Comparing surgical outcomes in low rectal cancer using different extraction methods
Postoperative Outcomes of Natural Orifice Specimen Extraction (NOSE) in Low Rectal Cancer Surgery
Istituto Clinico Humanitas · NCT06326892
This study is testing if a new way of removing tumors during low rectal cancer surgery leads to better recovery and satisfaction compared to the traditional method.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Clinico Humanitas (other) |
| Locations | 1 site (Rozzano, MI) |
| Trial ID | NCT06326892 on ClinicalTrials.gov |
What this trial studies
This observational study compares the postoperative outcomes of patients with low rectal cancer who underwent surgery using Natural Orifice Specimen Extraction (NOSE) versus traditional Pfannenstiel extraction. The research focuses on evaluating factors such as postoperative pain, bowel movements, cosmetic satisfaction, and psychological wellbeing. By utilizing a retrospective propensity score matched approach, the study aims to provide insights into the effectiveness of NOSE in low rectal cancer surgery, classified according to the English National Low Rectal Cancer Development Programme (LOREC).
Who should consider this trial
Good fit: Ideal candidates are patients undergoing low anterior resection with Total Mesorectal Excision (TME) for low rectal cancer.
Not a fit: Patients undergoing non-restorative procedures or those with inflammatory bowel disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative recovery and quality of life for patients undergoing low rectal cancer surgery.
How similar studies have performed: Previous studies have shown positive outcomes with NOSE in colorectal surgery, although most focused on colon surgery rather than low rectal cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing low anterior resection with Total Mesorectal Excision (TME) for low rectal cancer between January 2017 and January 2023 * Patients with rectal cancer classified as "low" according to the English National Low Rectal Cancer Development Programme (LOREC) Exclusion Criteria: * Patients undergoing non-restorative procedures * Patients undergoing immediate or delayed handsewn coloanal anastomosis * Patients undergoing planned open surgery or unplanned conversion from minimally invasive to open surgery * Patients with a concomitant diagnosis of Inflammatory Bowel Disease (IBD)
Where this trial is running
Rozzano, MI
- IRCCS Humanitas Research Hospital — Rozzano, MI, Italy (RECRUITING)
Study contacts
- Principal investigator: Antonino Spinelli, MD, PhD — IRCCS Huamanitas Research Hospital
- Study coordinator: Annalisa Maroli, PhD
- Email: colorapp@humanitas.it
- Phone: 02 8224 7776
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rectal Cancer, Surgery, Natural Orifice Specimen Extraction, Propensity score matched