| Abstract | Ciljevi: Sindrom karpalnog tunela predstavlja najčešću perifernu neuropatiju koja se javlja uslijed pritiska na medijalni živac unutar karpalnog tunela. Učinak tkivnih adheziva kao materijala za zatvaranje rana nakon otvorene operacije dekompresije karpalnog tunela nije do sada istraživan. Cilj ovog istraživanja bio je procijeniti rane i kasne kliničke ishode usporedbom dvaju metoda zatvaranja postoperacijske rane nakon otvorene operacije karpalnog tunela kod ispitanika koji su randomizirani za korištenje ljepila za tkivo ili šavova. Metodologija: Ova randomizirana jednocentrična jednostruko slijepa kontrolirana prospektivna studija započeta u travnju 2022. godine obuhvatila je 100 ispitanika (70 žena) u dobi od 61,56 ± 12,03 godina, nasumično raspoređenih na zatvaranje rane šavovima (n = 50) ili za zatvaranje rana tkivnim ljepilom (n = 50) Glubran Tiss 2®. Ishodi su procijenjeni postoperativno tijekom perioda praćenja u intervalima od 2, 6 i 12 tjedana. Procjena ožiljka provedena je korištenjem ljestvice za procjenu ožiljaka bolesnika i promatrača (POSAS) i kozmetičke vizualne analogne ljestvice (VAS). Za ocjenu boli upotrijebljena je verbalna numerička skala (VNRS). Zabilježene su rane i kasne postoperacijske komplikacije. Prije operacije i šest mjeseci nakon operacije procijenjeni su snaga ruke, elektroneurografske karakteristike medijalnog živca i Bostonski upitnik karpalnog tunela. Ishodi kvalitete života i kvalitete sna su procijenjeni tijekom 12-mjesečnog postoperativnog praćenja. Za procjenu poremećaja spavanja korišteni su Pittsburgh Sleep Quality Index (PQSI) i Insomnia Severity Scale (ISI), a za procjenu kvalitete života povezane sa zdravljem ukupni SF-36 (36-Item Short Form Survey). Rezultati: Postojale su značajne razlike između zatvaranja rane ljepilom i zatvaranja rane šavom u intervalima od dva tjedna i šest tjedana nakon operacije na ljestvicama POSAS i kozmetički VAS (bolji estetski učinak tehnikom zatvaranja rane ljepilom), s manje postoperativne boli u istim intervalima. S intervalom od 12 tjedana, razlike u rezultatima nisu bile statistički značajne. Nije bilo značajnih razlika u ranim ili kasnim postoperacijskim komplikacijama. Značajne razlike između tehnika zatvaranja rana na temelju ljepila i šavova utvrđene su u šestomjesečnoj postoperativnoj snazi stiska šake (25,06 ± 6,69 naspram 21,41 ± 5,62 kg, P = 0,002), postoperativnoj senzornoj amplitudi (10,08 ± 5,50 naspram 7,54 ± 5,41 mV, P = 0,012) i postoperativnoj senzornoj brzini medijalnog živca (42,22 ± 11,04 naspram 35,23 ± 16,40 m/s, P = 0,008). U skupini s tkivnim ljepilom, značajno je više ispitanika postiglo postoperativnu senzornu brzinu veću od 45 m/s (47,9% naspram 22,0%, P = 0,006), postoperativnu distalnu senzornu latenciju manju od 3,5 ms (89,6% naspram 84,0%, P = 0,304) i postoperativnu motoričku latenciju manju od 4,2 ms (60,42% prema 38,00%, P = 0,022). Ljestvice PQSI, ISI i SF-36 nisu pokazale statistički značajne razlike među skupinama tijekom praćenja, osim u rezultatu ISI dva tjedna nakon operacije (9,40 ± 1,18 u skupini koja je koristila tkivno ljepilo naspram 9,96 ± 1,09 u skupini sa šavovima, P = 0,008). Rezultati PQSI, ISI i SF-36 za sve ispitanike i skupine kontinuirano su se poboljšavali u svim vremenskim intervalima praćenja nakon operacije. Ukupan rezultat SF-36 povećao se 12 mjeseci nakon operacije (49,84 ± 5,85 naspram 82,46 ± 5,68, P < 0,001). Zaključak: Tkivna ljepila na bazi cijanoakrilata mogu imati prednost u usporedbi s konvencionalnim tehnikama šivanja kože za zatvaranje kirurških rana nakon otvorene dekompresije karpalnog tunela u pogledu bržeg poboljšanja estetskih učinaka i postoperacijske boli, s očekivanim boljim učincima na oporavak srednjeg živca i poboljšanje snage ruke, što u konačnici dovodi do poboljšanja kvalitete sna, smanjenja težine nesanice i poboljšanja ukupne kvalitete života. Zatvaranje rane nakon operacije dekompresije karpalnog tunela može se učinkovito i sigurno izvršiti tkivnim ljepilom na bazi cijanoakrilata, uz očekivano poboljšanje ranih i kasnih kliničkih ishoda. |
| Abstract (english) | Aims: Compression of the medial nerve in the carpal tunnel results in the most prevalent peripheral neuropathy, known as carpal tunnel syndrome. The effect of tissue adhesives as a wound closure material after open carpal tunnel decompression surgery has not been investigated. The aim of the study was to evaluate early and late clinical outcomes by comparing two modalities of postoperative wound closure after open carpal tunnel surgery in subjects randomized to either tissue adhesive or sutures. Methods: A randomized, single-center, single-blind, controlled prospective study started in April 2022 included 100 subjects (70 women) aged 61.56 ± 12.03 years, randomly assigned to wound closure with sutures (n = 50) or to closure wound with tissue glue (n = 50) Glubran Tiss 2®. During the follow-up phase, postoperative outcomes were assessed at 2, 6, and 12 week intervals. Cosmetic VAS (Visual Analog Scale) and POSAS (Patient and Observer Scar Evaluation Scale) were used for scar assessment. Pain was measured using the VNRS (Verbal Number Rating Scale). Early and late postoperative complications were recorded. Hand strength, electroneurographic characteristics of the median nerve and the Boston Carpal Tunnel Questionnaire were assessed before surgery and six months after surgery. Quality of life and sleep quality outcomes were assessed during the 12-month postoperative follow-up. The Pittsburgh Sleep Quality Index (PQSI) and Insomnia Severity Scale (ISI) were used to assess sleep disorders, and the overall SF-36 (36-Item Short Form Survey) was used to assess health- related quality of life. Results: There were significant differences between wound closure with glue and wound closure with suture at 2-week and 6-week postoperative intervals on the POSAS and cosmetic VAS scales (better aesthetic effect with the technique of wound closure with glue), with less postoperative pain at the same intervals. After 12 weeks, the differences were not statistically significant. There were no significant differences in early or late postoperative complications. Significant differences between wound closure techniques based on glue and sutures were found in 6-month postoperative hand grip strength (25.06 ± 6.69 vs. 21.41 ± 5.62 kg, P = 0.002), postoperative sensory amplitude (10.08 ± 5.50 vs. 7.54 ± 5.41 mV, P = 0.012) and postoperative sensory velocity of the median nerve (42.22 ± 11.04 vs. 35.23 ± 16.40 m/s, P = 0.008). In the tissue adhesive group, significantly more subjects achieved postoperative sensory velocity greater than 45 m/s (47.9% vs. 22.0%, P = 0.006), postoperative distal sensory latency less than 3.5 ms (89.6 % vs. 84.0%, P = 0.304) and postoperative motor latency less than 4.2 ms (60.42% vs. 38.00%, P = 0.022). With the exception of the ISI score two weeks following surgery (9.40 ± 1.18 in the tissue adhesive group vs. 9.96 ± 1.09 in the with sutures, P = 0.008), there was no statistically significant difference in the PQSI, ISI, or SF-36 scores across groups during follow-up. At every postoperative follow-up interval, the PQSI, ISI, and SF-36 scores for every subject and group showed steady improvement. A year following surgery, the SF-36 total score increased (49.84 ± 5.85 vs. 82.46 ± 5.68, P < 0.001). Conclusion: Cyanoacrylate-based tissue adhesives may have an advantage compared to conventional skin suturing techniques for surgical wound closure after open carpal tunnel decompression in better of aesthetic effects and less postoperative pain with expected better effects on median nerve recovery and improvement of hand strength, with consecutively improvement in the quality of sleep, reduction of insomnia severity and improvement in the overall quality of life. Wound closure after carpal tunnel decompression surgery can be effectively and safely performed with cyanoacrylate-based tissue adhesive with expected improvement in early and late clinical outcomes. |
