Neoplasms

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Carcinoma

Rectal Neoplasms

Colorectal Neoplasms

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Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

KOL stapler was used for rectal anastomosis

traditional stapler was used for rectal anastomosis

KOL staple was used for rectal anastomosis

traditional staple was used for rectal anastomosis

traditional staple

Li Xin-Xiang, M.D & Ph.D.

Li Yi-Wei, M.D & Ph.D.

SANJUN CAI, DOCTOR

XINXIANG LI, DOCTOR

YIWEI LI, DOCTOR

The most challenge for the surgery of low rectal carcinoma was whether to perform low anterior resection (LAR) and preserve anal function improving the quality of life for patients, for which anastomotic leak is a great obstacle with about 5-10% incidence in reported literature. Up to now, kinds of surgical devices have been employed to reduce anastomotic leak rate after LAR. Most of these anastomotic devices could not resolve the problem of "dog ear" phenomena. In the present clinical trial, the investigators use a double purse-string rectal anastomosis with KOL staple in laparoscopic anterior rectal resection for low or ultra-low rectal carcinoma, which will resolve the problem of dog ear. The investigators aim to demonstrate the safety, effectiveness of this procedure and establish a standard method for laparoscopic (ultra-)low anterior rectal resection.

About 5-10% of patients receiving low rectal resection using traditional anastomosis occurred anastomotic leak, risk factors for which included patient related (age, gender, tumor distance from the anal verge), hypoproteinemia, diabetes mellitus, etc), procedure related (emergency) and technical related (one stapler, double stapler or handsewn).

Anastomotic leak caused prolonged hospital stay, delayed post-operative adjuvant radiochemotherapy and need of stoma in some cases. Besides, anastomotic leak was reported to be associated with increased local recurrence rate. Thus, it's of great importance to develop new surgical devices to prevent "dog ear" problem and reduce the anastomotic leak rate.

Double stapled pursestring anastomosis was the one of the most widely used methods in lower rectal resection. One major problem of this procedure was creating one or double side "dog ear" phenomenon (Dis Colon Rectum. 2000 Apr;43(4):522-5. Fig 1). This weak spot was theoretically responsible for post-operative anastomotic leak as demonstrated by animal experiments and clinical practice.

In this clinical trial, we used a transanal double purse-string rectal anastomosis preformed with KOL stapler for lower rectal resection. This procedure would resolve the dog ear problem through circular anastomosis taking care that the anastomotic site contained only gut tissues without any staples. We aim to demonstrate the safety, effectiveness of this procedure and establish a standard method for laparoscopic (ultra-)low anterior rectal resection.

A Prospective Clinical Study for Transanal Double Purse-string Rectal Anastomosis Preformed With KOL Stapler

A Prospective Randomized Clinical Study for Transanal Double Purse-string Rectal Anastomosis Preformed With KOL Stapler

percentage of patients occuring anastomotic leak within 30 days since surgery

Fudan University

professor of colorectal surgery

Anti-Infective Agents

All Drugs and Chemicals

Anti-Bacterial Agents

Antibiotics, Antitubercular

Participants in this arm do not undergo the intervention of a protective ileostomy. The management for this group involves. The outcomes for this arm will be assessed in comparison to the group that receives the protective ileostomy. This arm serves as the control/comparative group to evaluate the impact of the intervention on the specified outcomes.

Ileostomy Arm Description: Participants in this arm undergo the intervention of a protective ileostomy. The surgical procedure involves. This arm serves as the experimental group to evaluate the impact of the protective ileostomy on specified outcomes. The outcomes for this arm will be compared to those in the non-interventional (comparative) arm to assess the effectiveness and potential benefits of the ileostomy intervention.

Preparation of the bowel was performed before surgery with the administration of intravenous perioperative antibiotic prophylaxis. The surgical procedure was performed by laparotomy, with resection of the rectum and mesorectum (TME) up to the level of the pelvic diaphragm, sparing the autonomic nerves. End-to-end anastomosis was performed either with a stapler or by hand-sewn.

protective ileostomy

The purpose of this prospective comparative cohort study was to assess the effect of protective ileostomy on the outcomes of patients with rectal cancer who underwent low anterior rectal (LAR) resection in patients with a diagnosis of colorectal cancer of both sexes and all ages that required low anterior resection(LAR) attending the Department of General Surgery at Tishreen University Hospital in Lattakia-Syria during the two years (May 2021- May 2023). the main question to answer is does protective ileostomy reduce leakage, SSI rate, and duration of hospitalization in patients with colorectal cancer. . Patients are divided into two groups: group 1: patients who underwent ileostomy (19 patients), and group 2 is the comparative group: patients who didn't (28 patients). Morbidity and mortality were compared between the two groups, to study the outcomes of protective ileostomy

Anastomotic leakage is encountered frequently after colorectal cancer (CRC) surgery, which is considered one of the potentially lethal complications, affecting the quality of life and increasing hospital costs. The role of a protective stoma has been debated. Therefore, The purpose of this study was to assess the effect of protective ileostomy on the outcomes of patients with rectal cancer who underwent low anterior rectal (LAR) resection.

This is a prospective comparative study of a group of patients with a diagnosis of colorectal cancer of both sexes and all ages that required low anterior resection(LAR) attending the Department of General Surgery at Tishreen University Hospital in Lattakia-Syria during the two years (May 2021- May 2023). The exclusion criteria were patients who underwent abdominoperineal resection with permanent ileostomy. The following workup included: a history and physical examination.

Preparation of the bowel was performed before surgery with the administration of intravenous perioperative antibiotic prophylaxis. The surgical procedure was performed by laparotomy, with resection of the rectum and mesorectum (TME) up to the level of the pelvic diaphragm, sparing the autonomic nerves. End-to-end anastomosis was performed either with a stapler or by hand-sewn. Patients were assigned to group I (19 patients) who had undergone temporary ileostomy, and group II (28 patients) who didn't undergo ileostomy. Patients were followed up at regular intervals and outcomes were compared between two groups.

The surgical procedure was performed by laparotomy, with resection of the rectum and mesorectum (TME) up to the level of the pelvic diaphragm, sparing the autonomic nerves. End-to-end anastomosis was performed either with a stapler or by hand-sewn. Patients were assigned to group I (19 patients) who had undergone temporary ileostomy, and group II (28 patients) who didn't undergo ileostomy. Patients were followed up at regular intervals and outcomes were compared between two groups.

No blinding or masking is implemented in this open-label study. Both participants and healthcare providers are aware of the intervention status. This design allows for transparency in the treatment approach, and outcomes will be assessed without blinding. The lack of masking is a characteristic of the study design and does not impact the validity of the results.

The Effects of Temporary Ileostomy on Outcome in Patients With Rectal Cancer

The Effects of Temporary Ileostomy on Outcome in Patients With Rectal Cancer, A Prospective Comparative Cohort Study

The Duration of Surgery is a critical parameter measured from the initiation of the surgical incision to the closure of the incision. This outcome is pivotal in understanding the efficiency and complexity of the surgical procedure. It encompasses the time required for key stages, such as tumor resection, anastomosis, and closure. A shorter duration may indicate a more streamlined and less invasive procedure, potentially contributing to reduced patient morbidity and improved postoperative outcomes. Monitoring the Duration of Surgery as a primary outcome provides valuable insights into the procedural intricacies and overall efficiency of the interventions, aiding in the evaluation of the protective ileostomy's impact on surgical timelines.

The Duration of Hospitalization refers to the total time a patient spends in the hospital after undergoing low anterior rectal (LAR) resection with or without protective ileostomy. This outcome is crucial in assessing the postoperative recovery period and resource utilization. A shorter duration may indicate a smoother recovery and reduced postoperative complications, potentially contributing to decreased healthcare costs. Monitoring the Duration of Hospitalization as a primary outcome provides essential information about the impact of protective ileostomy on the length of hospital stay, aiding in the evaluation of its influence on patient recovery and healthcare resource management.

Anastomosis leakage is defined as the unintended escape of gastrointestinal contents from the site of surgical anastomosis, typically occurring after a low anterior rectal (LAR) resection. It is a critical postoperative complication that can lead to various adverse effects, including peritonitis, abscess formation, and increased morbidity. The evaluation of anastomosis leakage involves careful monitoring for clinical signs, diagnostic imaging, and, if necessary, interventions such as reoperation or drainage procedures. The occurrence and management of anastomosis leakage serve as a key primary outcome measure in this study, contributing valuable insights into the efficacy and safety of the protective ileostomy intervention

Surgical Site Infection is a postoperative complication characterized by the invasion of microorganisms into the surgical incision or the deeper tissues surrounding the operative site. In the context of this study, the evaluation of SSI involves monitoring for clinical signs of infection, such as redness, swelling, warmth, or discharge, and may require additional diagnostic assessments. The occurrence of Surgical Site Infection is a critical parameter, impacting patient recovery, healthcare costs, and overall postoperative morbidity. As a primary outcome measure, the study aims to comprehensively assess the incidence and characteristics of SSI, providing crucial insights into the effectiveness of the protective ileostomy intervention.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Prospective Clinical Study for Transanal Double Purse-string Rectal Anastomosis Preformed With KOL Stapler	NCT02565667	Rectal Neoplasm...	KOL traditional sta...	18 Years - 70 Years	Fudan University
A Prospective Clinical Study for Transanal Double Purse-string Rectal Anastomosis Preformed With KOL Stapler	NCT02565667	Rectal Neoplasm...	KOL traditional sta...	18 Years - 70 Years	Fudan University
The Effects of Temporary Ileostomy on Outcome in Patients With Rectal Cancer	NCT06391385	Colorectal Canc...	protective ileo...	-	Tishreen University

Spots Global Cancer Trial Database for anterior rectal resection