Postoperative Ileus Clinical Trial
Official title:
Randomized Clinical Trial of Bisacodyl Versus Placebo on Postoperative Bowel Motility in Elective Colorectal Surgery
Postoperative bowel dysmotility is a frequent condition after colorectal surgery. The influence of colon stimulating laxatives have not been studied. This prospective, randomized, double blind, placebo controlled study assesses the influence of bisacodyl on postoperative bowel motility in patients undergoing elective colorectal surgery. The hypothesis of this trial was that bisacodyl has a beneficial effect on the duration of postoperative ileus.
All adult (>18 years) patients admitted for elective colorectal resection were evaluated for
eligibility.
Patients were randomized using a computer programme and received either 10mg of bisacodyl in
non-transparent capsules or identical placebo capsules, containing glucosemonohydricum. The
capsules were administered twice daily, starting one day before surgery and ending on
postoperative day three.Patients and all involved medical personnel were blinded.
Bowel preparation was not routinely used in open surgery, whereas in patients undergoing
laparoscopic resection two litres of sodium-sulfate / macrogol solution (Cololyt®, Spirig
Pharma AG, Switzerland) was administered. Standard colorectal surgery was performed in all
patients. In open surgery a midline incision was used for laparotomy. In laparoscopic
resections a four-port technique with removal of the specimen through a small transverse
incision in the lower abdomen was used. All patients received perioperative single shot
antibiotics, cefuroxime 1.5 g and metronidazole 1g. Nasogastric tube (NGT) was scheduled to
be removed at the end of surgery. Postoperative treatment was not changed during the study.
All patients received postoperatively a basic analgesia of 500 to 1000 mg oral paracetamol
every 6 h; additionally, metamizol was administrated intravenously or orally as needed.
The primary endpoint was the time to recovery of gastrointestinal function, defined as the
mean time to the occurrence of the following three events (GI-3): first flatus passed, first
defecation and first solid food tolerated. We did not include the presence of bowel
movement, as they may be present before recovery of the colon due to small bowel activity24.
Secondary endpoints were the incidence of NGT reinsertion, duration of NGS reinsertion,
incidence of postoperative vomiting and length of hospital stay. Additionally, consumption
of analgesics and pain, cramping and nausea scores (assessed with a visual analogue scale
[VAS]) during the first 8 postoperative days were monitored. Other variables recorded were
patients' demographics, use of epidural anaesthesia, type and duration of surgery and
morbidity.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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