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Recruiting NCT06335797

Optimization of Postoperative Bowel Habits

No phase Interventional Constipation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Senna Tab, Dulcolax Suppositories.
Who it may be relevant to
Registry conditions: Constipation. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Optimization of Postoperative Bowel Habits Following Pelvic Reconstructive Surgery: a Randomized Controlled Trial

Overview

Project is a trial, in which women undergoing vaginal surgery for pelvic organ prolapse will be randomized 1:1 to a postoperative bowel regimen of either oral senna or rectal bisacodyl suppository.

Detailed description

Delayed return to bowel function following vaginal surgery for pelvic organ prolapse has been deemed to be highly distressing for patients, and is ranked as one of the most common reasons for emergency department visits and telephone calls in the immediate post-operative period.

Despite the prevalence of constipation and significant effect on quality of life, few studies have examined an evidence-based bowel regimen for postoperative constipation prevention in the Urogynecology population.

As per available medical literature, the onset of action for oral senna occurs within 6-12 hours, while bisacodyl suppository can take effect between 15 and 60 minutes following rectal administration. Proposed trial comparing oral senna to rectal bisacodyl suppositories for the prevention of postoperative constipation in women undergoing vaginal reconstructive surgery for symptomatic prolapse.

Interventions

  • Dietary supplement Senna Tab
    Senna 8.6mg two tablets per day post operative day 1 and and if needed, then continue on the same dose regiment until post operative day 5.
  • Dietary supplement Dulcolax Suppositories
    Dulcolax 1 suppository to be placed rectally on the evening of post operative day 1 and if needed, then continue using the same dose regiment until the post operative day 5.

Primary outcome measures

  • Time in hours to first bowel movement comparison between the two arms [Time frame: up to Post Operative Day (POD) 5]
Secondary outcome measures (4)
  • Change in Overall Satisfaction (TSQM) Scores [Time frame: Day 7]
  • Visual Analog Scale (VAS) Pain Scores [Time frame: Post Operative Day (POD)1, POD2, POD3, POD4, and POD5]
  • Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) Scores [Time frame: Baseline and Day 7]
  • Bristol Stool Form Scale (BSFS) Scores [Time frame: Post Operative Day (POD)1, POD2, POD3, POD4, and POD5]

Eligibility criteria

Inclusion criteria

  • Women ages 18 and older scheduled to undergo vaginal pelvic organ prolapse repair

Exclusion criteria

  • Women younger than 18 years old
  • Those unable to provide consent
  • Preexisting chronic laxative use
  • Conditions that could affect bowel function including, inflammatory bowel disease, irritable bowel syndrome, colorectal cancer, rectovaginal fistula; concurrent bowel surgery; intraoperative bowel injury

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Wake Forest University Health Sciences — Winston-Salem

Publications

  • Caljouw MA, Hogendorf-Burgers ME. GYNOTEL: telephone advice to gynaecological surgical patients after discharge. J Clin Nurs. 2010 Dec;19(23-24):3301-6. doi: 10.1111/j.1365-2702.2010.03395.x. Epub 2010 Oct 14. PMID 20946445
  • Ramaseshan AS, LaSala C, O'Sullivan DM, Steinberg AC. Patient-Initiated Telephone Calls in the Postoperative Period After Female Pelvic Reconstructive Surgery. Female Pelvic Med Reconstr Surg. 2020 Oct;26(10):626-629. doi: 10.1097/SPV.0000000000000636. PMID 30247168
  • Arya LA, Novi JM, Shaunik A, Morgan MA, Bradley CS. Pelvic organ prolapse, constipation, and dietary fiber intake in women: a case-control study. Am J Obstet Gynecol. 2005 May;192(5):1687-91. doi: 10.1016/j.ajog.2004.11.032. PMID 15902178
  • 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. PMID 20207340
  • Tarumi Y, Wilson MP, Szafran O, Spooner GR. Randomized, double-blind, placebo-controlled trial of oral docusate in the management of constipation in hospice patients. J Pain Symptom Manage. 2013 Jan;45(1):2-13. doi: 10.1016/j.jpainsymman.2012.02.008. Epub 2012 Aug 11. PMID 22889861

Identifiers

NCT: NCT06335797 · IRB00110733

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗