Prunes for Gastrointestinal Function After Gynecologic Surgery

NCT ID: NCT03523715

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-30
• Study Completion Date: 2020-07-31

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.

Conditions

Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Prunes

The study group will be instructed to consume 4 oz of prunes as well as docusate sodium twice daily for 3 days after surgery.

Group Type: EXPERIMENTAL

Prunes

Intervention Type: DIETARY_SUPPLEMENT

12 oz of prunes daily

Docusate Sodium

Intervention Type: DRUG

Oral docusate sodium twice daily

Control

The placebo group will be instructed to take docusate sodium twice daily for 3 days after surgery.

Group Type: PLACEBO_COMPARATOR

Docusate Sodium

Intervention Type: DRUG

Oral docusate sodium twice daily

Interventions

Prunes

12 oz of prunes daily

Intervention Type: DIETARY_SUPPLEMENT

Docusate Sodium

Oral docusate sodium twice daily

Intervention Type: DRUG

Other Intervention Names

Dried plums; Colace

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Begum Ozel

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Begum Ozel, MD

Role: PRINCIPAL_INVESTIGATOR

Keck School of Medicine

Locations

Los Angeles Count + USC Medical Center

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 20207340 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22453316 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25109788 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29398337 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21323688 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35732845 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

HS-17-00548

Identifier Type: -

Identifier Source: org_study_id