Trial Title:
A Clinical Trial Comparing Staged Turnbull-Cutait Pull-through Anastomosis With Direct Anastomosis Plus Prophylactic Ileostomy in the Treatment of Low Rectal Cancer After Internal Sphincter Resection
NCT ID:
NCT06662643
Condition:
Rectal Cancer
Rectal Carcinoma
Conditions: Official terms:
Rectal Neoplasms
Conditions: Keywords:
Low Rectal Cancer
Turnbull-Cutait
Pull-through
Internal Sphincter Resection
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
Delayed transanal pull-through anastomosis
Description:
Laparoscopic surgery is recommended. A standard 5-port method is used to create
pneumoperitoneum after placing the trocar. The sigmoid colon and upper rectal mesentery
are dissected along Toldt's fascia. Autonomic nerves should be preserved, and high
ligation of the inferior mesenteric vessels with lymph node dissection is recommended.
TME: Using a posterior-to-anterior approach, the mesorectal plane is dissected down to
the pelvic floor, cutting the Waldeyer's fascia to enter the intersphincteric space,
where sharp dissection is carried out toward the levator ani muscle hiatus. The
dissection endpoint is the dentate line, where the proximal colon is exteriorized by at
least 2 cm and sutured to the anal canal with 6-8 stitches, without a protective
ileostomy.Two to four weeks after the first surgery, after the colon has adhered well to
the surrounding tissue, the exteriorized colon is excised (under epidural or spinal
anesthesia, trimming the exteriorized colon to form the anus).
Arm group label:
Staged Turnbull-Cutait Pull-through anastomosis group
Intervention type:
Procedure
Intervention name:
Direct Anastomosis Plus Prophylactic Ileostomy
Description:
ISR is categorized into partial ISR (PISR), subtotal ISR, and total ISR (TISR).
Correspondingly, the anastomosis site after coloanal anastomosis is located below the
levator ani hiatus (PISR, near the dentate line; subtotal-ISR and TISR, below the dentate
line).The dissection steps are the same as in the first stage of the Staged
Turnbull-Cutait Pull-through Anastomosis group (TME and intersphincteric space
dissection).The bowel is transected at least 1 cm below the tumor, leaving a larger
segment of healthy tissue on the non-tumor side while ensuring that no more than 1/3 of
the dentate line is resected to avoid impairing fecal control.Anastomosis is performed
using absorbable sutures under direct visualization. A protective ileostomy is created
25-30 cm from the ileocecal valve.3 to 6 months after surgery, the ileostomy is reversed.
Prior to closure, digital rectal examination, defecography, MRI, colonoscopy, and other
evaluation must perform.
Arm group label:
Direct anastomosis plus protective ileostomy group
Summary:
This study targets patients undergoing ultra-low rectal cancer surgery, which requires
internal sphincter resection for sphincter-saving procedures. The study compares the
staged Turnbull-Cutait Pull-through anastomosis (a delayed transanal pull-through
anastomosis without a protective stoma) as the experimental group with traditional
anastomosis (hand-sewn/stapled) plus protective ileostomy as the control group. The aim
is to assess whether the Turnbull-Cutait Pull-through colon-anal anastomosis is
non-inferior to traditional ISR surgery in terms of complications (short-term such as
anastomotic leakage/dehiscence, pelvic infection, anastomotic bleeding, ischemic bowel
necrosis, bowel obstruction, and long-term complications such as anastomotic stricture,
perianastomotic fistula, bowel obstruction, stoma-related complications, and others),
postoperative anal function, quality of life, long-term oncologic outcomes, hospital stay
duration, and total hospitalization costs.
Detailed description:
In recent years, with the increasing understanding of the anatomy and physiological
functions of the lower rectum, the biological behavior of rectal cancer tumors,
advancements in new surgical technologies, and the application of comprehensive treatment
methods, there has been growing emphasis on radical surgical procedures for low rectal
cancer that balance oncological safety with anal function preservation. After undergoing
total mesorectal excision for low rectal cancer and subsequent coloanal anastomosis,
patients often face a high risk of anastomotic leakage and pelvic infection. Therefore, a
protective ileostomy is usually performed to divert feces, providing a relatively
low-perfusion environment conducive to healing for ultra-low coloanal anastomoses. In the
event of an anastomotic leak, the protective stoma can mitigate infection and reduce the
likelihood of secondary surgeries. Nevertheless, complications following protective
ileostomy, such as dehydration, chronic renal failure, and parastomal hernia, occur at
rates as high as 43% . Additionally, complications related to stoma reversal exceed 20% ,
all of which significantly impact patients' quality of life. Approximately one-fifth of
patients with preventive stomas are unable to have their stomas reversed as planned, or
may require lifelong stoma formation.
In 1961, Turnbull and Cutait independently reported surgical techniques involving
transanal pull-through rectal resection and delayed manual coloanal anastomosis. From a
certain perspective, this procedure is the safest reconstructive method, effectively
reducing anastomotic leakage-related complications and avoiding the need for a protective
stoma. In recent years, its clinical application in challenging rectal cases involving
radiation proctitis, complex recto-vaginal/urethral fistulas, salvage surgeries for
anastomotic leaks, and low-stage progressive rectal cancer has gained increasing
attention and acceptance.In 2020, a multicenter randomized controlled study published in
JAMA Surgery found that the delayed anastomosis group (avoiding protective stoma) did not
increase the incidence of anastomotic leaks or other complications compared to the
standard coloanal anastomosis plus ileostomy group, and exhibited comparable oncological
and functional outcomes . Furthermore, a recent systematic review in 2022 included one
randomized controlled trial and nine observational studies with a total of 1,743
patients. This study found that staged Turnbull-Cutait anastomosis was associated with a
reduced rate of anastomotic leaks.
However, the aforementioned studies and systematic reviews on staged Turnbull-Cutait
anastomosis were all based on total mesorectal excision (TME), and there is a paucity of
data on postoperative anal function and quality of life following this procedure,
necessitating further research. As an extreme sphincter-saving surgery, ISR is currently
limited in widespread adoption due to the high incidence of postoperative complications
and suboptimal functional outcomes associated with anastomoses located very close to the
anal verge. To date, there is a lack of systematic studies applying the Turnbull-Cutait
Pull-through anastomosis to ISR procedures. Therefore, it is highly worthwhile to conduct
a multicenter prospective randomized controlled study to determine whether the modified
Bacon procedure (transanal pull-through, delayed anastomosis) can serve as an effective
alternative to ISR-coloanal anastomosis, achieving comparable or lower rates of
postoperative complications, as well as equivalent oncological radicality and defecatory
function. Such research is urgently needed in this largely unexplored field. If
successfully conducted and achieving its objectives, this clinical study could provide
highly valuable guidance for clinical practice. Existing reports on the application of
the modified Bacon procedure in low rectal cancer are generally small-sample,
single-center, retrospective studies with low levels of evidence. This study aims to
provide higher-level evidence through a larger-sample, prospective, multicenter,
randomized controlled design.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Histopathologically confirmed high- or moderate-grade adenocarcinoma or villous
adenoma with malignancy on preoperative colonoscopy; tumor located ≤ 5 cm from the
anal verge; primary tumor size < 5 cm in diameter.
2. All enrolled patients require intersphincteric dissection. PISR surgery must be
completed with hand-sewn (preferably) or stapled coloanal anastomosis. The
anastomosis should be located near the dentate line (intraoperative photos or videos
must be preserved).
3. Both male and female patients aged 18-75.
4. Non-recurrent rectal cancer.
5. No concurrent multiple primary colorectal cancers.
6. Initial staging or post-neoadjuvant therapy stage: T3 above the levator ani, T1-2
below.
7. Liver or lung oligometastases deemed resectable after evaluation by a
multidisciplinary team (MDT).
8. Patients may or may not have received neoadjuvant chemoradiotherapy.
9. Patients and families must understand and be willing to participate in this study,
providing written informed consent.
10. Good anal function (Wexner incontinence score ≤ 5).
Exclusion Criteria:
1. History of malignant colorectal tumors.
2. Previous colorectal or anorectal surgeries or diseases.
3. Patients requiring emergency surgery due to intestinal obstruction, perforation, or
bleeding.
4. Tumor invasion into the external sphincter, levator ani, or adjacent organs
requiring combined organ resection.
5. Poor preoperative anal function or incontinence (Wexner incontinence score ≥ 6).
6. History of inflammatory bowel disease (IBD) or familial adenomatous polyposis (FAP).
7. Recent diagnosis of other malignancies.
8. Participation in other clinical trials within the 4 weeks prior to enrollment.
9. ASA classification ≥ IV or ECOG performance status ≥ 2.
10. Severe hepatic, renal, cardiopulmonary, or coagulation dysfunction or serious
underlying disease precluding surgery.
11. History of severe mental illness.
12. Pregnant or breastfeeding women.
13. Uncontrolled preoperative infection.
14. Other clinical or laboratory findings making the patient unsuitable for the study,
as judged by the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of colorectal and anal surgery, Zhongnan Hospital of Wuhan University
Address:
City:
Wuhan
Zip:
430067
Country:
China
Start date:
May 8, 2024
Completion date:
December 30, 2029
Lead sponsor:
Agency:
Zhongnan Hospital
Agency class:
Other
Collaborator:
Agency:
Ezhou Central Hospital
Agency class:
Other
Collaborator:
Agency:
Jingzhou Central Hospital
Agency class:
Other
Collaborator:
Agency:
Taihe Hospital
Agency class:
Other
Collaborator:
Agency:
Suizhou Central Hospital
Agency class:
Other
Collaborator:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Collaborator:
Agency:
Beijing Chaoyang Hospital Affiliated to Capital Medical University
Agency class:
Other
Collaborator:
Agency:
Tianmen First People's Hospital
Agency class:
Other
Collaborator:
Agency:
Xiangyang Central Hospital
Agency class:
Other
Collaborator:
Agency:
Xiangyang First People's Hospital
Agency class:
Other
Collaborator:
Agency:
Xiaogan Central Hospital
Agency class:
Other
Collaborator:
Agency:
Yichang Central People's Hospital
Agency class:
Other
Collaborator:
Agency:
Yichang Second People's Hospital
Agency class:
Other
Collaborator:
Agency:
Rocket Force Special Medical Center of the People's Liberation Army
Agency class:
Other
Collaborator:
Agency:
Huashan Hospital
Agency class:
Other
Source:
Zhongnan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06662643
