Clinical trial · Interventional
A Study on the Efficacy of a Novel Approach to Achieving Laparoscopic Distal Rectal Transection for Rectal Cancers
A Prospective Non-randomized Controlled Multi-center Study of Laparoscopic Intracorporeal Distal Rectal Transection by Using the Traditional Approach vs. Using Transanterior Obturator Nerve Gateway Approach for Ultralow Rectal Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The wide application of ISR and DST has greatly improved the anal preservation rate for low rectal cancers, but the technical difficulty has also been obviously increased because of the limited pelvic space. Although many scholars have tried to solve this problem, all the methods have failed to fundamentally solve the problem of "the oblique dissection" of the distal rectum. To solve the problem above, the director of this clinical trial has explored a new distal rectal resection method-- transanterior obturator nerve gateway approach. The purpose of this clinical trial is to prospectively collect and compare data on the patients' perioperative variables and postoperative functional and oncological outcomes of this novel approach with the traditional approach to confirm the safety and feasibility of this novel approach and its advantages over the traditional approach.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Neoplasms Malignant | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Total mesorectal excision approach | Procedure | — | UNRESOLVED |
| Transanterior obturator nerve gateway approach | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- SHAM_COMPARATOR
- label
- Total mesorectal excision approach
- description
- Patients of the control group who are to receive the traditional approach-- total mesorectal excision approach to transect the distal rectum are assigned into this arm.
- interventionNames
- Procedure: Total mesorectal excision approach
- type
- EXPERIMENTAL
- label
- Transanterior obturator nerve gateway approach
- description
- Patients of the experimental group who are to receive the novel approach-- transanterior obturator nerve gateway approach to transect the distal rectum are assigned into this arm.
- interventionNames
- Procedure: Transanterior obturator nerve gateway approach
Primary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: Pathologically diagnosed as rectal cancer with the lower margin of the tumor from the anal margin ≤5cm;CT, MRI or endoscopic ultrasonography: Single tumor, clinical T stage ≤3 or no invasion of the internal sphincter, maximum diameter ≤10cm, no distant metastasis;The patient or the patient-authorized representative completely understands the study protocol and voluntarily participates in this study, agrees to sign written informed consent. Exclusion Criteria: The patient had previous abdominal surgery that will significantly infect the laparoscopic procedures; Patients requiring emergency surgery owing to intestinal obstruction, perforation, or uncontrolled bleeding caused by tumor; Patients with poor anal function preoperatively (Wexner score ≥10); ASA (American Society of Anesthesiologists) grading ≥ IV; Pregnant patients; Patients concomitant with severe mental illness; The patient or the patient-authorized representative can't understand the contents and objectives of the study. Withdraw criteria: ISR cannot be performed by intraoperative evaluation and is replaced by Miles surgery; Distant metastasis is confirmed intraoperatively or by postoperative pathological findings; Patients had other primary tumors requiring surgical/drug treatment during the study, or had other illnesses that prevent the patient from continuing to participate this study; Patients decide to withdraw from the study for any reason, or who are unable to complete the study because of any objective reasons.
References
Publications (12)
- BACKGROUNDScala D, Niglio A, Pace U, Ruffolo F, Rega D, Delrio P. Laparoscopic intersphincteric resection: indications and results. Updates Surg. 2016 Mar;68(1):85-91. doi: 10.1007/s13304-016-0351-6. Epub 2016 Mar 29. PMID 27022927
- BACKGROUNDChi P, Huang SH, Lin HM, Lu XR, Huang Y, Jiang WZ, Xu ZB, Chen ZF, Sun YW, Ye DX. Laparoscopic transabdominal approach partial intersphincteric resection for low rectal cancer: surgical feasibility and intermediate-term outcome. Ann Surg Oncol. 2015 Mar;22(3):944-51. doi: 10.1245/s10434-014-4085-8. Epub 2014 Sep 23. PMID 25245128
- BACKGROUNDFujimoto Y, Akiyoshi T, Kuroyanagi H, Konishi T, Ueno M, Oya M, Yamaguchi T. Safety and feasibility of laparoscopic intersphincteric resection for very low rectal cancer. J Gastrointest Surg. 2010 Apr;14(4):645-50. doi: 10.1007/s11605-009-1150-x. Epub 2010 Jan 22. PMID 20094813
- BACKGROUNDBraun J, Treutner KH, Winkeltau G, Heidenreich U, Lerch MM, Schumpelick V. Results of intersphincteric resection of the rectum with direct coloanal anastomosis for rectal carcinoma. Am J Surg. 1992 Apr;163(4):407-12. doi: 10.1016/0002-9610(92)90042-p. PMID 1532699
- BACKGROUNDPai VD, Sugoor P, Patil PS, Ostwal V, Engineer R, Arya S, Desouza A, Saklani AP. Laparoscopic Versus Open Approach for Intersphincteric Resection-Results from a Tertiary Cancer Center in India. Indian J Surg Oncol. 2017 Dec;8(4):474-478. doi: 10.1007/s13193-017-0672-z. Epub 2017 Jun 21. PMID 29203976
- BACKGROUNDMahalingam S, Seshadri RA, Veeraiah S. Long-Term Functional and Oncological Outcomes Following Intersphincteric Resection for Low Rectal Cancers. Indian J Surg Oncol. 2017 Dec;8(4):457-461. doi: 10.1007/s13193-016-0571-8. Epub 2016 Oct 28. PMID 29203973
- BACKGROUNDDenost Q, Rullier E. Intersphincteric Resection Pushing the Envelope for Sphincter Preservation. Clin Colon Rectal Surg. 2017 Nov;30(5):368-376. doi: 10.1055/s-0037-1606114. Epub 2017 Nov 27.