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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSixth Affiliated Hospital, Sun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Parks technique

    Procedure/Surgery

    compare different operational styles of low rectal cancer

  • Bacon technique

    Procedure/Surgery

    Bacon technique

Treatment groups

256 Participants
are divided into 2 treatment groups
Group A: Parks techniqueActive comparator 1 intervention
Group B: Bacon techniqueExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Low Anterior Resection Syndrome (LARS) score 1 year after surgery

use a scoring system for bowel dysfunction after LAR for rectal cancer on the basis of symptoms and impact on quality of life

Time frame
1 year after surgery

Secondary outcomes

1

LARS score at 3 months after surgery

to score bowel dysfunction after LAR

Time frame
3 months after surgery
2

LARS score at 6 months after surgery

to score bowel dysfunction after LAR

Time frame
6 months after surgery
3

Postoperative Quality of Life Score

using a score system to access the quality of life after surgery

Time frame
3, 6, and 12 months after operation
4

The incidence of postoperative anastomotic complications

the corresponding complications after surgery

Time frame
3, 6, and 12 months after operation

Other outcomes

Sponsors and contacts

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