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This study evaluates how advanced endoscopic resection techniques affect treatment outcomes in adults with rectal cancer.
Rectal cancer has traditionally been treated with standard abdominal surgery. Newer endoscopic techniques allow removal of selected early tumors and may reduce treatment-related complications. However, their effectiveness and safety in tumors with deeper invasion are not yet fully established.
This multicenter retrospective observational study uses existing medical records from adults who underwent endoscopic or surgical resection of rectal tumors between 2015 and 2025. Researchers will analyze anonymized information on procedures performed and treatment outcomes to assess the safety and effectiveness of advanced endoscopic approaches.
The results of this study may help guide treatment selection and improve care for people with rectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESD | Patients who underwent endoscopic submucosal dissection for rectal neoplasm |
| |
| EID | Patients who underwent endoscopic intermuscular dissection for rectal neoplasm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic submucosal dissection | Procedure | Endoscopic submucosal dissection is an advanced endoscopic technique used to remove rectal tumors in one piece through the endoscope. A circumferential incision is then made in the mucosa, followed by careful dissection within the submucosal layer until the lesion is completely removed. This technique enables precise pathological assessment of tumor margins and depth of invasion and is typically used for lesions suspected to have superficial submucosal invasion without clear evidence of lymph node involvement. The procedure is performed using standard therapeutic endoscopic equipment and electrosurgical devices. |
| Measure | Description | Time Frame |
|---|---|---|
| Major intraprocedural bleeding rate | Bleeding occurring during the procedure that required advanced endoscopic hemostatic interventions beyond standard coagulation with the tip of the knife of coagulation forceps, resulted in hemodynamic instability, caused a significant prolongation of the procedure over 15 minutes (based on video), or led to procedure interruption or conversion | During the procedure |
| Intraprocedural perforation rate | Full-thickness defect of the gastrointestinal wall identified during the procedure, evidenced by direct visualization of extraluminal structures (mesorectum or peritoneal cavity), or confirmed by the presence of free air on imaging performed immediately after the procedure. | During the procedure |
| Delayed bleeding rate | Symptomatic bleeding including hematemesis, melena, or a hemoglobin decrease of more than 2 g/dL. | Within 28 days after the procedure |
| Delayed perforation rate | Clinical signs of peritonitis accompanied by radiological evidence of free intraperitoneal air. | Within 14 days after the procedure |
| Post-coagulation syndrome rate | The occurrence of localized abdominal pain or peritoneal irritation signs after EID, accompanied by inflammatory response (elevated white blood cell count or C-reactive protein), in the absence of radiological or endoscopic evidence of perforation. | Within 28 days following the procedure |
| The need for emergency interventions | Any unplanned therapeutic intervention related to the index procedure during hospitalization or follow-up, including repeat endoscopy, endoscopic or radiological intervention, blood transfusion, or surgical treatment. Planned surveillance procedures were not considered additional interventions. |
| Measure | Description | Time Frame |
|---|---|---|
| En bloc resection rate | The rate of lesions removed in a single specimen, enabling accurate macroscopic and histological assessment as reported by an endoscopist in a procedure protocol. | Intraprocedural |
| Complete resection rate |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with rectal neoplasms treated with advanced endoscopic resection in a tertiary center.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zofia Orzeszko, MD | Contact | +123797145 | zofia.orzeszko@uj.edu.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jagiellonian University in Krakow | Krakow | 31061 | Poland |
Permission for data sharing was not included in the bioethics committee approval.
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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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| ID | Term |
|---|---|
| D000069916 | Endoscopic Mucosal Resection |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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|
| Endoscopic intramuscular dissection | Procedure | Endoscopic intermuscular dissection is an advanced endoscopic resection technique designed for rectal tumors with suspected deeper submucosal invasion. Following mucosal incision, the dissection is intentionally performed in the plane between the inner circular and outer longitudinal muscle layers of the rectal wall. This allows deeper en bloc tumor removal compared with conventional endoscopic submucosal dissection. The goal of this technique is to achieve complete resection while potentially avoiding radical surgery in selected patients. The procedure is performed endoscopically using specialized dissection knives and electrosurgical systems and requires advanced operator expertise. |
|
| Within 30 days after the procedure |
| Procedure-related mortality rate | Number of deaths occurring within 30 days of the index procedure that was directly attributable to the procedure or to procedure-related complications. Deaths unrelated to the procedure were reported but not considered procedure-related mortality. | Within 30 days after the procedure |
The rate of lesions resected completely according to the pathological examination of the resected specimen.
| Within 30 days after the procedure |
| Procedure time | Procedure time was evaluated on the procedure video and defined as the interval from the insertion of the scope to its final withdrawal measured in minutes; anesthesia-related time was not included. | Intraprocedural |
| Length of hospital stay | The number of days from the day of the procedure (day 0) to the day of hospital discharge. | Within 30 days after the procedure |
| The need for additional treatment | The number of patients who required completion surgery or adjuvant (chemo)radiotherapy. | Within 12 months after the procedure |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |