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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03009747
Acronym
PMCRBDSPS
Enrollment
460
Registered
2017-01-04
Start date
2017-01-31
Completion date
2019-12-31
Last updated
2017-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Dysfunction, Rectal Cancer

Keywords

rectal cancer, anterior resection syndrome, sphincter-preserving surgery

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Incidence of bowel dysfunction after sphincter-preserving surgeryone year
Risk factors of bowel dysfunction after sphincter-preserving surgeryone year

Secondary

MeasureTime frameDescription
Incidence of each symptoms of bowel dysfunctionone year
Prognosis of bowel dysfunction after sphincter-preserving surgeryone year
Incidence of bowel dysfunction after sphincter-preserving surgeryone yearcomparing incidences between high and low anastomsis site

Contacts

Primary ContactFan Liu, M.D.
liufan_md@126.com+86-188-1159-0087

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026