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ConstipationPhase 4NCT03523715

Prunes for Gastrointestinal Function After Gynecologic Surgery

A Phase 4 study testing Prunes and Docusate Sodium in people with Constipation, run by University of Southern California at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Constipation
What is being tested?
Prunes and Docusate Sodium
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
77 participants
Where
1 siteUnited States
Study dates
30 Nov 2017to 31 Jul 2020
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Age 18 or greater
  • Able to give informed consent
  • No contraindications to docusate or prune consumption

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Los Angeles Count + USC Medical Center

    Los Angeles, California, 90033

Other trials in United States

About this study

Official title: Effect of Prunes on Gastrointestinal Function After Gynecological Surgery: A Randomized Controlled Trial

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.

Read the 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
Being tested
Prunes, Docusate Sodium
Medical subject headings
Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrunesDietary supplement

    Also called Dried plums

    12 oz of prunes daily

  • Docusate SodiumDrug

    Also called Colace

    Oral docusate sodium twice daily

Study groups in NCT03523715
Study groupRoleWhat they receive
PrunesExperimentalThe study group will be instructed to consume 4 oz of prunes as well as docusate sodium twice daily for 3 days after surgery.
Receives: Dietary Supplement: Prunes; Drug: Docusate Sodium
ControlPlacebo comparatorThe placebo group will be instructed to take docusate sodium twice daily for 3 days after surgery.
Receives: Drug: Docusate Sodium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to First Bowel Movement

    Time to first bowel movement after surgery

    Measured: 3 days

Secondary outcomes (6)

  1. Stool Consistency of the First Bowel Movement

    Bristol Stool chart in which stool consistency is described as type 1 to 7 with higher values indicating more liquid stool

    Measured: 3 days

  2. Pain With Bowel Movement Measured

    Likert scale from 0 to 10 in which higher values indicate more pain

    Measured: 3 days

  3. Satisfaction With Bowel Regimen

    Likert scale from 0 to 10 in which higher values indicate more satisfaction

    Measured: 3 day

  4. Satisfaction With Surgery Overall

    Likert scale from 0 to 10 in which higher levels indicate more satisfaction

    Measured: 3 days

  5. Requirements for Laxatives

    The number of participants who used any laxatives (besides the prunes and stool softeners) during the study period.

    Measured: 3 days

  6. Bowel Movement in the Study Period

    The number of participants who had a bowel movement in the post operative study follow up

    Measured: 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2018
  2. Study start30 Nov 2017
  3. Primary completion30 Jun 2020
  4. Study completion31 Jul 2020

Why it stopped: Difficulty in recruiting participants

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03523715
Sponsor's protocol ID
HS-17-00548
Status last verified
Mar 2021
First submitted
1 May 2018
Last updated
8 Apr 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20207340

  • 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.

    PubMed 22453316

  • 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.

    PubMed 25109788

  • 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.

    PubMed 29398337

  • 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.

    PubMed 21323688

  • 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.

    PubMed 35732845

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Prunes and Docusate Sodium in people with Constipation, run by University of Southern California at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to First Bowel Movement (time frame: 3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03523715, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.

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