Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04017260 |
| Other study ID # |
zagazig university |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2015 |
| Est. completion date |
February 1, 2019 |
Study information
| Verified date |
July 2019 |
| Source |
Zagazig University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
