This prospective randomized study was done between October 2014 and April 2016. We compared the outcome and complications of RC when using enhanced recovery protocol versus standard protocol in bowel preparation.
Informed consent was signed in each case after explaining the nature of the disease, the risks and potential benefits of the study and the procedure.
Seventy-five patients were included in this study who were candidates for RC. They were randomized in two groups (closed envelope): Group A (43 patients) where they followed the standard preoperative and postoperative protocol and Group B (32 patients) where they followed the enhanced recovery protocol. Patients were assessed by full history taking. Full examination includes general, abdominal, genitalia and digital rectal examinations. Routine laboratory investigations were done. Radiological investigations included chest X-ray, abdomino-pelvic ultrasound and computed tomography with intra-venous contrast while in patients with elevated creatinine, MRI abdomen and pelvis were done. In addition, all patients underwent urethrocystoscopy and biopsy. The preoperative evaluation was the stratified by age-adjusted Charlson’s comorbidity index [6].
In group A, bowel preparation was started before surgery according to a standard 3-day bowel preparation regimen. On day 1, a low-residue diet, oral metronidazole 400 mg three times daily and oral neomycin 1 g three times daily were taken. On day 2, only clear fluids and oral antibiotics were taken with tap-water enema. On day 3, also clear fluids only and oral antibiotics were taken with rectal washouts until clear. Intravenous fluids were also administered to maintain hydration [7].
In group B, a day before radical cystectomy, the patients received a normal breakfast followed by unrestricted clear fluids and referred to stoma therapist to mark the site of the stoma.
The night before surgery, the region extending from the midchest to the midthigh was cleaned and prepared. Also, a prophylactic dose of enoxaparin sodium 40 IU subcutaneous was given and every 24 h thereafter until discharge.
All patients received general and epidural anesthesia with central venous line. A parenteral broad-spectrum antibiotic was given just before induction of anesthesia and continued postoperatively for 7 days. Intraoperative metronidazole was also given intravenously and continued 3 days after surgery. Compression stockings were used as prophylaxis for deep venous thrombosis.
A wide bore rectal tube (28 Fr) was placed after general anesthesia to avoid rectal injury during the operation. The patient was placed in the supine position with slight hyperextension of the table used to facilitate pelvic exposure and a Foley urethral catheter placed after draping. All male patients underwent a conventional RC, and anterior exenteration was done in female patients with standard lymphadenectomy. Two types of urinary diversions were planned, orthotopic urinary diversion and ileal conduit.
Wound closure was done by closure of the layers as 1 layer, in a simple running technique, using absorbable suture material (polyglactin) followed by closure of the subcutaneous layer and the skin. All postoperative events were graded according to an established five-grade modification of the original Clavien system [8].
Length of hospital stay (LOS) was recorded. Patients in group B started oral clear fluid from day 0, while in group A patients started oral fluid only after audible intestinal sounds or if they passed flatus, and they started to eat after tolerating clear fluids. Thus, patients in group B received free fluids as tolerated on day 1 with early mobilization. The epidural catheter was removed on day 2. Light diet as tolerated was introduced on day 3.
Data were coded and entered using the statistical package Statistical Package for the Social Sciences (SPSS) version 23. Data were summarized using mean, standard deviation, minimum and maximum in quantitative data and using frequency (count) and relative frequency (percentage) for categorical data.
Correlations between quantitative variables were done using Spearman correlation coefficient. P values less than 0.05 were considered as statistically significant.