Between January 2010 and October 2010, 37 patients were included in one of the following hospitals: University Medical Center Groningen (n = 16), Medical Center Leeuwarden (n = 6), Laurentius Hospital Roermond (n = 4), Ommelander Hospital Group (in Delfzijl and Winschoten, n = 5), Wilhelmina Hospital Assen (n = 3), and Antonius Hospital Sneek (n = 3).
Patients were operated for malignancy (n = 30), diverticulosis (n = 5), endometriosis (n = 1), and a rectovaginal fistula (n = 1). The median age was 65 years (range 27–79). Baseline characteristics are listed in Table 1.
Anastomotic leakage leading to reintervention
One anastomotic leakage (3 %) leading to reintervention occurred in a patient who underwent rectal resection en bloc with part of the posterior vaginal wall because of endometriosis located in the rectovaginal septum. The colorectal anastomosis was created at 4 cm distance from the anal verge. On postoperative day 16, this patient was readmitted to hospital with a vaginal bleeding originating from the pudendal artery. This artery was coiled, a loop ileostomy was created, and debridement of the inflammatory mass between rectum and vagina was performed. The anastomotic leakage from the rectum to the posterior vaginal wall had probably caused inflammation of the surrounding tissue resulting in a rectovaginal fistula and bleeding. The anastomosis was kept intact and maintained. The fistula healed by secondary intention, and after 3 months, the stoma was successfully taken down.
Anastomotic leakage not leading to reintervention
A female patient, treated for rectal cancer with a low anterior resection with deviating ileostomy (anastomosis at 3 cm from the anal verge), presented with abdominal pain and pus per vaginum 15 days after surgery. Vaginal and rectal examination revealed a rectovaginal fistula: the posterior vaginal wall was apparently stapled together with the anastomosis. This patient was initially treated conservatively. Since this fistula persisted, closure was attempted 8 months after the primary low anterior resection.
In three patients (8 %), rectal pus discharge occurred, which was interpreted as a perianastomotic abscess (CT proven in one of these three patients). One of these patients was initially treated for a fistula after previous low anterior resection for rectal cancer, and the other two underwent low anterior resection for rectal cancer. All three had a diverting ileostomy, and the anastomosis was situated at, respectively, 2, 6, and 6 cm from the anal verge. Another two patients (5 %) treated for rectal cancer with a low anterior resection (anastomosis at 4 and 7 cm; one with a diverting stoma) had a CT-proven presacral infiltration and were antibiotically treated. All recovered well, and none of these patients had a reintervention.
Clearly, patients with rectal cancer undergoing low anterior resection have a higher chance of developing anastomotic leakage compared to patients undergoing anterior resection for sigmoid pathologies with the anastomosis situated at greater distance from the anal verge. In our group, 28 patients underwent a low anterior resection for rectal cancer, and 7 patients underwent surgery for sigmoid pathologies (5 for diverticulosis and 2 for cancer). In this “sigmoid” subgroup, the anastomosis was situated between 10 and 15 cm above the anal verge, and none had an anastomotic related complication. Only one of the patients in this “sigmoid” group received a diverting stoma.
All anastomosis-related complications occurred in patients with the anastomosis situated within 8 cm distance from the anal verge.
Application of the C-seal
The C-seal was successfully applied without any complications in 35 patients. The extra time needed by the surgeon to apply the C-seal was on average 5 min.
In two cases (5 %), it was impossible to pull the C-seal through the anus after firing the stapler. It appeared that the C-seal was double-stapled at the anastomotic site after interposition of the “tail” of the C-seal due to inadequate positioning of this “tail” in the afferent loop. To solve this problem, the C-seal was cut transanally, which prevented any obstruction. Both patients are included in the analysis according to the intention to treat principle and had an uneventful recovery.
Upon survey of applicability, 65 % of the surgeons rated the use of the C-seal as “good” on a five-point scale ranging from excellent–good–average–fair to poor. Another 34 % rated the procedure as “average”. Upon feedback, it appeared that initially the insertion of the anvil with the attached C-seal into the proximal bowel loop was found to be cumbersome.
Rectal contrast enemas were performed on postoperative day 7 (range day 6–10). Contrast was inserted within the lumen of the C-seal as well as in the space between the C-seal and the rectum mucosa, so that leaks above and below the anastomosis will be demonstrated. In four patients, the enema was not performed because of logistic reasons. In five patients, the rectal contrast enemas demonstrated leakage of contrast outside the bowel contour. Among these five patients are the patient with anastomotic leakage leading to reintervention, the patient with the rectovaginal fistula, and a patient with a spontaneously drained abscess at the anastomosis as mentioned above. The two remaining patients with a radiological leakage had no clinical signs or complications of anastomotic leakage.
Clearance of the C-seal
The C-seal cleared from the bowel after a median of 14 days (range 5–63 days). In patients without a diverting stoma, median time to losing the C-seal was 10 days. In patients with a diverting stoma, the exact time of C-seal disappearance is not always known, since the C-seal fragments and resolves in the bowel lumen and becomes unrecognizable as such. In one patient with a diverting loop ileostomy, the anastomosis was checked by proctoscopy at 63 days after surgery (according to local hospital protocol), and a part of the C-seal was still visible at the anastomotic site.
Reinterventions not related to the C-seal
One patient (3 %) underwent surgical intervention in the postoperative phase for stoma retraction. This was not related to the C-seal, nor did this patient suffer from anastomotic leakage.
One patient (3 %) died because of a pulmonary embolism and myocardial infarction 10 days after surgery. No signs of anastomotic leakage or adverse events due to the C-seal were suspected at clinical and laboratory evaluation.