Clinical trial NCT05245565: Effects of Modified Precision Functional Sphincter-Preserving Surgery (PPS) on Ultralow Rectal Cancer
Official title: Effects of Modified Precision Functional Sphincter-Preserving Surgery (PPS) on Ultralow Rectal Cancer: A Multicenter Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectum Cancer
Stoma Colostomy
Faecal Incontinence
Leakage, Anastomotic
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our study population is the patients who diagnosed as low-lying rectal adenocarcinoma cases by preoperative pathology and meet the eligibility criteria.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of temporary defunctioning stoma
timeFrame: Within 30 days after operation
measure: The percentage of patients who develop anastomotic leakage
timeFrame: Within 30 days after operation
measure: Postoperative anal function assessed by Wexner scale
timeFrame: 2 years since the start of treatment
measure: Postoperative anal function assessed by Vaizey scale
timeFrame: 2 years since the start of treatment
Secondary outcomes:
measure: Rate of sphincter-preservation rates
timeFrame: Within 30 days after operation
measure: The number of short-term postoperative complications
timeFrame: Within 30 days after operation
measure: Postoperative hospital stay
timeFrame: Within 30 days after operation
measure: Hospitalization costs
timeFrame: Within 30 days after operation
measure: 30-Day Readmission Rate
timeFrame: Within 30 days after operation
measure: Disease-free survival
timeFrame: Up to 5 years after the last patient recruited
measure: Overall survival
timeFrame: Up to 5 years after the last patient recruited
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Cheng-Le Zhuang, MD, PhD
role: STUDY_CHAIR
References: