Application of Precision Partial Intersphincteric Resection (PPISR)

NCT07849023 | Recruiting

• 1 other identifier: KY2025-246
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to establish a standardized operating procedure for Precision Partial Intersphincteric Resection (PPISR), and to evaluate its surgical safety, functional benefits, and oncological efficacy.

Conditions

Low Rectal Cancer; Rectal Cancer Patients

Outcome Measures

Primary Outcomes (3)

• Postoperative anal function as assessed by Wexner Score

  Scale Title: Wexner Fecal Incontinence Score. The minimum values:0. The maximum values:20. Higher scores mean a worse outcome.

  At 3 and 6 months postoperatively

• Postoperative quality of life as assessed by EORTC QLQ-C30

  Scale Title: European Organization for Research and Treatment of cancer Quality of Life Questionnaire. The minimum values:0. The maximum values:100. Higher scores mean a worse outcome.

  At 1 year postoperatively

• 3-year local recurrence rate as assessed by abdominal contrast-enhanced MRI

  Participants have an MRI every 3 months postoperatively

  3 years postoperatively

Secondary Outcomes (4)

• Circumferential resection margin negative rate

  Immediately after the pathology results come out

• intraoperative blood loss

  Immediately after the surgery

• Postoperative-related complication incidence

  From the end of surgery to 3 months postoperatively

• Postoperative hospital stay duration

  From the end of surgery to discharge

Study Arms (2)

PPISR

EXPERIMENTAL

The experimental group underwent the PPISR procedure.

Procedure: Precision Partial Intersphincteric Resection (PPISR)

Traditional ISR

ACTIVE COMPARATOR

The control group underwent the traditional ISR procedure

Procedure: Traditional Intersphincteric Resection

Interventions

Traditional Intersphincteric Resection PROCEDURE

The control group underwent the traditional ISR procedure. The surgical process was as follows: 1. The abdominal team entered the abdominal cavity and mobilized the sigmoid colon and rectum according to the principle of total mesorectal excision (TME). The vessels were ligated at a high position, and the rectum was dissected downward along the presacral space to the level of the levator ani muscle (pelvic floor), fully exposing the distal rectum and the levator ani muscle. 2. The transanal team made a full-thickness circumferential incision in the rectal mucosa slightly above the dentate line (approximately ≥1 cm), entering the intersphincteric groove. A sharp circumferential dissection was performed along this groove to "pull" the rectum (along with its internal sphincter) out from within the external anal sphincter. During this dissection, care was taken to avoid damaging the external sphincter complex and its innervation. 3. When the perineal dissection plane reached the level of

Traditional ISR

Precision Partial Intersphincteric Resection (PPISR) PROCEDURE

The experimental group underwent the PPISR procedure. The surgical process was as follows: 1. The abdominal team performed the TME procedure, completely resecting the mesorectum at the level of the mesorectum termination line within the levator hiatus. 2. The transanal team completed routine preoperative preparation and disinfection, and located the distal and lateral resection margins of the tumor (with a margin distance ≥5 mm from the tumor boundary), thereby preserving part of the internal anal sphincter and normal intestinal wall tissue. 3. A "U"-shaped dissection was performed cranially along the marking line within the intersphincteric space, meeting the abdominal team at the level of the levator hiatus, as shown in Figure 1. 4. The specimen was removed either transanally or transabdominally. 5. The proximal intestinal segment was trimmed, intestinal anastomosis was performed manually, and the procedure was concluded.

PPISR

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-75 years old
• Pathology suggestive of moderately to highly differentiated rectal adenocarcinoma
• Tumor lower margin ≤ 5 cm from the anal verge
• Pre-operative tumor (T) staging of T1-T3 and T1-T2 below the level of the anal raphe muscle
• No distant metastasis such as lung, liver and other organs

You may not qualify if:

• Preoperative patients with severe underlying diseases (such as severe liver and kidney function, cardiopulmonary function, coagulation dysfunction, etc.)
• Patients with malignant tumors in other parts of the body
• Patients who underwent emergency surgery due to acute perforation, obstruction, etc.
• Patients with tumor infiltration of peripheral organs during the operation, which required combined resection or palliative resection
• Patients who had a mid-opening laparoscopic operation for various reasons -during the operation
• Patients with poor anal function before operation, which is not suitable for anus preservation surgery.

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

Central Study Contacts

shaotang li

CONTACT

86+18815039766; lishaotang163@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: September 30, 2026
• Study Start: February 8, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2030
• Last Updated: September 30, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)