Sebastiano Biondo1, Jordi Miquel2, Eloy Espin-Basany3, Jose Luis Sanchez3, Thomas Golda2, Ana Maria Ferrer-Artola4, Antonio Codina-Cazador5, Ricardo Frago2, Esther Kreisler2. 1. 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. 2. 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. 3. Colorectal Unit, Department of General and Digestive Surgery, Vall d'Hebron University Hospital, Barcelona, Spain. 4. Department of Pharmacy, Bellvitge University Hospital, University of Barcelona and IDIBELL, Barcelona, Spain. 5. Colorectal Unit, Department of General and Digestive Surgery, Josep Trueta University Hospital, Girona, Spain.
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.
RCT Entities:
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.
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