Single-port Versus Conventional Laparoscopic Surgery for Radical Proximal Gastric Cancer: A Randomized Controlled Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFirst Affiliated Hospital of Wenzhou Medical University

About this trial

To evaluate the safety and efficacy of SP1000 and conventional laparoscopy in radical gastrectomy for proximal gastric cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 75 years inclusive.

Disqualifiers

Clinical stage T4 or presence of distant metastasis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Single-Port Robotic Surgical System

    Device

    An investigational robotic-assisted surgical platform designed for single-port access. In this study, the system is utilized to perform radical proximal gastrectomy. The core surgical procedures are conducted through a centralized access point to assess the intraoperative safety and short-term clinical outcomes of this robotic-assisted approach.

  • Traditional Laparoscopic Surgery

    Procedure/Surgery

    Standard multi-port laparoscopic radical proximal gastrectomy performed as a clinical control. This procedure follows conventional laparoscopic techniques involving multiple abdominal incisions for the placement of surgical instruments and camera to treat proximal gastric cancer.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Single-Port GroupExperimental treatment 1 intervention
Group B: Traditional Laparoscopy GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Total Postoperative Complications (Clavien-Dindo Grade ≥ II)

The proportion of participants experiencing at least one postoperative complication graded II or higher according to the Clavien-Dindo Classification. This includes surgery-related, systemic, and anesthesia-related complications. If a patient experiences multiple complications, only the most severe grade will be used for statistical analysis.

Time frame
Within 30 days postoperatively.

Secondary outcomes

1

Estimated Blood Loss

The amount of blood lost during the surgical procedure, measured in milliliters (mL).

Time frame
During the surgical procedure (Day 0).
2

Time to First Flatus

The time from the end of surgery until the participant's first passage of flatus, measured in days.

Time frame
Up to 30 days postoperatively.
3

Total Operation Time

The duration from the initial skin incision to the completion of skin closure, measured in minutes.

Time frame
During the surgical procedure (Day 0).
4

Conversion Rate

The proportion of participants in the Single-Port group who require conversion to traditional multi-port laparoscopy or open surgery due to technical or safety factors.

Time frame
During the surgical procedure (Day 0).

Other outcomes

Sponsors and contacts

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