Neoplasms

Digestive System Diseases

All Conditions

Wounds and Injuries

Rectal Neoplasms

Surgical Wound

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Participants in this group underwent robotic surgery with transanal specimen extraction

Participants in this group underwent robotic surgery with transabdominal specimen extraction

Participants in this group underwent robotic rectal cancer resection ,the specimens were extracted through anus.

Transanal specimen extraction robotic surgery

Participants in this group underwent robotic assisted rectal cancer resection ,the specimens were extracted through the incision on the abdominal wall.

Transabdominal specimen extraction robotic surgery

Xishan Wang

Hongliang Yao

Dehai Xiong

Chunkang Yang

Xiangfu Zeng

Fanghai Han

Guiyu Wang

Taiyuan Li

Ye Wei

Junjun She

Jianchun Cai

Junhong Hu

This prospective, multicenter, randomized, open-label study aims to evaluate the perioperative safety and feasibility of specimen extraction through anus regarding robotic radical excision of rectal cancer.

In this study, investigators will evaluate the perioperative safety and feasibility of robotic transanal specimen extraction surgery with robotic transabdominal incision specimen extraction surgery as a control.The study is prospective, randomized, open-label, and multicenter conducted at 12 centers. Considering the significance level and abscission rate, it is expected that a total of 556 subjects will be included in the two groups from January 2023 to June 2024, with the incidence of postoperative complications as the main study endpoint.

Robotic Transanal Specimen Extraction Surgery Versus Robotic Transabdominal Incision Specimen Extraction Surgery for Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial

Complication rate within 1 month postoperatively.All complications of surgery will be documented and graded by the Clavien-Dindo classification system,generally including anastomotic leakage, abdominal infection, bleeding, incision infection, incision implantation, intestinal obstruction, and rectovaginal fistula.

Detection of serum CRP levels (mg/L) to evaluate surgical stress response and immune function.

Detection of serum levels of Interleukin-1 (IL-1), interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10) (pg/L) to evaluate surgical stress response and immune function.

Detection of Serum Cortisol Level (nmol/L) to evaluate surgical stress response and immune function.

Count CD3, CD4, and CD8 lymphocyte subsets (pieces/ul) to assess surgical stress response and immune function.

Intraoperative peritoneal lavage fluid will be collected both for aerobic culture and centrifuged ,stained and viewed to find exfoliated cancer cells.The sample will be considered positive if at least one tumor cell was detected.

Visual analogue scale (VAS) will be used to evaluate the postoperative pain. If analgesics were needed, the type and dose of analgesics after operation should be recorded.

Wexner scale (0 are normal continence, 20 are maximum incontinence with maximum disturbance of lifestyle) will be used to evaluate the defecation function.

LARS scale(0\~20 points are defined as no LARS, Scores from 21 to 29 were defined as mild LARS, and from 30 to 42 as severe LARS. The higher the score, the worse the anal bowel function) will be used to evaluate the defecation function.

Including the time to first flatus (record the patient's first self induced exhaust time after operation, accurate to hours, and perform auscultation of bowel sounds regularly every day after operation), the time to first ambulation (hours), the time to first eating (hours) and the time to first defecation (hours).

To assess the quality of life of all cancer patients.

To assess the quality of life in patients with rectal cancer.

To assess the quality of surgical specimens.

To assess the quality of surgical specimens and postoperative pathological evaluation.

To assess the financial burden difference.

To assess the long-term postoperative outcomes.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Robotic Transanal Specimen Extraction Surgery Versus Robotic Transabdominal Incision Specimen Extraction Surgery for Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial	NCT05468944	Rectal Neoplasm... Robotic Surgery Natural Orifice...	Transanal speci... Transabdominal ...	18 Years - 75 Years	The First Affiliated Hospital of Nanchang University
Robotic Transanal Specimen Extraction Surgery Versus Robotic Transabdominal Incision Specimen Extraction Surgery for Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial	NCT05468944	Rectal Neoplasm... Robotic Surgery Natural Orifice...	Transanal speci... Transabdominal ...	18 Years - 75 Years	The First Affiliated Hospital of Nanchang University

Spots Global Cancer Trial Database for transabdominal specimen extraction robotic surgery