Ignite Creation Date:
2024-05-06 @ 1:24 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04017260
Status:
COMPLETED
Last Update Posted:
2019-07-12
First Post:
2019-07-02
Brief Title:
Combined Open and Closed Approach for Management of Pilonidal Sinus by Special U-shaped Sutures Without Drain
Sponsor:
Zagazig University
Organization:
Zagazig University
Study Overview
Official Title:
Combined Open and Closed Approach for Management of Pilonidal Sinus by Special U-shaped Sutures Without Drain
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 26100000 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 sinussinuses 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 patients 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
21 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 2Fig3
Group AThe 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 BRhomboid 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 itundercutting 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
22 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 005 was considered statistically significant All data were collected tabulated and statistically analyzed using SPSS 200 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 hirsutismMost patients were young with the mean age in Group-A being 2443 SD 608 and the mean age in Group-B was 2740 SD 590 Group C was 254 53 Group D was 28242 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 9In 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 10In 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 25 and infection occurred in one patient25
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 techniques operation time is short but has significant postoperative morbidity as wound infection rate is 12-327 dehiscence rate is 10- 50 and recurrence rate is 5-12 11 In this study Group A showed infection in one patient25 and the recurrence rate was low 25
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 10In our study there is partial flattening of the intergluteal cleft and so the recurrence rate was low 25
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 Limbergs technique come with a recurrence rate of 0-6 13 in prospective randomized studies
In classic Limberg flap technique recurrence rate is 126-53 19 In our study Follow up time is 12 months and recurrence rate was in one case only 25 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 21Therefore 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
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 sinussinuses 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 patients 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
21 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 2Fig3
Group AThe 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 BRhomboid 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 itundercutting 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
22 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 005 was considered statistically significant All data were collected tabulated and statistically analyzed using SPSS 200 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 hirsutismMost patients were young with the mean age in Group-A being 2443 SD 608 and the mean age in Group-B was 2740 SD 590 Group C was 254 53 Group D was 28242 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 9In 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 10In 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 25 and infection occurred in one patient25
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 techniques operation time is short but has significant postoperative morbidity as wound infection rate is 12-327 dehiscence rate is 10- 50 and recurrence rate is 5-12 11 In this study Group A showed infection in one patient25 and the recurrence rate was low 25
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 10In our study there is partial flattening of the intergluteal cleft and so the recurrence rate was low 25
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 Limbergs technique come with a recurrence rate of 0-6 13 in prospective randomized studies
In classic Limberg flap technique recurrence rate is 126-53 19 In our study Follow up time is 12 months and recurrence rate was in one case only 25 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 21Therefore 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None