Effects of Modified Precision Functional Sphincter-Preserving Surgery (PPS) on Ultralow Rectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2026-05-01

Brief Summary

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RATIONALE: Colorectal cancer is one of the most common cancers. However, approaches to minimize surgical trauma, preserve anal function, avoid abdominal stoma, and improve quality of life for patients with ultralow rectal cancers were limited. Thus, new technologies are urgently needed to improve the anal preservation rate, reduce the incidence of anastomotic leakage and improve postoperative anal function in patients with ultralow rectal cancer.

PURPOSE: This one-arm multicenter prospective cohort study aims to collect the data of patients with ultralow rectal cancer who undergo sphincter-preserving surgeries, including modified PPS and conventional surgeries, then compare the effects of different operations on clinical outcomes and to see the efficacy and safety of modified PPS surgery when compared with conventional procedures in the treatment of ultralow rectal cancer.

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Detailed Description

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Conditions

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Rectum Cancer Stoma Colostomy Faecal Incontinence Leakage, Anastomotic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PPS surgery

Patients who undergo modified PPS surgery in order to preserve anal sphincter function under the premise of radical resection of ultralow rectal cancer.

No interventions assigned to this group

Conventional

Patients who undergo conventional sphincter-preserving surgeries.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Histological proof of newly diagnosed primary adenocarcinoma of the rectum
2. The lower edge of tumor \< 3 cm from the dentate line
3. Clinical T stage ≤ T3

Exclusion Criteria

1. The lower edge of tumor \< 1 cm from the dentate line
2. Locally advanced stage of tumor
3. Presence of metastatic disease or recurrent rectal tumor
4. Concomitant malignancies
5. Concurrent uncontrolled medical conditions
6. Impaired anal function before surgery
7. Presence of acute bowel obstruction or bowel perforation caused by cancer
8. Pregnancy or breast feeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No