Surgical Treatment for ODS With Rectal Prolapse Surgical Treatment for Rectal Prolapse

April 17, 2022 updated by: Weidong Tong, Third Military Medical University

Laparoscopica Hindgut Resection Plus Rectum Suspention Compare With Transanal Rectal Mucosa Resection for ODS With Rectal Prolapse

Chronic obstinate constipation is hard to deal with in clinic. Especially for obstructed defecation syndrome(ODS). Rectal prolapse is the most common type of ODS. Lots of surgical procedures have been suggested for it but with unsatisfactory results.To develop new surgical treatment and to provide higher quality proof for this intractable condition is of significance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

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

Study Locations

  • China
    • Chongqing
      • Yuzhong, Chongqing, China, 400042
        • Weidong Tong

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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Meet for Rome IV criteria for constipation.

Description

Inclusion Criteria:

  • Diagnosed with ODS by defecography, coloscopy, barium enema and dynamic MRI.
  • Patients should accord with Rome IV criteria.

Exclusion Criteria:

  • Severe heart or other organ disease.
  • test.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Transanal rectal mucosa resection
TARMR: Transanal resection of rectal mucosa for at least 5cm in length.
Procedure: TARMR
Transanal resection of rectal mucosa for at least 5cm in length.
Laparoscopic rectal suspension and colectomy
LARSC: We are going to suspend the rectum and to resect rigmarole hidgut Laparoscopically
Procedure: LARSC
We are going to suspend the rectum and to resect rigmarole hidgut Laparoscopically

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wexner constipation score
Time Frame: 2019.1-2019.12
The Wexner constipation score should be filled out
2019.1-2019.12
patients' satisfaction rate
Time Frame: 2019.1-2019.12
The researcher will statistic the satisfaction rate of the patients
2019.1-2019.12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
short period complications
Time Frame: 2018.1-2019.12
postoperative 30-day complications
2018.1-2019.12
operative time
Time Frame: 2018.1-2019.12
the total operative time
2018.1-2019.12
quality of life
Time Frame: 2019.1-2019.12
SF-36 form
2019.1-2019.12

Collaborators and Investigators

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

Sponsor

Third Military Medical University

Investigators

  • Study Chair: Yong Yang, Dr., Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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 (ACTUAL)

January 8, 2018

Primary Completion (ACTUAL)

January 8, 2021

Study Completion (ACTUAL)

December 31, 2021

Study Registration Dates

First Submitted

January 29, 2018

First Submitted That Met QC Criteria

March 27, 2018

First Posted (ACTUAL)

April 4, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2022

Last Update Submitted That Met QC Criteria

April 17, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LarTARP

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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