Rectal Neoplasms
Conditions
Keywords
endoscopic submucosal dissection, transanal endoscopic surgery, early rectal neoplasms
Brief summary
This prospective observational cohort study aims to compare the clinical and procedural outcomes of Endoscopic Submucosal Dissection (ESD) and Transanal Minimally Invasive Surgery (TAMIS) for the treatment of early-stage rectal neoplasia. The study will evaluate recurrence rates, en bloc resection rates, R0 resection rates, procedure time, complication rates, and length of hospital stay over a 1-year follow-up period. Data will be collected from patients treated at multiple centers with expertise in ESD and TAMIS.
Detailed description
Colorectal cancer (CRC) is one of the most common malignancies globally, with early-stage rectal neoplasms being increasingly diagnosed due to widespread screening programs. This trend has led to a greater focus on organ-preserving treatment options, with endoscopic submucosal dissection (ESD) and transanal endoscopic surgery (TES) emerging as key techniques for local excision. ESD allows for en bloc resection of superficial lesions with high histological completeness but has a steep learning curve and a higher perforation risk. In contrast, TES, performed using transanal minimally invasive surgery (TAMIS) or transanal endoscopic operation (TEO), facilitates full-thickness excision and is more commonly used in Western surgical practice. Each technique presents unique advantages and challenges. ESD is minimally invasive, preserves rectal function, and reduces postoperative complications such as fecal incontinence. However, its prolonged procedure time and technical difficulty limit its widespread adoption. TES, utilizing standard laparoscopic instruments, offers superior visualization and facilitates excision of deeper lesions but may lead to rectal wall defects, increased postoperative pain, and anorectal dysfunction. While studies suggest similar en bloc and recurrence rates between the two methods, discrepancies exist in procedural efficiency, hospital stay, and morbidity rates, with ESD potentially offering a shorter hospitalization period in certain cases. Despite the increasing use of ESD and TES, a clear consensus on the optimal approach for early rectal neoplasms remains lacking. Existing data, primarily from high-volume centers in Asia, may not be fully applicable to Western populations. To address these gaps, this study aims to conduct a prospective, multi-center observational comparison of ESD and TES, assessing key outcomes such as recurrence rates, resection quality, complications, and hospital stay. The findings will contribute to refining treatment strategies and improving clinical decision-making for rectal neoplasm management.
Interventions
Endoscopic excision of the rectal lesion by submucosal injection and circumferential mucosal incision using an electrosurgical knife with en-bloc resection intent
PROCEDURETransanal Endoscopic Surgery (TES)
Transanal endoscopic surgery procedures include Transanal Minimally Invasive Surgery (TAMIS) and Transanal Endoscopic Operation (TEO). TAMIS will be performed using a single-port transanal access platform with standard laparoscopic instruments, including a high-definition camera, an insufflation system, and endoscopic graspers. The lesion will be circumferentially excised using electrocautery or an energy device, ensuring full-thickness resection when necessary. The defect will be managed based on its size, with primary closure using absorbable sutures or left to heal by secondary intention. TEO will be conducted using a rigid transanal endoscopic platform with a stereoscopic optical system to enhance visualization. The lesion will be marked, and a full-thickness or submucosal excision will be performed using endoscopic instruments and electrosurgical devices. Post-resection, the rectal wall defect will be assessed, and primary closure will be performed when indicated to minimize post
Sponsors
Turkish Society of Colon and Rectal Surgery
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (\>18 years) * Non-pedunculated (sessile) lesions larger than 2 cm. * Lesions located within 15 cm from the anal verge confirmed by sigmoidoscopy or magnetic resonance imaging (MRI)
Exclusion criteria
* Evidence of lymph node involvement, T2 rectal tumors, or distant metastasis on preoperative imaging modalities (MRI, ERUS, CT) * Previous attempt at endoscopic resection * Previous rectal surgery * Previous pelvic radiation therapy * Inflammatory bowel diseases (Crohn's disease, Ulcerative colitis)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| R0 Resection Rate | Immediately post-procedure. | Proportion of patients with histologically confirmed tumor-free margins. All pathological evaluations will be performed according to the College of American Pathologists (CAP) protocol (version 4.3.0.0, 2023) |
| Recurrence Rate | 12 months post-procedure. | Proportion of patients with tumor recurrence at follow-up endoscopy within 12 months, histologically confirmed from resected visible residual disease or, if absent, from scar biopsies. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication Rate | Up to 30 days post-procedure. | Incidence of adverse events, including all intraoperative and postoperative according to Clavien-Dindo classification. |
| En Bloc Resection Rate | Immediately post-procedure. | Proportion of patients where the tumor was removed in a single piece. All pathological evaluations will be performed according to the College of American Pathologists (CAP) protocol (version 4.3.0.0, 2023) |
| Fecal Incontinence | Pre-procedure and within the first 12 months post-procedure. | Patient-reported outcomes will be assessed using the Wexner Incontinence Score, a validated instrument that quantifies the frequency and severity of fecal incontinence. Scores range from 0 (perfect continence) to 20 (complete incontinence), with higher scores indicating greater dysfunction. |
| Length of Hospital Stay | Perioperative/Periprocedural | Duration of hospitalization (days). |
| Procedure Time | Immediately post-procedure. | Total duration of the procedure (minutes). |
Countries
Turkey (Türkiye)
Contacts
Primary ContactTayfun Bisgin, MD
Outcome results
None listed