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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug Dulcolax for post-surgery constipation?

Research shows that Dulcolax, especially when used with a suppository, is effective in bowel preparation for radiological exams, suggesting it may help with post-surgery constipation. Additionally, Dulcolax combined with other treatments improved colonoscopy preparation, indicating its effectiveness in promoting bowel movements. ^{1 2 3 4 5}

How does the drug Senna differ from Dulcolax for treating post-surgery constipation?

Senna, often used in combination with other agents like dioctyl sodium sulfosuccinate, is effective in managing postoperative constipation with minimal side effects, while Dulcolax, although effective, is more expensive and can have more side effects. Senna is also noted for its gentle action and is generally well-tolerated, making it a preferred choice for patients sensitive to stronger laxatives. ^{1 2 3 6 7}

Research Team

Candace Parker-Autry, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

References

1. Nigeria 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. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Management of postoperative constipation in anorectal surgery. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of 12 colon-cleansing regimens with single-contrast barium enema. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

The use of GoLYTELY and Dulcolax in combination in outpatient colonoscopy. [2019]

5. Switzerland 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. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

Senna vs. bisacodyl in addition to Golytely lavage for colonoscopy preparation--a prospective randomized trial. [2018]

7. England pubmed.ncbi.nlm.nih.gov

A crossover comparative study with two bulk laxatives. [2018]