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Recruiting NCT05943444

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

No phase Interventional Rectal Neoplasms Low Anterior Resection Syndrome Anastomotic Leak Quality of Life

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Parks technique, Bacon technique.
Who it may be relevant to
Registry conditions: Rectal Neoplasms, Low Anterior Resection Syndrome, Anastomotic Leak, Quality of Life. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

objective: 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.

primary outcome: Low Anterior Resection Syndrome (LARS) score 1 year after surgery secondary outcomes: 1. LARS score at 3 months after surgery 2. LARS score at 6 months after surgery 3. Postoperative Quality of Life Score 4. The incidence of postoperative anastomotic complications

Interventions

  • Procedure Parks technique
    compare different operational styles of low rectal cancer
  • Procedure Bacon technique
    Bacon technique

Primary outcome measures

  • Low Anterior Resection Syndrome (LARS) score 1 year after surgery [Time frame: 1 year after surgery]
Secondary outcome measures (4)
  • LARS score at 3 months after surgery [Time frame: 3 months after surgery]
  • LARS score at 6 months after surgery [Time frame: 6 months after surgery]
  • Postoperative Quality of Life Score [Time frame: 3, 6, and 12 months after operation]
  • The incidence of postoperative anastomotic complications [Time frame: 3, 6, and 12 months after operation]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • Previous history of malignant colorectal tumors;
  • Complications such as obstruction and gastrointestinal bleeding that need an emergency operation;
  • Unachievable R0 resection due to invasion of adjacent organs by primary tumor;
  • Multiple primary tumors;
  • History of other malignancy;
  • Participation in other clinical trials within the previous 4 weeks of enrollment;
  • ASA physical status score ≥ IV level and/or ECOG performance status ≥ 2;
  • Intolerance of surgery due to liver, renal, cardiopulmonary or coagulation dysfunction, or underlying diseases;
  • History of serious mental disorders;
  • Women in pregnancy or lactation period;
  • Uncontrolled infection before operation;
  • Unsuitable to be included due to other clinical and laboratory conditions by the judgement of investigators.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

China · 1 center
  • The Sixth Affiliated Hospital, Sun Yatsen University — Guangzhou

Identifiers

NCT: NCT05943444 · E2023072

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗