Purpose: This study describes the specific use and sealing ability of Hemopatch® in patients undergoing routine laparoscopic cholecystectomy. Methods: A multicenter, prospective, open-label, non-randomized, control-group comparison was performed to compare the effects of adjunct Hemopatch® in patients undergoing laparoscopic cholecystectomy. The primary endpoint was the reduction of post-operative hospitalization. Secondary endpoints were the amount of post-operative drainage within the initial 6 hours, the total volume of drainage during 72 hours post-operatively, the need for re-operative/re-admission, and reported complications. Results: one hundred and fifty two consecutive patients were enrolled between March 2016 and May 2018. In 78 (51.3%) of these patients, Hemopatch® was used as an adjunct to surgical hemostasis to obtain hemostasis of the resected areas in the gallbladder bed. The remaining 74 patients (48.7%, the control-group) underwent a standard laparoscopic cholecystectomy using only L-shaped monopolar electrode and clip. No difference was observed between the groups in post-operative hospitalization course and most endpoints, including no surgical re-operations or re-admission in any patient. However, a substantially higher proportion of those in the adjunct Hemopatch® than the control group had no drainage after 6 hours (48.7% [38/78] and 16.2% [12/74], respectively; p < 0.001). In an analysis of drained volume, 30.7% (24/78) Hemopatch® cases and 13.5% (10/74) control cases had empty drains (p = 0.011). Reported complications occurred in 13.2% of cases, with 11.8% in the Hemopatch® cases and 1.4% in the control group. Conclusion: These findings suggest that the adjunctive use of Hemopatch® in patients undergoing elective laparoscopic cholecystectomy is safe and easy to utilize and that its sealing ability reduces the amount of post-operative site drainage. *Correspondence to: Tatiana Di Cesare, Department of General Surgery, Regina Apostolorum Hospital, Albano Laziale, Rome, Italy, Tel: 06932989; Fax: 0693298342; E-mail: tatiana.dicesare@hotmail.it
[1]
Ken Hagiwara,et al.
Short-term outcome of laparoscopic cholecystectomy for benign gall bladder diseases in 76 dogs
,
2018,
The Journal of veterinary medical science.
[2]
R. De Paulis,et al.
Prospective Randomized Clinical Trial of HEMOPATCH Topical Sealant in Cardiac Surgery.
,
2016,
Surgical technology international.
[3]
M. Carini,et al.
European Initial Hands-On Experience with HEMOPATCH, a Novel Sealing Hemostatic Patch: Application in General, Gastrointestinal, Biliopancreatic, Cardiac, and Urologic Surgery.
,
2014,
Surgical technology international.
[4]
A. Seifalian,et al.
Topical haemostatic agents
,
2008,
The British journal of surgery.
[5]
M. Catani,et al.
Use of floseal hemostatic matrix for control of hemostasis during laparoscopic cholecystectomy for acute cholecystitis: a multicenter historical control group comparison (the GLA study gelatin matrix for acute cholecystitis).
,
2014,
Journal of laparoendoscopic & advanced surgical techniques. Part A.
[6]
C. V. van Laarhoven,et al.
Laparoscopic versus open cholecystectomy for patients with symptomatic cholecystolithiasis.
,
2006,
The Cochrane database of systematic reviews.