A A Pronk1, N Smakman2, E J B Furnee3. 1. Department of Surgery, Diakonessenhuis, Bosboomstraat 1, P.O. Box 80250, 3508 TG, Utrecht, The Netherlands. apronk1@diakhuis.nl. 2. Department of Surgery, Diakonessenhuis, Bosboomstraat 1, P.O. Box 80250, 3508 TG, Utrecht, The Netherlands. 3. Department of Abdominal Surgery, University Medical Center Groningen, Groningen, The Netherlands.
Abstract
BACKGROUND: Phenolisation of Sacrococcygeal pilonidal sinus disease (SPSD) seems to have advantages over radical excision; however, a randomized-controlled trial (RCT) comparing both techniques is lacking. The aim of our study was to compare sinus pit excision and phenolisation of the sinus tract with radical excision in SPSD in terms of return to normal daily activities. METHODS: This study was a single-center RCT. Fifty patients who presented with primary SPSD were randomized to phenolisation and 50 patients to excision. The primary endpoint was time to return to normal daily activities. Secondary endpoints were quality of life, complaints related to SPSD, surgical site infection, and wound epithelialization. Patients were treated in a 1-day surgery setting. Complaints related to SPSD were evaluated and symptoms were scored by the participants on a 6-point scale before surgery, and patients kept a diary for 2 weeks on complaints related to the surgical treatment (the same scoring system as preoperatively) and pain, evaluated with a VAS. Quality of life (QoL) was measured preoperatively with a VAS and the Short Form-36 Health Survey (SF-36). At 2, 6, and 12 weeks after surgery, patients were evaluated using a questionnaire containing the following items: patients' satisfaction (disease, compared with preoperatively, scored as cured, improved, unchanged or worsened), five complaints related to the surgical treatment (the same scoring system as preoperatively and in the diary), QoL (VAS and SF-36), and return to normal daily activities. The wound was assessed 2, 6, and 12 weeks postoperatively by one of the investigators (EF or NS), using an assessment form RESULTS: The mean time to return to normal daily activities was significantly shorter after phenolisation (5.2 ± SD 6.6 days vs. 14.5 ± 25.0 days, p = 0.023). 2 weeks after surgery, all patients in the phenolisation group and 85.4% of patients in the excision group returned to normal daily activities (p = 0.026). Pain was significantly lower after phenolisation at 2 weeks postoperatively (0.8 ± 1.0 vs. 1.6 ± 1.3, p = 0.003). Surgical site infection occurred significantly more often after radical excision (n = 10, 21.7% vs. n = 2, 4.0%, p = 0.020). At 6 and 12 weeks, complete wound epithelialization was more frequently achieved after phenolisation (69.0% vs. 37.0%, p = 0.003 and 81.0% vs. 60.9%, p = 0.039, respectively). CONCLUSIONS:Pit excision with phenolisation of SPSD resulted in a quicker return to normal daily activities, less pain, and quicker wound epithelialization compared to radical excision. Surgeons should consider phenolisation in patients with primary SPSD.
RCT Entities:
BACKGROUND: Phenolisation of Sacrococcygeal pilonidal sinus disease (SPSD) seems to have advantages over radical excision; however, a randomized-controlled trial (RCT) comparing both techniques is lacking. The aim of our study was to compare sinus pit excision and phenolisation of the sinus tract with radical excision in SPSD in terms of return to normal daily activities. METHODS: This study was a single-center RCT. Fifty patients who presented with primary SPSD were randomized to phenolisation and 50 patients to excision. The primary endpoint was time to return to normal daily activities. Secondary endpoints were quality of life, complaints related to SPSD, surgical site infection, and wound epithelialization. Patients were treated in a 1-day surgery setting. Complaints related to SPSD were evaluated and symptoms were scored by the participants on a 6-point scale before surgery, and patients kept a diary for 2 weeks on complaints related to the surgical treatment (the same scoring system as preoperatively) and pain, evaluated with a VAS. Quality of life (QoL) was measured preoperatively with a VAS and the Short Form-36 Health Survey (SF-36). At 2, 6, and 12 weeks after surgery, patients were evaluated using a questionnaire containing the following items: patients' satisfaction (disease, compared with preoperatively, scored as cured, improved, unchanged or worsened), five complaints related to the surgical treatment (the same scoring system as preoperatively and in the diary), QoL (VAS and SF-36), and return to normal daily activities. The wound was assessed 2, 6, and 12 weeks postoperatively by one of the investigators (EF or NS), using an assessment form RESULTS: The mean time to return to normal daily activities was significantly shorter after phenolisation (5.2 ± SD 6.6 days vs. 14.5 ± 25.0 days, p = 0.023). 2 weeks after surgery, all patients in the phenolisation group and 85.4% of patients in the excision group returned to normal daily activities (p = 0.026). Pain was significantly lower after phenolisation at 2 weeks postoperatively (0.8 ± 1.0 vs. 1.6 ± 1.3, p = 0.003). Surgical site infection occurred significantly more often after radical excision (n = 10, 21.7% vs. n = 2, 4.0%, p = 0.020). At 6 and 12 weeks, complete wound epithelialization was more frequently achieved after phenolisation (69.0% vs. 37.0%, p = 0.003 and 81.0% vs. 60.9%, p = 0.039, respectively). CONCLUSIONS: Pit excision with phenolisation of SPSD resulted in a quicker return to normal daily activities, less pain, and quicker wound epithelialization compared to radical excision. Surgeons should consider phenolisation in patients with primary SPSD.
Authors: Hilda G Rijnhart-De Jong; Werner A Draaisma; André J P M Smout; Ivo A M J Broeders; Hein G Gooszen Journal: Scand J Gastroenterol Date: 2008 Impact factor: 2.423