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

• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02164136
• Collaborator: (none)
• Enrollment: 172
• Location: 1
• Arms: 2
• Duration (Months): 108
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Rectum Neoplasms	Procedure: L-PANP-TME; Procedure: O-PANP-TME	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 172 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparisons of Urinary and Sexual Function Protection and Long-term Outcomes Between Laparoscopy-assisted and Open Pelvic Autonomic Nerve Preservation Total Mesorectum Excision for Male Mid-low Rectal Cancer Patients: a Randomized Controlled Clinical Trial
• Study Start Date: Jun 1, 2014
• Anticipated Primary Completion Date: Jun 1, 2019
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 3-year disease free survival rate [36 months]

2. Urinary function [30 days]

   Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function

3. Sexual function [30 days]

   IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function

4. 5-year disease free survival rate [60 months]

5. Urinary function [36 months]

   Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function

6. Sexual function [36 months]

   IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function

Secondary Outcome Measures

1. Morbidity [30 days]

2. 3-year overall survival rate [36 months]

3. 3-year recurrence pattern [36 months]

4. Mortality [30 days]

5. Morbidity [36 months]

6. Mortality [36 months]

7. 5-year overall survival rate [60 months]

8. 5-year recurrence pattern [60 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong	China	510630

Sponsors and Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hongbo Wei, Chief of surgery, Third Affiliated Hospital, Sun Yat-Sen University
• ClinicalTrials.gov Identifier: NCT02164136
• Other Study ID Numbers: CUSTOMER-01
• First Posted: Jun 16, 2014
• Last Update Posted: Apr 26, 2018
• Last Verified: Apr 1, 2018

• Additional relevant MeSH terms: Rectal Neoplasms

Study Results

No Results Posted as of Apr 26, 2018