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This study aims to compare the postoperative outcomes of low rectal cancer patients who underwent surgery with Natural Orifice Specimen Extraction (NOSE) versus traditional Pfannenstiel extraction.
Natural Orifice Specimen Extraction (NOSE) in colorectal surgery allows the extraction of the surgical specimen through the anal orifice. Several studies demonstrated improved postoperative pain, bowel movements, patient-reported cosmetic satisfaction, and psychological wellbeing after NOSE compared with traditional Pfannenstiel extraction. However, most of these studies focused on colon surgery. The aim of this retrospective propensity score matched study is to investigate the postoperative outcomes of NOSE in low rectal cancer surgery, classified according to the English National Low Rectal Cancer Development Programme (LOREC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Natural Orifice Specimen Extraction (NOSE) | Patients with low rectal cancer who underwent rectal resection with Natural Orifice Specimen Extraction (NOSE) |
| |
| Controls | Patients with low rectal cancer who underwent rectal resection with traditional specimen extraction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natural Orifice Specimen Extraction (NOSE) | Procedure | Low rectal cancer resection with Total Mesorectal Excision (TME) and Natural Orifice Specimen Extraction (NOSE) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Site Infections (SSI) | Rate difference of 30-day Surgical Site Infections (SSI)- defined according to the definition of the Center for Disease Control and Prevention (CDC) [Ref]- between the study cohorts. | 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid rescue | Difference in the proportion of patients requiring opioid rescue during the hospitalization | From the date of surgery to the date of discharge |
| Postoperative pain | The median difference of 72-hour patient-reported pain- measured on the Visual Rating Scale (VRS) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with low rectal cancer to the English National Low Rectal Cancer Development Programme (LOREC) who underwent low rectal resection with Total Mesorectal Excision (TME)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annalisa Maroli, PhD | Contact | 02 8224 7776 | 0039 | colorapp@humanitas.it |
| Stefano De Zanet, MS | Contact | 02 8224 4623 | 0039 | colorapp@humanitas.it |
| Name | Affiliation | Role |
|---|---|---|
| Antonino Spinelli, MD, PhD | IRCCS Huamanitas Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Humanitas Research Hospital | Recruiting | Rozzano | MI | 20089 | Italy |
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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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| Traditional specimen extraction | Procedure | Low rectal cancer resection with Total Mesorectal Excision (TME) and specimen extraction through Pfannenstiel incision |
|
| 72 hours after surgery |
| Postoperative ileus | Rate difference of 30-day postoperative functional ileus (define as the absence of bowel function for at least three days) | 30 days after surgery |
| Incisional hernia | The rate difference of six-month incisional hernia | 6 months after surgery |
| Overall postoperative complications | The rate difference of overall 30-day postoperative complications, classified according to the Clavien-Dindo scale [ranging from 0 (no complications) to 5 (complications leading to death)] | 30 days after surgery |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |