Randomized Clinical Trial of Bisacodyl Versus Placebo on Postoperative Bowel Motility in Elective Colorectal Surgery
Condition: Postoperative Ileus
MeSH terms: Ileus
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): bisacodyl; glucosemonohydricum
Intervention type(s): Drug; Drug
Intervention description(s): 10mg capsule twice daily from one day preoperatively to day three postoperatively; 10mg of glucosemonohydricum twice daily from one day preoperative to day three postoperative
Intervention MeSH terms: Bisacodyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: postoperative ileus; colorectal surgery; bisacodyl; laxatives