Ireland
--:--IST
Recruiting Not applicable

Application of Precision Partial Intersphincteric Resection (PPISR)

NCT07849023 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-02-08
Last updated
2026-09-30

Condition(s) studied

Low Rectal CancerRectal Cancer Patients

Investigational drug(s) / intervention(s)

Precision Partial Intersphincteric Resection (PPISR)Traditional Intersphincteric Resection

Precision Partial Intersphincteric Resection (PPISR): 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.

Traditional Intersphincteric Resection: 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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Postoperative anal function as assessed by Wexner Score — At 3 and 6 months postoperatively
    Scale Title: Wexner Fecal Incontinence Score. The minimum values:0. The maximum values:20. Higher scores mean a worse outcome.
  • Postoperative quality of life as assessed by EORTC QLQ-C30 — At 1 year postoperatively
    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.
  • 3-year local recurrence rate as assessed by abdominal contrast-enhanced MRI — 3 years postoperatively
    Participants have an MRI every 3 months postoperatively

Trial sites (1)

FacilityCityRegionStatus
First Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07849023 on ClinicalTrials.gov ↗ ← All trials in China