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

Rectal Cancer Clinical Trial

— PMCRBDSPS  

Official title:

A Prospective, Randomization and Clinic Cohort Observational Study From Multi Institutions on Bowel Dysfunction Following Surgery for Rectal Cancers With Sphincter Preservation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03009747
• Other study ID #: BaS-1611
• Status: Not yet recruiting
• Phase: N/A
• First received: January 2, 2017
• Last updated: January 2, 2017
• Start date: January 2017
• Est. completion date: December 2019

Study information

• Verified date: January 2017
• Source: Peking University People's Hospital
• Contact: Fan Liu, M.D.
• Phone: +86-188-1159-0087
• Email: liufan_md[@]126.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology CommissionChina: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 460
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years

2. Adenocarcinoma confirmed by pathology

3. Distance from the lowest margin of tumor to the anal verge is = 12cm, confirmed by hard sigmoidoscope.

4. The tumor is estimated to be resectable and confirmed by multidisciplinary team (MDT).

5. The operation is estimated to be sphincter-preserving.

6. The Eastern Cooperative Oncology Group(ECOG) performance status score of patient is = 2.

7. The estimated life time is not less than one year.

8. The patient agree to sign the informed consent.

Exclusion Criteria:

1. The patient refuse to follow research plan.

2. Emergency case

3. Pregnant and lactating female patient

4. The patient did not accept radical resection.

5. The patient did not accept first stage resection and anastomosis.

6. The patient has experienced anal-rectal surgery.

7. The patient has experienced left colon surgery.

8. The patient suffered long-existing bowel dysfunction before rectal cancer diagnosis.

9. The patient was diagnosed with cognitive or communicative obstacles.

10. The patient was diagnosed with serious repeated infection or other concomitance diseases.

11. The patient has participated other medical research which may affect his/her bowel function.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bowel Dysfunction
• Gastrointestinal Diseases
• Intestinal Diseases
• Rectal Cancer
• Rectal Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (14)

Lead Sponsor

Collaborator

Peking University People's Hospital

Beijing Cancer Hospital, Beijing Friendship Hospital, Changshu NO.1 People's Hospital, China-Japan Friendship Hospital, First Hospital of Jilin University, Guangdong Provincial Hospital of Traditional Chinese Medicine, Hebei Medical University Fourth Hospital, Peking University International Hospital, Qilu Hospital of Shandong university in Qingdao, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences, The First Affiliated Hospital of Anhui Medical University, the first affiliated hospital of Jiamusi university, Xiangya Hospital of Central South University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of bowel dysfunction after sphincter-preserving surgery		one year	Yes
Primary	Risk factors of bowel dysfunction after sphincter-preserving surgery		one year	Yes
Secondary	Incidence of each symptoms of bowel dysfunction		one year	Yes
Secondary	Prognosis of bowel dysfunction after sphincter-preserving surgery		one year	Yes
Secondary	Incidence of bowel dysfunction after sphincter-preserving surgery	comparing incidences between high and low anastomsis site	one year	Yes