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lack of effect at interims analysis
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| Name | Class |
|---|---|
| Gottfried und Julia Bangerter- Rhyner-Stiftung, Basel | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caffeine (100 mg) | Experimental | Verum 1 with 100 mg caffeine |
|
| Caffeine (200 mg) | Experimental | Verum 2 with 200 mg caffeine |
|
| corn starch (250 mg approx.) | Placebo Comparator | approx. 250 mg corn starch as placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caffeine (100 mg) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| preoperative caffeine consumption | Questionnaire evaluation the caffeine consumption of patients (type of beverages, amount etc) | before surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Steffen, MD | Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen | Rorschach | 9400 | Switzerland | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22987303 | Background | Muller SA, Rahbari NN, Schneider F, Warschkow R, Simon T, von Frankenberg M, Bork U, Weitz J, Schmied BM, Buchler 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. | |
| 3023168 | Background |
| Label | URL |
|---|---|
| Web site of the Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen (German only) | View source |
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|
|
| Caffeine (200 mg) | Drug | 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.) | Drug | 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. |
|
|
| Radiopaque marker | Other | 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%). |
|
|
| 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 |
| Postoperative vomiting events | Number of times patient has to vomit. | 7 days |
| 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 |
| Actual postoperative hospital stay | Number of days from surgery until actual discharge. | 30 days |
| 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:
| 30 days |
| Daily doses of analgetics | Amount, type, and time of application of analgetics will be obtained from medical and nursing records. | 30 days |
| Postoperative pain | evaluated on the numeric rating scale (0 - 10, steps of 1) | 7 days |
| Postoperative mobilization | Scoring:
| 7 days |
| Overall fluid intake | all fluids in ml per day | 7 days |
| Blood pressure | 3 times daily | 7 days |
| Pulse | 3 times daily (or more often if required) | 7 days |
| Intensive care | number of days in intensive care unit | 14 days |
| 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 |
| Sleep behaviour | Leeds Sleep Evaluation Questionnaire (LSEQ) on day 2 and 4 after surgery. (Parrott 1986) | 4 days |
| Sleeping habits | Questionnaire evaluating duration and deepness of sleep. | 4 days |
| Satisfaction with surgery | Questionnaire on day 4 about satisfaction of treatment | 4 days |
| Consumption of sleep inducing drugs | amount and type of sleep inducing drugs | 7 days |
| Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen |
| Sankt Gallen |
| 9007 |
| Switzerland |
| 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. doi: 10.1016/0016-5085(87)90837-7. |
| 2928619 | Background | 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. |
| Background | Hobi V. Basler Befindlichkeits-Skala. Ein Self-Rating zur Verlaufsmessung der Befindlichkeit. Manual. 1 ed. Weinheim: Beltz Test GmbH, 1985. |
| 6777817 | Background | Parrott AC, Hindmarch I. The Leeds Sleep Evaluation Questionnaire in psychopharmacological investigations - a review. Psychopharmacology (Berl). 1980;71(2):173-9. doi: 10.1007/BF00434408. |
| 35909263 | Derived | Abbassi F, Muller SA, Steffen T, Schmied BM, Warschkow R, Beutner U, Tarantino I. Caffeine for intestinal transit after laparoscopic colectomy: randomized clinical trial (CaCo trial). Br J Surg. 2022 Nov 22;109(12):1216-1223. doi: 10.1093/bjs/znac265. |
| 27044596 | Derived | Kruse C, Muller SA, Warschkow R, Luthi C, Brunner W, Marti L, Sulz MC, Schmied BM, Tarantino I, Beutner U. Does caffeine reduce postoperative bowel paralysis after elective laparoscopic colectomy? (CaCo trial): study protocol for a randomized controlled trial. Trials. 2016 Apr 4;17:186. doi: 10.1186/s13063-016-1297-1. |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D004238 | Diverticulitis |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D000076385 | Diverticular Diseases |
| D005759 | Gastroenteritis |
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| ID | Term |
|---|---|
| D002110 | Caffeine |
| D013213 | Starch |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |
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