IRCCS Humanitas Research Hospital
Rozzano, Milan, 20089, Italy
Location contact
Annalisa Maroli, PhD
CONTACT
00390282247776 ext. 0039
Antonino Spinelli, MD, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07358247
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Rozzano, Milan, 20089, Italy
Annalisa Maroli, PhD
CONTACT
00390282247776 ext. 0039
Antonino Spinelli, MD, PhD
PRINCIPAL_INVESTIGATOR
Minimally invasive restorative total mesorectal excision (TME) conventionally requires an abdominal incision for specimen removal that limits its ability to reduce postoperative pain and would infection occurrence. Wound-related complications, including infections and incisional hernia, are well-recognized postoperative morbidities after minimally invasive colorectal surgery- with reported rates up to 20%- and the mini-laparotomy is often the primary site of infections and postoperative pain in colorectal surgery. Avoiding the abdominal wall extraction site may improve short-term outcomes and help reduce the cost associated with wound complications. As a result, there has been growing interest in natural orifice specimen extraction (NOSE), which eliminates the need for an extraction incision for specimen retrieval. Initially employed primarily for benign conditions, both transvaginal and transanal approaches have gradually expanded their utility to include colorectal cancer surgery without compromising bacteriological safety and oncological outcomes.
The introduction of the transanal techniques for rectal transection and single stapling anastomosis (TTSS) has enabled a more standardized application of NOSE in low rectal cancer surgery, where a complete TME and a low stapled colorectal anastomosis is required.
This study aims to compare short-term outcomes of low rectal cancer patients undergoing minimally invasive restorative TME with NOSE combined with single-stapling (SS) technique and conventional abdominal extraction incision and double-stapled anastomosis.
The primary objective of this study is to compare the postoperative outcomes of NOSE combined with SS anastomosis (NOSE) versus conventional abdominal extraction combined either with SS or double-stapled anastomosis (control), using a binary logistic regression-based Propensity Score Matched (PSM) approach.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 30 days after surgery
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 surgery
The rate difference of 30-day overall postoperative complications, classified according to the Clavien-Dindo scale.
Time frame: 24 hours after surgery
The median difference of 24-hour participant-reported pain measured on the Visual Rating Scale (VRS), between the study groups.
Time frame: 48 hours after surgery
The median difference of 48-hour participant-reported pain measured on the Visual Rating Scale (VRS), between the study groups.
Time frame: 72 hours after surgery
The median difference of 72-hour participant-reported pain measured on the Visual Rating Scale (VRS), between the study groups.
Contact information is provided by the study sponsor or research team.
Istituto Clinico Humanitas
Other
Postoperative Outcomes of Transanal Transection and Single-stapled Technique Combined With Transanal Natural Orifice Specimen Extraction: a Single-center Retrospective Cohort Study
Acronym: NOSE
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View the official ClinicalTrials.gov record (opens in a new tab)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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