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NCT Number: NCT06601985

Exploring the Effect of Colonic J-pouch in Anorectal Preservation Surgery for Ultra-low Rectal Cancer.

The occurrence of colorectal cancer has increased from the third most common cancer in 2018 to the second most common cancer in 2023. The practice of anal preservation surgery for ultra-low rectal cancer is being adopted gradually. Ultra-low rectal cancer patients who have undergone anal preservation are at an increased risk of developing significant bowel complications. The objective of this study was to examine the relationship between the type of bowel reconstruction following anal preservation surgery, and the subsequent outcomes of bowel function, quality of life and complication rates in patients with ultra-low rectal cancer.

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Key information

Conditions

Rectum Cancer Anastomotic Leak Behavior Behavioral Symptoms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Elimination Disorders Encopresis Faecal Incontinence Faecal Incontinence With Faecal Urgency Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Leakage, Anastomotic Low Anterior Resection Syndrome Mental Disorders Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases Rectal Neoplasms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Tenth People's Hospital, Yanchang Road, Jing'an District, Shanghai, China

Shanghai, Jingan, 200040, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A confirmed diagnosis of intestinal cancer, with the lower edge of the tumour <5 cm from the anus or <3 cm from the dentate line, and treated with anus-preserving surgery;
  • No distant metastasis;
  • Age >18 years old;
  • Voluntary enrollment in the study and signing of an informed consent.

Exclusion criteria

  • A combination of severe cardiopulmonary, hepatic, renal, and other underlying diseases with a greater anaesthetic risk (ASA ≥ grade 4);
  • preoperative anal stenosis and anal nonfunction;
  • temporary stoma diversion.

Treatment and study plan

J-pouch anastomosis

Procedure

Patient with ultra-low rectal cancer undergoing Sphincter- preserving surgery with one-stage anastomosis using a colon J-pouch.

direct anastomosis

Procedure

Patient with ultra-low rectal cancer undergoing Sphincter- preserving surgery with one-stage direct anastomosis.

Primary outcomes

  1. LARS score

    Time frame: From 1 month postoperatively to 12 months postoperatively

    The LARS scale has five questions with a total score of 42. A score of 0-20 lacks diagnostic value for LARS, while a score of 21-29 indicates mild LARS and a score above 29 indicates major LARS.

  2. FIQL

    Time frame: From 1 month postoperatively to 12 months postoperatively

    The FIQL is a specific quality-of-life assessment scale applicable to the symptoms of colorectal cancer patients. It comprises 29 items, which are divided into four dimensions: lifestyle (10 items), coping/behavior restriction(9 items), depression/self-perception (7 items), and embarrassment (3 items).

  3. Vaizey score

    Time frame: From 1 month postoperatively to 12 months postoperatively

    The Wexner scale has five parts with a total score of 20, while the Vaizey scale is further refined on the basis of Wexner and has seven parts with a total score of 24. Higher scores on these scales indicate poorer anal functioning.

  4. Wexner score

    Time frame: From 1 month postoperatively to 12 months postoperatively

    The Wexner scale has five parts with a total score of 20, while the Vaizey scale is further refined on the basis of Wexner and has seven parts with a total score of 24. Higher scores on these scales indicate poorer anal functioning.

Secondary outcomes

  1. Surgical complications

    Time frame: From 1 month postoperatively to 12 months postoperatively

    Records post-operative anastomotic fistula, infection, bleeding, etc.

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

Exploring the Effect of Applying Colonic J-pouch Forming in Anorectal Preservation Surgery for Ultra-low Rectal Cancer on Postoperative Bowel Control Function

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 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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