Table of Contents
- Trial overview
- Who participated
- What was studied
- Outcomes measured
- Trial status and size
- What the results are meant to show
Trial overview
The provided trial data includes one study of Glycerol in patients with bowel dysfunction after rectal cancer surgery.[1] The study title says it looked at treatment of bowel dysfunction after surgery for rectal cancer using transanal irrigation or laxatives.[1]
This was an interventional study, which means the researchers gave a treatment and then measured the effect.[1] The study status was completed.[1]
Who participated
The trial studied people with Low Anterior Resection Syndrome, a bowel problem that can happen after rectal cancer surgery.[1] The brief summary says the study involved patients who had unsatisfactory improvement of bowel function and quality of life with Glycerol suppositories, or who were being compared against another bowel treatment.[1]
The enrollment was 114 participants.[1] The study used a low-intervention design, which means the treatment approach was intended to be closer to routine care than a high-risk experimental study.[1]
What was studied
The intervention of interest was Glycerol “OBA” in suppository form, given by rectal use.[1] A suppository is a solid medicine placed in the rectum so it can act locally.[1]
The study compared Glycerol suppositories with transanal irrigation, which is a bowel washout method used to help empty the bowel.[1] The brief summary says the study aimed to see whether patients who did not improve enough with one approach would improve when switched to the other approach.[1]
Outcomes measured
The primary endpoint was the change in the main symptom score measured by the Measure Yourself Medical Outcome Profile (MYMOP).[1] This is a patient-reported score, meaning the patient reports how much the symptoms have changed.[1]
The brief summary also says the study looked at bowel function and quality of life.[1] Quality of life means how well a person feels and manages daily life.[1]
Trial status and size
The study is listed as completed, so the trial has already finished collecting its main data.[1] It included 114 people, which gives a moderate-sized group for this kind of focused bowel treatment study.[1]
The source data does not provide a formal drug-development phase such as Phase 1, Phase 2, or Phase 3 for this Glycerol trial.[1] Instead, it is described as a low-intervention study.[1]
What the results are meant to show
This trial was designed to find out whether Glycerol suppositories can help improve the symptoms that matter most to patients after rectal cancer surgery.[1] It also aimed to see whether another bowel treatment, transanal irrigation, might work better for some patients.[1]
In simple terms, the study asks which treatment gives better relief of bowel problems and better daily comfort for people living with Low Anterior Resection Syndrome.[1]
