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Search / Trial NCT04481659

Completely Abdominal Approach Laparoscopic Partial Intersphincteric Resection for Rectal Cancer

Launched by ZHONGNAN HOSPITAL · Jul 19, 2020

Trial Information

Current as of June 03, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring a new surgical approach for treating low rectal cancer, specifically looking at a technique called laparoscopic partial intersphincteric resection (ISR). This method is performed completely through the abdomen, making it simpler and potentially safer than the traditional approach, which requires incisions in both the abdomen and the perineum (the area between the anus and the genitals). The trial aims to compare the outcomes of patients who have received a combination of chemotherapy and radiation (neoadjuvant chemoradiotherapy) before surgery versus those who have surgery without this treatment. Researchers will assess how well patients recover in terms of their bowel and sexual function, as well as their overall quality of life after the procedure.

To participate in this trial, patients must have a confirmed diagnosis of a specific type of rectal cancer and meet certain health criteria. This includes being in a stage where the cancer is manageable for surgery. However, individuals who have serious health issues, significant bowel control problems, or who cannot undergo laparoscopic surgery will not be eligible. If you qualify and choose to participate, you can expect to receive detailed information about the procedure and what it involves, as well as ongoing support from the medical team throughout your treatment.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Biopsy-proven moderate or well differentiated adenocarcinoma
  • Rullier classification of low rectal cancer (types Ⅱ: juxta-anal tumor)
  • Clinical staging: initially staged as T1 -2 or down staged to T1-2 after neoadjuvant chemoradiotherapy;
  • Exclusion Criteria:
  • Without signing informed consent, poor compliance
  • Unfit for laparoscopy
  • Other serious diseases not suitable for participating in this clinical trial
  • A degree of preoperative fecal incontinence
  • After preoperative neoadjuvant chemoradiotherapy, the sphincter function, sexual function and others involved in this trail are seriously affected

About Zhongnan Hospital

Zhongnan Hospital, affiliated with Wuhan University, is a leading medical institution in China renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a focus on multidisciplinary collaboration, the hospital employs state-of-the-art facilities and a team of highly skilled professionals to conduct rigorous clinical studies aimed at improving patient outcomes. Zhongnan Hospital prioritizes ethical standards and patient safety, ensuring adherence to regulatory requirements while fostering a culture of scientific excellence. As a prominent sponsor of clinical trials, the hospital plays a pivotal role in contributing to the global medical community and enhancing the understanding of various health conditions.

Locations

Wuhan, Hubei, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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