Image

Complete Versus Partial Preservation of Denonvilliers' Fascia on Urogenital Function in Locally Advanced Rectal Cancer

Recruiting
18 - 71 years of age
Both
Phase N/A

Powered by AI

Overview

Total mesorectal resection (TME) is the standard surgical method for locally advanced rectal cancer, which significantly reduces the local recurrence rate. However, the incidence of urogenital dysfunction is higher. Studies found that Denonvilliers' Fascia contains autonomic nerves that may regulate urogenital function, while traditional TME surgery resects part of it. Recent Studies found that complete preservation of Denonvilliers' Fascia could improve urogenital in selected patients with rectal cancer. Locally advanced patient (T3-4 and/or N+, M0) accounts for a high proportion of mid-low rectal cancer. However, whether these patients can benefit from it has not fully been demonstrated. This project conducts a multi-center randomized controlled study to evaluate the effects of complete preservation and partial preservation of Denonvilliers' Fascia on postoperative urogenital function of locally advanced non-anterior mid-low rectal cancer.

Eligibility

Inclusion Criteria:

  1. Pathological diagnosis of rectal adenocarcinoma;
  2. Preoperative staging cT3-4 and or N+,M0 rectal cancer (AJCC- 7th);
  3. Non-anterior wall, mid-low rectal cancer from 0 to 12 cm from the anal verge measured by rigid proctoscope;
  4. R0 surgical results is expected by transabdominal or transanal TME/TSME;
  5. 18 < age (years) < 71, informed consent;
  6. Normal erection function (IIEF-5>21), ejaculation function grading as I level, FSFI > 26, normal urinary function (Bladder residual urine<100ml);
  7. Preoperative ASA grade I ~ III, no serious systemic disease;

Exclusion Criteria:

  1. Preoperatively confirmed peritoneum or distant metastasis;
  2. Intraoperative confirmed invasion of surrounding tissues or organs, cannot be R0 resected;
  3. With other malignant diseases;
  4. With acute ileus, perforation or hemorrhage,need emergency surgery;
  5. Critical organs dysfunction, unable to tolerate laparoscopic surgery;
  6. With severe mental illness, cannot be evaluated;

Study details

Rectal Cancer, Advanced Cancer

NCT04672603

Sixth Affiliated Hospital, Sun Yat-sen University

25 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.