An observational study in Defecation Function and Quality of Life, sponsored by Third Military Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-11-27.
Sponsored by Third Military Medical University · Observational
Although surgical options for slow transit constipation (STC) have been proven to be a definite treatment, improvements in the associated defecation function and quality of life are rarely studied. This study aims to investigate the effectiveness of total or subtotal colectomy, with respect to short- and long-term defecation function and overall quality of life in 5-year regular follow-up.
Constipation is an ever-growing problem and one of the most common gastrointestinal symptoms, affecting 10-15% of adults in the USA and 8.2% of the general population in China. Slow-transit constipation, representing 15\~30% constipated patients, is characterized by a loss in the colonic motor activity. Factors such as increasing age, female sex, physical inactivity, endocrine, metabolism, neurological factors, drug use, and depression are associated with constipation. While most patients with constipation are mild and treated easily by a behavioral and medical way, a minority of patients suffering from long-term intractable symptoms and poor quality of life and showing no response to any medical interventions are ultimately recommended for surgery.
Since the effectiveness of colectomy for constipation was first reported by Lane a century ago, surgical treatment for constipation has been greatly developed[6], including ileorectal anastomosis (IRA), cecorectal anastomosis(CRA), colonic exclusion, antegrade enemas (the Malone procedure), modified Duhamel surgery, and permanent ileostomy. Currently, the main surgical procedures for STC are IRA and CRA, which have been widely confirmed to increase bowel-movement frequency in a huge number of patients. However, the reported outcomes of colectomy are controversial and conflicting.In these studies, lack of prospectively defined follow-up intervals is a general problem. Moreover, long-term outcomes of surgery for STC are rarely reported. Furthermore, negatively persistent symptoms including abdominal pain, bloating, intractable diarrhea, malnutrition, constipation recurrence, fecal incontinence, and intestinal obstruction are not uncommon following surgery, adversely affecting defecation function and quality of life following these procedures.
This study aims to investigate the effectiveness of total or subtotal colectomy, with respect to short- and long-term defecation function and overall quality of life during 5-year regular follow-up.
1,018 studies on the registry are indexed under Constipation; 140 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 129 observational studies indexed under Constipation.
Browse Constipation studies →Third Military Medical University is the lead sponsor of 81 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients diagnosed with STC in the investigator's department were preoperatively included.
Exclusion Criteria:
patients diagnosed with slow transit constipation had undergone surgery.
Procedure: total colectomy, ileorectal anastomosis
all patients underwent total colectomy and ileorectal anastomosis.The anastomosis was stapled in all patients.
The number of bowel movements
the number of bowel movements will be recorded in terms of times per week.
Time frame: from the pre-operation to the five years following surgery
The scales of Wexner Constipation
the scales of Wexner Constipation will be recorded in terms of scores.
Time frame: from the pre-operation to the five years following surgery
The scales of Wexner Incontinence
the scales of Wexner Incontinence will be recorded in terms of scores.
Time frame: from the pre-operation to the five years following surgery
The incidence of abdominal pain
the incidence of abdominal pain will be recorded in terms of percent.
Time frame: from the pre-operation to the five years following surgery
The incidence of bloating
the incidence of bloating will be recorded in terms of percent.
Time frame: from the pre-operation to the five years following surgery
The incidence of diarrhea
the incidence of diarrhea will be recorded in terms of percent.
Time frame: from the pre-operation to the five years following surgery
The incidence of straining
the incidence of straining will be recorded in terms of percent.
Time frame: from the pre-operation to the five years following surgery
The incidence of laxative
the incidence of laxative will be recorded in terms of percent.
Time frame: from the pre-operation to the five years following surgery
The incidence of enema use
the incidence of enema use will be recorded in terms of percent.
Time frame: from the pre-operation to the five years following surgery
The scales of Gastrointestinal Quality of Life Index
the scales of Gastrointestinal Quality of Life Index will be recorded in terms of scores.
Time frame: from the pre-operation to the five years following surgery
The short-form(SF)-36 survey
There are eight spheres in the SF-36 survey, including physical function, role physical, role emotional, physical pain, vitality, mental health, social function and general health. Results of each sphere will be recorded in terms of scores.
Time frame: from the pre-operation to the five years following surgery
Number of Participants with complications
Postoperative complications includes short-term and long-term complications, such as ileus, anastomotic leak, small intestinal obstruction, constipation recurrence and so on. Number of Participants with complications will be recorded.
Time frame: from the pre-operation to the five years following surgery
Plan to share: Undecided
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Third Military Medical University