A Prospective Randomized Controlled Study of Natural Orifice Medium-low Rectal Endometriosis Resection

Colon Rectal Resection Clinical Trial

Official title:

A Prospective Randomized Controlled Study of Natural Orifice Medium-low Rectal Endometriosis Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01911962
• Other study ID #: nova-0425
• Status: Completed
• Phase: N/A
• First received: July 23, 2013
• Last updated: July 27, 2013
• Start date: January 2011
• Est. completion date: June 2012

Study information

• Verified date: July 2013
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Observational

Clinical Trial Summary

To evaluate the postoperative outcome of low medium-low rectal endometriosis: Natural orifice surgery VS transabdominal surgery.

Description:

To evaluate the postoperative outcome of low medium-low rectal endometriosis: Natural orifice surgery VS transabdominal surgery.Both of the two kinds of surgery is conventional,but the comparison is still unclear.The investigators divide the patients into two groups, and compare the differences of postoperative outcomes by statistics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: June 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

Childbearing age women,

older than 18 years,

diagnosed with intestinal endometriosis,

rectum clinical symptoms for invalid medical treatment,

dysmenorrhea, dyspareunia dyschezia, infertility, defecate carries blood,

endometriosis in the lower rectum by intraoperative judgment

Exclusion Criteria:

without endometriosis rectum,

history of colorectal surgery,

intolerance to laparoscopic surgery

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colon Rectal Resection
• Endometriosis

Intervention

Procedure:
• transvaginal laparoscopic surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	dyspareunia	number of patients	one year	Yes
Primary	rectovaginal fistula	number of participants	one year	Yes
Secondary	postoperative constipation	number of patients	one year	Yes
Secondary	postoperative uroschesis	number of patients	one year	Yes
Secondary	intestinal obstruction	number of patients	one year	Yes
Secondary	surgical wound infection	number of patients	one year	Yes