Senna vs Dulcolax for Post-Surgery Constipation

Overseen By Sachin N Vyas, MS, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must not be taking: Chronic laxatives

Disqualifiers: Under 18, Inflammatory bowel disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 5 days

88 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which treatment better alleviates constipation after vaginal surgery for pelvic organ prolapse: oral senna tablets or Dulcolax suppositories. Participants will be divided into two groups to receive either senna, a natural laxative, or Dulcolax, a rectal suppository, to aid bowel movements post-surgery. Women scheduled for this type of surgery, who do not regularly use laxatives or have certain bowel conditions, are suitable candidates for this study. As an unphased trial, this study provides participants the opportunity to contribute to valuable research that may enhance post-surgical care for others.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop your current medications. However, if you use laxatives regularly, you cannot participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that senna, a common over-the-counter laxative, is generally safe for short-term use. The FDA has approved it for treating constipation, and it typically works within 6 to 12 hours. Some people might experience side effects like stomach cramps, or less commonly, rectal bleeding or low potassium levels.

Dulcolax suppositories, containing bisacodyl, also offer quick relief from constipation. Common side effects include stomach cramps and dizziness. Avoid using them for more than a week without consulting a doctor to prevent further issues.

Both treatments are widely used and considered safe for short-term use. Always follow the dosage instructions and consult a healthcare provider if any severe side effects occur. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for post-surgery constipation because they offer two distinct approaches. Senna tablets, a natural laxative, work by gently stimulating the intestines to promote bowel movements. This oral option is convenient for patients and offers a gradual yet effective relief. On the other hand, Dulcolax suppositories provide a more direct method by stimulating the bowel locally, which can lead to quicker results. Both treatments offer alternative methods to traditional oral laxatives, giving patients and doctors more options tailored to individual needs and responses.

What evidence suggests that this trial's treatments could be effective for post-surgery constipation?

This trial will compare the effectiveness of Senna and Dulcolax in treating post-surgery constipation. Studies have shown that both Senna, which participants may receive, and Dulcolax, another treatment option, effectively treat constipation. The FDA has approved Senna, and it is known to be safe and effective, particularly for post-surgery constipation. Research has shown that it helps reduce the time to the first bowel movement after pelvic surgery. Dulcolax, a rectal suppository containing bisacodyl, has also proven to speed up bowel recovery after abdominal surgeries. Both treatments aid bowel movements, making them useful for relieving constipation after surgery. ^{6 7 8 9 10}

Who Is on the Research Team?

Candace Parker-Autry, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for women aged 18 or older who are scheduled for vaginal surgery to fix pelvic organ prolapse. It's not open to those under 18, unable to consent, using laxatives long-term, or with conditions like inflammatory bowel disease, irritable bowel syndrome, colorectal cancer, fistulas or concurrent bowel surgeries.

Inclusion Criteria

I am a woman over 18 scheduled for vaginal prolapse repair.

Exclusion Criteria

I am a woman under 18 years old.

I do not have any conditions that affect my bowel function.

I am unable to give consent by myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either oral senna or rectal bisacodyl suppository for postoperative bowel regimen following vaginal reconstructive surgery

5 days

Daily monitoring during hospital stay

Follow-up

Participants are monitored for bowel function and satisfaction with treatment using various scales and questionnaires

1 week

1 visit (in-person) at 1 week post-op

What Are the Treatments Tested in This Trial?

Interventions

• Dulcolax Suppositories
• Senna Tab

Trial Overview The study compares two methods of managing constipation after vaginal surgery: one group will use oral senna tablets and the other will use rectal bisacodyl suppositories. Women participating will be randomly assigned in equal numbers to either regimen.

How Is the Trial Designed?

Group I: SENNA Experimental Treatment 1 Intervention

Group A participants will be prescribed oral senna (Senokot; Atlantis Consumer Healthcare Inc., Bridgewater, NJ) 8.6mg tablets and be instructed to start with two tablets on the morning of Post Operative Day (POD)#1. Participant will continue taking two tablets on the daily. If no bowel movement on the morning of POD#3 participant may take 2 tablets in the morning and another 2 tablets that evening. The same can be replicated on POD#4. If no bowel movement on the morning of POD#5 participant may take magnesium hydroxide (Phillips' Milk of Magnesia; Bayer AG, Leverkusen, Germany) 30 mL by mouth and need to call the urology clinic for further instruction.

Group II: DULCOLAX Experimental Treatment 1 Intervention

Group B participants will be prescribed bisacodyl rectal (Dulcolax Suppository; Sanofi S.A., Paris, France) 1 suppository to be placed rectally on the morning of Post Operative Day (POD)#1. Participant will continue placing a nightly rectal suppository until their first bowel movement. If no bowel movement by the morning of POD#5 participant may take magnesium hydroxide (Phillips' Milk of Magnesia; Bayer AG, Leverkusen, Germany) 30 mL by mouth and need to call the clinic for further instruction.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

In a study involving 30 geriatric patients aged 65-94, bulk laxative plus senna was found to significantly increase the frequency of bowel movements compared to lactulose, with an average of 4.5 bowel movements per week versus 2.2-1.9 for lactulose.

Both treatments were deemed safe, but the bulk laxative plus senna was more effective for managing chronic constipation in elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a bulk laxative containing senna versus lactulose in the treatment of chronic constipation in geriatric patients. Kinnunen, O., Winblad, I., Koistinen, P., et al.[2018]

In a study of 160 patients, combining GoLYTELY with bisacodyl (Dulcolax) significantly improved the quality of colonoscopy preparation compared to GoLYTELY with a placebo, with p-values of 0.015 and 0.02 for overall preparation quality and liquid stool amount, respectively.

The combination treatment did not increase the risk of adverse effects, ensuring patient safety and comfort during the preparation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of GoLYTELY and Dulcolax in combination in outpatient colonoscopy. Clarkston, WK., Smith, OJ.[2019]

Dulcolax, especially when used as both a tablet and suppository, was the most effective laxative for bowel preparation, but it was also the most expensive and had more side effects compared to others.

Normacen was identified as the first choice laxative due to its effectiveness, low cost, and minimal side effects, making it a safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study of the comparative effectiveness of Dulcolax, Laxadine, Dorbanex, Normacen and Senokot laxatives in the bowel preparation of patients for radiological examinations. Obisesan, AA., Osinaike, I.[2019]

In a study of 50 patients who underwent proctologic surgeries, the combination of standardized senna concentrate and dioctyl sodium sulfosuccinate effectively prevented and treated postoperative constipation, with 94% of patients reporting excellent or good results.

All patients achieved bowel movements without the need for enemas, and there were minimal side effects, indicating that Senokot S tablets are a safe and effective option for managing constipation after such surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of postoperative constipation in anorectal surgery. Corman, ML.[2019]

In a study involving 120 patients, both Bisacodyl and Senna were found to be effective laxatives for colonoscopy preparation, achieving high cleansing results of 98.3% and 95%, respectively.

Both laxative regimens were safe, well tolerated, and showed no significant differences in effectiveness, making them suitable options for preparing patients for colonoscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Senna vs. bisacodyl in addition to Golytely lavage for colonoscopy preparation--a prospective randomized trial. Ziegenhagen, DJ., Zehnter, E., Tacke, W., et al.[2018]

In a study involving 20 elderly in-patients with severe constipation, both the new bulk laxative Agiolax and the older preparation Lunelax comp. were effective in relieving symptoms over a 2-week treatment period.

No side effects were reported for either laxative, indicating a good safety profile for both treatments in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A crossover comparative study with two bulk laxatives. Pers, M., Pers, B.[2018]

In a study involving 1,435 patients and 12 different preparation protocols for barium enemas, the combination of Dulcolax (bisacodyl) and a 2 L tap water enema was found to be the most effective preparation method across all parts of the colon, regardless of gender or age.

Other effective protocols included Dulcolax, castor oil, or X-Prep, each paired with a 2 L water enema, while water enema only or castor oil only were identified as the least effective options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of 12 colon-cleansing regimens with single-contrast barium enema. Present, AJ., Jansson, B., Burhenne, HJ., et al.[2016]

Citations

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Safety and efficacy of laxatives after major abdominal surgery Five RCTs with a total of 416 patients were included. Laxatives reduced the time to passage of stool (mean difference (MD) −0·83 (95 per cent ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06335797

NCT06335797 | Optimization of Postoperative Bowel Habits 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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/18665373/

Effect of bisacodyl on postoperative bowel motility in ... Conclusion: Bisacodyl accelerated gastrointestinal recovery and might be considered as part of multimodal recovery programs after colorectal surgery.

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Bisacodyl: A review of pharmacology and clinical evidence ... Patients receiving bisacodyl had a significantly increased mean number of CSBMs per week over the treatment period, from 1.1 at baseline for ...

5. ucsfhealth.org ucsfhealth.org/education/after-anal-and-rectal-surgery

After Anal and Rectal Surgery | Patient Education If you still have had no results after three days, take four Dulcolax tablets by mouth at one time. If this does not work within 12 hours, call your surgeon ...

6. medsafe.govt.nz medsafe.govt.nz/consumers/cmi/d/dulcolax.pdf

DULCOLAX® Use of Dulcolax with other laxatives may enhance gastrointestinal side effects. After taking DULCOLAX, avoid straining while passing a bowel motion. Dizziness ...

7. dulcolax.com dulcolax.com/en-us/products/laxative-suppositories

Laxative Suppositories for Constipation Relief Dulcolax Suppositories interact at the source of the problem by softening your stools to deliver fast & effective relief from occasional constipation.

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK547733/

Bisacodyl - StatPearls - NCBI Bookshelf - NIH [6][7] In a systematic review, bisacodyl has level 4 evidence regarding its safety and efficacy for chronic constipation.

9. webmd.com webmd.com/drugs/2/drug-12263/bisacodyl-oral/details

Bisacodyl (Dulcolax, Fleet, and others): Uses, Side Effects, ... Common side effects may include stomach discomfort, stomach cramps, or faintness. You should not use bisacodyl for more than one week unless ...

10. reference.medscape.com reference.medscape.com/drug/dulcolax-correctol-bisacodyl-342008

Dulcolax, Correctol (bisacodyl) dosing, indications, ... Comment: Stimulant laxatives may increase the risk of mucosal ulceration or ischemic colitis when coadministered with bowel preps. sodium sulfate/potassium ...