A Retrospective Cohort Study Evaluating the Safety and Clinical Efficacy of a Novel Anastomotic Technique for Restoring Ileocecal Valve Function During Laparoscopic Radical Resection of Right-Sided Colon Cancer
Conditions: Radical Right Hemicolectomy
Sponsor: Army Medical University, China

A Retrospective Cohort Study on the Safety and Clinical
Efficacy of an Anastomotic Technique for Ileocecal Valve
Function Reconstruction During Laparoscopic Right
Hemicolectomy for Colon Cancer
(Observational Clinical Study Protocol)
Department:
General Surgery
Principal Investigator：
Weidong Xiao
Contact Number:
+86-13996390860
Version Number:
1.0
Version Date:
June 26, 2025

1. Background
With changes in dietary habits and lifestyle, colorectal cancer has become the fourth
leading cause of cancer-related death worldwide, with a higher incidence in males
than females. The disease is increasingly showing trends of higher incidence and
younger onset 1−2. In China, the incidence of colorectal cancer is growing at an annual
rate of approximately 2% 3, posing a significant burden on the healthcare system and
society. Currently, surgical resection remains the primary treatment for colorectal
cancer. With the advancement of minimally invasive surgery (MIS), the safety and
efficacy of laparoscopic colorectal cancer resection have been widely validated and
adopted 4.
However, the optimal technique for bowel anastomosis remains a subject of debate.
Some studies suggest that totally laparoscopic anastomosis better aligns with the
principles of MIS and oncological clearance compared to extracorporeal anastomosis
5. Nevertheless, the complexity, longer operative time, and the requirement for highly
experienced surgeons limit its widespread application. Furthermore, there is ongoing
debate over side-to-side versus end-to-side anastomosis. Some literature reports
suggest that side-to-side anastomosis may be associated with a higher incidence of
postoperative bowel obstruction 6.
On one hand, advances in anatomical understanding—particularly the development of
the mesocolic plane theory—and improvements in surgical instruments have
significantly extended patient survival and reduced recurrence rates. On the other
hand, patients’ expectations regarding postoperative quality of life are also increasing.
Since the anastomotic technique is closely linked to postoperative bowel function and
complications, there is a growing clinical demand to optimize bowel reconstruction in
a way that preserves or restores physiological function while ensuring oncologic
radicality.
The ileocecal valve (ICV) functions as a sphincteric structure separating the small and
large intestines. It regulates the passage of intestinal contents under the influence of
hormonal and neural control
7. Some scholars propose that the concept of the
“ileocecal region” better reflects the physiological role of this anatomical structure 8.
For tumors located in the ascending colon or proximal hepatic flexure, resection often
includes removal of the ICV and part of the terminal ileum. Current anastomotic
techniques rarely address reconstruction of the ICV or its potential impact on
postoperative gastrointestinal function.
Existing studies suggest that preserving the ICV during extended right hemicolectomy
is both safe and feasible without compromising oncologic outcomes, while also
promoting faster bowel function recovery 9. Although this is a promising direction,

many patients, due to tumor location, still require resection of the ICV, leading to
several clinical challenges.
The concept of ICV reconstruction was first proposed by Kellogg in 1918
10.
Subsequent animal studies demonstrated that ICV reconstruction improved weight
gain, prevented reflux, and enhanced nutritional status, indicating potential clinical
benefits 11. Clinically, ICV reconstruction has been applied in pediatric patients with
congenital ileocecal valve atresia and in patients undergoing ICV resection for
non-malignant
reasons,
yielding
satisfactory
results.
However,
the
long-term
outcomes remain controversial 12−13.
In patients undergoing right hemicolectomy, removal of the ICV compromises the
natural bacterial barrier, allowing colonic bacteria to migrate into the terminal ileum
and even the proximal small intestine. Under certain conditions, this can lead to small
intestinal bacterial overgrowth (SIBO), manifesting as abdominal distension, diarrhea,
and severe malabsorption of bile acids, vitamin B12, fatty acids, and other nutrients
14.
Our
research
team
previously
established
an
animal
model
using
a
"Roll-Intussuscepted Sleeve Embedding" (RISE) anastomosis technique, which
showed improved outcomes compared to conventional anastomosis. Rats in the RISE
group experienced faster weight gain, earlier stool formation, and restoration of gut
microbiota closer to preoperative levels.
Based on these findings, reconstructing the function of the ICV during laparoscopic
right hemicolectomy may offer a solution to the aforementioned clinical problems.
However, to date, no studies have systematically evaluated the clinical efficacy or
safety of ICV reconstruction in right hemicolectomy for colon cancer. Therefore, this
retrospective cohort study aims to assess the safety, feasibility, and clinical outcomes
of an anastomotic technique designed to reconstruct ICV function, with the goal of
improving postoperative recovery and quality of life for patients.
Reference：
1. Dekker E, Tanis PJ, Vleugels JLA, Kasi PM, Wallace MB. Colorectal cancer.
Lancet (London, England). 2019;394(10207):1467-1480.
2. Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global
cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide
for
36
cancers
in
185
countries.
CA:
a
cancer
journal
for
clinicians.
2018;68(6):394-424.
3. Chen W, Zheng R, Baade PD, et al. Cancer statistics in China, 2015. CA: a
cancer journal for clinicians. 2016;66(2):115-132.
4.Lacy AM, García-Valdecasas JC, Delgado S, et al. Laparoscopy-assisted
colectomy versus open colectomy for treatment of non-metastatic colon cancer: a
randomised trial. Lancet (London, England). 2002;359(9325):2224-2229.

5.Ibañez N, Abrisqueta J, Luján J, Hernández Q, Parrilla P. Isoperistaltic versus
antiperistaltic side-to-side anastomosis after right laparoscopic hemicolectomy for
cancer (ISOVANTI) trial: study protocol for a randomised clinical trial. Int J
Colorectal Dis. 2017;32(9):1349-1356.
6. Baqar AR, Wilkins S, Wang WC, et al. A comparison of extracorporeal side to
side or end to side anastomosis following a laparoscopic right hemicolectomy for
colon cancer. ANZ J Surg. 2022;92(6):1472-1479.
7. Phillips SF, Quigley EM, Kumar D, Kamath PS. Motility of the ileocolonic
junction. Gut. 1988;29(3):390-406.
8. Shafik AA, Ahmed IA, Shafik A, Wahdan M, Asaad S, El Neizamy E.
Ileocecal junction: anatomic, histologic, radiologic and endoscopic studies with
special reference to its antireflux mechanism. Surg Radiol Anat. 2011;33(3):249-256.
9. Miller LS, Vegesna AK, Sampath AM, Prabhu S, Kotapati SK, Makipour K.
Ileocecal valve dysfunction in small intestinal bacterial overgrowth: a pilot study.
World J Gastroenterol. 2012;18(46):6801-6808.
10.Kellogg
JH.
TECHNIC
OF
OPERATION
FOR
REPAIR
OF
THE
ILEOCAECAL VALVE: WITH SUMMARY OF THE RESULTS IN A SERIES OF
TWENTY-SIX CASES. Annals of surgery. 1918;67(1):83-93.
11. Careskey J, Weber TR, Grosfeld JL. Ileocecal valve replacement. Its effect on
transit time, survival, and weight change after massive intestinal resection. Archives
of surgery (Chicago, Ill: 1960). 1981;116(5):618-622.
12. Cacciari A, Mordenti M, Ceccarelli PL, Ruggeri G. Ileocaecal valve atresia:
our surgical approach. European journal of pediatric surgery : official journal of
Austrian Association of Pediatric Surgery
[et al] = Zeitschrift fur Kinderchirurgie.
2004;14(6):435-439.
13. Johnston D, Holdsworth PJ, Smith AH. Preservation of ileocecal junction and
entire anal canal in surgery for ulcerative colitis--a "two-sphincter" operation.
Diseases of the colon and rectum. 1989;32(7):555-561.
14.Dekker E, Tanis PJ, Vleugels JLA, Kasi PM, Wallace MB. Colorectal cancer.
Lancet (London, England). 2019;394(10207):1467-1480.
2. Objectives
This is a retrospective study that systematically collects data from patients who have
undergone laparoscopic radical right hemicolectomy for colon cancer in our
department. Patients are categorized into two groups based on the type of anastomosis:
the conventional anastomosis group and the ileocecal valve function reconstruction
group. This study aims to investigate the impact of ileocecal valve (ICV) function
reconstruction on postoperative complications and bowel function recovery in patients
following right hemicolectomy.

The outcomes of interest include anastomotic leakage, anastomotic bleeding,
anastomotic stenosis, wound infection, time to first flatus, time to first defecation,
time to stool formation, incidence of postoperative diarrhea, and Bristol Stool Form
Scale classification.
Primary Objective
To evaluate the safety and feasibility of an anastomotic technique designed to
reconstruct ileocecal valve function during laparoscopic right hemicolectomy.
Secondary Objective
To evaluate the clinical efficacy of ileocecal valve function reconstruction in
laparoscopic right hemicolectomy, focusing on postoperative recovery of bowel
function and reduction in gastrointestinal complications.
3. Study Design
3.1 Overall Study Design
This study is a retrospective cohort study. Clinical data will be collected and analyzed
from patients who underwent laparoscopic radical right hemicolectomy for colon
cancer in our department. Patients will be categorized into two groups based on the
type of anastomosis: the conventional anastomosis group and the ileocecal valve
reconstruction group.
3.2 Study Setting and Population
This is a single-center observational study. All clinical data are derived from patients
who have previously undergone laparoscopic radical right hemicolectomy in the
Department of General Surgery.
Patients will be grouped according to the type of anastomosis (exposure factor):
Conventional Anastomosis Group:
Conventional anastomosis is defined as follows: After transecting the intestine 10 cm
proximal to the ileocecal valve and 10 cm distal to the tumor using a linear stapler, the
specimen is removed. The stapled ends are disinfected with alcohol. A side-to-side
ileocolic anastomosis is performed using a linear stapler. The common enterotomy is
closed with additional reinforcement sutures (3-0 absorbable sutures). Anastomotic
integrity, patency, and blood supply are verified to ensure no leakage.
Ileocecal Valve Reconstruction Group (RISE Anastomosis):

This study focuses on a novel anastomotic technique aimed at reconstructing ileocecal
valve function, based on literature review and accumulated surgical experience. The
method is referred to as Revolute Insert Side-End Ileocecal Valve Reconstruction
(RISE-ICVR), or simply the RISE Anastomosis. This technique is designed to
recreate the physiological valve structure that separates the bacterial-rich colon from
the relatively sterile small intestine, adhering to the principle that "form determines
function."
Surgical steps include:
1.
After resecting the tumor and relevant bowel segments within oncological safety
margins, the terminal ileum is everted at three equidistant points using 3-0 sutures
to form an "artificial ileocecal valve."
2.
A longitudinal incision of approximately 2 cm is made in the colonic wall, about
2 cm from the stapled colon end, along the taenia coli.
3.
After confirming that there is no mesenteric twisting, the ileal stump is inserted
into the colonic incision. Three anchoring sutures are placed between the
midpoint of each ileal suture and the colonic wall.
4.
A barbed suture is then used to continuously suture the ileal stump to the colonic
wall, creating a sleeve-like embedded anastomosis while simultaneously closing
the mesenteric defect between the bowel segments.

This technique complies with the technical standards outlined in the "Expert
Consensus on Digestive Tract Reconstruction After Colorectal Resection." All
patients underwent standard laparoscopic radical right hemicolectomy.
3.2.1 Inclusion Criteria
Participants must meet all of the following criteria:
1.
Aged between 18 and 80 years;
2.
American Society of Anesthesiologists (ASA) physical status score of ≤3;
3.
First-time diagnosis of colon cancer located in the appendix, cecum, ascending
colon, hepatic flexure, or the right one-third of the transverse colon, including
patients requiring additional surgery based on post-endoscopic pathological
findings;
4.
No history of other gastrointestinal diseases (except for benign conditions such as
intestinal polyps or gallstones);
5.
Complete and accessible clinical data.
3.2.2 Exclusion Criteria
Participants will be excluded if they meet any of the following conditions:
1.
Concurrent diagnosis of other malignant tumors;
2.
Presence of infectious diseases or autoimmune diseases (e.g., Crohn’s disease);
3.
Surgical plan changes resulting in the ileocecal valve not being included in the
resection;
4.
Incomplete or missing clinical data.

3.3 Sample Size
This is a retrospective cohort study. Based on screening of the hospital's electronic
medical records and application of the predefined inclusion and exclusion criteria, a
total of 50 patients were included. Among them, 30 patients underwent conventional
anastomosis and 20 patients underwent ileocecal valve reconstruction. All surgeries
and follow-up were conducted in the Department of General Surgery, Second
Affiliated Hospital of Army Medical University.
3.4 Study Factors and Observation Indicators
Clinical data will be collected
from
patients undergoing
laparoscopic right
hemicolectomy in the Department of General Surgery, Second Affiliated Hospital of
Army Medical University, starting from the date of ethics committee approval.
Observation Indicators:
Surgical Safety and Feasibility:
Successful completion of surgery without anastomotic leakage, anastomotic bleeding,
or stenosis.
No severe perioperative complications.
Intraoperative Indicators:
Total operative time
Anastomosis time
Intraoperative blood loss
Intraoperative blood transfusion volume
Incision length
Proximal and distal resection margins
Total number of lymph nodes harvested
Number of positive lymph nodes
Postoperative Indicators:
Postoperative complications within 30 days
Postoperative inflammatory markers
Time to first flatus
Time to first bowel movement
Time to first ambulation
Time to formed stool
Length of hospital stay
Reoperation rate
Readmission rate
Mortality rate
Bristol Stool Form Scale (BSFS) score
Defecation frequency

Urgency frequency
Incidence of fecal incontinence
Follow-up Indicators:
Anastomotic healing status
Gastrointestinal contrast imaging (e.g., iodine-based contrast, upper GI barium meal)
Colonoscopy findings
Metabolic parameters:
blood glucose, lipid profile, glycated hemoglobin (HbA1c), and other physiological
indicators
3.5 Data Collection Method
All clinical data are obtained from the hospital’s electronic medical record (EMR)
system. A dedicated research coordinator is responsible for data extraction and
verification.
3.6 Study Endpoints
Primary Endpoint:
Postoperative complications within 30 days, specifically anastomotic leakage,
anastomotic bleeding, and anastomotic stenosis.
Secondary Endpoints:
Time to first flatus
Time to first bowel movement
Time to formed stool
3.7 Data Management and Statistical Analysis
Statistical analyses will be performed using SPSS version 22.0.Categorical variables
will be expressed as n (%) and compared using the Chi-square (χ²) test.Continuous
variables will be tested for normality using the Shapiro-Wilk test (S-W test). Data
conforming to normal distribution will be presented as mean ± standard deviation (x̄
± s), and comparisons between groups will be performed using the t-test.A P-value <
0.05 will be considered statistically significant.
4. Study-Related Costs

4.1 Budget
This is a retrospective cohort study. Data collection and analysis do not require
dedicated funding.
4.2 Funding Source
None.
4.3 Financial Burden to Participants
All patients included in this study have completed surgery and were discharged prior
to study initiation. This study involves retrospective data analysis only and will
impose no additional financial burden on participants.
5. Quality Control
This study will be led by a senior chief physician with extensive clinical and research
experience. All other team members have completed Good Clinical Practice (GCP)
training and will be responsible for patient observation, data recording, and data
management. The overall quality of the study will be strictly controlled and ensured
throughout the research process.
6. Ethical Principles and Requirements
This clinical study will adhere to the ethical principles outlined in the Declaration of
Helsinki (World Medical Association) and comply with the "Administrative Measures
for Ethical Review of Life Science and Medical Research Involving Humans" issued
by the People’s Republic of China.
Key ethical considerations include:
Informed Consent:
Before the study begins, the study protocol will be reviewed and approved by the
Ethics Committee. If this study is not granted exemption from informed consent, the
investigator has the responsibility to fully inform each participant and/or their legal
representative about the study’s purpose, procedures, and potential risks before
enrollment.
Written informed consent will be obtained from all participants. Participation is
entirely voluntary, and subjects may refuse to participate or withdraw from the study
at any time without discrimination, penalty, or impact on their standard medical care
or legal rights.
Privacy and Confidentiality Protection:
Investigators will take strict measures to protect the privacy and confidentiality of
participants’ personal information. All study data will be stored securely at the Second
Affiliated Hospital of Army Medical University.

Exceptions to privacy protection will apply only in circumstances required by law or
regulation,
allowing
study-related
personnel,
regulatory
authorities,
or
ethics
committees to review individual participant data when necessary for study oversight.
Risk Control and Compensation for Research-Related Harm:
The research team commits to minimizing risk and will provide appropriate protection
for vulnerable populations if involved. Any research-related injury will be addressed
according to applicable laws and regulations.
Data Protection Measures:
To safeguard personal data confidentiality, measures will include:
Removal or anonymization of identifiable information in study reports
Access restrictions for identifiable data
Use of data encryption and anonymization procedures where applicable
Ensuring that any publication or presentation of study results will not reveal
individual participant identities
The research team hereby solemnly pledges to make every effort, within the limits
permitted by law, to protect participants' personal privacy and data confidentiality.
7. Study Timeline
June 2024 – August 2024:
Strictly collect patient medical records according to the inclusion and exclusion
criteria. Complete clinical data collection and preliminary data analysis.
September 2024 – December 2024:
Complete statistical analysis of the collected data. The principal investigator and core
research team will review the results, organize manuscript preparation, and
summarize the findings for publication and further improvement suggestions.
8. Study Team Members
8.1 On-Site Study Team Members
Name
Department Title
Institution Role in Study
GCP
Training
Date
Contact Number
Weidong
Xiao
General
Surgery
Chief
Physician
Xinqiao
Hospital
Principal
Investigator
April
2017
+86-13996390860
Guangsheng
Du
General
Surgery
Associate
Chief
Physician
Xinqiao
Hospital
Study Design February
2022
+86-18983380613

Name
Department Title
Institution Role in Study
GCP
Training
Date
Contact Number
Enlai Jiang
General
Surgery
Attending
Physician
Xinqiao
Hospital
Data
Collection and
Statistical
Analysis
May
2017
+86-18875114112
Kun Yu
General
Surgery
Resident
Physician
Xinqiao
Hospital
Data
Collection and
Manuscript
Preparation
None
+86-15826050221