Postoperative Outcomes of Single-stapled Anastomosis Combined With Transanal Natural Orifice Specimen Extraction
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstituto Clinico Humanitas
About this trial
Natural Orifice Specimen Extraction (NOSE) eliminates the need for additional abdominal incisions in minimally invasive colorectal procedures, potentially reducing the risk of wound complications and postoperative pain. In the context of restorative Total Mesorectal Excision (TME), single-stapling (SS) techniques facilitate NOSE through transanal rectal transection, as opposed to the conventional double-stapling technique. This study aims to explore the potential advantages of NOSE combined with SS anastomosis compared to conventional abdominal extraction in minimally invasive restorative TME.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged more than 18 years old at the time of surgery
Patients with a histological diagnosis of rectal adenocarcinoma
Patients who underwent surgery between January 2017 and January 2023
Patients with a low rectal tumor meeting the Low Rectal Cancer Development Programme (LOREC) criteria
Disqualifiers
Patients who underwent non-restorative procedures (including abdominoperineal resection or Hartmann's procedures).
Patients who underwent immediate or delayed coloanal anastomosis.
Patients who underwent open surgery.
Patients who underwent unplanned conversion from minimally invasive to open approach.
Trial population
The study population will include adult patients who underwent rectal cancer surgery between January 2017 and January 2023.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
190 Participants
are grouped into 2 trial groupsGroup A: NOSE
Group B: Control
Trial outcomes
Primary outcomes
1
Wound complications
The difference rate of 30-day wound complications between the study groups. Wound complications include Surgical Site Infections (SSI)- defined according to the definition of the Center for Disease Control and Prevention (CDC)-, wound hematoma, and wound seroma.
Time frame
30 days after surgerySecondary outcomes
1
Overall postoperative complications
The rate difference of 30-day overall postoperative complications, classified according to the Clavien-Dindo scale.
Time frame
30 days after surgery2
Postoperative 24-hour pain
The median difference of 24-hour participant-reported pain measured on the Visual Rating Scale (VRS), between the study groups.
Time frame
24 hours after surgery3
Postoperative 48-hour pain
The median difference of 48-hour participant-reported pain measured on the Visual Rating Scale (VRS), between the study groups.
Time frame
48 hours after surgery4
Postoperative 72-hour pain
The median difference of 72-hour participant-reported pain measured on the Visual Rating Scale (VRS), between the study groups.
Time frame
72 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: