BACKGROUND:Postoperative ileus, a common complication in patients after abdominal surgery, brings no benefit to the recovery of postoperative patients, and treatment targeted at restoring gastrointestinal motility may shorten the hospital stay. Studies have shown that escin accelerates gastrointestinal transit in mice and improves gastrointestinal motility in patients after abdominal surgery. A pilot study of escin's effect on the recovery of gastrointestinal motility was conducted in colorectal cancer patients in anticipation of a multiple-center randomized controlled trial. METHODS: A total of 72 postoperative colorectal cancer patients were randomly assigned to four parallel groups on the basis of sealed envelopes-escin 5 mg group (E5 mg), escin 15 mg group (E15 mg), escin 25 mg group (E25 mg), and placebo group-with 18 patients in each group. Escin or placebo was diluted in 500 ml 5% dextrose injection, which was given once daily through the subclavian vein. The first injection took place 6 h after completion of the surgery. The treatment continued for 7 days or stopped at the time of the patient's first bowel movement. Time to recovery of passage of gas (TRPG), time to recovery of gastrointestinal sounds (TRGS), and time to recovery of bowel movements (TRBM) were recorded to evaluate the efficacy of escin. RESULTS: The TRPGs of the three escin treatment groups were 76.78 + 28.81 h (E5 mg), 72.06 + 14.65 h (E15 mg), and 65.50 + 26.70 h (E25 mg), respectively, with differences of 6.03 +/- 7.64 h (p = 0.436; E5 mg), 10.75 +/- 4.92 h (p = 0.036; E15 mg), and 17.31 +/- 7.20 h (p = 0.022; E25 mg) compared with the placebo group. The TRGSs of the three escin treatment groups were 45.28 +/- 26.15 h (E5 mg), 41.22 +/- 16.98 h (E15 mg), and 40.33 +/- 14.09 h (E25 mg), respectively, with differences of 4.33 +/- 7.12 h (p = 0.547; E5 mg), 8.39 +/- 5.36 h (p = 0.127; E15 mg), and 9.28 +/- 4.87 h (p = 0.065; E25 mg) compared with the placebo group. The TRBMs of the three escin treatment groups were 89.25 +/- 23.77 h (E5 mg), 84.83 +/- 27.91 h (E15 mg), and 84.44 +/- 19.74 h (E25 mg), respectively, with differences of 19.03 +/- 10.13 h (p = 0.069; E5 mg), 23.44 +/- 10.70 h (p = 0.035; E15 mg), and 23.83 +/- 9.63 h (p = 0.019; E25 mg) compared with the placebo group. CONCLUSION: The results of this pilot Postoperative Ileus Study of Escin (PISE) showed that escin can shorten the time to recovery of gastrointestinal motility in cancer patients after colorectal surgery.
RCT Entities:
BACKGROUND: Postoperative ileus, a common complication in patients after abdominal surgery, brings no benefit to the recovery of postoperative patients, and treatment targeted at restoring gastrointestinal motility may shorten the hospital stay. Studies have shown that escin accelerates gastrointestinal transit in mice and improves gastrointestinal motility in patients after abdominal surgery. A pilot study of escin's effect on the recovery of gastrointestinal motility was conducted in colorectal cancerpatients in anticipation of a multiple-center randomized controlled trial. METHODS: A total of 72 postoperative colorectal cancerpatients were randomly assigned to four parallel groups on the basis of sealed envelopes-escin 5 mg group (E5 mg), escin 15 mg group (E15 mg), escin 25 mg group (E25 mg), and placebo group-with 18 patients in each group. Escin or placebo was diluted in 500 ml 5% dextrose injection, which was given once daily through the subclavian vein. The first injection took place 6 h after completion of the surgery. The treatment continued for 7 days or stopped at the time of the patient's first bowel movement. Time to recovery of passage of gas (TRPG), time to recovery of gastrointestinal sounds (TRGS), and time to recovery of bowel movements (TRBM) were recorded to evaluate the efficacy of escin. RESULTS: The TRPGs of the three escin treatment groups were 76.78 + 28.81 h (E5 mg), 72.06 + 14.65 h (E15 mg), and 65.50 + 26.70 h (E25 mg), respectively, with differences of 6.03 +/- 7.64 h (p = 0.436; E5 mg), 10.75 +/- 4.92 h (p = 0.036; E15 mg), and 17.31 +/- 7.20 h (p = 0.022; E25 mg) compared with the placebo group. The TRGSs of the three escin treatment groups were 45.28 +/- 26.15 h (E5 mg), 41.22 +/- 16.98 h (E15 mg), and 40.33 +/- 14.09 h (E25 mg), respectively, with differences of 4.33 +/- 7.12 h (p = 0.547; E5 mg), 8.39 +/- 5.36 h (p = 0.127; E15 mg), and 9.28 +/- 4.87 h (p = 0.065; E25 mg) compared with the placebo group. The TRBMs of the three escin treatment groups were 89.25 +/- 23.77 h (E5 mg), 84.83 +/- 27.91 h (E15 mg), and 84.44 +/- 19.74 h (E25 mg), respectively, with differences of 19.03 +/- 10.13 h (p = 0.069; E5 mg), 23.44 +/- 10.70 h (p = 0.035; E15 mg), and 23.83 +/- 9.63 h (p = 0.019; E25 mg) compared with the placebo group. CONCLUSION: The results of this pilot Postoperative Ileus Study of Escin (PISE) showed that escin can shorten the time to recovery of gastrointestinal motility in cancerpatients after colorectal surgery.
Authors: M J Heslin; L Latkany; D Leung; A D Brooks; S N Hochwald; P W Pisters; M Shike; M F Brennan Journal: Ann Surg Date: 1997-10 Impact factor: 12.969
Authors: Lenka Varinská; Lenka Fáber; Martin Kello; Eva Petrovová; Ľudmila Balážová; Peter Solár; Matúš Čoma; Peter Urdzík; Ján Mojžiš; Emil Švajdlenka; Pavel Mučaji; Peter Gál Journal: Molecules Date: 2018-01-17 Impact factor: 4.411