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

NCT03487640 | Completed DMC

• 1 other identifier: LarTARP
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Constipation by Outlet Obstruction

Keywords

constipation, surgery

Outcome Measures

Primary Outcomes (2)

• Wexner constipation score

  The Wexner constipation score should be filled out

  2019.1-2019.12

• patients' satisfaction rate

  The researcher will statistic the satisfaction rate of the patients

  2019.1-2019.12

Secondary Outcomes (3)

• short period complications

  2018.1-2019.12

• operative time

  2018.1-2019.12

• quality of life

  2019.1-2019.12

Study Arms (2)

Transanal rectal mucosa resection

TARMR: Transanal resection of rectal mucosa for at least 5cm in length.

Procedure: TARMR

Laparoscopic rectal suspension and colectomy

LARSC: We are going to suspend the rectum and to resect rigmarole hidgut Laparoscopically

Procedure: LARSC

Interventions

TARMR PROCEDURE

Transanal resection of rectal mucosa for at least 5cm in length.

Transanal rectal mucosa resection

LARSC PROCEDURE

We are going to suspend the rectum and to resect rigmarole hidgut Laparoscopically

Laparoscopic rectal suspension and colectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Meet for Rome IV criteria for constipation.

You may qualify if:

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

You may not qualify if:

• Severe heart or other organ disease.
• test.

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

Weidong Tong

Yuzhong, Chongqing Municipality, 400042, China

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yong Yang, Dr.

  Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Third Military Medical University

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: April 4, 2018
• Study Start: January 8, 2018
• Primary Completion: January 8, 2021
• Study Completion: December 31, 2021
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)