Page 10 - WJOLS - Surgery Journal

Cyriac Pappachan
laparoscopy. Integral was withdrawn from market in 2003. In STATISTICAL ANALYSIS
Europe the only instillate available during that time for reduction Using Student’s t-test for continuous variables and Fischer’s
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in postoperative adhesion formation was Adept. Clinical exact test of categorical variables, the treatment and control
studies showed that about 300 ml of N,O–carboxymethyl- groups were compared. Using Student’s t-test, the number and
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chitosan was having clinical benefit. Spray gel conducted proportion of sites with adhesion were compared. Wilcoxon
several clinical studies for the development of site specific rank-sum test was used to compare adhesion scores. Shift tables
adhesion prevention devices that could be delivered easily were analyzed by the Cochran-Mantel-Haenszel test with the
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during laparoscopy. Oxiplex/SP is used recently by spinal treatment scores which is based on the order of adhesion score
surgeons for reducing pain and weakness due to adhesion categories.
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formation following laminectomy. Viscoelastic gel, a similar
formulation of Oxiplex was found to be most effective in reducing RESULTS
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adhesions to peritoneal surface following surgery. The results
of the first clinical study using viscoelastic gel, a single Forty-nine female patients in total between 18-46 years of age
component adhesion preventive device that can be received treatment at four centers. Treatment patients were 25.
administered easily to the pelvic sites during operative surgery In these patients surgery was performed on 45 adnexa and
is reported in this paper. Oxiplex/AP Gel was applied on those adnexal sites. Control
patients were 24. In these patients surgery was performed on 41
CONTENT adnexa. There were no unusual postoperative complications
and all the patients did well after the surgery. After 6-10 weeks,
Like any surgical device for maximum patient benefit, careful patients returned for second look laparoscopy. For all 86 adnexa,
attention to the details of application is important. For the efficacy analyses are presented. For both the groups, the type
application of Oxiplex/ AP Gel, the following procedures were and frequency of the surgical procedures were similar.
done in the subjects. At the end of surgery, to facilitate the Adhesiolysis was done in 12 treatment and 8 control patients.
collection of residual fluid to the cul-de-sac, the subjects were By cystectomy removal of ovarian.
placed in reverse Trendelenberg position. From cul-de-sac the Endometriosis was done in 6 treatment and 3 control patients.
residual fluid was aspirated until it was less than 10 ml. Through 33 treatment and 33 control patients had endometriosis
a 30.5 cm long ×5 mm canula applicator, a single layer of gel was involving parietal and visceral peritoneum. 6 treatment and 6
applied in sufficient volume to coat the surgical site completely control patients had stage four endometriosis. No patient had
with a viscous layer of gel. The surgical sites included fallopian prolonged hospital stay, premature readmission, prolonged
tube including mesosalpinx, surface of the ampulla, lateral part constipation, fever, postoperative pain requiring evaluation on
of uterus that could come in contact with adnexa, anterior and hospitalization. During this study there was no discontinuation
posterior surface of ovary, the surfaces between the fallopian due to any adverse event and no death occurred.
tube and the ovary, and adjacent pelvic side wall including the A single layer of gel was applied to the adnexa with an
ovarian fossa. To coat the adnexa, it did not exceed more than Oxiplex applicator consisting of 30.5 cm long × 5 mm cannula.
30 ml of gel. Following this, the surgical instruments were Approximately 94 ± 21 seconds was taken for gel application
removed and the pneumoperitoneum was evacuated. and approximately 15 ml of gel was applied on each adnexa.
A second look laparoscopic procedure was performed 6-10
weeks after the initial surgery. This time the adnexa were EFFICACY
evaluated in a similar manner to the initial laparoscopic surgery.
The image was recorded on videotape. By the method of the As in Figure 1, the mean adnexal adhesion score for the control
American fertility society (AFS, 1988), blinded reviews of the adnexa was 8.8 and for the Oxiplex/AP Gel treated adnexa was
videotapes were performed to quantify the adhesion scores. 11.9. During the second look laparoscopy, the controlled adnexa
AFS adnexal adhesion score is determined by the severity showed an increase in adnexal adhesion score from 8.8 to 15.8.
(severe: If the adhesion requires cutting to remove or tears In contrast, the adnexa that were covered with Oxiplex/AP Gel
peritoneal surface on blunt removal or if hemostasis is required; showed a decrease in mean adnexal adhesion score from 11.9 to
not severe: if filmy) and extent (area of adnexal organ covered 9.1. In second look AFS scores, the difference (42% reduction;
by adhesions) of the adhesions of the ovary and fallopian tube. p < 0.01) was significant statistically. For the patient groups
Summing the scores up for the ovary and fallopian tube without (Fig. 2A) and with (Fig. 2B) endometriosis, the same
provided a clinical category for the adhesion score. Minimum directional difference in mean adnexal adhesion score was seen.
0-5; mild 6-10; moderate 11-20; severe 21-32. Safety evaluation A reduction in adnexal adhesion score in the Oxiplex/ AP Gel
was based on the patient’s recovery, postoperative condition treated group compared to controls (Fig. 2C) was seen for
and severity of adverse events recorded throughout the study. patients with grade one to three endometriosis. In patients with

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