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

Constipation by Outlet Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03487640
• Other study ID #: LarTARP
• Status: Completed
• Start date: January 8, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2022
• Source: Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 31, 2021
• Est. primary completion date: January 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Constipation by Outlet Obstruction
• Prolapse
• Rectal Prolapse

Intervention

Procedure:
• TARMR
Transanal resection of rectal mucosa for at least 5cm in length.
• LARSC
We are going to suspend the rectum and to resect rigmarole hidgut Laparoscopically

Locations

Country	Name	City	State
China	Weidong Tong	Yuzhong	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wexner constipation score	The Wexner constipation score should be filled out	2019.1-2019.12
Primary	patients' satisfaction rate	The researcher will statistic the satisfaction rate of the patients	2019.1-2019.12
Secondary	short period complications	postoperative 30-day complications	2018.1-2019.12
Secondary	operative time	the total operative time	2018.1-2019.12
Secondary	quality of life	SF-36 form	2019.1-2019.12