Resection Location of Rectum in Laparoscopic Surgery for Slow Transit Constipation
High Resection vs. Low Resection of Rectum in Laparoscopic Total Colectomy for Slow Transit Constipation
1 other identifier
interventional
78
0 countries
N/A
Brief Summary
Study the recurrence rate of constipation after laparoscopic total colectomy with high resection or low resection of rectum
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2020
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2020
CompletedFirst Posted
Study publicly available on registry
August 25, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedAugust 25, 2020
August 1, 2020
2.9 years
August 18, 2020
August 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
1-year recurrence rate of constipation
1-year recurrence rate of constipation
1 year
Secondary Outcomes (2)
1-year rate of diarrhea
1 year
perioperative complications
1 year
Study Arms (2)
High resection
ACTIVE COMPARATORLaparoscopic total colectomy + High resection of rectum
Low resection
EXPERIMENTALLaparoscopic total colectomy + Low resection of rectum
Interventions
Laparoscopic total colectomy + low resection of rectum
Laparoscopic total colectomy + High resection of rectum
Eligibility Criteria
You may qualify if:
- Diagnosed as constipation according to Rome IV criteria
- Diagnosed as slow transit constipation
- With more than 2 years' drug treatment or with outlet obstruction or with surgical history
You may not qualify if:
- Colon cancer
- History of colon, rectum, anus surgery
- With severe cardio, renal, neural disease
- Pregnant patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Minhua Zheng
Shanghai MISC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2020
First Posted
August 25, 2020
Study Start
September 1, 2020
Primary Completion
August 1, 2023
Study Completion
August 1, 2024
Last Updated
August 25, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share