Clinical trial NCT04304183: Defecation Function and Quality of Life in the Patients Treated With Surgery for Slow Transit Constipation
Official title: Defecation Function and Quality of Life in the Patients Treated With Surgery for Slow Transit Constipation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Defecation Function
Quality of Life
Keywords: Slow transit constipation
Defecation function
Quality of life
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients diagnosed with STC in the investigator's department were preoperatively included.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. The clinical manifestations all met the Roman IV standard for the diagnosis of functional constipation.
2. Patients with severe constipation symptoms were unable to defecate naturally and need laxatives to assist defecation or still unable to defecate.
3. Colonic transport tests showed that the opaque X-ray markers remained more than 20% after 72 hours.
4. All conservative treatment for more than 1 year failed.
5. Patients had a strong desire for surgery, and no other contraindications to surgery.

Exclusion Criteria:

1. Megacolon was detected with barium enema examination.
2. Colonoscopy suggested the presence of intestinal organic lesions or a history of colorectal cancer treatment.
3. Gastric and small intestinal transport dysfunction.
4. There are depression, anxiety and other mental symptoms.
5. Constipation type irritable bowel syndrome.
6. History of inflammatory bowel disease.

Primary outcomes:
measure: The number of bowel movements
timeFrame: from the pre-operation to the five years following surgery
measure: The scales of Wexner Constipation
timeFrame: from the pre-operation to the five years following surgery
measure: The scales of Wexner Incontinence
timeFrame: from the pre-operation to the five years following surgery
measure: The incidence of abdominal pain
timeFrame: from the pre-operation to the five years following surgery
measure: The incidence of bloating
timeFrame: from the pre-operation to the five years following surgery
measure: The incidence of diarrhea
timeFrame: from the pre-operation to the five years following surgery
measure: The incidence of straining
timeFrame: from the pre-operation to the five years following surgery
measure: The incidence of laxative
timeFrame: from the pre-operation to the five years following surgery
measure: The incidence of enema use
timeFrame: from the pre-operation to the five years following surgery
measure: The scales of Gastrointestinal Quality of Life Index
timeFrame: from the pre-operation to the five years following surgery
measure: The short-form(SF)-36 survey
timeFrame: from the pre-operation to the five years following surgery
Secondary outcomes:
measure: Number of Participants with complications
timeFrame: from the pre-operation to the five years following surgery
Other outcomes:
Locations:
city: Yuzhong
country: China
facility: Weidong Tong
state: Chongqing
Study officials:
affiliation: Army Military Medical University
name: Weidong Tong, MD
role: STUDY_CHAIR
References:
citation: Wei D, Cai J, Yang Y, Zhao T, Zhang H, Zhang C, Zhang Y, Zhang J, Cai F. A prospective comparison of short term results and functional recovery after laparoscopic subtotal colectomy and antiperistaltic cecorectal anastomosis with short colonic reservoir vs. long colonic reservoir. BMC Gastroenterol. 2015 Mar 18;15:30. doi: 10.1186/s12876-015-0257-7.
citation: Macha MR. The feasibility of laparoscopic subtotal colectomy with cecorectal anastomosis in community practice for slow transit constipation. Am J Surg. 2019 May;217(5):974-978. doi: 10.1016/j.amjsurg.2019.03.018. Epub 2019 Mar 26.