Multicenter Study on Laparoscopic Versus Open PANP-TME for Male Mid-low Rectal Cancer Patients

Rectum Neoplasms Clinical Trial

Official title:

Multicenter Study on Outcomes and Protection of Urinary and Sexual Function of Laparoscopic Versus Open PANP-TME for Male Mid-low Rectal Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02165800
• Other study ID #: CUSTOMER-001
• Status: Recruiting
• Phase: N/A
• First received: June 10, 2014
• Last updated: April 24, 2018
• Start date: January 2014
• Est. completion date: December 2023

Study information

• Verified date: April 2018
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Hongbo Wei, M.D,Ph.D.
• Phone: +86-189-2210-2969
• Email: drweihb[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

TME (Total mesorectum excision) is the golden standard of radical resection for mid-low rectal cancer. However, the damage of pelvic autonomic nerve following with TME principle will lead to high incidence of urinary and sexual function disorder. Open PANP (pelvic autonomic nerve preservation) TME surgery played a role in decreasing incidence of urinary and sexual function disorder. However, 32%-44% patients still suffered from urinary and sexual function disorder when underwent Open PANP TME surgery (O-PANP-TME).

Laparoscopy-assisted TME surgery (L-TME) is applied wildly nowadays. In the early stage of work, we performed laparoscopy-assisted PANP TME surgery (L-PANP-TME) to discuss the protection of urinary and sexual function of male mid-low rectal cancer patients. The results showed that L-PANP-TME significantly decreased incidence of urinary and sexual function disorder. In order to further confirm our early work, we design a multiple-center randomized controlled clinical trial to compare differences in urinary and sexual function protection and long-term outcomes between L-PANP-TME and O-PANP-TME.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 667
• Est. completion date: December 2023
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age from over 20 to under 60 years

• Primary rectal adenocarcinoma confirmed pathologically by endoscopic biopsy

• Mid-low rectal cancer (distance from anal edge=12cm); cT1-3, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition

• Expected curative resection through both L-PANP-TME and O-PANP-TME; Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale

• ASA (American Society of Anesthesiology) score class I, II, or III; Written informed consent

• Urinary and sexual function normal preoperatively

Exclusion Criteria:

• Women during pregnancy or breast-feeding

• Severe mental disorder

• History of previous pelvic surgery

• Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging

• History of other malignant disease within past five years

• History of unstable angina or myocardial infarction within past six months

• History of cerebrovascular accident within past six months

• History of continuous systematic administration of corticosteroids within one month

• Contraindication of heart, brain, lung, etc dysfunction

• Requirement of simultaneous surgery for other disease

• Emergency surgery due to complication (bleeding, obstruction or perforation) caused by rectal cancer

• Rectal cancer invades surrounding tissues

• Existence of genuine incontinence or severe stress incontinence preoperatively

Related Conditions & MeSH terms

• Rectal Neoplasms
• Rectum Neoplasms

Intervention

Procedure:
• L-PANP-TME

• O-PANP-TME

Locations

Country	Name	City	State
China	The Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (5)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University	First Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital of Southern Medical University, Sixth Affiliated Hospital, Sun Yat-sen University, Southern Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year disease free survival rate		36 months
Primary	Urinary function	Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function	30 days
Primary	Sexual function	IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function	30 days
Primary	5-year disease free survival rate		60 months
Primary	Urinary function	Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function	36 months
Primary	Sexual function	IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function	36 months
Secondary	Morbidity		30 days
Secondary	3-year overall survival rate		36 months
Secondary	Mortality		30 days
Secondary	Morbidity		36 months
Secondary	Mortality		36 months
Secondary	5-year overall survival rate		60 months