drugset / Trial / NCT03523715
Prunes for Gastrointestinal Function After Gynecologic Surgery
RandomizedParallel-groupOpen-labelPrevention
Summary
This is a prospective, randomized control trial that randomizes patients post-operatively into standard care versus standard care plus prunes. Patients in the control arm will take 100 mg docusate twice per day for 3 days (standard care). Participants in the treatment arm will consume 4 oz prunes daily and take 100 mg docusate twice per day for 3 days. The primary objective is to determine the time to first bowel movement after surgery.
Timeline
- Start
- 2017-11-30
- Primary completion
- 2020-06-30
- Completion
- 2020-07-31
Publications
- Background Patel M, Schimpf MO, O'Sullivan DM, LaSala CA. The use of senna with docusate for postoperative constipation after pelvic reconstructive surgery: a randomized, double-blind, placebo-controlled trial. Am J Obstet Gynecol. 2010 May;202(5):479.e1-5. doi: 10.1016/j.ajog.2010.01.003. Epub 2010 Mar 6.
- Background McNanley A, Perevich M, Glantz C, Duecy EE, Flynn MK, Buchsbaum G. Bowel function after minimally invasive urogynecologic surgery: a prospective randomized controlled trial. Female Pelvic Med Reconstr Surg. 2012 Mar-Apr;18(2):82-5. doi: 10.1097/SPV.0b013e3182455529.
- Background Lever E, Cole J, Scott SM, Emery PW, Whelan K. Systematic review: the effect of prunes on gastrointestinal function. Aliment Pharmacol Ther. 2014 Oct;40(7):750-8. doi: 10.1111/apt.12913. Epub 2014 Aug 11.
- Background Lever E, Scott SM, Louis P, Emery PW, Whelan K. The effect of prunes on stool output, gut transit time and gastrointestinal microbiota: A randomised controlled trial. Clin Nutr. 2019 Feb;38(1):165-173. doi: 10.1016/j.clnu.2018.01.003. Epub 2018 Feb 15.
- Background Attaluri A, Donahoe R, Valestin J, Brown K, Rao SS. Randomised clinical trial: dried plums (prunes) vs. psyllium for constipation. Aliment Pharmacol Ther. 2011 Apr;33(7):822-8. doi: 10.1111/j.1365-2036.2011.04594.x. Epub 2011 Feb 15.
- Rasouli MA, Dancz CE, Dahl M, Volpe KA, Horton CJ, Ozel BZ. Effect of prunes on gastrointestinal function after benign gynecological surgery: a randomized control trial. Langenbecks Arch Surg. 2022 Dec;407(8):3803-3810. doi: 10.1007/s00423-022-02584-8. Epub 2022 Jun 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Docusate Sodium | Unknown | 100 mg | Oral |