NCT03523715

Prunes for Gastrointestinal Function After Gynecologic Surgery

Terminated Phase 4 Results posted Last updated 8 April 2021

What this trial tests

Phase 4 trial testing Prunes in Constipation in 77 participants. Terminated before completion.

Timeline

30 November 2017

Primary endpoint
30 June 2020

31 July 2020

Quick facts

Lead sponsor	University of Southern California
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	77
Start date	30 November 2017
Primary completion	30 June 2020
Estimated completion	31 July 2020
Sites	1 location across United States

Drugs / interventions tested

• Prunes
• Docusate Sodium (docusate sodium) — full drug profile →

Conditions studied

• Constipation — all drugs for Constipation →

Sponsor

University of Southern California

Who can join

18 and older, female only, with Constipation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time to First Bowel Movement Primary · 3 days

Time to first bowel movement after surgery

Group	Value	95% CI
Prunes	57.6	± 19.3
Control	53.8	± 21.7

Stool Consistency of the First Bowel Movement Secondary · 3 days

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

Group	Value	95% CI
Prunes	3	2 – 5
Control	4	2 – 6

Pain With Bowel Movement Measured Secondary · 3 days

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

Group	Value	95% CI
Prunes	60	25 – 80
Control	40	10 – 70

Satisfaction With Bowel Regimen Secondary · 3 day

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

Group	Value	95% CI
Prunes	100	70 – 100
Control	80	45 – 95

Satisfaction With Surgery Overall Secondary · 3 days

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

Group	Value	95% CI
Prunes	100	90 – 100
Control	100	97.5 – 100

Requirements for Laxatives Secondary · 3 days

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

Group	Value	95% CI
Prunes	7
Control	6

Bowel Movement in the Study Period Secondary · 5 days

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

Group	Value	95% CI
Prunes	26
Control	17

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of prunes on gastrointestinal function after benign gynecological surgery: a randomized control trial.
   Rasouli MA, Dancz CE, Dahl M, Volpe KA, et al · · 2022 · cited 1× · PMID 35732845 · DOI 10.1007/s00423-022-02584-8