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NCT04525248 Clinical Trial

Resection Location of Rectum in Laparoscopic Surgery for Slow Transit Constipation

Constipation Clinical Trial

Official title:
High Resection vs. Low Resection of Rectum in Laparoscopic Total Colectomy for Slow Transit Constipation

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04525248
Other study ID # MISC-Constipation-Rectum
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date August 1, 2024

Study information
Verified date August 2020
Source Shanghai Minimally Invasive Surgery Center
Contact Junjun Ma, Dr
Phone +86 13917283686
Email marsnew1997@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study the recurrence rate of constipation after laparoscopic total colectomy with high resection or low resection of rectum

Description:

The investigators are going to study the recurrence rate of constipation after laparoscopic total colectomy with high resection or low resection of rectum. High resection is defined as resection at 12~15cm from anus and low resection as 6~8cm.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 78
Est. completion date August 1, 2024
Est. primary completion date August 1, 2023
Accepts healthy volunteers No
Gender All
Age group 15 Years to 75 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Colon cancer

- History of colon, rectum, anus surgery

- With severe cardio, renal, neural disease

- Pregnant patients

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Laparoscopic total colectomy + low resection of rectum
Laparoscopic total colectomy + low resection of rectum
• Laparoscopic total colectomy + High resection of rectum
Laparoscopic total colectomy + High resection of rectum

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Shanghai Minimally Invasive Surgery Center

Outcome
Type Measure Description Time frame Safety issue
Primary 1-year recurrence rate of constipation 1-year recurrence rate of constipation 1 year
Secondary 1-year rate of diarrhea 1-year rate of diarrhea 1 year
Secondary perioperative complications perioperative complications 1 year
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