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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOSE | Patients who underwent Natural Orifice Specimen Extraction (NOSE) in combination with Single-Stapled (SS) anastomosis approach | ||
| Control | Patients who underwent double-staple or Single-stapled (SS) anastomosis with standard abdominal incision extraction (including Pfannenstiel incision or left iliac fossa incision) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Overall postoperative complications | The rate difference of 30-day overall postoperative complications, classified according to the Clavien-Dindo scale. | 30 days after surgery |
| Postoperative 24-hour pain |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include adult patients who underwent rectal cancer surgery between January 2017 and January 2023.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annalisa Maroli, PhD | Contact | 00390282247776 | 0039 | annalisa.maroli@humanitas.it |
| Name | Affiliation | Role |
|---|---|---|
| Antonino Spinelli, MD, PhD | Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20072 Pieve Emanuele, Milan, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Humanitas Research Hospital | Rozzano | Milan | 20089 | Italy |
According to the local SOP the IPD will uploaded on a public repository (Zenodo) with an appropriate embargo and will be made available upon resonable request only with the approval of the local administration.
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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The median difference of 24-hour participant-reported pain measured on the Visual Rating Scale (VRS), between the study groups.
| 24 hours after surgery |
| Postoperative 48-hour pain | The median difference of 48-hour participant-reported pain measured on the Visual Rating Scale (VRS), between the study groups. | 48 hours after surgery |
| Postoperative 72-hour pain | The median difference of 72-hour participant-reported pain measured on the Visual Rating Scale (VRS), between the study groups. | 72 hours after surgery |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |