Endoscopic Submucosal Dissection vs. Transanal Endoscopic Surgery for Rectal Neoplasia

Not yet recruitingOBSERVATIONAL
Enrollment

156

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

June 1, 2027

Study Completion Date

July 1, 2028

Conditions
Rectal Neoplasms
Interventions
PROCEDURE

Endoscopic Submucosal Dissection (ESD)

Endoscopic excision of the rectal lesion by submucosal injection and circumferential mucosal incision using an electrosurgical knife with en-bloc resection intent

PROCEDURE

Transanal 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

Trial Locations (5)

34394

Private Office, Istanbul

35330

Dokuz Eylul University, Izmir

Unknown

Baskent University, Istanbul

Memorial Sisli Hospital, Istanbul

Acibadem Kent Hospital, Izmir

All Listed Sponsors
lead

Turkish Society of Colon and Rectal Surgery

OTHER

NCT06902701 - Endoscopic Submucosal Dissection vs. Transanal Endoscopic Surgery for Rectal Neoplasia | Biotech Hunter | Biotech Hunter