Does Caffeine Reduce Postoperative Bowel Paralysis After Elective Colectomy?

Diverticulitis Clinical Trial

— CaCo  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02510911
• Other study ID #: CaCo, Chir201401
• Status: Terminated
• Phase: N/A
• Start date: August 2015
• Est. completion date: December 22, 2020

Study information

• Verified date: August 2021
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: December 22, 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients scheduled for elective laparoscopic colectomy (right or left hemicolectomy, segmental resection, extended hemicolectomy, sigmoid resection, upper rectum (anastomosis higher than 7 cm ab ano))
• There will be no upper age limit. If elderly patients are considered fit for surgery, they will be included in the study.
• Informed consent
• Application of epidural analgesia

Exclusion Criteria:

• Participation in another concurrent interventional trial
• Need for a stoma (colostomy or ileostomy) or reversal of a stoma, if the patient had a complete bowel obstruction
• Known hypersensitivity or allergy to caffeine/coffee
• Expected lack of compliance
• American Society of Anesthesiologists (ASA) Physical Status Score of IV or V
• Impaired mental state or language problems
• Alcoholism or drug abuse
• Previous extensive abdominal surgery
• Inflammatory bowel disease
• Clinically significant cardiac arrhythmia
• Cardiac insufficiency
• Pregnancy, lactation, or childbearing potential without using adequate contraception
• Intake of opioid analgesics, or steroids >5mg/d for =7 days before surgery
• Under anti-depressive medication
• Liver cirrhosis or compromised liver function (MELD score >15)
• Emergency procedure

Related Conditions & MeSH terms

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

Intervention

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.
• 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.
• 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%).

Locations

Country	Name	City	State
Switzerland	Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen	Rorschach
Switzerland	Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen	St. Gallen

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Steffen	Gottfried und Julia Bangerter-Rhyner Foundation, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

Hobi V, Gerhard U, Gutzwiller F. [A report on experiences using Goldberg's GHQ (General Health Questionnaire)]. Schweiz Rundsch Med Prax. 1989 Feb 28;78(9):219-25. German. — View Citation

Hobi V. Basler Befindlichkeits-Skala. Ein Self-Rating zur Verlaufsmessung der Befindlichkeit. Manual. 1 ed. Weinheim: Beltz Test GmbH, 1985.

Metcalf AM, Phillips SF, Zinsmeister AR, MacCarty RL, Beart RW, Wolff BG. Simplified assessment of segmental colonic transit. Gastroenterology. 1987 Jan;92(1):40-7. — View Citation

Müller SA, Rahbari NN, Schneider F, Warschkow R, Simon T, von Frankenberg M, Bork U, Weitz J, Schmied BM, Büchler MW. Randomized clinical trial on the effect of coffee on postoperative ileus following elective colectomy. Br J Surg. 2012 Nov;99(11):1530-8. doi: 10.1002/bjs.8885. Epub 2012 Sep 14. — View Citation

Parrott AC, Hindmarch I. The Leeds Sleep Evaluation Questionnaire in psychopharmacological investigations - a review. Psychopharmacology (Berl). 1980;71(2):173-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	preoperative caffeine consumption	Questionnaire evaluation the caffeine consumption of patients (type of beverages, amount etc)	before surgery
Primary	Time to first bowel movement	Time from end of surgery (time of closing suture) until patient's first bowel movement (passage of stool) in hours.; A patient is considered to have met the primary endpoint when he or she had first tolerated food (recovery of upper GI function) and experienced a bowel movement for the first time (recovery of lower GI function).	7 days
Secondary	Time to first flatus	Time from end of surgery until patient's first flatus in hours. The passage of flatus will be determined by questioning the patient; the passage of a bowel movement will be determined by reference to nursing records or by the clinical judgment of the investigator or designee following questioning the patient.	7 days
Secondary	Time to tolerance of solid food	Time from end of surgery until patient tolerates intake of solid food in hours. Tolerance of food is defined as the first time the patient is able to eat solid food (any food re-quiring chewing) without vomiting or significant nausea within 4 h after the meal, and without reversion to only enteral fluids.	7 days
Secondary	Postoperative vomiting events	Number of times patient has to vomit.	7 days
Secondary	Colonic passage time	On day 1, 2 and 3 after surgery patients take one capsule with radioopaque markers. On day 4 location and count of markers is determined by X-ray imaging and the colonic passage time is determined (Metcalf 1987).	4 days
Secondary	Actual postoperative hospital stay	Number of days from surgery until actual discharge.	30 days
Secondary	Theoretical postoperative hospital stay	Days from surgery until patient would be fit for release. Often patients stay longer in hospital than clinically required. Thus, evaluation of theoretical hospital stay.; A patient is fit for release if: there had been bowel movement; solid food is tolerated; no serious pain; unproblematic mobilisation; surgical wound shows no sign of inflammation, or wound can be treated well in an outpatient setting; normal inflammatory markers (=135 mg/l C-reactive protein (CRP), =9 10?/l white blood cell count)	30 days
Secondary	Daily doses of analgetics	Amount, type, and time of application of analgetics will be obtained from medical and nursing records.	30 days
Secondary	Postoperative pain	evaluated on the numeric rating scale (0 - 10, steps of 1)	7 days
Secondary	Postoperative mobilization	Scoring: 0: 24 h in bed; 1: Out of bed only to go to bathroom; 2: Out of bed on free will	7 days
Secondary	Overall fluid intake	all fluids in ml per day	7 days
Secondary	Blood pressure	3 times daily	7 days
Secondary	Pulse	3 times daily (or more often if required)	7 days
Secondary	Intensive care	number of days in intensive care unit	14 days
Secondary	Well-being	well-being evaluating on day 2 and 4 after surgery using the Basle mental state scale as well as 5 additional items to evaluate the effects of caffeine. (Hobi 1985, Hobi 1989)	4 days
Secondary	Sleep behaviour	Leeds Sleep Evaluation Questionnaire (LSEQ) on day 2 and 4 after surgery. (Parrott 1986)	4 days
Secondary	Sleeping habits	Questionnaire evaluating duration and deepness of sleep.	4 days
Secondary	Satisfaction with surgery	Questionnaire on day 4 about satisfaction of treatment	4 days
Secondary	Consumption of sleep inducing drugs	amount and type of sleep inducing drugs	7 days

External Links

•   Web site of the Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen (German only)