Does caffeine reduce postoperative bowel paralysis after elective laparoscopic colectomy? (CaCo trial): study protocol for a randomized controlled trial.

BACKGROUND: Postoperative bowel paralysis is common after abdominal operations, including colectomy. As a result, hospitalization may be prolonged, thereby leading to increased cost. A recent randomized controlled trial showed that the consumption of regular black coffee after colectomy is associated with a significantly faster resumption of intestinal motility. The mechanism by which coffee stimulates intestinal motility is unknown, but caffeine seems to be the most likely stimulating agent. Thus, the effect of caffeine on postoperative bowel activity after colon surgery will be analyzed in this trial, herein referred to as CaCo. METHODS/DESIGN: Patients scheduled for elective laparoscopic colectomy or upper rectum resection are eligible to participate in this double-blinded, placebo-controlled, randomized trial. Patients fulfilling all inclusion criteria will be allocated after the surgical procedure to one of three treatment arms: 100 mg caffeine, 200 mg caffeine, or placebo (corn starch). Patients will take the capsules containing the study medication three times daily with a meal. The primary endpoint of the study is the time to a solid bowel movement. The study treatment will be stopped after the patient produces a solid bowel movement or has taken ten capsules, whichever occurs first. To determine the colonic passage time, patients will take a capsule with radiopaque markers at breakfast for the first 3 days after surgery. On the fourth day, the location of the markers will be determined with an abdominal X-ray scan. Further secondary objectives are the postoperative morbidity and mortality, well-being, sleeping behavior, and length of hospital stay. The study size was calculated to be 180 patients with an interim analysis occurring after 60 patients. DISCUSSION: From a previous study investigating coffee, evidence exists that caffeine might have a positive influence on the postoperative bowel activity. This double-blinded, placebo-controlled, randomized trial tries to show that caffeine will shorten the postoperative bowel paralysis and, thus, will improve recovery and shorten the hospital stay after colon surgery. TRIAL REGISTRATION: Clinicaltrials.gov NCT02510911 Swiss National Clinical Trials Portal SNCTP000001131.

Long-Term Survival is not Impaired After the Complete Resection of Neuroendocrine Tumors of the Appendix.

BACKGROUND: Appendiceal neuroendocrine tumors (aNET) are a common entity in routine medical care, with a rate per appendectomy as high as 0.3-0.9 %. Considering the relatively young age at diagnosis for these patients, exact information about the long-term prognosis of aNET is required. Survival rates vary substantially between 71 and 100 % and are mostly limited to 5 years. This investigation assessed the long-term mortality rates of patients who underwent aNET resections at fifteen hospitals. METHODS: Between 1990 and 2003, the 10-year survival rates of 79 patients were analyzed using risk-adjusted Cox proportional hazard regression models adjusted for population-based baseline mortality. Additionally, prognostic factors for the oncologic outcomes were assessed. RESULTS: The median follow-up of all patients was 12.1 and 13.7 years for those alive. All patients underwent curative R0 resections. No distant metastases were diagnosed. A total of 31 (39.2 %), 29 (36.7 %), 18 (22.8 %), and 1 (1.3 %) patients had stage I, IIA, IIB, and IIIB aNET, respectively, according to the latest classification by the European Neuroendocrine Tumor Society. The 10-year overall and relative survival rates were 83.6 % (95 % CI 75.5-92.6 %) and 96.7 % (95 % CI 87.5-107 %), respectively. The 10-year relative survival rate after resection of aNET did not differ from the survival of the average national population with the same age and gender (p = 0.947). Second primary malignancies (hazard ratio of death 7.0, 95 % CI 1.6-30.6) were identified as a significant prognosticator for long-term survival. CONCLUSIONS: Long-term survival is not significantly depreciated after the curative resection of aNET.

Efficacy of a Single Preoperative Dexamethasone Dose to Prevent Nausea and Vomiting After Thyroidectomy (the tPONV Study): A Randomized, Double-blind, Placebo-controlled Clinical Trial.

OBJECTIVE: Does dexamethasone given before thyroidectomy reduce postoperative nausea and vomiting (PONV) in a randomized controlled trial? BACKGROUND: PONV is an unsettling problem that commonly occurs in patients after thyroidectomy. Various preventive measures have been studied; however, many of these studies have been criticized for their biases (eg, use of opioids, sex selection) or were even retracted. METHODS: This single-institution, randomized, double-blind, placebo-controlled, superiority study was performed between January 1, 2011, and May 30, 2013. Patients undergoing thyroidectomy for benign disease were allocated by a block randomized list to receive a preoperative single dose of dexamethasone (8 mg) or placebo. Patients and staff were blinded to the treatment assignment. The primary endpoint was the incidence of PONV assessed at 4, 8, 16, 24, 32, and 48 hours after surgery. To observe an incidence reduction of 50%, a total of 152 patients were required for the study. RESULTS: The total incidence of PONV was reported in 65 of 152 patients (43%; 95% confidence interval [CI], 35-51). In the intention-to-treat analysis, PONV occurred in 22 of 76 patients (29%; 95% CI, 20-40) in the treatment arm and in 43 of 76 patients (57%; 95% CI, 45-67) in the control arm (P = 0.001; odds ratio = 0.31; 95% CI, 0.16-0.61; absolute risk reduction = 28%; 95% CI, 12-42). The number needed to treat was 4. No severe dexamethasone-related adverse events were observed during the study. CONCLUSIONS: A single dose of preoperative dexamethasone administration is an effective, safe, and economical measure to reduce PONV incidence after thyroidectomy.

Survival after renal cell carcinoma metastasis to the thyroid: single center experience and systematic review of the literature.

BACKGROUND: Renal cell carcinoma can metastasize to uncommon sites, for example, the thyroid gland where metastases are rarely found. To determine the patient survival and the time between cancer diagnosis and thyroid metastasis, we analyzed a large patient cohort from our hospital records and performed a systematic review. PATIENTS AND METHODS: Patients diagnosed between 1978 and 2007 with thyroid metastases from renal cell carcinoma were retrospectively identified from the hospital database. A systematic literature search was performed for publications describing at least three cases of thyroid metastasis from renal cell carcinoma. Case data from the identified studies were collected and used to determine the survival data. RESULTS: We identified 34 patients (19 females) from our hospital records with a mean age of 67 years (range, 33-79) when thyroid metastasis was diagnosed. Median time to primary metastasis after resection of renal cell carcinoma was 6.5 years (range, 0-25) with a single case of synchronous metastasis. Median survival after primary metastasis was 4.7 years (95% confidence interval [CI]: 1.8-7.6). The systematic review included 32 studies with 285 patients. Case data could be extracted for 202 patients. Median time to thyroid metastasis (without synchronous cases) was 8.8 years (95% CI: 7.5-10.1). Median actuarial survival after thyroid metastasis was 3.4 years (95% CI: 2.2-4.6). Total thyroidectomy was not associated with a better survival compared to partial thyroidectomies. CONCLUSIONS: Time to thyroid metastasis of renal cell carcinoma can be very long, and survival after thyroidectomy is favorable compared to metastasis to other sites.

Use of human fibrin glue (Tisseel) versus staples for mesh fixation in laparoscopic transabdominal preperitoneal hernioplasty (TISTA): a randomized controlled trial (NCT01641718).

BACKGROUND: Inguinal hernia repair is one of the most common surgical procedures worldwide. This procedure is increasingly performed with endoscopic techniques (laparoscopy). Many surgeons prefer to cover the hernia gap with a mesh to prevent recurrence. The mesh must be fixed tightly, but without tension. During laparoscopic surgery, the mesh is generally fixed with staples or tissue glue. However, staples often cause pain at the staple sites, and they can cause scarring of the abdominal wall, which can lead to chronic pain. We designed a trial that aims to determine whether mesh fixation with glue might cause less postoperative pain than fixation with staples during a transabdominal preperitoneal patch plastic repair. METHODS/DESIGN: The TISTA trial is a prospective, randomized, controlled, single-center trial with a two-by-two parallel design. All patients and outcome-assessors will be blinded to treatment allocations. For eligibility, patients must be male, ≥18 years old, and scheduled for laparoscopic repair of a primary inguinal hernia. One group comprises patients with a unilateral inguinal hernia that will be randomized to receive mesh fixation with either tissue glue or staples. The second group comprises patients with bilateral inguinal hernias. They will be randomized to receive mesh fixation with tissue glue either on the right or the left side and with staples on the other side. The primary endpoint will be pain under physical stress, measured at 24 h after surgery. Pain will be rated by the patient based on a numeric rating scale from 0 to 10, where 10 equals the worst pain imaginable. A total of 82 patients will be recruited (58 patients with unilateral inguinal hernias and 24 patients with bilateral hernias). This number is estimated to provide 90% power for detecting a pain reduction of one point on a numeric rating scale, with a standard deviation of one. DISCUSSION: Patients with bilateral hernias will receive two meshes, one fixed with glue, and the other fixed with staples. This design will eliminate the inter-individual bias inherent in comparing pain measurements between two groups of patients. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01641718.

Study protocol for a randomized, double-blind, placebo-controlled trial of a single preoperative steroid dose to prevent nausea and vomiting after thyroidectomy: the tPONV study.

BACKGROUND: Postoperative nausea and vomiting after general anesthesia is not only an unpleasant problem affecting 20-30% of surgical patients but may also lead to severe postoperative complications. There is a particularly high incidence of postoperative nausea and vomiting following thyroidectomy. Dexamethasone has been described as highly effective against chemotherapy-induced nausea and vomiting and has been proposed as a first-line method of postoperative nausea and vomiting prophylaxis. Despite this possible beneficial effect, the prophylactic administration of dexamethasone before surgery to prevent or ameliorate postoperative nausea and vomiting has not been established. A bilateral superficial cervical plexus block during thyroid surgery under general anesthesia significantly reduces pain. Of even greater clinical importance, this block prevents the need for postoperative opioids. Therefore, patients undergoing thyroidectomy and a bilateral superficial cervical plexus block are an ideal group to investigate the efficacy of dexamethasone for postoperative nausea and vomiting. These patients have a high incidence of postoperative nausea and vomiting and do not require opioids. They have no abdominal surgery, which can cause nausea and vomiting via a paralytic ileus. Combined with the highly standardized anesthesia protocol in use at our institution, this setting allows all known biases to be controlled. METHODS/DESIGN: We will perform a parallel two-arm, randomized (1:1), double-blind, placebo-controlled, single-center trial. Adults (≥18 years) scheduled for primary partial or total thyroidectomy because of a benign disease will be eligible for inclusion. The participants will be randomized to receive a single, intravenous preoperative dose of either 8 mg of dexamethasone in 2 ml saline (treatment group) or saline alone (placebo group). All the patients will receive a bilateral superficial cervical plexus block and standardized anesthesia. The primary outcome will be the incidence of postoperative nausea and vomiting. A total of 152 patients will be recruited, providing 80% power to detect a 50% reduction in the incidence of postoperative nausea and vomiting. Any patients who require opioid treatment will be excluded from the per-protocol analysis. DISCUSSION: In the present protocol, we reduced bias to the greatest extent possible. Thus, we expect to definitively clarify the efficacy of dexamethasone for postoperative nausea and vomiting prophylaxis. TRIAL REGISTRATION: http://www.clinicaltrials.gov: NCT01189292.

A rapid and accurate new bedside test to assess maximal liver function: a case report.

BACKGROUND: In liver surgery, appropriate preoperative evaluation and preparation of the patient is of cardinal importance. The up-to-date, preoperative prediction of residual liver function has thus far been limited. As post-hepatectomy liver failure is a major cause of mortality, a new and simple bedside test (LiMAx) has been developed to predict postoperative liver function in conjunction with preoperative volumetric analysis of the liver. CASE PRESENTATION: A 45-year-old patient presented with a cecal carcinoma and a large synchronous liver metastasis for major liver surgery. Liver function was determined by the LiMAx-test for the enzymatic capacity of cytochrome P450 1A2, which is ubiquitously and solely active in the liver. A solution of 2 mg/kg body weight (13)C-labeled methacetin was injected as a bolus into an intravenous catheter and, thereafter, was metabolized into acetaminophen and (13)CO2 and pulmonarily exhaled. The analysis of the (13)CO2/(12)CO2 ratio was performed using online breath sampling over a period of maximally 60 minutes. Based on this test, a value of more than 315 µg/kg/h represents normal liver function. A laparoscopic right hemihepatectomy was planned during virtual resection with a residual liver volume of 48% and a preoperative anticipated residual LiMAx of 301 µg/kg/h. After successful resection, the initial postoperative LiMAx value was 316 µg/kg/h, indicating good liver function and a correct prediction of the outcome. CONCLUSION: In the presented patient, residual liver function could be accurately predicted preoperatively using a combination of the new LiMax test with CT-volumetry. This test might significantly improve preoperative evaluation and postoperative outcomes in liver surgery.