title: A Double-Blinded Randomized Clinical Study on the Therapeutic Effect of Gastrografin in Prolonged Postoperative Ileus After Elective Colorectal Surgery.
abstract: BACKGROUND
  Postoperative ileus is a common problem with significant clinical and economic consequences. We hypothesized that Gastrografin may have therapeutic utility by accelerating the recovery of postoperative ileus after colorectal surgery. The aim of this trial was to study the impact of oral Gastrografin administration on postoperative prolonged ileus (PPI) after elective colorectal surgery.
  
  
  METHODS
  The main endpoint of this randomized, double-blinded, controlled trial was time of resolution of PPI. The secondary endpoints were overall hospital length of stay, time to start oral intake, time to first passage of flatus or stools, time of need of nasogastric tube, and need of parenteral nutrition. Included criteria were patients older than 18 years, operated for colonic neoplasia, inflammatory bowel disease, or diverticular disease. There were two treatments: Gastrografin administration and placebo. The sample size was calculated taking into account the average length of postoperative ileus after colorectal resection until tolerance to oral intake. Statistical analysis showed that 29 subjects in each group were needed.
  
  
  RESULTS
  Twenty-nine patients per group were randomized. Groups were comparable for age, gender, ASA Physical Status Classification System, stoma construction, and surgical technique. No statistical differences were observed in mean time to resolution between the two groups, 9.1 days (CI 95%, 6.51-11.68) in Gastrografin group versus 10.3 days (CI 6.96-10.29) in Placebo group (P = 0.878). Even if not statistically significant, time of resolution of PPI, overall length of stay, time of need of nasogastric tube, and time to tolerance of oral intake were shorter in the G group.
  
  
  CONCLUSIONS
  Gastrografin does not accelerate significantly the recovery of prolonged postoperative ileus after elective colorectal resection when compared with placebo. However, it seems to clinically improve all the analyzed variables.
authors.affiliation: Colorectal Unit, Department of General and Digestive Surgery, Bellvitge University Hospital, University of Barcelona and IDIBELL, C/Feixa Llarga s/n, L'Hospitalet de Llobregat, 08907, Barcelona, Spain. sbn.biondo@gmail.com.
authors.forename: Sebastiano
authors.initials: S
authors.lastname: Biondo
authors.affiliation: Colorectal Unit, Department of General and Digestive Surgery, Bellvitge University Hospital, University of Barcelona and IDIBELL, C/Feixa Llarga s/n, L'Hospitalet de Llobregat, 08907, Barcelona, Spain.
authors.forename: Jordi
authors.initials: J
authors.lastname: Miquel
authors.affiliation: Colorectal Unit, Department of General and Digestive Surgery, Vall d'Hebron University Hospital, Barcelona, Spain.
authors.forename: Eloy
authors.initials: E
authors.lastname: Espin-Basany
authors.affiliation: Colorectal Unit, Department of General and Digestive Surgery, Vall d'Hebron University Hospital, Barcelona, Spain.
authors.forename: Jose Luis
authors.initials: JL
authors.lastname: Sanchez
authors.affiliation: Colorectal Unit, Department of General and Digestive Surgery, Bellvitge University Hospital, University of Barcelona and IDIBELL, C/Feixa Llarga s/n, L'Hospitalet de Llobregat, 08907, Barcelona, Spain.
authors.forename: Thomas
authors.initials: T
authors.lastname: Golda
authors.affiliation: Department of Pharmacy, Bellvitge University Hospital, University of Barcelona and IDIBELL, Barcelona, Spain.
authors.forename: Ana Maria
authors.initials: AM
authors.lastname: Ferrer-Artola
authors.affiliation: Colorectal Unit, Department of General and Digestive Surgery, Josep Trueta University Hospital, Girona, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Codina-Cazador
authors.affiliation: Colorectal Unit, Department of General and Digestive Surgery, Bellvitge University Hospital, University of Barcelona and IDIBELL, C/Feixa Llarga s/n, L'Hospitalet de Llobregat, 08907, Barcelona, Spain.
authors.forename: Ricardo
authors.initials: R
authors.lastname: Frago
authors.affiliation: Colorectal Unit, Department of General and Digestive Surgery, Bellvitge University Hospital, University of Barcelona and IDIBELL, C/Feixa Llarga s/n, L'Hospitalet de Llobregat, 08907, Barcelona, Spain.
authors.forename: Esther
authors.initials: E
authors.lastname: Kreisler
mesh_terms: D000368:Aged; D003107:Colorectal Surgery / Q000009:adverse effects*; D003974:Diatrizoate Meglumine / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D045823:Ileus / Q000188:drug therapy* / Q000209:etiology; D007441:Intubation, Gastrointestinal; D008297:Male; D008875:Middle Aged; D011182:Postoperative Care / Q000379:methods; D011183:Postoperative Complications; D013997:Time Factors
chemical_list: D005765:Gastrointestinal Agents; D003974:Diatrizoate Meglumine