A Prospective Single-center Randomized Controlled Trial of Robotic Surgery With Transrectal Resection Specimens (NOSES-IV) and Traditional Assisted Robotic Surgery for the Treatment of High Rectal and Sigmoid Colon Cancer

Nanchang University

Status: Invitation-only

Conditions: Short-term Outcomes; Natural Orifice Specimen Extraction Surgery; Robotic Surgery

Treatments: Procedure: robotic transabdominal specimen extraction surgery; Procedure: robotic natural orifice specimen extraction surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT06906952

ZL078

Details and patient eligibility

About

This study aimed to compare the short-term efficacy of robotic radical resection of high rectal cancer and sigmoid colon cancer (NOSES-IV) with transrectal resection specimens and traditional robotic surgery in the treatment of high rectal cancer and sigmoid colon cancer. At the same time, the safety and advantages of robotic radical resection of high rectal cancer and sigmoid colon cancer (NOSES-IV) with transrectal resection specimens and traditional robotic surgery in the treatment of high rectal cancer and sigmoid colon cancer were compared.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1) The age is more than 18 years old and less than or equal to 85 years old 2) Eastern Cooperative Oncology Group score ≤2 3) Preoperative pathological diagnosis of rectal adenocarcinoma 4) cT1-3NxM0 rectal cancer defined by preoperative contrast-enhanced MRI 5) The maximum diameter of tumor ≤5cm on preoperative enhanced MRI 6) The body can tolerate the operation and sign the informed consent

Exclusion criteria

• 1) multiple primary colorectal cancer 2) recurrent rectal cancer 3) preoperative neoadjuvant chemoradiotherapy 4) complicated with intestinal obstruction or intestinal bleeding requiring emergency surgery 5) previous anal surgery history 6) BMI≥30kg/m2 7) severe mental illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

NOSES-IV Group

Experimental group

Description:

After the body is free, the tumor segment of the bowel is pulled out through the anus. Excise the tumor segment of the colon outside the anus.

Treatment:

Procedure: robotic natural orifice specimen extraction surgery

non-NOSES Group

Sham Comparator group

Description:

After internal mobilization, the tumor segment of the bowel was removed through an abdominal incision. Excise the tumor segment of the bowel outside the incision.

Treatment:

Procedure: robotic transabdominal specimen extraction surgery