A Study on the Efficacy of a Novel Approach to Achieving Laparoscopic Distal Rectal Transection for Rectal Cancers

NCT05067413 | Unknown

• 2 other identifiers: 2020149320.6750.2021-04-2
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

Brief Summary

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

Rectal Neoplasms Malignant

Keywords

Laparoscopic; Ultralow rectal cancer; Intersphincteric resection; Total mesorectal excision; Transanterior obturator nerve gateway; Distal rectal transection

Outcome Measures

Primary Outcomes (5)

• The degree of Angle

  The degree of angle between the linear stapler and the longitudinal axis of the rectum when transecting the distal rectum.

  The degree of Angle will be measured on the resected specimen immediately after the surgery.

• The degree of △Angle

  The degree of angle between the simulated stapling line with the total mesorectal excision approach and the real stapling line with the transanterior obturator nerve gateway approach (this outcome is measured only in patients of the experimental group).

  The degree of △Angle will be measured on the resected specimen immediately after the surgery.

• Length of distal resection margin

  The shortest distance between the distal border of the tumor and the edge of the distal resection.

  Length of distal resection margin will be measured by the operator immediately after the surgery and by the pathologist during the pathological test within a week after surgery, the final outcome will be the mean value of the two.

• Rate of conversion to transanal transection and anastomosis of the rectum.

  The gross conversion rate (No. of cases undergoing conversion/total No. of cases enrolled \*100%) will be calculated immediately after the last patient's surgery.

  The gross conversion rate will be calculated immediately after the last patient's surgery.

• Rate of anastomotic leakage

  The gross anastomotic leakage rate (No. of cases diagnosed with anastomotic leakage/total No. of cases enrolled \*100%) will be calculated 6 months after the last patient's surgery. Anastomotic leakage will be diagnosed if the patient has clinically apparent leakage signs (such as the emission of gas, pus, or feces from the pelvic drain, or peritonitis) or extravasation of endoluminally administered watersoluble contrast medium according to CT.

  For each case, whether complicated with anastomotic leakage will be supervised up to 6 months after surgery. The gross rate of anastomotic leakage will be calculated 6 months after the last patient's surgery.

Secondary Outcomes (11)

• Operative time

  Operative time will be recorded immediately after the surgery.

• Volume of blood loss

  The gross volume of blood loss during the operation will be measured and recorded immediately after the surgery.

• Anastomotic height from anal verge

  Anastomotic height will be measured and recorded by the operator using digital rectal exam immediately after the surgery.

• Length of stapling line

  Length of stapling line will be measured directly on the resected specimen immediately after the surgery.

• Postoperative hospital stay

  Postoperative hospital stay will be recorded on the day the patient is discharged from hospital.

Study Arms (2)

Total mesorectal excision approach

SHAM COMPARATOR

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.

Procedure: Total mesorectal excision approach

Transanterior obturator nerve gateway approach

EXPERIMENTAL

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.

Procedure: Transanterior obturator nerve gateway approach

Interventions

Transanterior obturator nerve gateway approach PROCEDURE

Distal rectal transection of cases in the experimental group will be performed using transanterior obturator nerve gateway approach

Transanterior obturator nerve gateway approach

Total mesorectal excision approach PROCEDURE

Distal rectal transection of cases in the control group will be performed using total mesorectal excision approach

Total mesorectal excision approach

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead
• Shengli Oilfield Hospital: collaborator
• The Second Affiliated Hospital of Baotou Medical College: collaborator

Study Sites (4)

The Second Affiliated Hospital of Baotou Medical University

Baotou, Inner Mongolia, 014030, China

Location

Dalian University Affiliated Xinhua Hospital

Dalian, Liaoning, 116000, China

Location

Shengli Oilfield Hospital

Dongying, Shandong, 257034, China

Location

The Third People's Hospital of Datong

Datong, Shanxi, 037001, China

Location

Related Publications (12)

• Scala 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 BACKGROUND

• Chi 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 BACKGROUND

• Fujimoto 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 BACKGROUND

• Braun 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 BACKGROUND

• Pai 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 BACKGROUND

• Mahalingam 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 BACKGROUND

• Denost 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.

  PMID: 29184472 BACKGROUND

• Park SY, Choi GS, Park JS, Kim HJ, Ryuk JP. Short-term clinical outcome of robot-assisted intersphincteric resection for low rectal cancer: a retrospective comparison with conventional laparoscopy. Surg Endosc. 2013 Jan;27(1):48-55. doi: 10.1007/s00464-012-2405-2. Epub 2012 Jun 30.

  PMID: 22752275 BACKGROUND

• Bi L, Deng X, Meng X, Yang X, Wei M, Wu Q, Ren M, Wang Z. Ligating the rectum with cable tie facilitates rectum transection in laparoscopic anterior resection of rectal cancer. Langenbecks Arch Surg. 2020 Mar;405(2):233-239. doi: 10.1007/s00423-020-01863-6. Epub 2020 Apr 8.

  PMID: 32266529 BACKGROUND

• Hotta T, Takifuji K, Yokoyama S, Matsuda K, Oku Y, Hashimoto T, Yamamoto N, Yamaue H. Rectal transection by the Nelaton catheter pulling method during a laparoscopic low anterior resection. Dis Colon Rectum. 2011 Apr;54(4):495-500. doi: 10.1007/DCR.0b013e318207026f.

  PMID: 21383572 BACKGROUND

• Park SJ, Choi SI, Lee SH, Lee KY. Endo-satinsky clamp for rectal transection during laparoscopic total mesorectal excision. Dis Colon Rectum. 2010 Mar;53(3):355-9. doi: 10.1007/DCR.0b013e3181c388e9.

  PMID: 20173486 BACKGROUND

• Brannigan AE, De Buck S, Suetens P, Penninckx F, D'Hoore A. Intracorporeal rectal stapling following laparoscopic total mesorectal excision: overcoming a challenge. Surg Endosc. 2006 Jun;20(6):952-5. doi: 10.1007/s00464-005-0536-4. Epub 2006 May 12.

  PMID: 16738989 BACKGROUND

Study Officials

• Jianqiang Tang, MD

  Peking University First Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: October 5, 2021
• Study Start: December 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2025
• Last Updated: October 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)