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Intra-abdominal adhesions are the commonest cause of small-bowel obstruction and secondary female infertility. At operation, strategies to prevent adhesions include the use of absorbable barriers. Seprafilm (Genzyme BV, Naarden, Netherlands) is a sterile translucent membrane comprising sodium hyaluronate and carboxymethylcellulose; it temporarily separates potentially adherent surfaces, turning to a gel within 24 h and being cleared from the abdominal cavity in 7 days. Sepracoat (Genzyme BV) is a solution of hyaluronidase in phosphate buffered saline, reabsorbed from the body cavity and excreted in 5 days. In animal models and patients, these agents have reduced adhesion formation by about 44% without any apparent excess of adverse events1,2,3.
A woman aged 71 developed small-bowel obstruction which resolved with conservative management. She had undergone four previous laparotomies—for hysterectomy, for salpingo-oophorectomy and for adhesiolysis (two). She continued to experience episodic abdominal pain but contrast studies showed no evidence of obstruction. At laparotomy, performed four months later to identify the cause of her recurrent symptoms, the entire small bowel was found to be affected by multiple adhesions, with partial obstruction. The adhesions were carefully divided throughout the small bowel, polyglactin (Vicryl) ligatures being used for haemostasis. Sepracoat was instilled into the abdominal cavity in accordance with the manufacturer's instructions. One sheet of Seprafilm was placed under the midline incision before closure with polydioxanone (PDS) sutures. Salbutamol was required at extubation for bronchospasm.
Normal bowel sounds returned on the third post-operative day. On day 14 a barium meal and follow-through examination was performed because of high-volume nasogastric aspirates. This showed a distended duodenum and proximal jejunum, but contrast passed through an undilated distal small bowel in 80 min.
A second laparotomy was performed 21 days later because of unresolved high intestinal obstruction. This revealed a dense, thick, glue-like mass involving 95% of the small bowel and part of the transverse colon, anchoring the abdominal contents to the anterior abdominal wall. An attempt to release the small-bowel loops was abandoned because of the extent and density of the encasing mass. 90% of the small bowel was resected and a jejunocolic anastomosis fashioned in two layers of chromic catgut. During the dissection a serosal tear was made in the mid transverse colon which was repaired by suturing it to the serosal surface of the ascending colon. The patient's condition deteriorated three days later with a faeculent bloodstained wound discharge, signs of peritonitis and renal failure. Further surgical intervention was deemed inappropriate and she died the following day.
At necropsy the jejunocolic anastomosis was found to be intact, but closure of the defect in the transverse colon had broken down, causing faeculent peritonitis. Examination of the resected specimen showed multiple loops of small bowel matted together within an extensive mass of densely fibrotic tissue (Figure 1). On microscopy the serosal surface was congested and encased in adherent fat and fibrous tissue containing numerous foreign-body-type giant-cell granulomata. Birefringent foreign material was identified in the giant cells, appearing as small particles and short fibres.
Foreign-body granulomata may be related to suture material1, but the extent and severity of the changes observed in this case suggest the possibility of another cause. At the first laparotomy hyaluronidase was instilled throughout the abdominal cavity and as a film between the bowel and anterior abdominal wall. The only other materials used were a small number of Vicryl ligatures and PDS sutures for closure. Reaction to suture material, however extreme, would be expected to occur in the immediate vicinity of the sutures, rather than cause the widespread changes seen in this case. The second laparotomy did not reveal any evidence of leakage or sepsis that could have caused such a diffuse reaction. The dense fibrotic reaction, containing foreign-body-type giant cell granulomata, was florid and universal affecting the whole serosal surface of the small bowel.
Concerned that these remarkable findings might represent an idiosyncratic response to Seprafilm and Sepracoat, the operating surgeon filed an adverse incident report with the Medical Devices Agency. Four similar cases of foreign-body-type granulomatous reaction following the use of a hyaluronate barrier had been reported to agencies in the USA and the UK. Three involved placement of the barrier following adhesiolysis, and the fourth occurred after repair of a paraduodenal hernia. All patients required subsequent surgery within 6-13 days for small-bowel obstruction, two undergoing extensive small-bowel resection. These five cases in total since marketing approval would represent an occurrence of less than 0.1% for Seprafilm and 0.01% for Sepracoat.