Resection Location of Rectum in Laparoscopic Surgery for Slow Transit Constipation

NCT ID: NCT04525248

Last Updated: 2020-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2024-08-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Slow Transit Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High resection

Laparoscopic total colectomy + High resection of rectum

Group Type ACTIVE_COMPARATOR

Laparoscopic total colectomy + High resection of rectum

Intervention Type PROCEDURE

Laparoscopic total colectomy + High resection of rectum

Low resection

Laparoscopic total colectomy + Low resection of rectum

Group Type EXPERIMENTAL

Laparoscopic total colectomy + low resection of rectum

Intervention Type PROCEDURE

Laparoscopic total colectomy + low resection of rectum

Interventions

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Laparoscopic total colectomy + low resection of rectum

Laparoscopic total colectomy + low resection of rectum

Intervention Type PROCEDURE

Laparoscopic total colectomy + High resection of rectum

Laparoscopic total colectomy + High resection of rectum

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Minimally Invasive Surgery Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Minhua Zheng

Role: STUDY_CHAIR

Shanghai MISC

Central Contacts

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Junjun Ma, Dr

Role: CONTACT

+86 13917283686

Xuan Zhao, Dr

Role: CONTACT

+86 15900826056

Other Identifiers

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MISC-Constipation-Rectum

Identifier Type: -

Identifier Source: org_study_id

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