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NCT05943444Recruiting

Comparison of Postoperative Anal Function Between Parks and Bacon Techniques in Low Rectal Cancer

Comparison of Postoperative Anal Function Between Different Anastomosis Techniques(Parks Versus Bacon) in Low Rectal Cancer: A Prospective, Multicentric and Randomized Controlled Study

Source: ClinicalTrials.gov · Last updated 18 Dec 2025

Brief summary (registry, in English)

The goal of this study is to compare the postoperative anal function of patients with ultra-low rectal cancer after Parks operation (colon anal anastomosis) and Bacon operation (colon anal pull-out anastomosis), which may provide clinical evidence for the improvement of anal function and quality of life. The main questions it aims to answer are: the difference of anal function 1 year after surgery type of study: clinical trial participant population: patients with low rectal cancer Participants will receive Parks operation of Bacon operation If there is a comparison group: Researchers will compare Parks and Bacon operation to see if the anal function 1 year after surgery is different.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
256 (estimated)
First submitted
28 Jun 2023
Start date
8 Aug 2023
Primary completion date
8 Aug 2027
Lead sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
NCT number
NCT05943444

What you commit to

  • Study type: Interventional
  • Planned participants: 256
  • From 8 Aug 2023 to the primary completion date, 8 Aug 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Unachievable R0 resection due to invasion of adjacent organs by primary tumor;
  • Participation in other clinical trials within the previous 4 weeks of enrollment;

Other illness

  • Previous history of malignant colorectal tumors;
  • Complications such as obstruction and gastrointestinal bleeding that need an emergency operation;
  • History of other malignancy;
  • Intolerance of surgery due to liver, renal, cardiopulmonary or coagulation dysfunction, or underlying diseases;
  • History of serious mental disorders;
  • Uncontrolled infection before operation;

Lab values

  • Unsuitable to be included due to other clinical and laboratory conditions by the judgement of investigators.

Other

  • Multiple primary tumors;
  • ASA physical status score ≥ IV level and/or ECOG performance status ≥ 2;
  • Women in pregnancy or lactation period;

Who the study is looking for

  • Men or women, aged between 18 and 75 years;
  • Pathological diagnosis of rectal cancer before operation, with the distance from the lower edge of the tumor to the dentate line ≤ 3cm by MR imaging;
  • No local complications (including complete/ incomplete obstruction, active bleeding, local invasion of sphincter or levator ani, etc.) before operation;
  • Suitable for anal preservation surgery discussed by MDT;
  • Adequate bone marrow, liver, renal and cardiac function meeting the requirements of surgery and anesthesia;
  • R0 resection is expected technically;
  • Provision of written informed consent.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Sixth Affiliated Hospital, Sun Yatsen University
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.