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Application of Precision Partial Intersphincteric Resection (PPISR)

ConditionsLow Rectal CancerRectal Cancer Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFirst Affiliated Hospital of Wenzhou Medical University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Precision Partial Intersphincteric Resection (PPISR)

    Procedure/Surgery

    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

    Procedure/Surgery

    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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: PPISRExperimental treatment 1 intervention
Group B: Traditional ISRActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At 3 and 6 months postoperatively
2

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.

Time frame
At 1 year postoperatively
3

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

Participants have an MRI every 3 months postoperatively

Time frame
3 years postoperatively

Secondary outcomes

1

Circumferential resection margin negative rate

Time frame
Immediately after the pathology results come out
2

intraoperative blood loss

Time frame
Immediately after the surgery
3

Postoperative-related complication incidence

Complications include postoperative bleeding, abdominal cavity infection, thoracic cavity infection, urinary tract infection, etc.

Time frame
From the end of surgery to 3 months postoperatively
4

Postoperative hospital stay duration

Time frame
From the end of surgery to discharge

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital of Wenzhou Medical University

Lead sponsor

Source ClinicalTrials.gov
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