NCT02510911

Does Caffeine Reduce Postoperative Bowel Paralysis After Elective Colectomy?

Does Caffeine Reduce Postoperative Bowel Paralysis After Elective Colectomy? - A Randomized, Placebo-controlled Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Thomas Steffen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Postoperative bowel paralysis is common after abdominal operations, including colectomy. As a result, hospitalization may be prolonged leading to increased cost. A recent randomized controlled trial from the University of Heidelberg showed that consumption of regular black coffee after colectomy is safe and associated with a significantly faster resumption of intestinal motility (Müller 2012). The mechanism how coffee stimulates intestinal motility is unknown but caffeine seems to be the most likely stimulating agent. Thus, this trial addresses the question: Does caffeine reduce postoperative bowel paralysis after elective laparoscopic colectomy? Patients after laparoscopic colectomy will receive either 100 mg caffeine, 200 mg caffeine, or 250mg corn starch (placebo) 3 times daily in identically looking gelatin capsules. The study is a randomized, controlled trial, with blinding of physicians, patients and nursing stuff (evaluating the endpoints). Primary endpoint will be the time to first bowel movement.

Conditions

• Postoperative Ileus
• Laparoscopic Colectomy Without Stoma Formation
• Colorectal Neoplasm
• Diverticulitis

Interventions

Type	Name	Description
DRUG	Caffeine (100 mg)	Patients after laparoscopic colectomy will receive 3 times daily capsules with 100 mg caffeine together with the meals. First capsule will be taken on the evening of surgery if surgery was completed before 1 pm, otherwise the first capsule will be taken on the morning of the next day. Treatment consists of 10 capsules and will be stopped after the first solid bowel movement.
DRUG	Caffeine (200 mg)	Patients after laparoscopic colectomy will receive 3 times daily capsules with 200 mg caffeine together with the meals. First capsule will be taken on the evening of surgery if surgery was completed before 1 pm, otherwise the first capsule will be taken on the morning of the next day. Treatment consists of 10 capsules and will be stopped after the first solid bowel movement.
DRUG	corn starch (250 mg approx.)	Patients after laparoscopic colectomy will receive 3 times daily capsules with 250 mg corn starch together with the meals. First capsule will be taken on the evening of surgery if surgery was completed before 1 pm, otherwise the first capsule will be taken on the morning of the next day. Treatment consists of 10 capsules and will be stopped after the first solid bowel movement.
OTHER	Radiopaque marker	On the morning of the first, second and third day after surgery patients will take 1 capsule each day with radiopaque markers . On day 4 after surgery an abdominal X-ray will be performed to localize the markers. Each gelatin capsule contains 10 markers consisting of polyurethane encapsulated barium sulfate (40%).

Timeline

• Start date: 2015-08-01
• Primary completion: 2020-08-01
• Completion: 2020-12-22
• First posted: 2015-07-29
• Last updated: 2021-08-04

Locations

2 sites across 1 country: Switzerland