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OpenTrials
Completed

NCT Number: 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

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.

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Surgical Treatment

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200071, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Subtotal colectomy was performed

Procedure

Colonic subtotal resection, also known as subtotal colectomy, is a surgical procedure used to treat colonic diseases such asconstipation, colon cancer, ulcerative colitis, and others.

The purpose of this surgery is to remove a portion of the colon in the patient's body. Unlike a total colectomy, which involves removing the entire colon, a subtotal colectomy only removes a portion of the colon. The procedure typically involves removing the diseased part of the colon and reconnecting the remaining colon. This allows for the preservation of some normal colonic function, enabling the patient to have regular bowel movements.

Primary outcomes

  1. The nutritional status of the patients was assessed according to the scores of nutritional risk screening and assessment tool Nutritional Risk Screening2022（NRS2002)

    Time frame: Baseline and 1、6、12 and 24 months after surgery

    The full length of NRS2002 is called Nutritional Risk Screening2022. The minimum score is 0 and the maximum score is 3, with higher scores indicating higher nutritional risk.

  2. The nutritional status of the patients was assessed according to the scores of nutritional risk screening and assessment tool Malnutrition Universal Screening Tool （MUST).

    Time frame: Baseline and 1、6、12 and 24 months after surgery

    The full name of MUST is Malnutrition Universal Screening Tool, score 0: low risk; Score 1: moderate risk; A score of 2 or higher is considered high risk.

  3. The nutritional status of the patients was assessed according to the scores of nutritional risk screening and assessment tool Mini Nutritional Assessment （MNA).

    Time frame: Baseline and 1、6、12 and 24 months after surgery

    Mini Nutritional Assessment (MNA) is defined as "good nutritional status" when MNA≥24. 17≤MNA < 24, nutritional risk; MNA < 17 indicated malnutrition.

  4. The peristalsis status of patients was evaluated according to the frequency of defecation and the character of feces.

    Time frame: Baseline and 1、6、12 and 24 months after surgery

  5. The changes of fecal microbiota were detected by 16SDNA sequencing.

    Time frame: Baseline and 1、6、12 and 24 months after surgery

  6. Quantitative changes in immune cells were determined by flow cytometry of blood samples.

    Time frame: Baseline and 1、6、12 and 24 months after surgery

  7. Changes of intestinal motility after surgical treatment for constipation.

    Time frame: Baseline and 1、6、12 and 24 months after surgery

    The intestinal transit time of patients was detected

  8. Changes of defecation after surgical treatment for constipation.

    Time frame: Baseline and 1、6、12 and 24 months after surgery

    The frequency of postoperative defecation, the characteristics of stool and the force of defecation were studied by asking patients to record their defecation diary.

  9. Changes of quality of life after surgical treatment for constipation.

    Time frame: Baseline and 1、6、12 and 24 months after surgery

    Patients were evaluated using the quality of Life assessment scale.

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 9, 2023
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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