) is a common surgical disease frequently seen in
      the intergluteal cleft. The treatment of this problem is mainly surgical.

      Aim: introduce a novel technique of combined open and closed approach for management of
      primary pilonidal sinus (non-recurrent) by special U-shaped sutures and compare it with other
      techniques as regard operative time, time of complete wound healing, postoperative pain ,
      time to stop analgesic drugs and evaluate the result of surgery without drain.

      Patients: this study was conducted on 160 patients with PSD in the sacrococcygeal region who
      underwent operation between December 2015 and December 2017. All cases are divided randomly
      into four groups each consists of 40 patients.
    

Detailed description: 
      1. Introduction Pilonidal sinus disease (PSD) is a common disease seen in the intergluteal
           cleft. This disease is usually seen between the ages of 15 years and 35 years, and males
           are affected more often than females [1]. The incidence of the disease is 26/100,000 in
           the general population [2]. The most accepted theory for this disease development is the
           penetration of shed hair into the skin and is associated with inflammation, abscess and
           sinus formation [1]. The depth of the intergluteal sulcus, the number of loose hair, and
           the stiffness of the hairs play important role in the disease etiology [3]. The reason
           for the wide acceptance of the acquired theory may be the high recurrence rates of up to
           30% even after the most radical local excisions of pilonidal disease, which suggests
           that a pilonidal sinus is an acquired new disease rather than the persistence of some
           existing sinuses [4]. Although many medical and surgical methods have been proposed for
           this disease management, no clear consensus about the best method of treatment has been
           reported so far in the literature. Medical treatment modalities include phenol, silver
           nitrate, and electro cauterization of the cavity .The surgical options include excising
           the sinus to the level of the sacrococcygeal fascia and primary closure, or leaving it
           to secondary healing, Z-plasty, split-skin grafting, Rhomboid flap rotation, or
           Karydakis flap [5]. Eradication of the pilonidal sinus through wide surgical excision is
           still the cornerstone of treatment, yielding good long-term results, but at the expense
           of postoperative complications, prolonged hospital stay and a period of off-work up to
           4-8 weeks, substantial pain, sub-optimal aesthetic results and recurrence [6].

           The main problem after PSD surgery is recurrence, and recurrence rates have been
           reported in the literature to range from 3% to 46%, depending on the technique used [7].

           The aim of the present study was to analyze , evaluate and compare the short term and
           long term clinical results of this novel technique of combined closed and open approach
           for management of pilonidal sinus by special U-shaped sutures without drain, Rhomboid
           flap technique, Karydakis technique and open technique, an approach that allows surgeons
           to overcome these techniques complications.

        2. Materials and methods This is a controlled clinical trial on 160 patients who had been
           operated on for PSD between December 2015 and December 2017 in faculty of medicine,
           Zagazig University, after approval from medical ethical committee. Fifteen patients were
           lost during the study as we cannot reach them by any way and were excluded from the
           study. The remaining consecutive patients were included in this prospective analysis.

           The patients were divided into 4 groups: Group A: 40 patients underwent combined open
           and closed technique, Group B: 40 patients underwent Rhomboid flap technique, Group C:
           40 patients underwent Karydakis technique and Group D: 40 patients underwent open
           technique and wound is left to heal with secondary intention. Patients are grouped
           randomizally that patient 1 went to group A and patient 2 went to group B and patient 3
           went to group c and patient 4 went to group D and the process is repeated.

           Time of operation, postoperative morbidity and hospital stay, and loss of work days,
           duration of wound healing and recurrence were analyzed. Informed consent was obtained
           from all individual participants included in the study.

           Inclusion criteria include primary PSD in intergluteal region between 18-35 years. Also
           those fulfilling the diagnostic criteria of Chronic discharging sinus/sinuses in natal
           cleft with or without surrounding tissue inflammation and with associated pain and
           bleeding on clinical evaluation were also included in our study. Exclusion criteria
           include recurrent pilonidal sinus, patients who were terminally ill, had Uncontrolled
           diabetics, were Immunocompromised and immunosuppressed patients, had acute pilonidal
           abscess.

           The patients with PSD underwent the procedure by the same surgeon. Infected sinuses were
           treated with antibiotics prior to the surgery for at least 2 weeks.

           The patient's age, sex, operation time, mean hospital stay, postoperative wound
           complications, cosmetic appearance and recurrence rate, and hypoesthesia in the gluteal
           region were recorded during follow-up period. Clinical assessments were performed
           postoperatively on the 1st day, 3rd day, 7th day, and 10th day and by telephone on the
           1st month, 3rd month, 6th month, and 12th month.

           2.1. Operative technique The patients were hospitalized, and the site of the operation
           was shaved on the day of the surgery. All Patients were operated on under spinal
           anesthesia. Antibiotic was administered to all patients as prophylaxis 60 minutes prior
           to the surgery. An adhesive tape was used to part the buttocks. The patients were placed
           in the jack-knife position. (Fig. 1). Methylene blue was injected without pressure
           through the external opening to delineate the sinus. The operation site was cleaned with
           10% povidone-iodine. All sinus tracts were resected en bloc via elliptical incision down
           to presacral fascia with meticulous hemostasis. (Fig 2)(Fig.3).

           Group A:The wound was closed with 0 polypropylene sutures including skin, subcutaneous
           tissue and including the presacral fascia starting 5cm from the edge of the wound and
           pass to the other side 5cm from the edge of the wound including presacral fascia,
           subcutaneous tissue and the skin. Then pass 2cm from the edge of the wound and pass
           through the three layers to the other side in double u-shaped sutures. Multiple sutures
           are used according to the length of the wound. Sutures were approximated together
           without tension (Fig. 4-11).

           Group B:Rhomboid flap technique: involve closure of the defect after excision of all
           sinuses with Rhomboid flap of skin and subcutaneous tissue.

           Group C: Karydakis flap technique: the long axis of the ellipse is parallel to the
           midline and 2cm from it.undercutting incision is made along the whole length 1cm below
           the skin surface then unrolling the flap over the midline.

           Group D: Open procedure involved a wide excision of the pilonidal sinus tract and
           healing by secondary intention.

           2.2. Postoperative follow-up Postoperative management included pressure dressings, low
           residual diet until the fifth postoperative day, inspection of dressings in every other
           day, and suture removal on the 21th postoperative day. Instructions on discharge
           included avoidance of prolonged sitting and riding a bicycle until 8 weeks
           postoperatively to prevent wound disruption, improving local hygiene and regular removal
           of hairs by depilatory creams.

           Before discharge from hospital, patients are asked to return to the clinic on
           postoperative Day 3, Day 7, and Day 10. The skin sutures were removed on the 21th
           postoperative day. The long-term follow-up (1st month, 3rd month, 6th month, and 12th
           month) was performed via outpatient interview or by telephone interview.

           Successful treatment was the healing of the wound by subcutaneous scar formation and
           epithelization of the wound at 8-12 weeks. If skin and subcutaneous tissue reopened with
           discharge, it is reported as wound dehiscence. The wound that seemed to have healed
           within the first 8 weeks but recurred later on during the study period (either
           re-opening of a primarily healed pit or emerging of a new one) was documented as
           recurrence. A visual analogue scale (VAS) score was used to assess pain.

        3. Statistical analysis:

      Qualitative data were expressed as absolute frequencies (number) & relative frequencies
      (percentage). Categorical data were compared using Chi-square test. All tests were two sided.
      p-value < 0.05 was considered statistically significant. All data were collected, tabulated
      and statistically analyzed using SPSS 20.0 for windows (SPSS Inc., Chicago, IL, USA).

      . 4. Discussion There is still no consensus about treatment of pilonidal sinus disease.
      Ideally, therapy should be associated with short hospital stay, less painful postoperative
      time, rapidly healing and return to work, less painful dressing of wound, short term wound
      care and a low recurrence rate. No techniques fulfill all of these criteria. We compared our
      results with other studies to estimate the reliability of our data.

      Pilonidal sinus is more common in male [8]. In our study, male predominate than female (out
      of the total 160 patients 85% were males and 15% were females). Men are more affected thanks
      to their natural hirsutism.Most patients were young with the mean age in Group-A being 24.43
      (SD ±6.08) and the mean age in Group-B was 27.40 (SD ± 5.90), Group C was 25.4 ± 5.3, Group D
      was 28.2±4.2. . Comparable results were shown in other similar studies [17].

      Acute pilonidal abscess should be treated by incision and drainage. In the present study the
      patients presenting with an acute abscess in the sacrococcygeal region in 12 cases that were
      initially treated with incision and drainage then postoperatively they were treated by third
      generation cephalosporin and metronidazole for 10 days. Patients were scheduled for our
      technique after 15-30 days.

      In a prospective randomized study performed on 50 patients and divided into two equal groups:
      drained and non-drained. Fluid collections were encountered in two patients (8%) of the
      drained group compared with eight patients (32%) in the no drained group with the difference
      being statistically significant [9].In our study, absence of wound collection, Seroma and
      hematoma in Group A and Group D are due to wide drainage by our special sutures technique and
      the use of third generation cephalosporin antibiotics, choosing non-infected pilonidal
      disease in most of cases.

      A controlled study showed that wound problems, length of hospital stay, morbidity, and
      recurrence rates did not increase in the absence of postoperative draining of the cavity.
      Another study also demonstrated that drain placement after rhomboid excision and Limberg flap
      technique might negatively affect the postoperative complication rate, although the mean
      operation time was significantly longer in the non-drained group [10].In our study, we did
      not use drain in group A and the results showed decreased hospital stay, no Seroma nor
      hematoma , very low recurrence rate (2.5%) and infection occurred in one patient(2.5%).

      In group A: most patients stopped analgesic drug on postoperative 3 days. Our patients
      started to sit on chair without pain on postoperative 10 days .It may result from low tension
      in the wound.

      Primary closure technique's operation time is short but has significant postoperative
      morbidity as wound infection rate is 12-32.7%, dehiscence rate is 10- 50% and recurrence rate
      is 5-12% [11]. In this study, Group A showed infection in one patient(2.5%) and the
      recurrence rate was low (2.5%).

      Incision and curettage, unroofing, curettage and excision with marsupialization procedures
      are common used surgical techniques. But these procedures had painful postoperative time,
      delayed healing and return to work, painful dressing of wound and long term wound care. But
      they have a low recurrence rate [12]. In this study, postoperative pain was low on pain
      scale, rapid wound healing, rapid return to work, and painless dressings and in addition, low
      recurrence rate (1%) When the midline lateralized or flattened, recurrences are less likely
      to occur [10].In our study there is partial flattening of the intergluteal cleft, and so the
      recurrence rate was low (2.5%).

      Hospital stay varied from 2 to 5 days [13]. Using wide-excision techniques and median time
      off work was reported from 19 up to 38 days [14]. Other studies reported a mean length of
      hospital stay 2-4 days [9]. In the present study the length of hospital stay was 1 day in
      most cases of Group A and Group C.

      The incidence of wound infection was ranged from 0% to 12% [15]. In our study, Group A showed
      Wound infection in one patient and Seroma did not occur in any patients.

      Gupta [16] reported recurrence rates of 13% using wide-excision techniques, while other
      studies achieved 5% in larger trials [17]. A recurrence rate of 3-10% is described for
      excision with marsupialization of the wound [18]. Reconstructive flaps according to Limberg's
      technique come with a recurrence rate of 0-6% [13] in prospective randomized studies.

      In classic Limberg flap technique recurrence rate is 1.26-5.3% [19]. In our study, Follow up
      time is 12 months and recurrence rate was in one case only (2.5%). Some studies have shown
      that, in addition to a good surgical technique, elimination of preventable risk factors such
      as hygiene at the intergluteal sulcus is important to prevent recurrence [20] [21].Therefore,
      patients in this study were advised regarding the importance of local hygiene.

      Primary closure of the wound after excision of the pilonidal sinus is associated with a high
      recurrence rate. In the literature, the recurrence rate after primary closure has ranged from
      4% to 25% [21].

      A common complaint after flap surgery was hypoesthesia on the flap, in our study hypothesia
      occurred in 59 cases (37%).

      Considering the problems of our study, there are two issues that have to be respected when
      interpreting our results: First, the recurrence rate of this study might be higher than
      demonstrated in the result due to shorter of follow up period and missing patients in the
      follow up period. Second, the wound healing time might have been shorter than it is reported
      in this study. The wound healing time was assessed by the patients themselves and was not
      determined by a physician. The wound healing time might more reflect the disappearance of any
      discomfort at the intergluteal fold than the complete closure of the skin after surgery.
    

Intervention name(s): open and closed approach; Rhomboid flap technique; Karydakis technique; open technique
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): The patients were hospitalized, and the site of the operation was shaved on the day of the surgery. All Patients were operated on under spinal anesthesia. Antibiotic was administered to all patients as prophylaxis 60 minutes prior to the surgery. An adhesive tape was used to part the buttocks. The patients were placed in the jack-knife position. (Fig. 1). Methylene blue was injected without pressure through the external opening to delineate the sinus. The operation site was cleaned with 10% povidone-iodine. All sinus tracts were resected en bloc via elliptical incision down to presacral fascia with meticulous hemostasis.
Group A:The wound was closed with 0 polypropylene u-shaped sutures .; The patients were hospitalized, and the site of the operation was shaved on the day of the surgery. All Patients were operated on under spinal anesthesia. Antibiotic was administered to all patients as prophylaxis 60 minutes prior to the surgery. An adhesive tape was used to part the buttocks. The patients were placed in the jack-knife position. (Fig. 1). Methylene blue was injected without pressure through the external opening to delineate the sinus. The operation site was cleaned with 10% povidone-iodine. All sinus tracts were resected en bloc via elliptical incision down to presacral fascia with meticulous hemostasis.Rhomboid flap technique: involve closure of the defect after excision of all sinuses with Rhomboid flap of skin and subcutaneous tissue; The patients were hospitalized, and the site of the operation was shaved on the day of the surgery. All Patients were operated on under spinal anesthesia. Antibiotic was administered to all patients as prophylaxis 60 minutes prior to the surgery. An adhesive tape was used to part the buttocks. The patients were placed in the jack-knife position. (Fig. 1). Methylene blue was injected without pressure through the external opening to delineate the sinus. The operation site was cleaned with 10% povidone-iodine. All sinus tracts were resected en bloc via elliptical incision down to presacral fascia with meticulous hemostasis.the long axis of the ellipse is parallel to the midline and 2cm from it.undercutting incision is made along the whole length 1cm below the skin surface then unrolling the flap over the midline.; The patients were hospitalized, and the site of the operation was shaved on the day of the surgery. All Patients were operated on under spinal anesthesia. Antibiotic was administered to all patients as prophylaxis 60 minutes prior to the surgery. An adhesive tape was used to part the buttocks. The patients were placed in the jack-knife position. (Fig. 1). Methylene blue was injected without pressure through the external opening to delineate the sinus. The operation site was cleaned with 10% povidone-iodine. All sinus tracts were resected en bloc via elliptical incision down to presacral fascia with meticulous hemostasis.Open procedure involved a wide excision of the pilonidal sinus tract and healing by secondary intention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pilonidal sinus, combined, sutures, drain