Clinical trial NCT05983926: To Explore the Efficacy and Safety of Surgical Treatment for Constipation, as Well as the Changes of Postoperative Intestinal Motility, Flora, Nutritional Status and Other Indicators
Official title: To Explore the Efficacy and Safety of Surgical Treatment for Constipation, as Well as the Changes of Postoperative Intestinal Motility, Flora, Nutritional Status and Other Indicators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Surgical Treatment
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Chronic constipation is a heterogeneous disease with multiple symptoms, and its incidence is on the rise in many countries. It has become a common disease affecting the quality of life. When these patients fail to respond to standardized and systematic non-surgical treatment, and the relevant examination suggests that there are surgical indications, surgical treatment should be considered. TThe objective of this study was to explore the efficacy and safety of surgical treatment for constipation, as well as the changes in postoperative nutrition, intestinal motility, intestinal flora and quality of life.


Eligibility criteria: Inclusion Criteria:

* Disease duration more than 6 years;
* Wexner constipation score \>15;
* No response to medical treatment, biofeedback and fecal microbiota transplantation;
* according to the surgical indications;
* All patients were informed of this study and signed the informed consent.

Exclusion Criteria:

* Suffering from mental disorders or cognitive impairment;
* With malignant tumors; -
* With history of gastrointestinal surgery;
* Complicated with other organ dysfunction;
* With immune system diseases.

Primary outcomes:
measure: The nutritional status of the patients was assessed according to the scores of nutritional risk screening and assessment tool Nutritional Risk Screening2022（NRS2002)
timeFrame: Baseline and 1、6、12 and 24 months after surgery
measure: The nutritional status of the patients was assessed according to the scores of nutritional risk screening and assessment tool Malnutrition Universal Screening Tool （MUST).
timeFrame: Baseline and 1、6、12 and 24 months after surgery
measure: The nutritional status of the patients was assessed according to the scores of nutritional risk screening and assessment tool Mini Nutritional Assessment （MNA).
timeFrame: Baseline and 1、6、12 and 24 months after surgery
measure: The peristalsis status of patients was evaluated according to the frequency of defecation and the character of feces.
timeFrame: Baseline and 1、6、12 and 24 months after surgery
measure: The changes of fecal microbiota were detected by 16SDNA sequencing.
timeFrame: Baseline and 1、6、12 and 24 months after surgery
measure: Quantitative changes in immune cells were determined by flow cytometry of blood samples.
timeFrame: Baseline and 1、6、12 and 24 months after surgery
measure: Changes of intestinal motility after surgical treatment for constipation.
timeFrame: Baseline and 1、6、12 and 24 months after surgery
measure: Changes of defecation after surgical treatment for constipation.
timeFrame: Baseline and 1、6、12 and 24 months after surgery
measure: Changes of quality of life after surgical treatment for constipation.
timeFrame: Baseline and 1、6、12 and 24 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
affiliation: Intestinal Microenvironment Treatment Center of General Surgery, Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University
name: Le Wang, Master
role: PRINCIPAL_INVESTIGATOR
References: