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NCT Number: NCT06405308

Robotic Natural Orifice Specimen Extraction Surgery Versus Robotic Transabdominal Specimen Extraction Surgery for Early-Stage Rectal Cancer

A retrospective cohort study, conducted nationwide（China） and across multiple centers, aimed to compare the surgical quality and short-term outcomes of R-NOSES （robotic natural orifice specimen extraction surgery）with R-TSES （robotic transabdominal specimen extraction surgery） for early-stage rectal cancer.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Natural Orifice Specimen Extraction Surgery Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms Robotic Surgery

Age range

20 year–86 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Xiangya Hospital of Central South University, Changsha, Hunan, China

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About this study

In this retrospective cohort study, data from 1086 patients who underwent R-NOSES or R-TSES for early-stage rectal cancer between October 2015 and November 2023 were collected from a prospectively maintained database of 8 experienced surgeons from 8 high-volume centers in china. The study was aimed to compare the surgical quality and short-term outcomes of R-NOSES with R-TSES for early-stage rectal cancer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • histologically confirmed rectal adenocarcinoma
  • robotic TME for rectal adenocarcinoma
  • postoperative pathological staging of T1-2N0M0
  • complete surgical and postoperative follow-up information

Exclusion criteria

  • body mass index (BMI) ≥ 35 kg/m2
  • history of abdominal surgery
  • history of pelvic surgery
  • presence of another primary cancer
  • previous endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR)
  • anal or vaginal disease
  • ileostomy or transverse colostomy
  • conversion to open operation
  • tumor distant metastasis

Treatment and study plan

R-NOSES group

Procedure

robotic natural orifice specimen extraction surgery

R-TSES group

Procedure

robotic transabdominal specimen extraction surgery

Primary outcomes

  1. Complication rate

    Time frame: Up to 30 days postoperatively

    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.

Secondary outcomes

  1. Operative time

    Time frame: Intraoperative

  2. Estimated blood loss

    Time frame: Intraoperative

  3. Postoperative recovery composite

    Time frame: Up to 2 weeks

    Including the time to first flatus (record the patient's first self induced exhaust time after operation, accurate to hours) and time to first oral feeding.

  4. Postoperative hospital stay

    Time frame: Up to 4 weeks

    From surgery to discharge

  5. Pain assessment

    Time frame: 1, 3, 5 days postoperatively

    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.

  6. C-reactive protein (CRP)

    Time frame: 1, 3, 5 days postoperatively

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

  7. Postoperative white blood

    Time frame: 1, 3, 5 days postoperatively

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

  8. EORTC QLQ-C30

    Time frame: Three months after surgery

    The EORTC QLQ-C30 includes functional score, symptom score, and Global Health Status. All project scores range from 0 to 100. The Functional score includes physical functioning, role functioning, emotion functioning, social functioning and cognitive functioning. The higher the functional score, the better the functional status of the patient. Symptom score includes nausea and vomiting, pain, dyspnoea, insomnia, loss of appetite, constipation, diarrhea, financial impact. A higher symptom score is associated with more severe symptoms and worse outcomes. The higher the Global Health Status, the better the health of the patient.

  9. BIQ

    Time frame: Three months after surgery

    The BIQ is an eight-item questionnaire incorporating body image and cosmetic subscales, The body image scale measures patients' perception and satisfaction with their bodies after surgery. it ranges from 5 to 20 with a higher number representing greater body image perception. The cosmetic scale assesses satisfaction with surgical scars for a score range of 3-24, with a higher score indicating greater cosmetic satisfaction.

Sponsors and collaborators

Lead sponsor

Taiyuan Li

Other

Registry information

Official study title

Robotic Natural Orifice Specimen Extraction Surgery Versus Robotic Transabdominal Specimen Extraction Surgery for Rectal Cancer: a Multicentre Propensity Score-Matched Analysis

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 8, 2024
Registry last updated
May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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