Senna vs Dulcolax for Post-Surgery Constipation
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Wake Forest University Health Sciences
Must not be taking: Chronic laxatives
Disqualifiers: Under 18, Inflammatory bowel disease, others
No Placebo Group
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.
12345How 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.
12367Eligibility 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.
+1 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: SENNAExperimental Treatment1 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: DULCOLAXExperimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Wake Forest University Health SciencesWinston-Salem, NC
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Who Is Running the Clinical Trial?
Wake Forest University Health SciencesLead Sponsor
References
Study of the comparative effectiveness of Dulcolax, Laxadine, Dorbanex, Normacen and Senokot laxatives in the bowel preparation of patients for radiological examinations. [2019]The effectiveness of five laxatives - Dulcolax, Normacen, Laxadine, Dorbanex and Senokot in the bowel preparation of adult patients for radiological examinations has been compared. The value of using suppositories in addition to the tablets in those preparations that have tablet and suppository forms has also been assessed. The use of Dulcolax tablets plus suppository was most effective. Dulcolax, especially its suppository, was however very expensive and more frequently attended by side effects when compared with the other preparations. Normacen tablet was the second most effective and it is cheap and quite free of side effects. It is therefore given the position of first choice. Laxadine tablet plus its suppository was third best. It is cheap and free of side effects. Dorbanex was fourth best but it is rather expensive. Senokot tablet was the least effective but it is cheap and relatively free from side effects. In those laxatives with tablet and suppository forms, the use of both tablet and suppository is much more effective than the use of the tablet form alone.
Management of postoperative constipation in anorectal surgery. [2019]Fifty patients who had undergone proctologic operations were given a combination of standardized senna concentrate and dioctyl sodium sulfosuccinate for prevention or treatment of postoperative constipation. Two Senokot S tablets were given on the evening of the first postoperative day. Patients who had bowel movements after receiving this dose and remained in the hospital received two tablets on each of the following two days. Otherwise, dosage was increased gradually to a maximum of four tablets twice daily until defecation occurred or until the four-day treatment period was over. All patients achieved bowel movements, and in no case was it necessary to administer an enema. No hard stools were passed on the day patients were discharged from the hospital. Overall results were excellent or good in 94 per cent of cases; these results were not affected by age. Ninety-two per cent had bowel movements after the first or second dose was administered. On the day of discharge from the hospital, fecal consistency was satisfactory in 88 per cent of cases and loose in 12 per cent. Except for a single instance of diarrhea after administration of one dose, which involved a patient with a history of loose stools, no side effect occurred during the trial. In view of these responses and the virtual absence of side effects in this study group, Senokot S tablets are judged to be of demonstrated value in the postoperative management of patients undergoing proctologic operations.
Evaluation of 12 colon-cleansing regimens with single-contrast barium enema. [2016]In a study of patient preparation for barium enemas, 1,435 patients were examined at six different institutions with 12 different preparation protocols. There were 2,870 films evaluated a total of 7,839 times by seven different radiologists who were blind to both the institution and the preparations used. The statistical design, randomization, and analysis of the data obtained was performed by one of the authors, a statistician, and the following conclusions were made: Dulcolax (bisacodyl) plus 2 L tapwater enema is better than all the other protocols in all parts of the colon for both genders and all ages. Dulcolax or castor oil or X-Prep, each with 2 L water enema, are logically similar and better than the other protocols. Water enema only or castor oil only are the least effective protocols.
The use of GoLYTELY and Dulcolax in combination in outpatient colonoscopy. [2019]One hundred and sixty patients were enrolled in a double-blind, placebo-controlled trial to evaluate the effectiveness of the combination of the polyethylene glycol electrolyte lavage solution GoLYTELY (Braintree Laboratories, Inc., Braintree, MA, U.S.A.) and the contact laxative bisacodyl (Dulcolax, Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, U.S.A.) in improving outpatient preparation for colonoscopy. One hundred and fourteen patients completed the study; 59 received GoLYTELY followed by three Dulcolax capsules and 55 received GoLYTELY followed by three placebo capsules. A statistically significant improvement in the group receiving Dulcolax was noted in overall quality of preparation (p = 0.015) and amount of liquid stool present during colonoscopy (p = 0.02). We noted no significant difference in the occurrence of adverse effects. No patient in either group suffered from symptomatic orthostatic hypotension. These results suggest that an improved colonoscopy preparation can be obtained by combining a standard GoLYTELY preparation with three 5-mg Dulcolax tablets, without sacrificing patient safety or comfort.
Safety and efficacy of a bulk laxative containing senna versus lactulose in the treatment of chronic constipation in geriatric patients. [2018]Thirty geriatric long-stay patients aged 65-94 years (mean 81.8) participated in the trial the aim of which was to examine bulk laxative plus senna (Agiolax) in the treatment of chronic constipation using lactulose (Levolac) as a reference medicine. Bulk laxative plus senna (daily doses 14.8 g) produced more frequent (p
Senna vs. bisacodyl in addition to Golytely lavage for colonoscopy preparation--a prospective randomized trial. [2018]Colonoscopy preparation with lavage is a clinically accepted procedure. After having shown that its results can be improved by the additional intake of Senna this randomized prospective trial was designed to evaluate the effects of different laxatives in a combined preparation regimen. The day before endoscopy either Bisacodyl or extractum Sennae was given to 120 patients. Immediately before examination all patients underwent whole gut irrigation with Golytely solution. Patient acceptance and effectiveness of the two procedures were excellent and no relevant intolerance was observed. Satisfactory cleansing results were achieved with Bisacodyl as well as with Senna (98.3 vs. 95%). There was no significant difference between the laxatives used. We conclude that both regimens are safe, generally well tolerated and effective ways of preparation for colonoscopy.
A crossover comparative study with two bulk laxatives. [2018]Twenty elderly in-patients suffering from severe constipation were treated once daily for 2 weeks with each of two bulk laxatives. The preparations were allocated randomly as the first and second preparation. Agiolax, the new preparation, contained 15 mg senna glucosides, the old preparation, Lunelax comp., contained 25 mg senna glucoside A + B per dose. Both preparations worked well and no side-effects were seen.