Single-port Versus Multi-port Robotic Surgery for Rectal Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University

About this trial

Single-port versus multi-port robotic surgery for rectal cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Single-port robotic total mesorectal excision

    Procedure/Surgery

    Single-port robotic total mesorectal excision

  • Multi-port robotic total mesorectal excision

    Procedure/Surgery

    Multi-port robotic total mesorectal excision

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Single-port robotic total mesorectal excisionExperimental treatment 1 intervention
Group B: Multi-port robotic total mesorectal excisionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of perioperative complications

Perioperative complications will be described using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACAE) v. 4.03 criteria. Complications will refer to any medical occurrence directly attributed to the surgical procedure during and within the first 30 days.

Time frame
Intraoperative and postoperative 30 days
2

Number of participants with conversion procedures

The number of patients converted from robotic to open or laparoscopic surgery

Time frame
Date of surgery (Day 1)

Secondary outcomes

1

Pain scores

Visual Analog Scale (VAS) pain scores for patients on postoperative days 1-3

Time frame
Postoperative days 1-3
2

Quality of specimen

As proposed and published by Quirke et al(Macroscopic evaluation of rectal cancer resection specimen: clinical significance of the pathologist in quality control. J Clin Oncol. 2002 Apr 1;20(7):1729-34.)

Time frame
Date of surgery (Day 1)
3

Total length of incisions

Total length of all abdominal incisions (measured in millimeters).

Time frame
Date of surgery (Day 1)

Other outcomes

Sponsors and contacts

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