Clinical trial NCT06824688: Single-port Versus Multi-port Robotic Surgery for Rectal Cancer
Official title: Efficacy and Safety Assessment of Single-port Versus Multi-port Robotic Surgery for Rectal Cancer: a Phase 2a Non-randomized Controlled Study Based on the IDEAL Framework
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rectal Cancer Patients
Robotic Surgical Procedures
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Single-port versus multi-port robotic surgery for rectal cancer

Detailed description: This study is a phase 2a clinical trial based on the IDEAL framework, which aims to evaluate the safety and short-term clinical efficacy of single-port robotic total mesorectal excision by comparing it with multi-port robotic total mesorectal excision. The primary endpoint is short-term clinical efficacy, including intraoperative complications, blood loss, conversion rate, operation time, postoperative complications within 30 days, time to first flatus after surgery, and postoperative hospital stay. Secondary endpoints include incision length, visual analog scale (VAS) scores for postoperative pain on days 1-3, completeness of mesorectal excision grading, positive circumferential resection margin rate, positive distal resection margin rate, and the number of harvested lymph nodes.

Eligibility criteria: Inclusion Criteria:

* Rectal cancer with the lower tumor margin less than 15 centimeters from the anal verge (defined by MRI);
* Histological biopsy confirms adenocarcinoma of the rectum;
* Stage I-III (assessed by MRI and abdominal CT), including downstaging after neoadjuvant therapy;
* Intends to perform anal sphincter-preserving surgery and plans for primary anastomosis;
* Informed consent has been obtained from the patient and family;
* Age greater than 18 years old.

Exclusion Criteria:

* Previous rectal resection (excluding local excision);
* Emergency surgery due to complications from rectal tumors;
* Pregnancy;
* Signs of acute intestinal obstruction;
* Multifocal colorectal tumors requiring multisegment bowel resection;
* Familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC), active Crohn's disease, or active ulcerative colitis;
* Planned synchronous resection of abdominal organs;
* History of other malignancies, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix;
* Absolute contraindications to general anesthesia or prolonged abdominal insufflation, such as severe cardiovascular or respiratory diseases (ASA classification \>III);
* Preoperative MRI suggests tumor invasion of the levator ani muscle or external anal sphincter, and preoperative assessment indicates inability to achieve curative resection or the need for abdominoperineal resection;
* Clinical or radiological evidence of distant metastasis of rectal cancer;
* Unsuitable for robotic surgery;
* Local excision of tumor;
* Anal cancer.

Primary outcomes:
measure: Incidence of perioperative complications
timeFrame: Intraoperative and postoperative 30 days
measure: Number of participants with conversion procedures
timeFrame: Date of surgery (Day 1)
Secondary outcomes:
measure: Pain scores
timeFrame: Postoperative days 1-3
measure: Quality of specimen
timeFrame: Date of surgery (Day 1)
measure: Total length of incisions
timeFrame: Date of surgery (Day 1)
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Huichao Zheng
Study officials:
affiliation: Army Medical Center (Daping Hospital), Army Medical University
name: Fan Li
role: STUDY_DIRECTOR
References: