Ignite Creation Date:
2024-05-06 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05356208
Status:
COMPLETED
Last Update Posted:
2023-03-29
First Post:
2022-04-26
Brief Title:
Long-term Outcome After Cleft-lift for Pilonidal Sinus Disease
Sponsor:
Nordsjaellands Hospital
Organization:
Nordsjaellands Hospital
Study Overview
Official Title:
Long-term Outcome After Bascoms Cleft-lift Procedure Under Tumescent Local Analgesia for Pilonidal Sinus Disease a Cohort Study
Status:
COMPLETED
Status Verified Date:
2022-04
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:
Single-center cohort study of 10-year risk of treatment failure after cleft-lift under tumescent local analgesia for pilonidal sinus disease
Detailed Description:
The standard treatment at Nordsjællands Hospital in Hillerød NOH has since 2007 been Bascoms pit-pick procedure PP for simple pilonidal sinus disease PSD while Bascoms cleft-lift procedure CLhas been performed in complicated cases not suitable for PP operation recurrences following previous excisions including PP and unhealed midline wounds
CL has mainly been performed under tumescent local analgesia TLA in a day-surgery setting TLA is well tolerated with high patient satisfaction and acceptable short-term outcomes TLA provides a potentially higher cost-effectiveness not requiring presence of an anesthesiologist shorter duration of the complete procedure and elimination of the risks and discomforts associated with general anesthetics
The study is based on data of patients in a local pilonidal database The patients in the database have all undergone surgery for pilonidal sinus disease at NOH during the period of 2007 to 2014 Data in the database has been collected prospectively up to one year following surgery and subsequently supplemented with data collected by questionnaire and telephone interviews for the period from one year follow-up and until the date of long-term follow-up Study data were collected and managed using REDCap electronic data capture tools hosted at NOH
Patients receive a REDCap survey per e-mail to a personal digital mailbox or are asked to participate in a telephone interview to fill out a standardized questionnaire Patients without a personal digital mailbox receive the questionnaire by regular mail The survey is sent out twice with a four-week interval Only patients who do not fill out the questionnaire the first time receive the survey a second time as a reminder Telephone interviews are only conducted if patients do not reply to the questionnaire received digitally or as a physical copy The questionnaire includes questions regarding demographic characteristics lifestyle complications recurrence and new interventions pain and cosmetic satisfaction Medical records are reviewed to verify answers from the questionnaire if consent by the patient is given through the survey or during the telephone interview Patients experiencing symptoms of recurrence are offered an assessment at the hospital
The procedure has been described previously and performed with minor modifications of the original description by John Bascom All procedures were performed in a day-surgical setting With the patient in the prone position the natal cleft was opened and exposed by retraction with elastic bandage tape before the sterile surgical draping was applied The resection area and a flap on the less affected side were outlined with the intention of 2-3 cm lateralization of the wound A hockey incision was outlined in the distal part of the excision to achieve lateralization at the distal end of the wound Subcutaneous TLA with a modified Kleins solution containing mepivacaine 08 mgmL adrenaline 1 µgmL and sodium bicarbonate 42 µgmL in isotonic saline water was infused through a 2-inch 21-gauge needle under a pressure of approximately 300 mm hg using a pressure infusion bag If fibrous tissue affected the subcutaneous tissue the solution was infiltrated by a 20-ml syringe In case of pain during surgery a supplementary tumescent solution was administered If acceptable analgesia could not be obtained intravenous sedation or analgesia was administrated at the patients request
A flap with a thickness of approximately 7 mm was mobilized to the marked outer line to ensure tension-free tissue coverage of the excision All primary pits in the midline were excised en-bloc and all hair and granulation tissue in the subcutis was removed with a surgical swap or by curettage saving as much fibrotic tissue as possible to provide padding The retraction tape was released and the surgical wound was closed with absorbable monofilament multilayer sutures subcutaneously with the intention of reducing any dead space in the subcutis before intracutaneous closure with polypropylene or monofilament short-term absorbable suture A 10-French drain with no vacuum or silicon ribbon drains was placed under the flap The wound was reinforced with strips and covered by a hydrofiber bandage All patients received one dose of cefuroxime 15 g and metronidazole 10 g intravenously preoperatively and cephalexin 500 mg and metronidazole 500 mg orally three times daily for three days as prophylaxis
Risk of recurrence is analyzed using competing risk analysis as well as univariate and multivariate Cox regression analyses including the following risk factors sex age smoking BMI relevant co-morbidities diabetes mellitus acne hidradenitis previous interventions preoperative abscess number of primary and secondary pits number of lateral incisions and postoperative complications Time to complete wound healing is analyzed by Kaplan-Meier plots Remaining outcomes are analyzed as categorical variables using descriptive data analyses
CL has mainly been performed under tumescent local analgesia TLA in a day-surgery setting TLA is well tolerated with high patient satisfaction and acceptable short-term outcomes TLA provides a potentially higher cost-effectiveness not requiring presence of an anesthesiologist shorter duration of the complete procedure and elimination of the risks and discomforts associated with general anesthetics
The study is based on data of patients in a local pilonidal database The patients in the database have all undergone surgery for pilonidal sinus disease at NOH during the period of 2007 to 2014 Data in the database has been collected prospectively up to one year following surgery and subsequently supplemented with data collected by questionnaire and telephone interviews for the period from one year follow-up and until the date of long-term follow-up Study data were collected and managed using REDCap electronic data capture tools hosted at NOH
Patients receive a REDCap survey per e-mail to a personal digital mailbox or are asked to participate in a telephone interview to fill out a standardized questionnaire Patients without a personal digital mailbox receive the questionnaire by regular mail The survey is sent out twice with a four-week interval Only patients who do not fill out the questionnaire the first time receive the survey a second time as a reminder Telephone interviews are only conducted if patients do not reply to the questionnaire received digitally or as a physical copy The questionnaire includes questions regarding demographic characteristics lifestyle complications recurrence and new interventions pain and cosmetic satisfaction Medical records are reviewed to verify answers from the questionnaire if consent by the patient is given through the survey or during the telephone interview Patients experiencing symptoms of recurrence are offered an assessment at the hospital
The procedure has been described previously and performed with minor modifications of the original description by John Bascom All procedures were performed in a day-surgical setting With the patient in the prone position the natal cleft was opened and exposed by retraction with elastic bandage tape before the sterile surgical draping was applied The resection area and a flap on the less affected side were outlined with the intention of 2-3 cm lateralization of the wound A hockey incision was outlined in the distal part of the excision to achieve lateralization at the distal end of the wound Subcutaneous TLA with a modified Kleins solution containing mepivacaine 08 mgmL adrenaline 1 µgmL and sodium bicarbonate 42 µgmL in isotonic saline water was infused through a 2-inch 21-gauge needle under a pressure of approximately 300 mm hg using a pressure infusion bag If fibrous tissue affected the subcutaneous tissue the solution was infiltrated by a 20-ml syringe In case of pain during surgery a supplementary tumescent solution was administered If acceptable analgesia could not be obtained intravenous sedation or analgesia was administrated at the patients request
A flap with a thickness of approximately 7 mm was mobilized to the marked outer line to ensure tension-free tissue coverage of the excision All primary pits in the midline were excised en-bloc and all hair and granulation tissue in the subcutis was removed with a surgical swap or by curettage saving as much fibrotic tissue as possible to provide padding The retraction tape was released and the surgical wound was closed with absorbable monofilament multilayer sutures subcutaneously with the intention of reducing any dead space in the subcutis before intracutaneous closure with polypropylene or monofilament short-term absorbable suture A 10-French drain with no vacuum or silicon ribbon drains was placed under the flap The wound was reinforced with strips and covered by a hydrofiber bandage All patients received one dose of cefuroxime 15 g and metronidazole 10 g intravenously preoperatively and cephalexin 500 mg and metronidazole 500 mg orally three times daily for three days as prophylaxis
Risk of recurrence is analyzed using competing risk analysis as well as univariate and multivariate Cox regression analyses including the following risk factors sex age smoking BMI relevant co-morbidities diabetes mellitus acne hidradenitis previous interventions preoperative abscess number of primary and secondary pits number of lateral incisions and postoperative complications Time to complete wound healing is analyzed by Kaplan-Meier plots Remaining outcomes are analyzed as categorical variables using descriptive data analyses
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