The Effect of Different Reconstruction Methods on Anterior Resection Syndrome

NCT04023448 | Unknown

• 1 other identifier: CPSCA-01
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of prerectal resection syndrome (LARS) after middle and low rectal cancer surgery is as high as 70%, which seriously affects the quality of life of patients. Studies have shown that colon pouch can reduce and alleviate LARS symptoms. However, most previous studies focused on open surgery, and the evaluation index lacked objectivity. Therefore, in the context of minimally invasive rectal cancer surgery, it is necessary to re-evaluate the value of improved surgical methods for the prevention of LARS, so as to improve the quality of life of patients.

Conditions

Rectal Cancer; Low Anterior Resection Syndrome

Keywords

rectal cancer

Outcome Measures

Primary Outcomes (1)

• anterior resection syndrome incidence

  LARS score≥21

  1 year after surgery

Secondary Outcomes (4)

• Early postoperative complication incidence

  30 days after surgery

• Length of hospital stay after surgery

  30 days after surgery

• Bowel recovery time

  7 days after surgery

• Long-term postoperative complication incidence

  1 year after surgery

Study Arms (2)

coloplasty(CP)

EXPERIMENTAL

After purse-string suture and ligation of the head of the stapler at the colonic end, 5cm away from the colonic end, 5cm longitudinal incision was made to the proximal end of the teniae coli in the anterior wall of the colon, transverse suture was performed, and the plasmomuscular layer was embedded, then end to end colon-rectum (or anal canal) anastomosis was performed

Procedure: transverse coloplasty pouch

straight colorectal anastomosis (SCA)

NO INTERVENTION

End to end colon-rectum (or anal canal) anastomosis was performed routinely

Interventions

transverse coloplasty pouch PROCEDURE

a transverse coloplasty pouch was performed before end to end colon-rectum (or anal canal) anastomosis

coloplasty(CP)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old ≤80 years old, regardless of gender, signed informed consent,
• BMI≤kg/m\^2,
• Primary rectal lesions are pathologically diagnosed as rectal adenocarcinoma by endoscopic biopsy,
• The distance between the tumor and the anal margin is 5cm to 12cm,
• Preoperative tumor stage is T1-4N0-3M0,(according to AJCC-8th TNM tumor staging),
• Normal anorectal function and LARS score ≤20.

You may not qualify if:

• Patients with inflammatory bowel disease, chronic constipation, irritable bowel syndrome and other intestinal diseases that may affect bowel function,
• Patients with large tumors or extensive invasion of surrounding tissues and organs, TME is not applicable,
• Long-term use of drugs (such as morphine) that may affect bowel function,
• Patients with a history of abdominal, pelvic and anorectal surgery,
• Patients with severe mental illness or who cannot be evaluated due to cultural or psychological reasons.

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-Sen university

Guanzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms; Low Anterior Resection Syndrome

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colonic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hongbo Wei, Ph.D

  Third Affiliated Hospital, Sun Yat-Sen University

  STUDY DIRECTOR

Central Study Contacts

Bo Wei, M.D

CONTACT

(86)20-85252228; sanpi2013@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 13, 2019
• First Posted: July 17, 2019
• Study Start: September 1, 2019
• Primary Completion: May 1, 2022
• Study Completion: September 1, 2022
• Last Updated: July 17, 2019

Record last verified: 2019-07

Locations

CN (1)