Intersphincteric space dissection approaches related to oncological and functional results after intersphincteric resection for patients with ultra-low rectal cancer: a single-center, prospective cohort study

Development of a model for optimal approach-selection for intersphincteric space dissection in intersphincteric resection procedure for ultra-low rectal cancer

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2000036819

Enrollment

Unknown

Registered

2020-08-25

Start date

2020-10-01

Completion date

Unknown

Last updated

2020-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rectal cancer

Interventions

Case series:using machine-learning algorithms to develop a model for optimal approach-selection for intersphincteric space dissection

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years; 2. Primary rectal adenocarcinoma; highly or moderately differentiated. 3. Preoperative imaging: Lower margin of the tumor is above the anorectal ring but less than 1 cm. (1) Preoperative staging T3 or less, CRF-; (2) Patients meet the needs of (1) after neo-adjuvant therapy; Lower margin of the tumor is below the anorectal ring: (1) Preoperative staging T1-2; (2) Downstaging to T1-2 after neoadjuvant therapy; 4. Underwent ISR procedure (including total, sub-total and partial ISR); 5. Understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. History of colon or rectum segmental resection/radical resection; 2. Complicated with other malignancies; 3. patients with cognitive or communication disorder, or serious psychiatric comorbidity; 4. Severe systemic disease, including cardiac function class >=II, respiratory failure, renal and hepatic failure, severe hematologic disorders; 5. Severe uncontrolled infections, or other uncontrolled concomitant diseases; 6. Patients enrolled in other clinical studies with interventions that may affect postoperative functional assessment; 7. Inadequate cooperation in follow-up visits; 8. Data missing resulting in unanalyzable state.

Design outcomes

Primary

Measure	Time frame
Anal resting pressure;Max anal squeezing pressure;Length of anal canal high pressure zone;Rectoanal Inhibitory Reflex;Anorectal pressure gradient;Anal function scoring;Quality of life;	—

Secondary

Measure	Time frame
Postoperative morbidity rate;3-year overall survival;3-year disease-free survival;	—

Countries

China

Contacts

Public ContactYiming Zhou

Huashan Hospital, Fudan University

iron_zhou@hotmail.com+86 13817374958

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026