Efficacy and safety of RD2 Ver.02, a whole blood clot therapy, coupled with a minimally invasive procedure in pilonidal sinus: a phase II study.

BACKGROUND: PNS is caused by an infection in the sacrococcygeal area triggered by hair particle accumulation in skin tunnels, resulting in infection. Surgical options range from simple excision to complex flap constructions. Primary wound healing failure and recurrence rates contribute to the burden of PNS. RD2 Ver.02, a novel autologous whole-blood clot product, demonstrated safety and efficacy in treating complex cutaneous wounds and was investigated for the management of PNS. METHODS: A Phase II open-label, pilot, single-arm prospective study was conducted from May 2021 to May 2023 (Ethics Committee approval #7952-20). Patients with PNS underwent a minimally invasive trephine procedure under local anesthesia followed by RD2 Ver.02 instillation into the cavity. Primary healing was assessed at 3, 6, and 12 months. Secondary outcomes included the collection of adverse events. RESULTS: Overall, 51 patients participated in the study. At 3 months, 42/51 healed (82.4%), 7/51 (13.7%) were granulating but not completely healed, and 2/51 (3.9%) failed to heal. At 6 and 12 months, 46/51 (90.2%) and 42/51 (82.4%) achieved complete healing, respectively. At 6 months, two PNSs recurred after initial healing and an additional four instances of PNS recurrence observed in 12 months, so a total of recurrence in six patients (11.8%). There were five adverse events (AEs) with no severe adverse events. CONCLUSION: RD2 Ver.02 is a safe and effective treatment of PNS when coupled with a minimally invasive trephine PNS procedure. Further comparative studies are needed to fully assess the role of this novel therapy for PNS.

Surgical outcomes of minimally invasive trephine surgery for pilonidal sinus disease with and without laser therapy: a comparative study.

BACKGROUND: Over the last decades, novel therapeutic options have emerged for the surgical treatment of pilonidal sinus disease (PSD). The aim of this study was to evaluate the outcomes of trephine/pit excision surgery with or without laser therapy in patients with PSD. METHODS: A retrospective cohort study was conducted at a large tertiary medical center, including all adult patients with PNS who underwent trephine surgery with/without laser therapy between 2016 and 2021[AUTHORS TO INSERT MONTH]. Propensity score matching was used to address confounding factors, and the primary outcome was the 1-year recurrence rate. RESULTS: The study included 221 patients with PSD, with a mean age of 23.73 years (87.7% male). In the unmatched cohort (130 trephine surgery alone, 91 trephine surgery + laser therapy), significant differences were observed in mean age (23 vs. 25 years; p < 0.01)[AUTHROS TO USE MEDIAN PLUS RANGE OR ADD SD] and surgeons' experience (p = 0.014). Propensity score matching was applied to overcome confounding factors, resulting in a matched cohort including 73 patients in each group. The addition of laser therapy demonstrated a significantly lower recurrence rate (8.2% vs. 32.9%; p < 0.001) compared to pit excision without laser therapy. Logistic regression analysis showed that the addition of laser was significantly associated with a lower risk for recurrence (OR 0.23; 95% CI 0.089-0.633; p < 0.01). CONCLUSION: The incorporation of laser therapy along with trephine/pit excision surgery significantly reduces the recurrence rate in patients with PNS. Further prospective studies are needed to confirm our findings.

Laparoscopic fixation of volvulus by extra-peritonealization: a case series.

BACKGROUND: Volvulus is one of the leading causes of colonic obstruction with a high recurrence rate following endoscopic decompression. Although colonic resection remains the treatment of choice, it is often associated with significant morbidity and mortality, especially in elderly patients. Colonic fixation with extra-peritonealization has been suggested as an alternative to colonic resection. The aim of this study was to evaluate the surgical outcomes of patients with colonic volvulus in our initial experience with this procedure. METHODS: A retrospective analysis of a prospectively maintained database of all patients who underwent colonic extra-peritonealization for volvulus between January 2016 and April 2021 in Sheba medical center (Ramat-Gan, Israel) was performed. Patients' demographics, clinical, peri-operative and post-operative data were recorded and analyzed. RESULTS: One hundred and thirty nine patients were admitted due to acute colonic volvulus, 48 of whom were treated surgically. Eleven patients underwent extra-peritonealization of the sigmiod or cecum during the study period. Mean age was 64.5 years. Six patients (54.55%) were males. Seven patients (63.63%) presented with sigmoid volvulus and 4 (36.36%) with cecal volvulus. Median American Society of Anesthesiologists (ASA) class was 3 (range 2-4). One patient (9.09%) was required urgent surgery. The majority of patients was operated on using a laparoscopic approach (10 patients, 90.9%). Median length of stay was 3 days (range 1-6 days) and no post-operative complications or readmissions within 30 days after surgery were recorded. Median length of follow-up was 283 days (range 21-777 days). During the follow-up period, three patients (27.27%) presented with recurrent volvulus and required an additional surgical intervention with colonic resection. Of the patients with volvulus recurrence, one patient (9.09%) required an urgent surgical intervention. CONCLUSIONS: Extra-peritonealization of colonic volvulus is feasible and safe. Although recurrence rates are fairly high, the low morbidity associated with the procedure makes it an appealing alternative to colonic resection, especially in patients with high risk for post-operative complications.

Implications of Stoma Formation as Part of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy.

BACKGROUND: Formation of protective stoma as part of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) may be an effective tool in reducing anastomotic leak incidence. Our aim was to evaluate the incidence and implications of stoma formation during CRS-HIPEC and to examine whether a creation of protective stoma reduces the postoperative morbidity. METHODS: A cohort retrospective analysis of all CRS-HIPEC procedures performed between 2004 and 2016 was conducted. Predicting factors for stoma formation were assessed by comparing all patients who underwent stoma formation to those who did not; both groups were then restricted to cases with ≥2 bowel anastomoses and compared in terms of perioperative outcomes in order to determine whether protective stoma confers a morbidity benefit. RESULTS: One hundred and ninety-nine CRS-HIPEC procedures were performed on 186 patients. Thirty-four patients (17%) underwent stoma formation, 24 of them as protective stoma. Formation of a stoma was correlated with higher peritoneal carcinomatosis index score (13.6 ± 8 vs. 9.5 ± 7.7, p = 0.007), larger number of organs resected (p < 0.001), greater number of anastomoses (p < 0.001), prolonged operative time (8.1 ± 2.7 vs. 6.6 ± 2.2 h, p = 0.002), and prolonged hospital stay (12 vs. 8.5 days, p = 0.001). In procedures requiring ≥2 anastomoses, formation of protective stoma reduced the anastomotic leak rate (6 vs. 37%, p = 0.025), the morbidity rate (6 vs. 41%, p = 0.017), and reoperation rate (0 vs. 28%, p = 0.03). Overall, 15 patients (44%) underwent stoma reversal, 3 of whom had a complication treated non-operatively. CONCLUSIONS: Protective stoma should be considered in extensive CRS-HIPEC procedures requiring two or more bowel anastomoses in order to reduce the postoperative morbidity rate.