A Prospective Multi-Center Research on Bowel Dysfunction After Sphincter Preservative Surgery

NCT03009747 | Unknown DMC

• 1 other identifier: BaS-1611
• Study Type: observational
• Target: 460
• Locations: 0 countries
• Sites: N/A

Brief Summary

This research plans to collect rectal cancer patients after sphincter-preserving surgery from 14 institutions in China mainland, observe the incidence and risk factors about bowel dysfunction after operation.

Conditions

Bowel Dysfunction; Rectal Cancer

Keywords

rectal cancer; anterior resection syndrome; sphincter-preserving surgery

Outcome Measures

Primary Outcomes (2)

• Incidence of bowel dysfunction after sphincter-preserving surgery

  one year

• Risk factors of bowel dysfunction after sphincter-preserving surgery

  one year

Secondary Outcomes (3)

• Incidence of each symptoms of bowel dysfunction

  one year

• Prognosis of bowel dysfunction after sphincter-preserving surgery

  one year

• Incidence of bowel dysfunction after sphincter-preserving surgery

  one year

Study Arms (1)

sphincter-preserving surgery

Patients meet the inclusion criteria will be enrolled into this observing group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Rectal cancer patients who accept sphincter-preserving surgery

You may qualify if:

• Age ≥ 18 years
• Adenocarcinoma confirmed by pathology
• Distance from the lowest margin of tumor to the anal verge is ≤ 12cm, confirmed by hard sigmoidoscope.
• The tumor is estimated to be resectable and confirmed by multidisciplinary team (MDT).
• The operation is estimated to be sphincter-preserving.
• The Eastern Cooperative Oncology Group(ECOG) performance status score of patient is ≤ 2.
• The estimated life time is not less than one year.
• The patient agree to sign the informed consent.

You may not qualify if:

• The patient refuse to follow research plan.
• Emergency case
• Pregnant and lactating female patient
• The patient did not accept radical resection.
• The patient did not accept first stage resection and anastomosis.
• The patient has experienced anal-rectal surgery.
• The patient has experienced left colon surgery.
• The patient suffered long-existing bowel dysfunction before rectal cancer diagnosis.
• The patient was diagnosed with cognitive or communicative obstacles.
• The patient was diagnosed with serious repeated infection or other concomitance diseases.
• The patient has participated other medical research which may affect his/her bowel function.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• The First People's Hospital of Changzhou: collaborator
• Peking University Cancer Hospital & Institute: collaborator
• Beijing Friendship Hospital: collaborator
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator
• Hebei Medical University Fourth Hospital: collaborator
• First Affiliated Hospital of Jiamusi University: collaborator
• China-Japan Friendship Hospital: collaborator
• The First Hospital of Jilin University: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• The Affiliated Hospital of the Chinese Academy of Military Medical Sciences: collaborator
• Xiangya Hospital of Central South University: collaborator
• Qilu Hospital of Shandong University (Qingdao): collaborator
• Peking University International Hospital: collaborator

Related Publications (1)

• Liu F, Guo P, Su X, Cui M, Jiang J, Wang S, Yu Z, Zhou R, Ye Y. A Novel Remote Follow-Up Tool Based on an Instant Messaging/Social Media App for the Management of Patients With Low Anterior Resection Syndrome: Pilot Prospective Self-Control Study. JMIR Mhealth Uhealth. 2021 Mar 19;9(3):e22647. doi: 10.2196/22647.

  PMID: 33739295 DERIVED

MeSH Terms

Conditions

Intestinal Diseases; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Rectal Diseases

Study Officials

• Yingjiang Ye, M.D./ PhD

  Chinese Society of Colon and Rectal Surgeons

  STUDY CHAIR

Central Study Contacts

Fan Liu, M.D.

CONTACT

+86-188-1159-0087; liufan_md@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2017
• First Posted: January 4, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: January 4, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share