Clinical trial NCT03523715: Prunes for Gastrointestinal Function After Gynecologic Surgery
Official title: Effect of Prunes on Gastrointestinal Function After Gynecological Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Constipation
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 77
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: A major postoperative complaint among benign gynecological surgery patients is constipation. Improved management of constipation among these patients has the potential to both alleviate pain and for significant savings for health care systems. This is a prospective, randomized control trial that randomizes patients post-operatively into standard care versus standard care plus prunes. The primary objective is to determine the time to first bowel movement after surgery. Secondary objectives are pain associated with first bowel movement, stool consistency using Bristol stool form scale, compliance and patient satisfaction. The study population includes women over the age of 18 undergoing benign gynecologic surgery with overnight stay. 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. Follow-up phone calls will be made 3 and 5 days postoperatively to inquire about primary and secondary outcomes. Participants will be randomized to the treatment or control group at a 1:1 ratio and using randomization blocks of 6. Participant characteristics will be presented as means and standard deviations for continuous variables and counts and percentages for categorical variables. The primary and secondary outcomes will be assessed using two-sample t-tests.

Eligibility criteria: Inclusion Criteria:

1. Female patients seen in the Gynecology or Urogynecology clinics at LAC+USC Medical Center who are planned for surgery requiring at least 24 hour stay
2. Age 18 or greater
3. Able to give informed consent
4. No contraindications to docusate or prune consumption

Exclusion Criteria:

1. Unable to give informed consent
2. Unwilling to follow protocol
3. Active malignancy
4. Emergency surgery
5. Diabetes mellitus
6. Inflammatory bowel disease, gastroparesis, or other bowel disorder
7. History of bowel resection or presence of colostomy
8. Dependence on regular laxative use prior to surgery
9. Baseline frequency of bowel movements less than weekly
10. Intraoperative enterotomy or any bowel surgery performed at the time of surgery
11. Patient unable to initiate oral intake on post op day 1 for any reason
12. Allergy to docusate or prunes

Primary outcomes:
measure: Time to First Bowel Movement
timeFrame: 3 days
Secondary outcomes:
measure: Stool Consistency of the First Bowel Movement
timeFrame: 3 days
measure: Pain With Bowel Movement Measured
timeFrame: 3 days
measure: Satisfaction With Bowel Regimen
timeFrame: 3 day
measure: Satisfaction With Surgery Overall
timeFrame: 3 days
measure: Requirements for Laxatives
timeFrame: 3 days
measure: Bowel Movement in the Study Period
timeFrame: 5 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles Count + USC Medical Center
state: California
Study officials:
affiliation: Keck School of Medicine
name: Begum Ozel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.