Page 13 - WJOLS - Surgery Journal

Clinical Evaluation for Reduction of Adhesions by a Viscoelastic Gel in gynecological Laparoscopic Surgery
worsened reveals a significant treatment benefit. At the time of investigators found that, with experience, a single layer of gel
second look, 87% of Oxiplex/AP Gel applied adnexa did not was sufficient enough to cover the adnexal surface and adjacent
have a worse adhesion score in contrast to 32% of the control sites. In some cases, when multiple layers of gel were coated
adnexa. Even when the individual adnexal adhesion scores are over one another, the weight of the excess gel overcame the
grouped by prognostic category (Table 2) , the number of adnexa innate tissue adherence resulting in falling of the gel from the
that improved or stayed the same from first look to second look surgical site. Typical volume of gel required to cover an adnexum
laparoscopy versus those that shifted to a worse category also was approximately 15 ml which was administered in approximately
shows a significant treatment effect of Oxiplex/AP Gel. For 90 seconds. It was easy to apply Oxiplex/AP Gel to adnexal
example—During second look, 93% of the adnexa that received surfaces including the ovarian fossa and between the ovary and
Oxiplex/AP Gel did not have a worse score in contrast to 56% of mesosalpinx. The gel coverage facilitated the cessation of
the control adnexa. vascular oozing and thereby helping to prevent adhesion.
To protect the tissue during postsurgical repair, only a
DISCUSSION single layer of gel was sufficient. Within six weeks, prior to
the second look laparoscopy, the gel was absorbed from the
During minimally invasive surgery, the most commonly used peritoneal cavity. In 4 cases, small collections (approximately
adhesion preventive devices cannot be applied or are difficult 5×5 mm) of gelatinous material (presumably residual gel) were
to apply. So in many surgical procedures, prophylaxis for noted in areas deep in the cul-de-sac where intraperitoneal
adhesion prevention is not used. As a result Oxiplex/AP Gel clearance have been affected particularly in cases of grade
was developed specifically for the needs of surgeons performing four endometriosis, or in areas where multiple layers of gel
procedures that result in adhesion formation leading to failed had been applied. In 2 cases, biopsies of these sites where
12
surgical therapy. For a gynecological surgeon, the challenges consistent with the residual gel. There was no clinical
facing for an adhesion preventive device include ease of use significance of the residual gel. The residuum did not
and retention of the device at the site of application. To address interconnect the tissue surfaces. It was not associated with
these needs Oxiplex/ AP Gel was specifically developed. any adhesions. It did not obstruct organ mobility.
The polyethylene glycol and carboxymethylcellulose
formulation is a transparent viscoelastic gel that is readily ADHESION REDUCTION
administered to the specific anatomical sites where there is
concern for adhesion formation. The ease of use of viscoelastic The reduction in postoperative adnexal adhesions demonstrates
gel includes single unit packaging stored at room temperature, a clinically significant benefit of Oxiplex/AP Gel, a categorical
which when opened delivers the sterile gel and applicator directly reduction in adnexal adhesion and has been associated with
17
into the field of operation. The viscosity of the gel allows the better clinical outcomes. Adhesion scoring is not only used
18
surgeon to control directly the rate of Oxiplex/AP Gel delivery for prognosis, but also to determine the therapy. The US food
to the operation site. The flow of gel is automatically stopped and drug administration recently recommended that the AFS
by depressing the syringe. The gel which is residing within the adnexal adhesion classification can be used as a clinical outcome
applicator tube doesn’t harden. This allows for the continued measure in clinical studies of devices intended to reduce the
application of the viscoelastic gel at the convenience of the postsurgical adhesion formation.
surgeon.
To maximise tissue adherence, Oxiplex/AP Gel was developed CONCLUSION
by complex of two polymers. The gel remains in its place due to Laparoscopic administration of viscoelastic gel was easy and
13
its mucoadherent property. This property allows the gel to had significant reduction in adnexal adhesions. The patients
remain in place even in gravitational dependent areas such as the undergoing gynecological surgeries were benefited. Although
anterior abdominal wall after removal of an omental adhesion, or it is reassuring to see gel persisting at the site of application, it
even at the posterior surface of the uterus in case of myomectomy. is recommended to avoid excess gel application.
In preclinical studies, a similar formulation of Oxiplex (Oxiplex/ SP
Gel) showed to be safe and effective in reducing adhesions to REFERENCES
14
dura following spinal surgery. Another clinical study done
recently showed that patients with severe back pain and lower 1. Canis M, Botchorishvili R, Tambiurro S, et al. Adhesion
prevention in the surgical treatment of pelvic endometriosis.
extremity weakness who had Oxiplex/AP Gel applied over their Gynecol Endosc 2001;10:99-106.
nerve roots following laminectomy or laminotomy had signi- 2. Lower AM, Hawthorn RJS, Ellis H, O’Brien F, Buchan S and
ficantly reduced symptoms compared to surgery only(controls). 15 Crowe AM. The impact of adhesions on hospital readmissions
Oxiplex/AP Gel, which is specifically designed for use in the over ten years after 8849 open gynaecological operations: An
16
peritoneal cavity was evaluated in women undergoing assessment from the Surgical and Clinical Adhesions Research
conservative gynecological surgery. In this case, the principle Study. Br J Obstet Gynecol 2000;107:855-62.
11