Resection Location of Rectum in Laparoscopic Surgery for Slow Transit Constipation

August 23, 2020 updated by: Shanghai Minimally Invasive Surgery Center

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: High resection
Laparoscopic total colectomy + High resection of rectum
Procedure: Laparoscopic total colectomy + High resection of rectum
Laparoscopic total colectomy + High resection of rectum
EXPERIMENTAL: Low resection
Laparoscopic total colectomy + Low resection of rectum
Procedure: Laparoscopic total colectomy + low resection of rectum
Laparoscopic total colectomy + low resection of rectum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year recurrence rate of constipation
Time Frame: 1 year
1-year recurrence rate of constipation
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year rate of diarrhea
Time Frame: 1 year
1-year rate of diarrhea
1 year
perioperative complications
Time Frame: 1 year
perioperative complications
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Minimally Invasive Surgery Center

Investigators

  • Study Chair: Minhua Zheng, Shanghai MISC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2020

Primary Completion (ANTICIPATED)

August 1, 2023

Study Completion (ANTICIPATED)

August 1, 2024

Study Registration Dates

First Submitted

August 18, 2020

First Submitted That Met QC Criteria

August 23, 2020

First Posted (ACTUAL)

August 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 25, 2020

Last Update Submitted That Met QC Criteria

August 23, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MISC-Constipation-Rectum

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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