Fetus-Placenta-Newborn

Gelatin sponge plug to seal fetoscopy port sites: Technique in ovine and primate models
Franois I. Luks, MD,a, b Jan A. Deprest, MD,a Koen H.E. Peers, MD,a Eric A.P. Steegers, MD,c and Bas van der Wildt, MDc Leuven, Belgium, Providence, Rhode Island, and Nijmegen, The Netherlands
Amniotic fluid leakage and rupture of membranes are common complications of fetoscopy. We describe a plug technique for leakproof removal of endoscopic cannulas. Thirty gelatin sponge plugs were introduced in 5 pregnant ewes and 5 pregnant rhesus monkeys. In the primate model no evidence of amniorrhexis was noted on postoperative ultrasonography. Myometrium and membranes at the port sites were intact at term. A gelatin sponge plug technique may facilitate leakproof port removal after fetoscopy. (Am J Obstet Gynecol 1999;181:995-6.)

Key words: Amniorrhexis, amniotic membranes, endoscopic fetal surgery, fetoscopy, preterm premature rupture of membranes, primate, sheep

Endoscopic fetoplacental surgery is gaining acceptance as a treatment modality for indications such as twin-twin transfusion, umbilical cord ligation, and congenital diaphragmatic hernia. Although uterine trauma appears to be less than with open fetal surgery, fetoscopy remains fraught with postoperative amniotic fluid leakage and premature rupture of membranes. Refinements in access techniques of the amniotic sac, including the use of balloon cannulas, radial dilatation, and the Seldinger technique, may reduce initial uterine trauma; however, leakproof removal of the cannulas remains difficult, particularly in percutaneous procedures. In this report we describe the use of a gelatin sponge plug to produce instantaneous sealing of the access sites without subsequent evidence of fluid loss or premature rupture of membranes. The technique was applied to ovine and nonhuman primate models of fetal surgery. Technique Five ewes with time-dated pregnancies (95-108 days gestation, term 145 days gestation) and 5 rhesus monkeys with time dated pregnancies (Macaca mulatta, 105110 days gestation, term 167 days gestation) were used
From the Centre for Surgical Technologies, Catholic University Leuven,a the Division of Pediatric Surgery, Brown University School of Medicine,b and the Department of Obstetrics and Gynecology, Catholic University Nijmegen.c Received for publication March 3, 1999; revised May 6, 1999; accepted June 9, 1999. Reprint requests: Franois I. Luks, MD, Division of Pediatric Surgery, 2 Dudley St, Suite 180, Providence, RI 02905. Copyright 1999 by Mosby, Inc. 0002-9378/99 $8.00 + 0 6/1/100657

for these experiments. A different aspect of the experiments on the same primates has been reported elsewhere.1 Three endoscopic ports were introduced in each animal. The technique of endoscopic access to the gravid uterus has been described elsewhere.1, 2 After maternal laparotomy 5-mm (internal diameter) balloon-tipped cannulas (LaparoSAC; Marlow Surgical Technologies, Willoughby, Ohio) were introduced by the Seldinger technique inside a plastic sheath to avoid axial shearing forces on the myometrium and the membranes. Endoscopic exploration and manipulation of the amniotic cavity and the fetus were performed. At the end of the procedure the cannulas were removed sequentially over a gelatin sponge (Gelfoam; Pharmacia & Upjohn, Bridgewater, NJ) as follows. Before cannula removal a precut strip of gelatin sponge (2.0 cm long 1.5 cm wide 0.7 cm thick) was introduced into the shaft by means of an applicator (Fig 1, A). While the plug was maintained in place with the plunger, the cannula was withdrawn, releasing the plug in the hysterotomy wound (Fig 1, B). A figure-of-8 suture was placed through the myometrium only. The procedure was completed and the animal was allowed to recover. In primates ultrasonographic examination was performed immediately postoperatively, at 24 hours, and weekly thereafter until spontaneous delivery near term (155 days gestation). Because of technical limitations detailed ultrasonographic examination of the ewes could not be preformed. Experiments were approved by the respective ethics committees on animal experimentation (Katholieke Universiteit Leuven for the sheep, Katholieke Universiteit Nijmegen for the pri995

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viving fetuses revealed normal amniotic fluid volume, suggesting absence of leakage or membrane rupture. Because the animals delivered spontaneously, the uteri were not examined histologically. Comment Amniotic fluid leakage, membrane disruption, and chronic oligohydramnios are known complications of invasive procedures on the gravid uterus. Endoscopic interventions have recently gained in popularity. Although they may be less invasive for the fetus than open fetal operations, they have been associated with postoperative rupture of membranes, amniotic fluid leakage, oligohydramnios, or a combination in as many as 50% of cases.3 Although better access techniques, including atraumatic balloon-tipped cannulas, may decrease the incidence of membrane-related complications, few satisfactory techniques for membrane and hysterotomy closure have as yet been reported.4 In this study we describe the use of a plug to mechanically obliterate the uterine access site. In 2 different animal models this technique was found to be reproducible and to achieve the expected goals. In our opinion this method is superior to the use of liquid sealants, which may not produce a complete seal, and the surgical closure of membranes, which potentially increases membrane trauma and perforation. Although a maternal laparotomy was performed in this study, this seal technique is applicable to percutaneous procedures as well. Whether the routine use of sponge plugs in endoscopic fetal surgery will decrease the incidence of postoperative complications in the clinical arena awaits further study. In addition, the fate of dislodged plugs, whether in the maternal abdomen or in the amniotic cavity, is not yet known. We speculate that these plugs behave like any other degrading biomaterial, such as absorbable sutures, but further studies may be necessary to establish their safety.
REFERENCES

Fig 1. Technique of gelatin sponge plug insertion. A, Plug (C) is inserted in endoscopic cannula (T) and maintained in place with plunger (P) at level of uterine myometrium (U) and membranes (M). B, Cannula is withdrawn (arrow).

mates), and all animals were treated in accordance with current guidelines on animal welfare. Results In sheep a total of 15 cannulas were introduced and removed as described. Successful placement of a gelatin sponge plug was achieved in all cases, and all fetuses survived the intervention. When the sheep were killed near term (136-142 days gestation) no transuterine amniotic fluid leakage could be detected macroscopically and all hysterotomy wounds had healed without scarring. However, histologic analysis of the uterus or the membranes was not performed. There were no intra-amniotic adhesions at the port sites or elsewhere. Three cannulas were placed and removed in each of the 5 primates. In each animal the first 2 cannula removals were performed under direct endoscopic control. On cannula removal the membranes were drawn outward while the hysterotomy wound was immediately plugged with the gelatin foam. Fluid absorption by the material caused rapid swelling of the plug, as witnessed endoscopically. Postoperative ultrasonographic examination revealed a viable fetus, normal amniotic fluid volume, and absence of membrane dehiscence. One animal aborted within 24 hours. This fetal death was ascribed to excessive mobilization and exteriorization of the uterus with compression of the uterine vessels. Uterine manipulation was minimized in subsequent experiments. A second animal aborted at 6 days from unknown causes. In neither case was the abortion associated with amniorrhexis or amnionitis. Weekly ultrasonography of the sur-

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