First report of a combined hemostatic technique using Hydrofit® and SURGICEL Absorbable HemostatTM for intraoperative hemorrhage in gynecologic oncology surgery: a video article
Article information
Abstract
Objective
To report the first use of Hydrofit® (Sanyo Chemical Industries, Kyoto, Japan), a polyurethane prepolymer sealant, combined with SURGICEL Absorbable Hemostat™ (Johnson & Johnson MedTech, Somerville, NJ, USA) as an oxidized cellulose carrier, for intraoperative hemorrhage control in gynecologic oncology surgery, with video documentation.
Methods
Two patients undergoing open gynecologic oncology surgery developed hemorrhage refractory to conventional hemostatic measures. SURGICEL Absorbable Hemostat™ (Johnson & Johnson MedTech) coated with Hydrofit® (Sanyo Chemical Industries) was applied to the bleeding site with 3 minutes of manual compression. Surgical findings and postoperative courses were retrospectively reviewed. Institutional ethics approval and written informed consent were obtained from both patients.
Result
Case 1: high-grade serous carcinoma of the fallopian tube with neuroendocrine features; total blood loss 4,439 g. Hemostasis at the resection surface was visually confirmed; the patient was discharged 7 days after surgery. At interval debulking surgery 4 months later, a fibrous mass adherent to the sigmoid colon with foreign body giant cells was noted at the application site; R0 resection was achieved. Case 2: cervical squamous cell carcinoma, International Federation of Gynecology and Obstetrics (2018) stage IIB; total blood loss 886 g. Hemorrhage from the right internal iliac vein was controlled within 3 minutes; the patient was discharged 11 days after surgery.
Conclusion
This combined hemostatic technique may serve as an adjunctive option when conventional measures fail during gynecologic oncology surgery. The adhesion formation observed at reoperation warrants caution. Prospective evaluation using site-specific blood loss measurements is required to establish efficacy and safety.
Introduction
Massive intraoperative hemorrhage remains a serious complication of gynecologic oncology surgery with blood loss exceeding 1,000 mL reported in 15–40% of radical tumor resection procedures and transfusion rates reaching 30–60% [1]. Perioperative transfusion is independently associated with surgical site infection, morbidity, mortality [2], and massive hemorrhage can compound hemostatic failure due to dilutional coagulopathy [3]. When conventional surgical hemostasis (suture ligation and electrocautery) is technically challenging, such as in cases of extensive venous oozing from a tumor resection surface or acute deep pelvic venous injury, adjunctive hemostatic agents are indispensable.
Hydrofit® (Sanyo Chemical Industries, Kyoto, Japan) is a polyether-urethane prepolymer sealant approved in Japan for adjunctive hemostasis at vascular anastomoses [4,5]. It polymerizes upon contact with tissue moisture to form a flexible gel, achieving hemostasis independent of the coagulation cascade [4,5]. In a multicenter randomized trial for thoracic aortic surgery, Hydrofit® (Sanyo Chemical Industries) demonstrated significantly higher hemostatic success compared with controls [6]. Naganuma et al. [7] reported that combining Hydrofit® (Sanyo Chemical Industries) with oxidized cellulose (Surgicel® [Johnson & Johnson MedTech, Somerville, NJ, USA]) enhanced handling and prevented sealant dislodgment. However, no prior report of Hydrofit® (Sanyo Chemical Industries) use in gynecologic surgery exists. We present the first report of Hydrofit® (Sanyo Chemical Industries) use in gynecologic oncology surgery, documented with intraoperative video.
Case presentations
1. Case 1
A 71-year-old woman with a history of aortic valve replacement presented with lower-extremity edema, anemia, and massive ascites. Serum carbohydrate antigen 125 was 650 U/mL. Pelvic magnetic resonance imaging (MRI) revealed a solid pelvic mass suggestive of ovarian or primary peritoneal carcinoma. Diagnostic laparoscopy was planned; however, upon admission, persistent intra-abdominal hemorrhage necessitated immediate conversion to open laparotomy.
Laparotomy revealed a head-sized tumor adherent to the anterior rectal and posterior adnexal surfaces, with dense adhesions and peritoneal implants. Complete tumor resection was infeasible; therefore, manual debulking was performed. Extensive venous oozing from the tumor resection surface was refractory to gauze packing. The combined hemostatic technique was applied as follows: SURGICEL Absorbable Hemostat ™ (Johnson & Johnson MedTech), trimmed to fit the bleeding surface, was coated with Hydrofit® (Sanyo Chemical Industries) using the supplied syringe and placed directly on the site with 3 minutes of manual compression. The compression material was removed with concurrent saline irrigation to prevent sealant dislodgment and hemostasis was confirmed by the absence of active bleeding for 30 seconds. Subsequently, right salpingectomy and left salpingo-oophorectomy were performed for biopsy to control the adnexal bleeding. Total blood loss was 4,439 g from multiple intraoperative sources rather than solely from the sealant application site. The intraoperative transfusion consisted of 16 units of packed red blood cells, 10 units of fresh frozen plasma, and 50 units of platelets. The patient was extubated 1 day after surgery and discharged 7 days after surgery. The final pathology was a high-grade serous carcinoma of the fallopian tube with neuroendocrine features, staged as International Federation of Gynecology and Obstetrics (FIGO) stage IIIC (2014).
After four cycles of neoadjuvant chemotherapy (paclitaxel/carboplatin), interval debulking surgery was performed 4 months later. A fibrous mass with adhesion to the sigmoid colon was observed at the application site, requiring adhesiolysis, and the dissection was straightforward and uneventful. Histopathological examination revealed inflammatory infiltrates and foreign-body giant cells surrounding both materials [7]. Total abdominal hysterectomy, right adnexectomy, and omentectomy achieved R0 resection.
2. Case 2
A 54-year-old woman was referred with 6 months of continuous vaginal bleeding and severe anemia (hemoglobin 4.4 g/dL). Pelvic MRI revealed a 47-mm cervical tumor with a suspected right parametrial extension. Biopsy confirmed squamous cell carcinoma; staging was FIGO 2018 IIB. After a multidisciplinary discussion, open radical hysterectomy with bilateral salpingo-oophorectomy was performed according to the patient’s preference for surgery over chemoradiotherapy.
During the dissection of the right cardinal ligament using the Okabayashi technique, the right internal iliac vein was injured, resulting in acute hemorrhage with an estimated blood loss of 200 mL within seconds. Gauze compression failed and surgical access was limited by the deep pelvic location of the injury. The combined hemostatic technique was applied using the same procedural steps as in case 1. After 3 minutes of manual compression, the compression material was removed with concurrent saline irrigation, and hemostasis was confirmed. The operative time was 5 hours 24 minutes and the total blood loss was 886 g. Intraoperative transfusion consisted of 4 units of packed red blood cells and 4 units of fresh frozen plasma. The patient was discharged 11 days after surgery without complications.
Discussion
To our knowledge, this is the first report of Hydrofit® (Sanyo Chemical Industries) use in gynecologic oncology surgery. We do not claim established efficacy in the two cases, but present this technique and initial experience for educational purposes (Fig. 1).
Hydrofit® (Sanyo Chemical Industries, Kyoto, Japan) and the combined hemostatic technique.
The rationale for this combined approach is twofold: Hydrofit®’s (Sanyo Chemical Industries) polymerization is independent of coagulation factors and platelet function, potentially allowing the sealant to remain effective despite dilutional coagulopathy from massive hemorrhage - an advantage over agents requiring an intact coagulation cascade [4–6]; and SURGICEL Absorbable Hemostat™ (Johnson & Johnson MedTech) as an absorbable carrier avoids retrieval of non-absorbable materials (e.g., silicone sheet) and reduces sealant-layer dislodgment upon gauze removal [7–9].
The acute hemorrhage encountered in case 2 arose from injury to the right internal iliac vein during dissection of the right cardinal ligament, underscoring the vulnerability of the parametrial vasculature during radical hysterectomy. Meticulous, standardized handling of parametrial tissue - such as a knotless ligation technique reported for laparoscopic hysterectomy - has been proposed to reduce the risk of such vascular injury and may be similarly relevant to open radical hysterectomy [10]. Such venous injuries are difficult to control, as the thin-walled, low-pressure vessel retracts into surrounding tissue and the deep pelvic location limits surgical exposure [10].
The adhesion observed at the application site in case 1 warrants careful consideration as a potential safety signal rather than an incidental finding. Oxidized regenerated cellulose is a well-known cause of foreign body reactions and adhesion formation [7] and Güney et al. [11] demonstrated in a rat uterine horn model that oxidized cellulose induces postoperative adhesion after gynecologic surgery. Although adhesiolysis was required, it did not compromise completion of interval debulking surgery or achievement of an R0 resection. However, in other anatomical locations, such adhesions could increase the risk of bowel injury, adhesive obstruction, or hazardous dissection during reoperation. When reoperation is anticipated, we recommend using the smallest amount of necessary material; exercising caution near the bowel serosa, ureter, or major vessels; and clearly documenting the application site in the operative note to facilitate safe subsequent dissection.
Limitations include the small number of cases, absence of a comparison group, lack of prior attempts with other topical hemostatic agents, and the inability to measure site-specific blood loss separately from total blood loss. This off-label use was conducted in accordance with institutional regulations. Prospective evaluations with site-specific blood loss measurement, standardized time-to-hemostasis recording, and systematic adhesion grading at reoperation are needed to establish the efficacy and safety of this technique.
Notes
Conflict of interest
The authors declare no conflict of interest.
Ethical approval
The off-label use of Hydrofit® (Sanyo Chemical Industries, Kyoto, Japan) was conducted in accordance with institutional regulations governing the use of medical devices outside their approved indications. Ethics committee approval was obtained from the Institutional Review Board of Juntendo University Nerima Hospital (approval number: S26-06).
Patient consent
Written informed consent was obtained from both patients for the publication of this case report and accompanying images and videos. Written informed consent for the off-label use of Hydrofit® (Sanyo Chemical Industries, Kyoto, Japan) was obtained from each patient. The consent process was documented in the medical records.
Funding information
This research received no specific grants from any funding agency in the public, commercial, or not-for-profit sectors.
Video clip
Video can be found with this article online at https://doi.org/10.5468/ogs.26200.