AzTrials
AzTrials

Rectal CancerNCT05049317

Multicenter Study on Postoperative Urinary and Sexual Function During Laparoscopic Functional Total Mesorectum Excision

A study testing Laparoscopic FTME surgery in people with Rectal Cancer, run by Renmin Hospital of Wuhan University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Urinary and sexual dysfunctions are among the most common complications in rectal cancer surgery. The aim of this study was to investigate the protective effect of laparoscopic functional total mesorectum excision (FTME) on urinary and sexual function in male patients with mid-low rectal cancer. Read more about this study

Who is it for?
Ages 18 to 70 years, men only
Conditions the study is for
Rectal Cancer
What is being tested?
Laparoscopic FTME surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteChina
Study dates
24 Nov 2021to 24 Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male, 18-70 years of age, informed consent;
  • Tumors from anal edge 6 ~ 12 cm (measured by rigid proctoscope);
  • Rectal cancer confirmed pathologically by endoscopic biopsy;
  • Preoperative cT1-3aN0M0 stage (ESMO, 2013);
  • Ro resection is expected;
  • Normal urinary function, normal erection function and ejaculation function grading as I level;

Who cannot join

  • History of abdominal and pelvic major surgery;
  • Emergency surgery is needed due to the complication (bleeding, obstruction, or perforation) caused by rectal cancer;
  • Pelvic or distant metastasis;
  • Neoadjuvant radiotherapy or chemoradiotherapy;
  • No sexual life;

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yongbin Zheng, M.D,Ph.D contact

13871189698

yongbinzheng@whu.edu.cn

China1 site, 1 recruiting

  • Yongbin Zheng

    Wuhan, Hubei, 436513

    Yongbin Zheng, M.D,Ph.D, 07133141796, yongbinzheng@whu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Multicenter Clinical Study of Preservative Effect on Postoperative Urinary and Sexual Function During Laparoscopic Functional Total Mesorectum Excision for Male Rectal Cancer Patients

Urinary and sexual dysfunctions are among the most common complications in rectal cancer surgery. The aim of this study was to investigate the protective effect of laparoscopic functional total mesorectum excision (FTME) on urinary and sexual function in male patients with mid-low rectal cancer. This is a prospective, single-arm, multicenter, uncontrolled, clinical study in 88 eligible subjects with mid-low rectal cancer. After informed consent, eligible patients will be performed laparoscopic FTME surgery. Patients' demographic, operative detail, postoperative outcomes and follow-up will be recorded prospectively.

Read the detailed description

Previously, our studies have demonstrated the presence of nerve plane in laparoscopic rectal cancer surgery, which was the overlying tiny membranous tissue including the nerves, the adipose tissue, and the extremely tiny capillaries around the nerve. As a consequence, the concept of nerve plane-oriented functional total mesorectal excision (FTME) was proposed as an optimal surgical procedure about pelvic autonomic nerve preservation in rectal cancer surgery. Following the TME principles, the surgical procedure of FTME was guided by the nerve plane and dissected between the proper fascia of the rectum and nerve plane (the first gap), which could ensure completeness of the nerve plane and the proper fascia of the rectum. This surgical procedure not only ensures radical resection but also protects PAN better, and the investigators also showed the difference between routine TME and FTME in our previous study, which included inferior mesenteric plexus preservation, station 253 nodes dissection, existence of the first gap, Waldeyer's fascia and Denonvillier's fascia (DVF) preservation, neurovascular bundles preservation, and completeness of mesorectum and nerve plane. Currently, it was a lack of higher-level evidence-based evidence to confirm the protective effect of laparoscopic FTME on urinary and sexual function in male patients with mid-low rectal cancer. In the present study, the investigators performed the prospective, single-arm, multicenter, uncontrolled clinical study, eligible patients will be performed laparoscopic FTME surgery. Postoperative sexual function, urinary function, complications, quality of life, recurrence rate, recurrence patterns, disease-free survival, and overall survival will be recorded prospectively. The results of the patients will be assessed to validate postoperative functional outcomes and oncologic outcomes of laparoscopic FTME surgery.

Conditions
Rectal Cancer
Being tested
Laparoscopic FTME surgery
Keywords
Rectal Cancer, Nerve plane, Sexual dysfunction, Urinary dysfunction, Total mesorectal excision
Medical subject headings
Rectal Neoplasms, Sexual Dysfunction, Physiological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic FTME surgeryProcedure or surgery

    Nerve plane was defined as the overlying tiny membranous tissue including the nerves, the adipose tissue and the extremely tiny capillaries around the nerve. Following the TME principles, the surgical procedure of FTME was guided by the nerve plane and dissected between the proper fascia of the rectum and nerve plane (the first gap), which could ensure completeness of the nerve plane and the proper fascia of the rectum.

Study groups in NCT05049317
Study groupRoleWhat they receive
FTME groupExperimentalParticipants will undergo laparoscopic FTME surgery.
Receives: Procedure: Laparoscopic FTME surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of sexual dysfunction

    The 5-item version of the International Index of Erectile Function (IIEF-5) and ejaculation function are used to assess sexual function. the IIEF-5 total score ranged from 1 to 25, with a lower score indicating more severe erectile dysfunction, male sexual dysfunction was defined as the IIEF-5 score ≤11points. Ejaculation function was classified as: Grade I, normal ejaculation; Grade II: retrograde ejaculation; Grade III: anejaculation, and ejaculation dysfunction was identified as ejaculation function of grade II/III.

    Measured: 6 months

  2. Incidence of urinary dysfunction

    The International Prostate Symptom Score (IPSS) are used to assess urinary function. the IIEF-5 total score ranged from 0 to 35, with a higher score indicating more severe erectile dysfunction,moderate-to-severe urinary dysfunction was defined as the IPSS score >8 points.

    Measured: 3 months

Secondary outcomes (8)

  1. Morbidity

    incidence of postoperatvie complications

    Measured: 30 days

  2. Mortality

    incidence of postoperatvie deaths

    Measured: 30 days

  3. 3-year overall survival rate

    3-year overall survival rate

    Measured: 36 months

  4. 3-year disease free survival rate

    3-year disease free survival rate

    Measured: 36 months

  5. 5-year overall survival rate

    5-year overall survival rate

    Measured: 60 months

  6. 5-year disease free survival rate

    5-year disease free survival rate

    Measured: 60 months

  7. Incidence of sexual dysfunction

    The 5-item version of the International Index of Erectile Function (IIEF-5) and ejaculation function are used to assess sexual function. the IIEF-5 total score ranged from 1 to 25, with a lower score indicating more severe erectile dysfunction, male sexual dysfunction was defined as the IIEF-5 score ≤11points. Ejaculation function was classified as: Grade I, normal ejaculation; Grade II: retrograde ejaculation; Grade III: anejaculation, and ejaculation dysfunction was identified as ejaculation function of grade II/III.

    Measured: 12 months

  8. Incidence of urinary dysfunction

    The International Prostate Symptom Score (IPSS) are used to assess urinary function. the IIEF-5 total score ranged from 0 to 35, with a higher score indicating more severe erectile dysfunction,moderate-to-severe urinary dysfunction was defined as the IPSS score >8 points.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2021
  2. Study start24 Nov 2021 (estimated)
  3. Primary completion24 Sep 2022 (estimated)
  4. Study completion24 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05049317
Sponsor's protocol ID
zhengyongbin01
Status last verified
Sep 2021
First submitted
10 Sep 2021
Last updated
1 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li K, He X, Tong S, Zheng Y. Nerve plane: An optimal surgical plane for laparoscopic rectal cancer surgery? Med Hypotheses. 2021 Sep;154:110657. doi: 10.1016/j.mehy.2021.110657. Epub 2021 Aug 5.

    PubMed 34388537

  • Li K, He X, Zheng Y. An Optimal Surgical Plane for Laparoscopic Functional Total Mesorectal Excision in Rectal Cancer. J Gastrointest Surg. 2021 Oct;25(10):2726-2727. doi: 10.1007/s11605-021-05035-9. Epub 2021 Jun 9.

    PubMed 34109532

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic FTME surgery in people with Rectal Cancer, run by Renmin Hospital of Wuhan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yongbin Zheng, M.D,Ph.D (13871189698, yongbinzheng@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of sexual dysfunction (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05049317, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021; AzTrials last refreshed its copy on 28 Oct 2026.

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