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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rectum Neoplasms
• Intervention / Treatment: Procedure: O-PANP-TME; Procedure: L-PANP-TME

• Study Type: Interventional
• Enrollment (Anticipated): 667
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hongbo Wei, M.D,Ph.D.; Phone Number: +86-189-2210-2969; Email: drweihb@126.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • Recruiting
      • The Third Affiliated Hospital of Sun Yat-Sen University
      • Contact: Hongbo Wei, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: O-PANP-TME; Open pelvic autonomic nerve preservation total mesorectum excision for male mid-low rectal cancer patients	Procedure: O-PANP-TME
Experimental: L-PANP-TME; Laparoscopy-assisted pelvic autonomic nerve preservation total mesorectum excision for male mid-low rectal cancer patients	Procedure: L-PANP-TME

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year disease free survival rate		36 months
Urinary function	Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function	30 days
Sexual function	IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function	30 days
5-year disease free survival rate		60 months
Urinary function	Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function	36 months
Sexual function	IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function	36 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality	30 days
Morbidity	30 days
3-year overall survival rate	36 months
5-year overall survival rate	60 months
Morbidity	36 months
Mortality	36 months

Collaborators and Investigators

• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
• Collaborators: First Affiliated Hospital, Sun Yat-Sen University; Nanfang Hospital of Southern Medical University; Sixth Affiliated Hospital, Sun Yat-sen University; Southern Medical University, China

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: June 10, 2014
• First Submitted That Met QC Criteria: June 12, 2014
• First Posted (Estimate): June 18, 2014

Study Record Updates

• Last Update Posted (Actual): April 26, 2018
• Last Update Submitted That Met QC Criteria: April 24, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: CUSTOMER-001